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    <title>Off Script: A Pharma Manufacturing Podcast</title>
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    <description>The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing’s print and online coverage, which follows the industry’s biggest issues surrounding scale-up, technology innovations, regulations and more!</description>
    <pubDate>Tue, 07 Apr 2026 05:30:00 -0500</pubDate>
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        <copyright>Copyright 2020 All rights reserved.</copyright>
    <category>News:Business News</category>
    <ttl>1440</ttl>
    <itunes:type>episodic</itunes:type>
          <itunes:summary>The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing’s print and online coverage, which follows the industry’s biggest issues surrounding scale-up, technology innovations, regulations and more.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
	<itunes:category text="News">
		<itunes:category text="Business News" />
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    <itunes:owner>
        <itunes:name>Pharma Manufacturing</itunes:name>
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        <title>Off Script: A Pharma Manufacturing Podcast</title>
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    <item>
        <title>Reshoring APIs and Scaling Continuous Manufacturing for Generic Drug Supply</title>
        <itunes:title>Reshoring APIs and Scaling Continuous Manufacturing for Generic Drug Supply</itunes:title>
        <link>https://pharmamanu.podbean.com/e/reshoring-apis-and-scaling-continuous-manufacturing-for-generic-drug-supply/</link>
                    <comments>https://pharmamanu.podbean.com/e/reshoring-apis-and-scaling-continuous-manufacturing-for-generic-drug-supply/#comments</comments>        <pubDate>Tue, 07 Apr 2026 05:30:00 -0500</pubDate>
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                                    <description><![CDATA[<p>Generic medicines account for the vast majority of prescriptions in the U.S., yet much of their underlying supply chain remains heavily dependent on foreign-sourced active pharmaceutical ingredients (APIs). As concerns around drug shortages and supply chain resilience intensify, attention is shifting upstream toward how APIs are manufactured, where they are sourced, and what it will take to rebuild domestic production capacity. At the same time, advanced manufacturing approaches like continuous flow are gaining traction as a way to improve efficiency, safety, and cost competitiveness in a traditionally low-margin market.</p>
<p>In this episode of Off Script, we spoke with Brian Doty, vice president of R&amp;D and programs at the API Innovation Center (<a href='https://apicenter.org/'>APIIC</a>), about the structural challenges facing generic drug manufacturing and the role advanced technologies could play in addressing them. The conversation explores why API supply is often the cause of downstream drug shortages, the technical and economic limitations of traditional batch processing, and how continuous manufacturing can reduce process steps, improve control, and enable safer production. Doty also discusses the practical barriers to adoption as well as the growing role of FDA engagement programs and policy incentives in accelerating change.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Generic medicines account for the vast majority of prescriptions in the U.S., yet much of their underlying supply chain remains heavily dependent on foreign-sourced active pharmaceutical ingredients (APIs). As concerns around drug shortages and supply chain resilience intensify, attention is shifting upstream toward how APIs are manufactured, where they are sourced, and what it will take to rebuild domestic production capacity. At the same time, advanced manufacturing approaches like continuous flow are gaining traction as a way to improve efficiency, safety, and cost competitiveness in a traditionally low-margin market.</p>
<p>In this episode of <em>Off Script</em>, we spoke with Brian Doty, vice president of R&amp;D and programs at the API Innovation Center (<a href='https://apicenter.org/'>APIIC</a>), about the structural challenges facing generic drug manufacturing and the role advanced technologies could play in addressing them. The conversation explores why API supply is often the cause of downstream drug shortages, the technical and economic limitations of traditional batch processing, and how continuous manufacturing can reduce process steps, improve control, and enable safer production. Doty also discusses the practical barriers to adoption as well as the growing role of FDA engagement programs and policy incentives in accelerating change.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/83dzvzgqc7bz3is7/APIIC_mixdown.mp3" length="24206873" type="audio/mpeg"/>
        <itunes:summary>Generic medicines account for the vast majority of prescriptions in the U.S., yet much of their underlying supply chain remains heavily dependent on foreign-sourced active pharmaceutical ingredients (APIs). As concerns around drug shortages and supply chain resilience intensify, attention is shifting upstream toward how APIs are manufactured, where they are sourced, and what it will take to rebuild domestic production capacity. At the same time, advanced manufacturing approaches like continuous flow are gaining traction as a way to improve efficiency, safety, and cost competitiveness in a traditionally low-margin market.

In this episode of Off Script, we spoke with Brian Doty, vice president of R&amp;D and programs at the API Innovation Center (APIIC), about the structural challenges facing generic drug manufacturing and the role advanced technologies could play in addressing them. The conversation explores why API supply is often the cause of downstream drug shortages, the technical and economic limitations of traditional batch processing, and how continuous manufacturing can reduce process steps, improve control, and enable safer production. Doty also discusses the practical barriers to adoption as well as the growing role of FDA engagement programs and policy incentives in accelerating change.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1008</itunes:duration>
                <itunes:episode>117</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Engineering the Next Generation of ADCs</title>
        <itunes:title>Engineering the Next Generation of ADCs</itunes:title>
        <link>https://pharmamanu.podbean.com/e/engineering-the-next-generation-of-adcs/</link>
                    <comments>https://pharmamanu.podbean.com/e/engineering-the-next-generation-of-adcs/#comments</comments>        <pubDate>Tue, 31 Mar 2026 05:30:00 -0500</pubDate>
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                                    <description><![CDATA[<p>Antibody–drug conjugates (ADCs) are rapidly evolving from experimental hybrid molecules into mature, platform-driven therapeutics, with the global market projected to reach $36 billion by 2029. As pipelines expand and molecular designs grow more complex, developers are rethinking how ADCs are designed, characterized, and manufactured. In this episode of Off Script, we spoke with <a href='https://www.lonza.com/'>Lonza</a>'s Sandro Holzer, PhD, director and head of development bioconjugates, and Anette Sommer, PhD, head of bioconjugates research, about how the ADC field has changed over the last several years and what is driving the next wave of innovation.</p>
<p>The conversation explores the industry’s shift toward standardized linker–payload platforms, site-specific conjugation, higher drug-to-antibody ratios, and emerging dual-payload ADCs aimed at overcoming tumor heterogeneity and drug resistance. Holzer and Sommer discuss how rising molecular complexity is reshaping CMC strategy, analytics, and downstream processing, and why early integration of biology, chemistry, and manufacturability is essential to de-risk development and enable scale-up. The episode also examines how ADC manufacturing paradigms are now informing adjacent bioconjugate modalities signaling a broader move toward integrated, multi-component therapeutics beyond oncology.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Antibody–drug conjugates (ADCs) are rapidly evolving from experimental hybrid molecules into mature, platform-driven therapeutics, with the global market projected to reach $36 billion by 2029. As pipelines expand and molecular designs grow more complex, developers are rethinking how ADCs are designed, characterized, and manufactured. In this episode of <em>Off Script</em>, we spoke with <a href='https://www.lonza.com/'>Lonza</a>'s Sandro Holzer, PhD, director and head of development bioconjugates, and Anette Sommer, PhD, head of bioconjugates research, about how the ADC field has changed over the last several years and what is driving the next wave of innovation.</p>
<p>The conversation explores the industry’s shift toward standardized linker–payload platforms, site-specific conjugation, higher drug-to-antibody ratios, and emerging dual-payload ADCs aimed at overcoming tumor heterogeneity and drug resistance. Holzer and Sommer discuss how rising molecular complexity is reshaping CMC strategy, analytics, and downstream processing, and why early integration of biology, chemistry, and manufacturability is essential to de-risk development and enable scale-up. The episode also examines how ADC manufacturing paradigms are now informing adjacent bioconjugate modalities signaling a broader move toward integrated, multi-component therapeutics beyond oncology.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/25jr2dykakndhku9/Lonza_Final_mixdown.mp3" length="29702624" type="audio/mpeg"/>
        <itunes:summary>Antibody–drug conjugates (ADCs) are rapidly evolving from experimental hybrid molecules into mature, platform-driven therapeutics, with the global market projected to reach $36 billion by 2029. As pipelines expand and molecular designs grow more complex, developers are rethinking how ADCs are designed, characterized, and manufactured. In this episode of Off Script, we spoke with Lonza’s Sandro Holzer, PhD, director and head of development bioconjugates and Anette Sommer, PhD, head of bioconjugates research about how the ADC field has changed over the last several years and what is driving the next wave of innovation.

The conversation explores the industry’s shift toward standardized linker–payload platforms, site-specific conjugation, higher drug-to-antibody ratios, and emerging dual-payload ADCs aimed at overcoming tumor heterogeneity and drug resistance. Holzer and Sommer discuss how rising molecular complexity is reshaping CMC strategy, analytics, and downstream processing, and why early integration of biology, chemistry, and manufacturability is essential to de-risk development and enable scale-up. The episode also examines how ADC manufacturing paradigms are now informing adjacent bioconjugate modalities signaling a broader move toward integrated, multi-component therapeutics beyond oncology.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1237</itunes:duration>
                <itunes:episode>116</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Automating Cell and Gene Therapy Manufacturing for Scale</title>
        <itunes:title>Automating Cell and Gene Therapy Manufacturing for Scale</itunes:title>
        <link>https://pharmamanu.podbean.com/e/automating-cell-and-gene-therapy-manufacturing-for-scale/</link>
                    <comments>https://pharmamanu.podbean.com/e/automating-cell-and-gene-therapy-manufacturing-for-scale/#comments</comments>        <pubDate>Tue, 24 Mar 2026 05:30:00 -0500</pubDate>
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                                    <description><![CDATA[<p>Cell and gene therapies (CGTs) have demonstrated transformative clinical potential, but manufacturing remains a major barrier to broader patient access. Highly manual, labor-intensive production processes limit throughput, introduce variability, and drive up costs, making it difficult to scale these therapies to meet growing demand. As the industry looks to expand access, there is increasing focus on how automation, robotics, and digitalization can enable more consistent, efficient, and scalable manufacturing without compromising the underlying biology.</p>
<p>In this episode of Off Script, we spoke with Edwin Stone, PhD, CEO of <a href='https://cellularorigins.com/'>Cellular Origins</a>, about the core bottlenecks constraining CGT manufacturing and how automation is beginning to address them. The conversation explores why labor remains a dominant cost driver, how process variability extends beyond patient starting material into everyday manual operations, and what it takes to transition from fragmented workflows to fully integrated, robotic production environments. Stone also discusses the importance of preserving biological integrity during automation, the role of digital data capture in improving consistency and regulatory confidence, and more.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Cell and gene therapies (CGTs) have demonstrated transformative clinical potential, but manufacturing remains a major barrier to broader patient access. Highly manual, labor-intensive production processes limit throughput, introduce variability, and drive up costs, making it difficult to scale these therapies to meet growing demand. As the industry looks to expand access, there is increasing focus on how automation, robotics, and digitalization can enable more consistent, efficient, and scalable manufacturing without compromising the underlying biology.</p>
<p>In this episode of <em>Off Script</em>, we spoke with Edwin Stone, PhD, CEO of <a href='https://cellularorigins.com/'>Cellular Origins</a>, about the core bottlenecks constraining CGT manufacturing and how automation is beginning to address them. The conversation explores why labor remains a dominant cost driver, how process variability extends beyond patient starting material into everyday manual operations, and what it takes to transition from fragmented workflows to fully integrated, robotic production environments. Stone also discusses the importance of preserving biological integrity during automation, the role of digital data capture in improving consistency and regulatory confidence, and more.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/unf8y7jmz233zy4i/Cellular_Origins_mixdown7gsyd.mp3" length="34400145" type="audio/mpeg"/>
        <itunes:summary>Cell and gene therapies (CGTs) have demonstrated transformative clinical potential, but manufacturing remains a major barrier to broader patient access. Highly manual, labor-intensive production processes limit throughput, introduce variability, and drive up costs, making it difficult to scale these therapies to meet growing demand. As the industry looks to expand access, there is increasing focus on how automation, robotics, and digitalization can enable more consistent, efficient, and scalable manufacturing without compromising the underlying biology.

In this episode of Off Script, we spoke with Edwin Stone, PhD, CEO of Cellular Origins, about the core bottlenecks constraining CGT manufacturing and how automation is beginning to address them. The conversation explores why labor remains a dominant cost driver, how process variability extends beyond patient starting material into everyday manual operations, and what it takes to transition from fragmented workflows to fully integrated, robotic production environments. Stone also discusses the importance of preserving biological integrity during automation, the role of digital data capture in improving consistency and regulatory confidence, and more.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1432</itunes:duration>
                <itunes:episode>115</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Bridging Precision and Scale in Microparticle Drug Delivery Manufacturing</title>
        <itunes:title>Bridging Precision and Scale in Microparticle Drug Delivery Manufacturing</itunes:title>
        <link>https://pharmamanu.podbean.com/e/bridging-precision-and-scale-in-microparticle-drug-delivery-manufacturing/</link>
                    <comments>https://pharmamanu.podbean.com/e/bridging-precision-and-scale-in-microparticle-drug-delivery-manufacturing/#comments</comments>        <pubDate>Tue, 17 Mar 2026 05:23:00 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/92cb6f32-4acc-3534-8f4f-dd17d5544bf9</guid>
                                    <description><![CDATA[<p>Producing uniform drug delivery particles at scale has long presented a challenge for pharmaceutical manufacturers. Techniques that offer tight control over particle size and structure often struggle with throughput, while traditional industrial methods deliver volume but less consistency. As advanced drug delivery systems become more important for long-acting therapies and targeted treatments, manufacturers are increasingly seeking production methods that can balance precision, scalability, and reproducibility.</p>
<p>
In this episode of Off Script, we spoke with Nathalie Pinkerton, PhD, assistant professor of the chemical and biomolecular engineering department at the NYU Tandon School of Engineering, about <a href='https://engineering.nyu.edu/news/its-snap-new-technique-paves-way-scalable-therapeutic-nanoparticle-manufacturing'>Sequential NanoPrecipitation</a> (SNaP), a continuous flow technique designed to bring greater control to polymeric particle manufacturing. The conversation explores how separating particle formation into sequential mixing stages enables more predictable control over particle size and composition, the role of micromixer design in achieving consistent mixing and scale-up, and why encapsulation efficiency plays a critical role in manufacturing economics. Pinkerton also discusses the remaining steps needed to translate emerging particle manufacturing technologies from the lab into commercially viable pharmaceutical production platforms.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Producing uniform drug delivery particles at scale has long presented a challenge for pharmaceutical manufacturers. Techniques that offer tight control over particle size and structure often struggle with throughput, while traditional industrial methods deliver volume but less consistency. As advanced drug delivery systems become more important for long-acting therapies and targeted treatments, manufacturers are increasingly seeking production methods that can balance precision, scalability, and reproducibility.</p>
<p><br>
In this episode of <em>Off Script</em>, we spoke with Nathalie Pinkerton, PhD, assistant professor of the chemical and biomolecular engineering department at the NYU Tandon School of Engineering, about <a href='https://engineering.nyu.edu/news/its-snap-new-technique-paves-way-scalable-therapeutic-nanoparticle-manufacturing'>Sequential NanoPrecipitation</a> (SNaP), a continuous flow technique designed to bring greater control to polymeric particle manufacturing. The conversation explores how separating particle formation into sequential mixing stages enables more predictable control over particle size and composition, the role of micromixer design in achieving consistent mixing and scale-up, and why encapsulation efficiency plays a critical role in manufacturing economics. Pinkerton also discusses the remaining steps needed to translate emerging particle manufacturing technologies from the lab into commercially viable pharmaceutical production platforms.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/c3dx86qvcczd7y43/SNaP_Chat_mixdown.mp3" length="27199739" type="audio/mpeg"/>
        <itunes:summary>Producing uniform drug delivery particles at scale has long presented a challenge for pharmaceutical manufacturers. Techniques that offer tight control over particle size and structure often struggle with throughput, while traditional industrial methods deliver volume but less consistency. As advanced drug delivery systems become more important for long-acting therapies and targeted treatments, manufacturers are increasingly seeking production methods that can balance precision, scalability, and reproducibility.

In this episode of Off Script, we spoke with Nathalie Pinkerton, PhD, assistant professor of the chemical and biomolecular engineering department at the NYU Tandon School of Engineering, about Sequential NanoPrecipitation (SNaP), a continuous flow technique designed to bring greater control to polymeric particle manufacturing. The conversation explores how separating particle formation into sequential mixing stages enables more predictable control over particle size and composition, the role of micromixer design in achieving consistent mixing and scale-up, and why encapsulation efficiency plays a critical role in manufacturing economics. Pinkerton also discusses the remaining steps needed to translate emerging particle manufacturing technologies from the lab into commercially viable pharmaceutical production platforms.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1132</itunes:duration>
                <itunes:episode>114</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Fixing the Structural Weaknesses in the Global Drug Supply Chain: Part Two</title>
        <itunes:title>Fixing the Structural Weaknesses in the Global Drug Supply Chain: Part Two</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fixing-the-structural-weaknesses-in-the-global-drug-supply-chain-part-two/</link>
                    <comments>https://pharmamanu.podbean.com/e/fixing-the-structural-weaknesses-in-the-global-drug-supply-chain-part-two/#comments</comments>        <pubDate>Tue, 10 Mar 2026 05:32:00 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/c15a2b44-c2d1-3274-a3fd-4d82013b5120</guid>
                                    <description><![CDATA[<p>In this episode of Off Script, we continue our conversation on the structural vulnerabilities in the global pharmaceutical supply chain with Ronald T. Piervincenzi, CEO, <a href='https://www.usp.org/'>USP</a>, turning the focus toward practical strategies for strengthening the resilience of the global medicine supply chain.</p>
<p>Piervincenzi discusses the economic and structural barriers to rebuilding domestic capacity for APIs and key starting materials, and explains why resilience will require coordinated incentives that reward supply security rather than simply the lowest price. He also explores how advanced manufacturing approaches could help make domestic production more viable by improving efficiency and reducing environmental impact.</p>
<p>The conversation also examines how global quality standards can enable trusted international manufacturing networks among allied countries, and how USP’s new Resilience Center aims to bring together data, benchmarking frameworks, and stakeholder collaboration to help industry and policymakers better measure supply chain resilience.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>In this episode of <em>Off Script</em>, we continue our conversation on the structural vulnerabilities in the global pharmaceutical supply chain with Ronald T. Piervincenzi, CEO, <a href='https://www.usp.org/'>USP</a>, turning the focus toward practical strategies for strengthening the resilience of the global medicine supply chain.</p>
<p>Piervincenzi discusses the economic and structural barriers to rebuilding domestic capacity for APIs and key starting materials, and explains why resilience will require coordinated incentives that reward supply security rather than simply the lowest price. He also explores how advanced manufacturing approaches could help make domestic production more viable by improving efficiency and reducing environmental impact.</p>
<p>The conversation also examines how global quality standards can enable trusted international manufacturing networks among allied countries, and how USP’s new Resilience Center aims to bring together data, benchmarking frameworks, and stakeholder collaboration to help industry and policymakers better measure supply chain resilience.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/n6etkfnuqt4a63gr/USP_Pt2_1_b7cef.mp3" length="23473278" type="audio/mpeg"/>
        <itunes:summary>In this episode of Off Script, we continue our conversation on the structural vulnerabilities in the global pharmaceutical supply chain with Ronald T. Piervincenzi, CEO, USP, turning the focus toward practical strategies for strengthening the resilience of the global medicine supply chain.

Piervincenzi discusses the economic and structural barriers to rebuilding domestic capacity for APIs and key starting materials, and explains why resilience will require coordinated incentives that reward supply security rather than simply the lowest price. He also explores how advanced manufacturing approaches could help make domestic production more viable by improving efficiency and reducing environmental impact.

The conversation also examines how global quality standards can enable trusted international manufacturing networks among allied countries, and how USP’s new Resilience Center aims to bring together data, benchmarking frameworks, and stakeholder collaboration to help industry and policymakers better measure supply chain resilience.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>977</itunes:duration>
                <itunes:episode>113</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Fixing the Structural Weaknesses in the Global Drug Supply Chain: Part One</title>
        <itunes:title>Fixing the Structural Weaknesses in the Global Drug Supply Chain: Part One</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fixing-the-structural-weaknesses-in-the-global-drug-supply-chain-part-one/</link>
                    <comments>https://pharmamanu.podbean.com/e/fixing-the-structural-weaknesses-in-the-global-drug-supply-chain-part-one/#comments</comments>        <pubDate>Tue, 03 Mar 2026 05:30:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/e34f5b59-1f1e-31dc-970b-017841706e59</guid>
                                    <description><![CDATA[<p>The global medicine supply chain faces mounting strain from chronic generic drug shortages, geopolitical tensions, and heavy reliance on geographically concentrated manufacturing. Quality failures, pricing pressures, and opaque sourcing of key starting materials have exposed structural vulnerabilities that extend beyond routine disruptions to broader national security and public health risks. This episode is part one of a two-part series examining the root causes of these vulnerabilities and the structural changes needed to address them.</p>
<p>In this series, we spoke with Ronald T. Piervincenzi, Ph.D., CEO of the <a href='https://www.usp.org/'>U.S. Pharmacopeia</a>, about how these risks emerged and what it will take to build a more resilient pharmaceutical supply chain. In part one, Piervincenzi explains why generic drug shortages and national security concerns are often conflated, how extreme price erosion is driving manufacturers out of the market, and what USP’s data reveals about supply concentration, including the critical role of key starting materials sourced from countries like China and India. The conversation also dives into USP’s new Resilience Center and the strategic role it will serve in improving supply chain security.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>The global medicine supply chain faces mounting strain from chronic generic drug shortages, geopolitical tensions, and heavy reliance on geographically concentrated manufacturing. Quality failures, pricing pressures, and opaque sourcing of key starting materials have exposed structural vulnerabilities that extend beyond routine disruptions to broader national security and public health risks. This episode is part one of a two-part series examining the root causes of these vulnerabilities and the structural changes needed to address them.</p>
<p>In this series, we spoke with Ronald T. Piervincenzi, Ph.D., CEO of the <a href='https://www.usp.org/'>U.S. Pharmacopeia</a>, about how these risks emerged and what it will take to build a more resilient pharmaceutical supply chain. In part one, Piervincenzi explains why generic drug shortages and national security concerns are often conflated, how extreme price erosion is driving manufacturers out of the market, and what USP’s data reveals about supply concentration, including the critical role of key starting materials sourced from countries like China and India. The conversation also dives into USP’s new Resilience Center and the strategic role it will serve in improving supply chain security.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/rzbhttwf99n5v7tb/USP_Pt1bui4n.mp3" length="24652487" type="audio/mpeg"/>
        <itunes:summary>The global medicine supply chain faces mounting strain from chronic generic drug shortages, geopolitical tensions, and heavy reliance on geographically concentrated manufacturing. Quality failures, pricing pressures, and opaque sourcing of key starting materials have exposed structural vulnerabilities that extend beyond routine disruptions to broader national security and public health risks. This episode is part one of a two-part series examining the root causes of these vulnerabilities and the structural changes needed to address them.

In this series, we spoke with Ronald T. Piervincenzi, Ph.D., CEO of the U.S. Pharmacopeia, about how these risks emerged and what it will take to build a more resilient pharmaceutical supply chain. In part one, Piervincenzi explains why generic drug shortages and national security concerns are often conflated, how extreme price erosion is driving manufacturers out of the market, and what USP’s data reveals about supply concentration, including the critical role of key starting materials sourced from countries like China and India. The conversation also dives into USP’s new Resilience Center and the strategic role it will serve in improving supply chain security.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1026</itunes:duration>
                <itunes:episode>112</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Connected Packaging and the Future of Pharma Manufacturing</title>
        <itunes:title>Connected Packaging and the Future of Pharma Manufacturing</itunes:title>
        <link>https://pharmamanu.podbean.com/e/connected-packaging-and-the-future-of-pharma-manufacturing/</link>
                    <comments>https://pharmamanu.podbean.com/e/connected-packaging-and-the-future-of-pharma-manufacturing/#comments</comments>        <pubDate>Tue, 24 Feb 2026 05:30:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/650be156-b853-389f-a742-92e34928b442</guid>
                                    <description><![CDATA[<p>Pharmaceutical packaging is undergoing rapid transformation as connectivity, sustainability, automation, and evolving regulatory demands reshape how medicines are protected, tracked, and delivered. From smart packaging features and prefilled injectables to e-commerce fulfillment and digital compliance systems, packaging and equipment investment decisions are increasingly tied to flexibility, data visibility, and long-term modernization.</p>
<p>In this episode of Off Script, we spoke with Rebecca Marquez, director of custom research at <a href='https://www.pmmi.org/'>PMMI</a>, about the association’s latest <a href='https://www.pmmi.org/report/2025-trends-and-challenges-in-pharmaceutical-manufacturing'>Trends and Challenges in Pharmaceutical Manufacturing</a> white paper. The conversation explores how connected packaging technologies are strengthening relationships between manufacturers, regulators, and patients; why sustainability initiatives are advancing despite material performance and validation challenges; and how growth in biologics and prefilled injectables is driving new packaging and equipment demands. Marquez also breaks down the regulatory documentation gap between OEMs and end users, the rise of automation technologies, and more.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Pharmaceutical packaging is undergoing rapid transformation as connectivity, sustainability, automation, and evolving regulatory demands reshape how medicines are protected, tracked, and delivered. From smart packaging features and prefilled injectables to e-commerce fulfillment and digital compliance systems, packaging and equipment investment decisions are increasingly tied to flexibility, data visibility, and long-term modernization.</p>
<p>In this episode of <em>Off Script</em>, we spoke with Rebecca Marquez, director of custom research at <a href='https://www.pmmi.org/'>PMMI</a>, about the association’s latest <a href='https://www.pmmi.org/report/2025-trends-and-challenges-in-pharmaceutical-manufacturing'><em>Trends and Challenges in Pharmaceutical Manufacturing</em></a> white paper. The conversation explores how connected packaging technologies are strengthening relationships between manufacturers, regulators, and patients; why sustainability initiatives are advancing despite material performance and validation challenges; and how growth in biologics and prefilled injectables is driving new packaging and equipment demands. Marquez also breaks down the regulatory documentation gap between OEMs and end users, the rise of automation technologies, and more.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/earieywyseq72a22/PMMI-Final_mixdown.mp3" length="24888014" type="audio/mpeg"/>
        <itunes:summary>Pharmaceutical packaging is undergoing rapid transformation as connectivity, sustainability, automation, and evolving regulatory demands reshape how medicines are protected, tracked, and delivered. From smart packaging features and prefilled injectables to e-commerce fulfillment and digital compliance systems, packaging and equipment investment decisions are increasingly tied to flexibility, data visibility, and long-term modernization.

In this episode of Off Script, we spoke with Rebecca Marquez, director of custom research at PMMI, about the association’s latest Trends and Challenges in Pharmaceutical Manufacturing white paper. The conversation explores how connected packaging technologies are strengthening relationships between manufacturers, regulators, and patients; why sustainability initiatives are advancing despite material performance and validation challenges; and how growth in biologics and prefilled injectables is driving new packaging and equipment demands. Marquez also breaks down the regulatory documentation gap between OEMs and end users, the rise of automation technologies, and more.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1036</itunes:duration>
                <itunes:episode>111</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Why Cell Line Development Determines Biologics Success</title>
        <itunes:title>Why Cell Line Development Determines Biologics Success</itunes:title>
        <link>https://pharmamanu.podbean.com/e/why-cell-line-development-determines-biologics-success/</link>
                    <comments>https://pharmamanu.podbean.com/e/why-cell-line-development-determines-biologics-success/#comments</comments>        <pubDate>Tue, 17 Feb 2026 05:36:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/9e588515-2aff-319a-845e-b5cec698823a</guid>
                                    <description><![CDATA[<p>As biologics grow more complex, cell line development remains a key driver of speed, yield, and manufacturability. What was once a technical milestone is now a competitive differentiator, directly impacting time to Investigational New Drug (IND), cost of goods, and long-term scalability.</p>
<p>In this episode of Off Script, we spoke with Brett Verstak, director of cell line development at <a href='https://abzena.com/'>Abzena</a>, to discuss how advanced Chinese hamster ovary (CHO)-based platforms, glutamine synthetase (GS) knockout systems, automation, and AI-driven workflows are accelerating clone selection and reducing downstream risk. The conversation explores persistent bottlenecks in hard-to-express proteins, the value of integrated upstream development models, and how smarter platform design is helping drug developers move complex biologics to the clinic faster.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>As biologics grow more complex, cell line development remains a key driver of speed, yield, and manufacturability. What was once a technical milestone is now a competitive differentiator, directly impacting time to Investigational New Drug (IND), cost of goods, and long-term scalability.</p>
<p>In this episode of <em>Off Script</em>, we spoke with Brett Verstak, director of cell line development at <a href='https://abzena.com/'>Abzena</a>, to discuss how advanced Chinese hamster ovary (CHO)-based platforms, glutamine synthetase (GS) knockout systems, automation, and AI-driven workflows are accelerating clone selection and reducing downstream risk. The conversation explores persistent bottlenecks in hard-to-express proteins, the value of integrated upstream development models, and how smarter platform design is helping drug developers move complex biologics to the clinic faster.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/9b9baecfd2z47wwd/Abzena_Final.mp3" length="20717672" type="audio/mpeg"/>
        <itunes:summary>As biologics grow more complex, cell line development remains a key driver of speed, yield, and manufacturability. What was once a technical milestone is now a competitive differentiator, directly impacting time to Investigational New Drug (IND), cost of goods, and long-term scalability.

In this episode of Off Script, we spoke with Brett Verstak, director of cell line development at Abzena, to discuss how advanced Chinese hamster ovary (CHO)-based platforms, glutamine synthetase (GS) knockout systems, automation, and AI-driven workflows are accelerating clone selection and reducing downstream risk. The conversation explores persistent bottlenecks in hard-to-express proteins, the value of integrated upstream development models, and how smarter platform design is helping drug developers move complex biologics to the clinic faster.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>862</itunes:duration>
                <itunes:episode>110</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Designing CGT Manufacturing for Scale, Speed, and Access</title>
        <itunes:title>Designing CGT Manufacturing for Scale, Speed, and Access</itunes:title>
        <link>https://pharmamanu.podbean.com/e/designing-cgt-manufacturing-for-scale-speed-and-access/</link>
                    <comments>https://pharmamanu.podbean.com/e/designing-cgt-manufacturing-for-scale-speed-and-access/#comments</comments>        <pubDate>Tue, 10 Feb 2026 05:28:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/67acac0d-887b-3165-8a8c-a5227f44620c</guid>
                                    <description><![CDATA[<p>As cell and gene therapies continue to deliver promising clinical results, manufacturing remains one of the biggest barriers to broader commercialization. Persistent challenges around cost, complexity, labor intensity, and vein-to-vein timelines—particularly for autologous CAR-T therapies—are limiting the industry’s ability to scale beyond niche and last-line indications. Addressing these constraints will be critical if CGTs are to move earlier in treatment paradigms and reach more patients globally.</p>
<p>In this episode of Off Script, we spoke with Jon Ellis, CEO of <a href='https://www.trenchantbio.com/'>Trenchant BioSystems</a>, about the current state of cell and gene therapy manufacturing and where the industry must go next. The conversation explores why traditional centralized manufacturing models are struggling to scale, how automation and digital batch records can significantly compress manufacturing timelines, and how emerging platforms are rethinking cell recovery, analytics integration, and starting material strategies.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>As cell and gene therapies continue to deliver promising clinical results, manufacturing remains one of the biggest barriers to broader commercialization. Persistent challenges around cost, complexity, labor intensity, and vein-to-vein timelines—particularly for autologous CAR-T therapies—are limiting the industry’s ability to scale beyond niche and last-line indications. Addressing these constraints will be critical if CGTs are to move earlier in treatment paradigms and reach more patients globally.</p>
<p>In this episode of <em>Off Script</em>, we spoke with Jon Ellis, CEO of <a href='https://www.trenchantbio.com/'>Trenchant BioSystems</a>, about the current state of cell and gene therapy manufacturing and where the industry must go next. The conversation explores why traditional centralized manufacturing models are struggling to scale, how automation and digital batch records can significantly compress manufacturing timelines, and how emerging platforms are rethinking cell recovery, analytics integration, and starting material strategies.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/4d9izusmgdgv7k86/Trenchant_Pod.mp3" length="29097977" type="audio/mpeg"/>
        <itunes:summary>As cell and gene therapies continue to deliver promising clinical results, manufacturing remains one of the biggest barriers to broader commercialization. Persistent challenges around cost, complexity, labor intensity, and vein-to-vein timelines—particularly for autologous CAR-T therapies—are limiting the industry’s ability to scale beyond niche and last-line indications. Addressing these constraints will be critical if CGTs are to move earlier in treatment paradigms and reach more patients globally.

In this episode of Off Script, we spoke with Jon Ellis, CEO of Trenchant BioSystems, about the current state of cell and gene therapy manufacturing and where the industry must go next. The conversation explores why traditional centralized manufacturing models are struggling to scale, how automation and digital batch records can significantly compress manufacturing timelines, and how emerging platforms are rethinking cell recovery, analytics integration, and starting material strategies.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1211</itunes:duration>
                <itunes:episode>109</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Robotics and Automation in Pharma Manufacturing</title>
        <itunes:title>Robotics and Automation in Pharma Manufacturing</itunes:title>
        <link>https://pharmamanu.podbean.com/e/robotics-and-automation-in-pharma-manufacturing/</link>
                    <comments>https://pharmamanu.podbean.com/e/robotics-and-automation-in-pharma-manufacturing/#comments</comments>        <pubDate>Tue, 03 Feb 2026 05:48:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/b1efa2e6-1762-34cf-8d09-32435814fab1</guid>
                                    <description><![CDATA[<p>The technologies are playing an increasingly central role in pharmaceutical manufacturing as companies contend with labor constraints, rising demand, and the need to modernize highly regulated operations. </p>
<p>
In this episode of Off Script, we spoke with Alexander Shikany, executive vice president of the <a href='https://www.automate.org/'>Association for Advancing Automation (A3)</a>, about how robotics adoption is reshaping pharma manufacturing today. The conversation explores why automation is now considered a core manufacturing strategy, where demand is emerging across the production lifecycle, how collaborative robots are gaining traction in regulated environments, and why human-in-the-loop automation remains essential for quality, compliance, and operational resilience.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>The technologies are playing an increasingly central role in pharmaceutical manufacturing as companies contend with labor constraints, rising demand, and the need to modernize highly regulated operations. </p>
<p><br>
In this episode of Off Script, we spoke with Alexander Shikany, executive vice president of the <a href='https://www.automate.org/'>Association for Advancing Automation (A3)</a>, about how robotics adoption is reshaping pharma manufacturing today. The conversation explores why automation is now considered a core manufacturing strategy, where demand is emerging across the production lifecycle, how collaborative robots are gaining traction in regulated environments, and why human-in-the-loop automation remains essential for quality, compliance, and operational resilience.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/62ktxm3vv9kj733a/A3_Robotics_Podcast_Final.mp3" length="27465902" type="audio/mpeg"/>
        <itunes:summary>The technologies are playing an increasingly central role in pharmaceutical manufacturing as companies contend with labor constraints, rising demand, and the need to modernize highly regulated operations. 

In this episode of Off Script, we spoke with Alexander Shikany, executive vice president of the Association for Advancing Automation (A3), about how robotics adoption is reshaping pharma manufacturing today. The conversation explores why automation is now considered a core manufacturing strategy, where demand is emerging across the production lifecycle, how collaborative robots are gaining traction in regulated environments, and why human-in-the-loop automation remains essential for quality, compliance, and operational resilience.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1143</itunes:duration>
                <itunes:episode>108</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Manufacturing Agility in a Changing Biopharma Landscape</title>
        <itunes:title>Manufacturing Agility in a Changing Biopharma Landscape</itunes:title>
        <link>https://pharmamanu.podbean.com/e/manufacturing-agility-in-a-changing-biopharma-landscape/</link>
                    <comments>https://pharmamanu.podbean.com/e/manufacturing-agility-in-a-changing-biopharma-landscape/#comments</comments>        <pubDate>Tue, 27 Jan 2026 05:30:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/fd74fd84-3fc5-3b94-b155-577d7c25ee60</guid>
                                    <description><![CDATA[<p>As biopharma pipelines grow more complex, manufacturers are under increasing pressure to scale faster, adapt to new modalities, and build resilience into highly regulated operations. Meeting these demands means manufacturing agility is no longer just a competitive advantage, it’s a necessity. Yet, structural constraints, talent shortages, and legacy processes continue to impact progress across the industry.</p>
<p>In this episode of Off Script, we spoke with Iwan Roberts, vice president of technology and innovation strategy at <a href='https://www.cytivalifesciences.com/en/us'>Cytiva</a>, for a deep dive into Cytiva’s latest <a href='https://www.pharmamanufacturing.com/quality-risk/article/55325871/biopharmas-manufacturing-agility-wanes-amid-supply-chain-resilience-survey'>Global Biopharma Index</a>. The conversation explores why manufacturing agility remains a major industry pain point, why modalities like cell and gene therapy and mRNA are uniquely difficult to scale, and how CDMOs, digitalization, and new supplier relationships are reshaping the path forward.</p>
<p> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>As biopharma pipelines grow more complex, manufacturers are under increasing pressure to scale faster, adapt to new modalities, and build resilience into highly regulated operations. Meeting these demands means manufacturing agility is no longer just a competitive advantage, it’s a necessity. Yet, structural constraints, talent shortages, and legacy processes continue to impact progress across the industry.</p>
<p>In this episode of <em>Off Script</em>, we spoke with Iwan Roberts, vice president of technology and innovation strategy at <a href='https://www.cytivalifesciences.com/en/us'>Cytiva</a>, for a deep dive into Cytiva’s latest <a href='https://www.pharmamanufacturing.com/quality-risk/article/55325871/biopharmas-manufacturing-agility-wanes-amid-supply-chain-resilience-survey'><em>Global Biopharma Index</em></a>. The conversation explores why manufacturing agility remains a major industry pain point, why modalities like cell and gene therapy and mRNA are uniquely difficult to scale, and how CDMOs, digitalization, and new supplier relationships are reshaping the path forward.</p>
<p> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/n9s7ktx4jhcwsxez/Cytiva_Final.mp3" length="25353089" type="audio/mpeg"/>
        <itunes:summary>As biopharma pipelines grow more complex, manufacturers are under increasing pressure to scale faster, adapt to new modalities, and build resilience into highly regulated operations. Meeting these demands means manufacturing agility is no longer just a competitive advantage, it’s a necessity. Yet, structural constraints, talent shortages, and legacy processes continue to impact progress across the industry.

In this episode of Off Script, we spoke with Iwan Roberts, vice president of technology and innovation strategy at Cytiva, for a deep dive into Cytiva’s latest Global Biopharma Index. The conversation explores why manufacturing agility remains a major industry pain point, why modalities like cell and gene therapy and mRNA are uniquely difficult to scale, and how CDMOs, digitalization, and new supplier relationships are reshaping the path forward.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1055</itunes:duration>
                <itunes:episode>107</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Understanding Pharma Manufacturing’s Domestic Investment Surge: Part Two</title>
        <itunes:title>Understanding Pharma Manufacturing’s Domestic Investment Surge: Part Two</itunes:title>
        <link>https://pharmamanu.podbean.com/e/understanding-pharma-manufacturing-s-domestic-investment-surge-part-two/</link>
                    <comments>https://pharmamanu.podbean.com/e/understanding-pharma-manufacturing-s-domestic-investment-surge-part-two/#comments</comments>        <pubDate>Tue, 20 Jan 2026 04:00:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/b4f8a226-2f02-3f59-975b-81970f91da8c</guid>
                                    <description><![CDATA[<p>In this episode of Off Script, we continue our conversation with David Grote, vice president of strategy at <a href='https://www.graymatterpartners.com/'>GrayMatter Partners</a>, focusing on the execution challenges that will define the success of today’s pharmaceutical manufacturing investment boom.</p>
<p>David explores the growing tension between speed, quality, and cost as companies race to bring new facilities online, and explains how early collaboration with regulators can help accelerate validation without sacrificing compliance or long-term resilience. He also discusses the strategic decisions that separate proactive manufacturers from reactive ones, the lasting impact this investment cycle will have on U.S. manufacturing footprints, and the expanding set of options that could open new opportunities for smaller companies.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>In this episode of <em>Off Script</em>, we continue our conversation with David Grote, vice president of strategy at <a href='https://www.graymatterpartners.com/'>GrayMatter Partners</a>, focusing on the execution challenges that will define the success of today’s pharmaceutical manufacturing investment boom.</p>
<p>David explores the growing tension between speed, quality, and cost as companies race to bring new facilities online, and explains how early collaboration with regulators can help accelerate validation without sacrificing compliance or long-term resilience. He also discusses the strategic decisions that separate proactive manufacturers from reactive ones, the lasting impact this investment cycle will have on U.S. manufacturing footprints, and the expanding set of options that could open new opportunities for smaller companies.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/ux5gxc8m33bgeppj/David_Grote_Part_2b8lwh.mp3" length="15039824" type="audio/mpeg"/>
        <itunes:summary>In this episode of Off Script, we continue our conversation with David Grote, vice president of strategy at GrayMatter Partners, focusing on the execution challenges that will define the success of today’s pharmaceutical manufacturing investment boom.

David explores the growing tension between speed, quality, and cost as companies race to bring new facilities online, and explains how early collaboration with regulators can help accelerate validation without sacrificing compliance or long-term resilience. He also discusses the strategic decisions that separate proactive manufacturers from reactive ones, the lasting impact this investment cycle will have on U.S. manufacturing footprints, and the expanding set of options that could open new opportunities for smaller companies.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>626</itunes:duration>
                <itunes:episode>106</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Understanding Pharma Manufacturing’s Domestic Investment Surge: Part One</title>
        <itunes:title>Understanding Pharma Manufacturing’s Domestic Investment Surge: Part One</itunes:title>
        <link>https://pharmamanu.podbean.com/e/understanding-pharma-manufacturing-s-domestic-investment-surge-part-one/</link>
                    <comments>https://pharmamanu.podbean.com/e/understanding-pharma-manufacturing-s-domestic-investment-surge-part-one/#comments</comments>        <pubDate>Tue, 13 Jan 2026 05:30:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/83f8fab7-c85b-3206-959f-faeff7067a40</guid>
                                    <description><![CDATA[<p>After years of volatility, pharmaceutical manufacturing is entering a new investment cycle, with hundreds of billions of dollars flowing into U.S. facilities. The surge promises expanded capacity, but also raises questions about workforce availability, infrastructure readiness, and long-term execution.</p>
<p>In this episode of Off Script, we spoke with David Grote, vice president of strategy at <a href='https://www.graymatterpartners.com/'>GrayMatter Partners</a>, about what this wave of funding means in practice. The conversation explores where investment is concentrating, how competition for skilled talent is shaping project timelines, the strain on shared resources, and why flexible facility design will be critical to sustaining growth beyond today’s political and economic cycle.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>After years of volatility, pharmaceutical manufacturing is entering a new investment cycle, with hundreds of billions of dollars flowing into U.S. facilities. The surge promises expanded capacity, but also raises questions about workforce availability, infrastructure readiness, and long-term execution.</p>
<p>In this episode of <em>Off Script</em>, we spoke with David Grote, vice president of strategy at <a href='https://www.graymatterpartners.com/'>GrayMatter Partners</a>, about what this wave of funding means in practice. The conversation explores where investment is concentrating, how competition for skilled talent is shaping project timelines, the strain on shared resources, and why flexible facility design will be critical to sustaining growth beyond today’s political and economic cycle.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/wd4zzv95sqphukxa/David_Grote_Part_One8athi.mp3" length="24090895" type="audio/mpeg"/>
        <itunes:summary>After years of volatility, pharmaceutical manufacturing is entering a new investment cycle, with hundreds of billions of dollars flowing into U.S. facilities. The surge promises expanded capacity, but also raises questions about workforce availability, infrastructure readiness, and long-term execution.

In this episode of Off Script, we spoke with David Grote, vice president of strategy at GrayMatter Partners, about what this wave of funding means in practice. The conversation explores where investment is concentrating, how competition for skilled talent is shaping project timelines, the strain on shared resources, and why flexible facility design will be critical to sustaining growth beyond today’s political and economic cycle.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1003</itunes:duration>
                <itunes:episode>105</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>AI and the Future of Drug Development</title>
        <itunes:title>AI and the Future of Drug Development</itunes:title>
        <link>https://pharmamanu.podbean.com/e/ai-and-the-future-of-drug-development/</link>
                    <comments>https://pharmamanu.podbean.com/e/ai-and-the-future-of-drug-development/#comments</comments>        <pubDate>Tue, 06 Jan 2026 05:30:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/cee61b88-6c2a-3ad1-83b8-2ae933906ce6</guid>
                                    <description><![CDATA[<p>Artificial intelligence is rapidly reshaping drug development by accelerating timelines, enabling more complex biologics, and changing how therapies are designed, delivered, and scaled. But as innovation speeds up, manufacturers face new challenges around delivery platforms, regulatory expectations, and operational agility.</p>
<p>In this episode of Off Script, we spoke with Anthony Vico, Head of Business Line, US Technology Excellence Center at Stevanato Group, about how the industry is navigating this shift. The conversation explores the evolving role of drug delivery systems, where AI and machine learning are having the most immediate impact, how advanced therapeutic modalities fit into this changing landscape, and what manufacturers must do to remain competitive.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Artificial intelligence is rapidly reshaping drug development by accelerating timelines, enabling more complex biologics, and changing how therapies are designed, delivered, and scaled. But as innovation speeds up, manufacturers face new challenges around delivery platforms, regulatory expectations, and operational agility.</p>
<p>In this episode of <em>Off Script</em>, we spoke with Anthony Vico, Head of Business Line, US Technology Excellence Center at Stevanato Group, about how the industry is navigating this shift. The conversation explores the evolving role of drug delivery systems, where AI and machine learning are having the most immediate impact, how advanced therapeutic modalities fit into this changing landscape, and what manufacturers must do to remain competitive.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/kdirnxh8cz2ndkh2/Anthony_vico.mp3" length="34209449" type="audio/mpeg"/>
        <itunes:summary>Artificial intelligence is rapidly reshaping drug development by accelerating timelines, enabling more complex biologics, and changing how therapies are designed, delivered, and scaled. But as innovation speeds up, manufacturers face new challenges around delivery platforms, regulatory expectations, and operational agility.

In this episode of Off Script, we spoke with Anthony Vico, Head of Business Line, US Technology Excellence Center at Stevanato Group, about how the industry is navigating this shift. The conversation explores the evolving role of drug delivery systems, where AI and machine learning are having the most immediate impact, how advanced therapeutic modalities fit into this changing landscape, and what manufacturers must do to remain competitive.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1424</itunes:duration>
                <itunes:episode>104</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Predictive Maintenance for a Modern Cold Chain</title>
        <itunes:title>Predictive Maintenance for a Modern Cold Chain</itunes:title>
        <link>https://pharmamanu.podbean.com/e/predictive-maintenance-for-a-modern-cold-chain/</link>
                    <comments>https://pharmamanu.podbean.com/e/predictive-maintenance-for-a-modern-cold-chain/#comments</comments>        <pubDate>Tue, 30 Dec 2025 05:30:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/884c73de-c85b-34b4-ad1e-570e25b4e8bb</guid>
                                    <description><![CDATA[<p>While pharma supply chains are becoming increasingly digitized, the cold chain segment continues to face major vulnerabilities, from aging infrastructure and equipment failures to new refrigerant regulations. As manufacturers work to protect temperature-sensitive products and avoid costly disruptions, predictive monitoring is emerging as a critical tool for strengthening resilience.</p>
<p>
In this episode of Off Script: A Pharma Manufacturing Podcast, we spoke with Laurie and John Masiello, co-founders of Predictive Monitor, about how predictive maintenance solutions are helping pharma manufacturers prevent downtime, extend the life of cold chain assets, and safeguard product integrity.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>While pharma supply chains are becoming increasingly digitized, the cold chain segment continues to face major vulnerabilities, from aging infrastructure and equipment failures to new refrigerant regulations. As manufacturers work to protect temperature-sensitive products and avoid costly disruptions, predictive monitoring is emerging as a critical tool for strengthening resilience.</p>
<p><br>
In this episode of <em>Off Script: A Pharma Manufacturing Podcast</em>, we spoke with Laurie and John Masiello, co-founders of Predictive Monitor, about how predictive maintenance solutions are helping pharma manufacturers prevent downtime, extend the life of cold chain assets, and safeguard product integrity.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/qd2wtuszngegejxd/Predictive_Monitor_Final_V383qx6.mp3" length="21714823" type="audio/mpeg"/>
        <itunes:summary>While pharma supply chains are becoming increasingly digitized, the cold chain segment continues to face major vulnerabilities, from aging infrastructure and equipment failures to new refrigerant regulations. As manufacturers work to protect temperature-sensitive products and avoid costly disruptions, predictive monitoring is emerging as a critical tool for strengthening resilience.

In this episode of Off Script: A Pharma Manufacturing Podcast, we spoke with Laurie and John Masiello, co-founders of Predictive Monitor, about how predictive maintenance solutions are helping pharma manufacturers prevent downtime, extend the life of cold chain assets, and safeguard product integrity.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>904</itunes:duration>
                <itunes:episode>103</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Building a Future for Curative Cell Therapies: Part Two</title>
        <itunes:title>Building a Future for Curative Cell Therapies: Part Two</itunes:title>
        <link>https://pharmamanu.podbean.com/e/building-a-future-for-curative-cell-therapies-part-two/</link>
                    <comments>https://pharmamanu.podbean.com/e/building-a-future-for-curative-cell-therapies-part-two/#comments</comments>        <pubDate>Tue, 23 Dec 2025 05:27:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/20a44484-0288-3809-8957-d318f73c01e4</guid>
                                    <description><![CDATA[<p>In this episode of Off Script, we continue our conversation with Jason Bock, co-founder and CEO of CTMC, diving deeper into the operational and manufacturing challenges shaping the future of curative cell therapies.</p>
<p>Jason discusses how CTMC—through its partnership with MD Anderson Cancer Center—is eliminating inefficiencies across development timelines to significantly accelerate clinical progress without increasing risk. He also shares a forward-looking perspective on how cell therapies could one day be ordered and delivered like traditional pharmaceuticals, and what scientific, regulatory, and manufacturing innovations will be required to make that vision a reality.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>In this episode of <em>Off Script</em>, we continue our conversation with Jason Bock, co-founder and CEO of CTMC, diving deeper into the operational and manufacturing challenges shaping the future of curative cell therapies.</p>
<p>Jason discusses how CTMC—through its partnership with MD Anderson Cancer Center—is eliminating inefficiencies across development timelines to significantly accelerate clinical progress without increasing risk. He also shares a forward-looking perspective on how cell therapies could one day be ordered and delivered like traditional pharmaceuticals, and what scientific, regulatory, and manufacturing innovations will be required to make that vision a reality.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/uddjn35cr88qt84y/CTMC_Pod_pt2bso2p.mp3" length="19940577" type="audio/mpeg"/>
        <itunes:summary>In this episode of Off Script, we continue our conversation with Jason Bock, co-founder and CEO of CTMC, diving deeper into the operational and manufacturing challenges shaping the future of curative cell therapies.

Jason discusses how CTMC—through its partnership with MD Anderson Cancer Center—is eliminating inefficiencies across development timelines to significantly accelerate clinical progress without increasing risk. He also shares a forward-looking perspective on how cell therapies could one day be ordered and delivered like traditional pharmaceuticals, and what scientific, regulatory, and manufacturing innovations will be required to make that vision a reality.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>830</itunes:duration>
                <itunes:episode>102</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Building a Future for Curative Cell Therapies: Part One</title>
        <itunes:title>Building a Future for Curative Cell Therapies: Part One</itunes:title>
        <link>https://pharmamanu.podbean.com/e/building-a-future-for-curative-cell-therapies-part-one/</link>
                    <comments>https://pharmamanu.podbean.com/e/building-a-future-for-curative-cell-therapies-part-one/#comments</comments>        <pubDate>Tue, 16 Dec 2025 04:30:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/f90090d7-8a95-32cb-8a09-edfcd15c6959</guid>
                                    <description><![CDATA[<p>Autologous cell therapies have shown the promise of single-dose, curative treatments for patients with advanced cancers. But even with major scientific and regulatory progress, the field now faces its toughest challenge yet: achieving sustainable, scalable manufacturing for highly personalized therapies.</p>
<p>In this episode of Off Script, we spoke with Jason Bock, co-founder and CEO of CTMC, a purpose-driven cell therapy accelerator. Jason discusses why scale remains the central barrier for autologous therapies, the significance of CTMC’s partnership with MD Anderson Cancer Center, and how fit-for-purpose manufacturing models can shorten vein-to-vein time and bring transformative treatments to patients faster.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Autologous cell therapies have shown the promise of single-dose, curative treatments for patients with advanced cancers. But even with major scientific and regulatory progress, the field now faces its toughest challenge yet: achieving sustainable, scalable manufacturing for highly personalized therapies.</p>
<p>In this episode of <em>Off Script</em>, we spoke with Jason Bock, co-founder and CEO of CTMC, a purpose-driven cell therapy accelerator. Jason discusses why scale remains the central barrier for autologous therapies, the significance of CTMC’s partnership with MD Anderson Cancer Center, and how fit-for-purpose manufacturing models can shorten vein-to-vein time and bring transformative treatments to patients faster.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/4btjbuzdvudhqmv6/CTMC_Pod_Pt16ivwx.mp3" length="24943701" type="audio/mpeg"/>
        <itunes:summary>Autologous cell therapies have shown the promise of single-dose, curative treatments for patients with advanced cancers. But even with major scientific and regulatory progress, the field now faces its toughest challenge yet: achieving sustainable, scalable manufacturing for highly personalized therapies.

In this episode of Off Script, we spoke with Jason Bock, co-founder and CEO of CTMC, a purpose-driven cell therapy accelerator. Jason discusses why scale remains the central barrier for autologous therapies, the significance of CTMC’s partnership with MD Anderson Cancer Center, and how fit-for-purpose manufacturing models can shorten vein-to-vein time and bring transformative treatments to patients faster.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1038</itunes:duration>
                <itunes:episode>101</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Modular Flow Chemistry and the Future of Continuous Manufacturing</title>
        <itunes:title>Modular Flow Chemistry and the Future of Continuous Manufacturing</itunes:title>
        <link>https://pharmamanu.podbean.com/e/modular-flow-chemistry-and-the-future-of-continuous-manufacturing/</link>
                    <comments>https://pharmamanu.podbean.com/e/modular-flow-chemistry-and-the-future-of-continuous-manufacturing/#comments</comments>        <pubDate>Tue, 09 Dec 2025 05:30:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/b3bcb308-1c44-38b0-87f2-601dd56fb8a9</guid>
                                    <description><![CDATA[<p>Flow chemistry and modular continuous platforms are gaining momentum as pharma searches for faster, more flexible, and more sustainable ways to develop and scale small-molecule processes. Yet questions around integration, scale-up, and regulatory expectations continue to influence how quickly these technologies can be fully adopted.</p>
<p>In this episode of Off Script, we spoke with Hovione’s Christoph Brücher and Microinnova’s Dirk Kirschneck about their collaboration on advancing flow chemistry and continuous manufacturing. They discuss how plug-and-play modular systems can accelerate process transfer, streamline scale-up, and reduce waste and energy use, as well as how digital tools and regulatory guidance under ICH Q13 are shaping the next generation of continuous manufacturing.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Flow chemistry and modular continuous platforms are gaining momentum as pharma searches for faster, more flexible, and more sustainable ways to develop and scale small-molecule processes. Yet questions around integration, scale-up, and regulatory expectations continue to influence how quickly these technologies can be fully adopted.</p>
<p>In this episode of <em>Off Script</em>, we spoke with Hovione’s Christoph Brücher and Microinnova’s Dirk Kirschneck about their collaboration on advancing flow chemistry and continuous manufacturing. They discuss how plug-and-play modular systems can accelerate process transfer, streamline scale-up, and reduce waste and energy use, as well as how digital tools and regulatory guidance under ICH Q13 are shaping the next generation of continuous manufacturing.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/zu6zndwaw3deuhwp/Flow_Chem_Continuous_Manufacturing_mixdown.mp3" length="23776500" type="audio/mpeg"/>
        <itunes:summary>Flow chemistry and modular continuous platforms are gaining momentum as pharma searches for faster, more flexible, and more sustainable ways to develop and scale small-molecule processes. Yet questions around integration, scale-up, and regulatory expectations continue to influence how quickly these technologies can be fully adopted.

In this episode of Off Script, we spoke with Hovione’s Christoph Brücher and Microinnova’s Dirk Kirschneck about their collaboration on advancing flow chemistry and continuous manufacturing. They discuss how plug-and-play modular systems can accelerate process transfer, streamline scale-up, and reduce waste and energy use, as well as how digital tools and regulatory guidance under ICH Q13 are shaping the next generation of continuous manufacturing.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>990</itunes:duration>
                <itunes:episode>100</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>The Economics Behind U.S. Generic Drug Manufacturing: Part Two</title>
        <itunes:title>The Economics Behind U.S. Generic Drug Manufacturing: Part Two</itunes:title>
        <link>https://pharmamanu.podbean.com/e/the-economics-behind-us-generic-drug-manufacturing-part-two/</link>
                    <comments>https://pharmamanu.podbean.com/e/the-economics-behind-us-generic-drug-manufacturing-part-two/#comments</comments>        <pubDate>Tue, 25 Nov 2025 05:30:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/60df69c0-37fd-38e1-af33-789f5affd459</guid>
                                    <description><![CDATA[<p>In this episode of Off Script, we continue our conversation with John Murphy III, president and CEO of the Association for Accessible Medicines, to dig deeper into the vulnerabilities and structural challenges shaping U.S. generic and biosimilar drug production.</p>
<p>Murphy examines the most fragile links in the supply chain — from the lack of domestic API production to key starting-material constraints — and explains why long-term, coordinated policy action is essential for restoring supply chain resiliency. He also outlines the legislative, regulatory, and market reforms that could strengthen domestic capacity without compromising patient access or affordability.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>In this episode of Off Script, we continue our conversation with John Murphy III, president and CEO of the Association for Accessible Medicines, to dig deeper into the vulnerabilities and structural challenges shaping U.S. generic and biosimilar drug production.</p>
<p>Murphy examines the most fragile links in the supply chain — from the lack of domestic API production to key starting-material constraints — and explains why long-term, coordinated policy action is essential for restoring supply chain resiliency. He also outlines the legislative, regulatory, and market reforms that could strengthen domestic capacity without compromising patient access or affordability.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/53kt3ybx6mpeps3w/John_Murphy_Generics_Pt2_mixdown6i75u.mp3" length="23446833" type="audio/mpeg"/>
        <itunes:summary>In this episode of Off Script, we continue our conversation with John Murphy III, president and CEO of the Association for Accessible Medicines, to dig deeper into the vulnerabilities and structural challenges shaping U.S. generic and biosimilar drug production.

John examines the most fragile links in the supply chain — from the lack of domestic API production to key starting-material constraints — and explains why long-term, coordinated policy action is essential for restoring supply chain resiliency. He also outlines the legislative, regulatory, and market reforms that could strengthen domestic capacity without compromising patient access or affordability.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>976</itunes:duration>
                <itunes:episode>99</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>The Economics Behind U.S. Generic Drug Manufacturing: Part One</title>
        <itunes:title>The Economics Behind U.S. Generic Drug Manufacturing: Part One</itunes:title>
        <link>https://pharmamanu.podbean.com/e/the-economics-behind-us-generic-drug-manufacturing-part-one/</link>
                    <comments>https://pharmamanu.podbean.com/e/the-economics-behind-us-generic-drug-manufacturing-part-one/#comments</comments>        <pubDate>Thu, 20 Nov 2025 05:42:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/e9d426d0-20df-3826-8f4a-6417faacf329</guid>
                                    <description><![CDATA[<p>In this episode of Off Script, we spoke with John Murphy III, president and CEO of the Association for Accessible Medicines, about the forces shaping the future of U.S. generic and biosimilar manufacturing.</p>
<p>Murphy provides a high-level look at the pivotal shifts defining the generic drug landscape and breaks down the economic realities driving drug shortages, the complexities of global ingredient sourcing, and the policy reforms needed to build a more resilient domestic supply chain.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>In this episode of <em>Off Script</em>, we spoke with John Murphy III, president and CEO of the Association for Accessible Medicines, about the forces shaping the future of U.S. generic and biosimilar manufacturing.</p>
<p>Murphy provides a high-level look at the pivotal shifts defining the generic drug landscape and breaks down the economic realities driving drug shortages, the complexities of global ingredient sourcing, and the policy reforms needed to build a more resilient domestic supply chain.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/6bj2y4gaimzxnf5i/John_Murphy_Generics_Pt1_Finalbgglt.mp3" length="23594868" type="audio/mpeg"/>
        <itunes:summary>In this episode of Off Script, we spoke with John Murphy III, president and CEO of the Association for Accessible Medicines, about the forces shaping the future of U.S. generic and biosimilar manufacturing.

Murphy provides a high-level look at the pivotal shifts defining the generic drug landscape and breaks down the economic realities driving drug shortages, the complexities of global ingredient sourcing, and the policy reforms needed to build a more resilient domestic supply chain.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>982</itunes:duration>
                <itunes:episode>98</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>CGT Manufacturing Challenges and Opportunities</title>
        <itunes:title>CGT Manufacturing Challenges and Opportunities</itunes:title>
        <link>https://pharmamanu.podbean.com/e/cgt-manufacturing-challenges-and-opportunities/</link>
                    <comments>https://pharmamanu.podbean.com/e/cgt-manufacturing-challenges-and-opportunities/#comments</comments>        <pubDate>Tue, 11 Nov 2025 04:00:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/9b4e0c4d-597e-35db-a2a4-620d1497b2c6</guid>
                                    <description><![CDATA[<p>While the cell and gene therapy space represents one of the most exciting therapeutic frontiers in modern biopharma by offering highly personalized, transformative treatments, the sector still faces significant hurdles before it can achieve widespread commercialization. From steep manufacturing costs and a lack of standardization to persistent inefficiencies in scaling production, the road to maturity remains complex.</p>
<p>In this episode of Off Script: A Pharma Manufacturing Podcast, we spoke with Sharon Anderson, VP of Scientific Affairs, Alliance for Regenerative Medicine, about what’s driving progress in CGT manufacturing and where the industry is still lagging.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>While the cell and gene therapy space represents one of the most exciting therapeutic frontiers in modern biopharma by offering highly personalized, transformative treatments, the sector still faces significant hurdles before it can achieve widespread commercialization. From steep manufacturing costs and a lack of standardization to persistent inefficiencies in scaling production, the road to maturity remains complex.</p>
<p>In this episode of <em>Off Script: A Pharma Manufacturing Podcast</em>, we spoke with Sharon Anderson, VP of Scientific Affairs, Alliance for Regenerative Medicine, about what’s driving progress in CGT manufacturing and where the industry is still lagging.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/u874dyn9rp9tyd9g/Sharon_CGT_Podcast_V2.mp3" length="28055325" type="audio/mpeg"/>
        <itunes:summary>While the cell and gene therapy space represents one of the most exciting therapeutic frontiers in modern biopharma by offering highly personalized, transformative treatments, the sector still faces significant hurdles before it can achieve widespread commercialization. From steep manufacturing costs and a lack of standardization to persistent inefficiencies in scaling production, the road to maturity remains complex.

In this episode of Off Script: A Pharma Manufacturing Podcast, we spoke with Sharon Anderson, VP of Scientific Affairs, Alliance for Regenerative Medicine, about what’s driving progress in CGT manufacturing and where the industry is still lagging.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1168</itunes:duration>
                <itunes:episode>97</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>The State of CDMO Funding: 2025 in Review (Part Two)</title>
        <itunes:title>The State of CDMO Funding: 2025 in Review (Part Two)</itunes:title>
        <link>https://pharmamanu.podbean.com/e/the-state-of-cdmo-funding-2025-in-review-part-two/</link>
                    <comments>https://pharmamanu.podbean.com/e/the-state-of-cdmo-funding-2025-in-review-part-two/#comments</comments>        <pubDate>Tue, 04 Nov 2025 03:30:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/db934b95-1b2d-3e69-8133-9142ea56d1f4</guid>
                                    <description><![CDATA[<p>In part two of our conversation with Brian Scanlan, Advisor of Life Sciences at Edgewater Capital Partners, we explore how today’s CDMO funding trends are shaping the next phase of growth and specialization across the contract research and manufacturing ecosystem.</p>
<p>Brian shares his perspective on:</p>
<ul>
<li style="font-weight:400;">The outlook for cell and gene therapies, where clinical setbacks, overcapacity, and high costs are balanced by steady innovation and cautious optimism;

</li>
<li style="font-weight:400;">Why “specialization over scale” is defining the next wave of CDMO success, as niche providers in radiopharma, peptides, and other complex modalities gain traction; and

</li>
<li style="font-weight:400;">How the evolving Biosecure Act and U.S. reshoring efforts are reshaping global supply chains and creating new opportunities for domestic manufacturing.</li>
</ul>
]]></description>
                                                            <content:encoded><![CDATA[<p>In part two of our conversation with Brian Scanlan, Advisor of Life Sciences at Edgewater Capital Partners, we explore how today’s CDMO funding trends are shaping the next phase of growth and specialization across the contract research and manufacturing ecosystem.</p>
<p>Brian shares his perspective on:</p>
<ul>
<li style="font-weight:400;">The outlook for cell and gene therapies, where clinical setbacks, overcapacity, and high costs are balanced by steady innovation and cautious optimism;<br>
<br>
</li>
<li style="font-weight:400;">Why “specialization over scale” is defining the next wave of CDMO success, as niche providers in radiopharma, peptides, and other complex modalities gain traction; and<br>
<br>
</li>
<li style="font-weight:400;">How the evolving Biosecure Act and U.S. reshoring efforts are reshaping global supply chains and creating new opportunities for domestic manufacturing.</li>
</ul>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/xwdpxuwusgjh4m2v/Brian_Scanlan_Part2.mp3" length="24899011" type="audio/mpeg"/>
        <itunes:summary>In part two of our conversation with Brian Scanlan, Advisor of Life Sciences at Edgewater Capital Partners, we explore how today’s CDMO funding trends are shaping the next phase of growth and specialization across the contract research and manufacturing ecosystem.

Brian shares his perspective on:

-The outlook for cell and gene therapies, where clinical setbacks, overcapacity, and high costs are balanced by steady innovation and cautious optimism;

-Why “specialization over scale” is defining the next wave of CDMO success, as niche providers in radiopharma, peptides, and other complex modalities gain traction; and

-How the evolving Biosecure Act and U.S. reshoring efforts are reshaping global supply chains and creating new opportunities for domestic manufacturing.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1037</itunes:duration>
                <itunes:episode>96</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>The State of CDMO Funding: 2025 in Review (Part One)</title>
        <itunes:title>The State of CDMO Funding: 2025 in Review (Part One)</itunes:title>
        <link>https://pharmamanu.podbean.com/e/the-state-of-cdmo-funding-2025-in-review-part-one/</link>
                    <comments>https://pharmamanu.podbean.com/e/the-state-of-cdmo-funding-2025-in-review-part-one/#comments</comments>        <pubDate>Tue, 28 Oct 2025 10:00:48 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/de9085c4-b1d3-3827-9f4c-599ca4b40298</guid>
                                    <description><![CDATA[<p>As we near the end of 2025, the CDMO industry finds itself at a pivotal financial and strategic juncture — shaped by constrained funding, shifting demand, and renewed investor scrutiny. </p>
<p>In this episode of Off Script, we speak with Brian Scanlan, Advisor of Life Sciences at Edgewater Capital Partners, to examine how the year’s market and investment trends align with his predictions from an earlier CPHI Annual Report.
Brian shares his perspective on:</p>
<ul>
<li>How accurately his forecast of stability and growth for clinical CROs and CDMOs has held up amid tighter capital markets;</li>
<li>The ongoing softness among early-stage pharma service providers and what it reveals about funding flows across the sector; and</li>
<li>Where investor interest is gravitating — from ADCs and small molecules to biologics — and what this signals for the next phase of CDMO evolution.</li>
</ul>
]]></description>
                                                            <content:encoded><![CDATA[<p>As we near the end of 2025, the CDMO industry finds itself at a pivotal financial and strategic juncture — shaped by constrained funding, shifting demand, and renewed investor scrutiny. </p>
<p>In this episode of <em>Off Script</em>, we speak with Brian Scanlan, Advisor of Life Sciences at Edgewater Capital Partners, to examine how the year’s market and investment trends align with his predictions from an earlier CPHI Annual Report.<br>
Brian shares his perspective on:</p>
<ul>
<li>How accurately his forecast of stability and growth for clinical CROs and CDMOs has held up amid tighter capital markets;</li>
<li>The ongoing softness among early-stage pharma service providers and what it reveals about funding flows across the sector; and</li>
<li>Where investor interest is gravitating — from ADCs and small molecules to biologics — and what this signals for the next phase of CDMO evolution.</li>
</ul>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/pk6q7dufyaiswi3z/Brian_Scanlan_Part_1_Finalbkqg6.mp3" length="31785272" type="audio/mpeg"/>
        <itunes:summary>As we near the end of 2025, the CDMO industry finds itself at a pivotal financial and strategic juncture — shaped by constrained funding, shifting demand, and renewed investor scrutiny. 

In this episode of Off Script, we speak with Brian Scanlan, Advisor of Life Sciences at Edgewater Capital Partners, to examine how the year’s market and investment trends align with his predictions from an earlier CPHI Annual Report.
Brian shares his perspective on:

-How accurately his forecast of stability and growth for clinical CROs and CDMOs has held up amid tighter capital markets;
-The ongoing softness among early-stage pharma service providers and what it reveals about funding flows across the sector; and
-Where investor interest is gravitating — from ADCs and small molecules to biologics — and what this signals for the next phase of CDMO evolution.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1323</itunes:duration>
                <itunes:episode>95</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Corporate compliance involves more than just cGMP and quality</title>
        <itunes:title>Corporate compliance involves more than just cGMP and quality</itunes:title>
        <link>https://pharmamanu.podbean.com/e/corporate-compliance-involves-more-than-just-cgmp-and-quality/</link>
                    <comments>https://pharmamanu.podbean.com/e/corporate-compliance-involves-more-than-just-cgmp-and-quality/#comments</comments>        <pubDate>Fri, 17 Oct 2025 14:02:16 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/8730ce16-3334-3ade-8770-d445f6c286f5</guid>
                                    <description><![CDATA[<p>This episode of Off Script: A Pharma Manufacturing Podcast features a conversation with Jana Falkenberg, senior legal counsel and corporate compliance officer at Vetter Pharma, a global contract development and manufacturing organization (CDMO) headquartered in Germany.</p>
<p>Falkenberg, who is responsible for the continuous improvement of the compliance management system at Vetter, makes the case that corporate compliance encompasses legal, ethical, and internal standards. At Vetter, which this year is celebrating its 75th anniversary, building trust and fostering an environment of integrity is a critical component of the company’s culture and operations as a family-owned business.</p>
<p>This episode is sponsored by Vetter Pharma.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>This episode of <em>Off Script: A Pharma Manufacturing Podcast</em> features a conversation with Jana Falkenberg, senior legal counsel and corporate compliance officer at Vetter Pharma, a global contract development and manufacturing organization (CDMO) headquartered in Germany.</p>
<p>Falkenberg, who is responsible for the continuous improvement of the compliance management system at Vetter, makes the case that corporate compliance encompasses legal, ethical, and internal standards. At Vetter, which this year is celebrating its 75th anniversary, building trust and fostering an environment of integrity is a critical component of the company’s culture and operations as a family-owned business.</p>
<p>This episode is sponsored by Vetter Pharma.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/ij93zk68z79eyshv/Vetter_Pharma_podcast_final9osry.mp3" length="8091116" type="audio/mpeg"/>
        <itunes:summary><![CDATA[This episode of Off Script: A Pharma Manufacturing Podcast features a conversation with Jana Falkenberg, senior legal counsel and corporate compliance officer at Vetter Pharma, a global contract development and manufacturing organization (CDMO) headquartered in Germany.
Falkenberg, who is responsible for the continuous improvement of the compliance management system at Vetter, makes the case that corporate compliance encompasses legal, ethical, and internal standards. At Vetter, which this year is celebrating its 75th anniversary, building trust and fostering an environment of integrity is a critical component of the company’s culture and operations as a family-owned business.
This episode is sponsored by Vetter Pharma.]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1011</itunes:duration>
                <itunes:episode>94</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Charting Pharma Manufacturing Trends: Part Two</title>
        <itunes:title>Charting Pharma Manufacturing Trends: Part Two</itunes:title>
        <link>https://pharmamanu.podbean.com/e/charting-pharma-manufacturing-trends-part-two/</link>
                    <comments>https://pharmamanu.podbean.com/e/charting-pharma-manufacturing-trends-part-two/#comments</comments>        <pubDate>Tue, 14 Oct 2025 03:00:00 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/73c12419-8dea-36f7-869d-510c99671062</guid>
                                    <description><![CDATA[<p>Building on insights from CRB’s <a href='https://go.crbgroup.com/horizons-life-sciences-2025'>Horizons: Life Sciences 2025</a> report, this second installment of our conversation with Peter Walters, Fellow of Advanced Therapies at CRB, explores the modalities driving forward momentum across the life sciences industry, the expanding role of standardization in manufacturing networks, and how tariffs and domestic investment strategies are shaping the future of pharma manufacturing.</p>
<p>If you missed Part One, catch our discussion on the rise of continuous manufacturing and its growing adoption across large pharma.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Building on insights from CRB’s <a href='https://go.crbgroup.com/horizons-life-sciences-2025'>Horizons: Life Sciences 2025</a> report, this second installment of our conversation with Peter Walters, Fellow of Advanced Therapies at CRB, explores the modalities driving forward momentum across the life sciences industry, the expanding role of standardization in manufacturing networks, and how tariffs and domestic investment strategies are shaping the future of pharma manufacturing.</p>
<p>If you missed Part One, catch our discussion on the rise of continuous manufacturing and its growing adoption across large pharma.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/mvbzhuvq98da9vkq/Charting_Pharma_Manufacturing_Trends_-_Part_Twoahzv2.mp3" length="23695989" type="audio/mpeg"/>
        <itunes:summary>Building on insights from CRB’s Horizons: Life Sciences 2025 report (https://go.crbgroup.com/horizons-life-sciences-2025), this second installment of our conversation with Peter Walters, Fellow of Advanced Therapies at CRB, explores the modalities driving forward momentum across the life sciences industry, the expanding role of standardization in manufacturing networks, and how tariffs and domestic investment strategies are shaping the future of pharma manufacturing.

If you missed Part One, catch our discussion on the rise of continuous manufacturing and its growing adoption across large pharma.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>986</itunes:duration>
                <itunes:episode>93</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Charting Pharma Manufacturing Trends: Part One</title>
        <itunes:title>Charting Pharma Manufacturing Trends: Part One</itunes:title>
        <link>https://pharmamanu.podbean.com/e/charting-pharma-manufacturing-trends-part-one/</link>
                    <comments>https://pharmamanu.podbean.com/e/charting-pharma-manufacturing-trends-part-one/#comments</comments>        <pubDate>Tue, 07 Oct 2025 06:15:00 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/177ea201-99ce-32a2-9702-3cc4550458b5</guid>
                                    <description><![CDATA[<p>Based on insights from CRB’s Horizons: Life Sciences 2025 report, this episode of Off Script: A Pharma Manufacturing Podcast features a conversation with Peter Walters, Fellow of Advanced Therapies at CRB. Walters discusses how the industry is advancing toward continuous manufacturing, highlighted by a key finding from the report — 65% of large companies are pursuing end-to-end continuous manufacturing.</p>
<p>This is part one of a two-part series. In part two, dropping Oct. 14, 2025, Walters will return to explore advanced therapies, tariffs, and regulatory changes shaping the global pharma manufacturing landscape.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Based on insights from CRB’s Horizons: Life Sciences 2025 report, this episode of <em>Off Script: A Pharma Manufacturing Podcast </em>features a conversation with Peter Walters, Fellow of Advanced Therapies at CRB. Walters discusses how the industry is advancing toward continuous manufacturing, highlighted by a key finding from the report — 65% of large companies are pursuing end-to-end continuous manufacturing.</p>
<p>This is part one of a two-part series. In part two, dropping Oct. 14, 2025, Walters will return to explore advanced therapies, tariffs, and regulatory changes shaping the global pharma manufacturing landscape.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/armqxunvrj3z9xaz/Charting_Pharma_Manufacturing_Trends_-_Part_Oneap6bj.mp3" length="19136422" type="audio/mpeg"/>
        <itunes:summary>Based on insights from CRB’s Horizons: Life Sciences 2025 report, this episode of Off Script: A Pharma Manufacturing Podcast features a conversation with Peter Walters, Fellow of Advanced Therapies at CRB. Walters discusses how the industry is advancing toward continuous manufacturing, highlighted by a key finding from the report — 65% of large companies are pursuing end-to-end continuous manufacturing.

This is part one of a two-part series. In part two, dropping Oct. 14, 2025, Walters will return to explore advanced therapies, tariffs, and regulatory changes shaping the global pharma manufacturing landscape.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>796</itunes:duration>
                <itunes:episode>92</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Editor’s (re)View: It matters if Big Pharma is fudging its US investment numbers</title>
        <itunes:title>Editor’s (re)View: It matters if Big Pharma is fudging its US investment numbers</itunes:title>
        <link>https://pharmamanu.podbean.com/e/editor-s-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbers/</link>
                    <comments>https://pharmamanu.podbean.com/e/editor-s-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbers/#comments</comments>        <pubDate>Tue, 16 Sep 2025 03:22:00 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/262b7616-1642-31a6-8c53-8e6fdc9f18eb</guid>
                                    <description><![CDATA[Large biopharma companies in recent months have pledged billions of dollars in capital expenditures for U.S. manufacturing and R&amp;D facilities. What if it’s not accurate?




<a href='https://www.pharmamanufacturing.com/55247313'>Greg Slabodkin</a>

Read by Brittany Duncan 

<a href='https://www.pharmamanufacturing.com/editors-review/article/55314470/editors-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbers'>https://www.pharmamanufacturing.com/editors-review/article/55314470/editors-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbers</a> 



]]></description>
                                                            <content:encoded><![CDATA[Large biopharma companies in recent months have pledged billions of dollars in capital expenditures for U.S. manufacturing and R&amp;D facilities. What if it’s not accurate?




<a href='https://www.pharmamanufacturing.com/55247313'>Greg Slabodkin</a><br>
<br>
Read by Brittany Duncan <br>
<br>
<a href='https://www.pharmamanufacturing.com/editors-review/article/55314470/editors-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbers'>https://www.pharmamanufacturing.com/editors-review/article/55314470/editors-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbers</a> 



]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/r5re3asz5tvpf5gy/Tarrifs_Mixdown_16e8c1.mp3" length="5784430" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Large biopharma companies in recent months have pledged billions of dollars in capital expenditures for U.S. manufacturing and R&amp;D facilities. What if it’s not accurate?




Greg SlabodkinRead by Brittany Duncan https://www.pharmamanufacturing.com/editors-review/article/55314470/editors-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbers 



]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>240</itunes:duration>
                <itunes:episode>91</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Can CDMOs keep up with the increasing demand for GLP-1 medications?</title>
        <itunes:title>Can CDMOs keep up with the increasing demand for GLP-1 medications?</itunes:title>
        <link>https://pharmamanu.podbean.com/e/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-medications/</link>
                    <comments>https://pharmamanu.podbean.com/e/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-medications/#comments</comments>        <pubDate>Wed, 10 Sep 2025 17:22:05 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/3ad520f5-26bd-3329-9fb6-35d75997bcd0</guid>
                                    <description><![CDATA[The wildly popular drugs, prescribed for weight loss and type 2 diabetes, are putting a strain on the capabilities of contract development and manufacturing organizations.




<a href='https://www.pharmamanufacturing.com/55247313'>Greg Slabodkin</a>

Read by Brittany Duncan

<a href='https://www.pharmamanufacturing.com/sector/contract-manufacturing/article/55314756/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-medications'>https://www.pharmamanufacturing.com/sector/contract-manufacturing/article/55314756/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-medications</a> 



]]></description>
                                                            <content:encoded><![CDATA[The wildly popular drugs, prescribed for weight loss and type 2 diabetes, are putting a strain on the capabilities of contract development and manufacturing organizations.




<a href='https://www.pharmamanufacturing.com/55247313'>Greg Slabodkin</a><br>
<br>
Read by Brittany Duncan<br>
<br>
<a href='https://www.pharmamanufacturing.com/sector/contract-manufacturing/article/55314756/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-medications'>https://www.pharmamanufacturing.com/sector/contract-manufacturing/article/55314756/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-medications</a> 



]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/dish8qyhhjnfu499/GLP-1_final_Mixdown_28psjp.mp3" length="8304732" type="audio/mpeg"/>
        <itunes:summary><![CDATA[The wildly popular drugs, prescribed for weight loss and type 2 diabetes, are putting a strain on the capabilities of contract development and manufacturing organizations.




Greg SlabodkinRead by Brittany Duncanhttps://www.pharmamanufacturing.com/sector/contract-manufacturing/article/55314756/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-medications 



]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>345</itunes:duration>
                <itunes:episode>90</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA’s program to speed up US manufacturing buildouts is short on detail</title>
        <itunes:title>FDA’s program to speed up US manufacturing buildouts is short on detail</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-s-program-to-speed-up-us-manufacturing-buildouts-is-short-on-detail/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-s-program-to-speed-up-us-manufacturing-buildouts-is-short-on-detail/#comments</comments>        <pubDate>Tue, 26 Aug 2025 03:58:00 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/9c44f7d4-8348-3d3e-9634-fbf82f5d69f3</guid>
                                    <description><![CDATA[ 


While the agency’s PreCheck regulatory framework is a good first step, it remains to be seen whether the program boosts U.S. drug manufacturing, says former FDA official.




<a href='https://www.pharmamanufacturing.com/home/contact/55247313/greg-slabodkin'>Greg Slabodkin</a>
 
Read by Brittany Duncan
 
<a href='https://www.pharmamanufacturing.com/all-articles/article/55309136/fdas-program-to-speed-up-us-manufacturing-buildouts-is-short-on-detail'>https://www.pharmamanufacturing.com/all-articles/article/55309136/fdas-program-to-speed-up-us-manufacturing-buildouts-is-short-on-detail</a> 



]]></description>
                                                            <content:encoded><![CDATA[ 


While the agency’s PreCheck regulatory framework is a good first step, it remains to be seen whether the program boosts U.S. drug manufacturing, says former FDA official.




<a href='https://www.pharmamanufacturing.com/home/contact/55247313/greg-slabodkin'>Greg Slabodkin</a>
 
Read by Brittany Duncan
 
<a href='https://www.pharmamanufacturing.com/all-articles/article/55309136/fdas-program-to-speed-up-us-manufacturing-buildouts-is-short-on-detail'>https://www.pharmamanufacturing.com/all-articles/article/55309136/fdas-program-to-speed-up-us-manufacturing-buildouts-is-short-on-detail</a> 



]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/uehnnckww5qpgc5k/FDA_Mixdown_1bwjpu.mp3" length="8387472" type="audio/mpeg"/>
        <itunes:summary><![CDATA[ 


While the agency’s PreCheck regulatory framework is a good first step, it remains to be seen whether the program boosts U.S. drug manufacturing, says former FDA official.




Greg Slabodkin
 
Read by Brittany Duncan
 
https://www.pharmamanufacturing.com/all-articles/article/55309136/fdas-program-to-speed-up-us-manufacturing-buildouts-is-short-on-detail 



]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>349</itunes:duration>
                <itunes:episode>89</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>New Jersey remains hot life sciences hub despite macroeconomic, funding headwinds</title>
        <itunes:title>New Jersey remains hot life sciences hub despite macroeconomic, funding headwinds</itunes:title>
        <link>https://pharmamanu.podbean.com/e/new-jersey-remains-hot-life-sciences-hub-despite-macroeconomic-funding-headwinds/</link>
                    <comments>https://pharmamanu.podbean.com/e/new-jersey-remains-hot-life-sciences-hub-despite-macroeconomic-funding-headwinds/#comments</comments>        <pubDate>Tue, 19 Aug 2025 10:57:00 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/0740f161-1cd2-30d8-8703-aba75808cf7c</guid>
                                    <description><![CDATA[ 


The Garden State, called the “medicine chest” to the world, continues to show robust activity with life sciences firms accounting for nearly 30% of all Q2 leasing activity.




<a href='https://www.pharmamanufacturing.com/home/contact/55247313/greg-slabodkin'>Greg Slabodkin</a>
 
Read by Brittany Duncan 
 
<a href='https://www.pharmamanufacturing.com/all-articles/article/55308250/new-jersey-remains-hot-life-sciences-hub-despite-macroeconomic-funding-headwinds'>https://www.pharmamanufacturing.com/all-articles/article/55308250/new-jersey-remains-hot-life-sciences-hub-despite-macroeconomic-funding-headwinds</a> 



]]></description>
                                                            <content:encoded><![CDATA[ 


The Garden State, called the “medicine chest” to the world, continues to show robust activity with life sciences firms accounting for nearly 30% of all Q2 leasing activity.




<a href='https://www.pharmamanufacturing.com/home/contact/55247313/greg-slabodkin'>Greg Slabodkin</a>
 
Read by Brittany Duncan 
 
<a href='https://www.pharmamanufacturing.com/all-articles/article/55308250/new-jersey-remains-hot-life-sciences-hub-despite-macroeconomic-funding-headwinds'>https://www.pharmamanufacturing.com/all-articles/article/55308250/new-jersey-remains-hot-life-sciences-hub-despite-macroeconomic-funding-headwinds</a> 



]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/3k2p4gi6s9vyggnf/NJ_Mixdown_172icp.mp3" length="7813194" type="audio/mpeg"/>
        <itunes:summary><![CDATA[ 


The Garden State, called the “medicine chest” to the world, continues to show robust activity with life sciences firms accounting for nearly 30% of all Q2 leasing activity.




Greg Slabodkin
 
Read by Brittany Duncan 
 
https://www.pharmamanufacturing.com/all-articles/article/55308250/new-jersey-remains-hot-life-sciences-hub-despite-macroeconomic-funding-headwinds 



]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>325</itunes:duration>
                <itunes:episode>88</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Critical Timing: Hikma’s Billion-Dollar U.S. Investment</title>
        <itunes:title>Critical Timing: Hikma’s Billion-Dollar U.S. Investment</itunes:title>
        <link>https://pharmamanu.podbean.com/e/critical-timing-hikma-s-billion-dollar-us-investment/</link>
                    <comments>https://pharmamanu.podbean.com/e/critical-timing-hikma-s-billion-dollar-us-investment/#comments</comments>        <pubDate>Tue, 15 Jul 2025 14:51:40 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/42b04fbc-175e-3c0d-8e45-1cf36e5ffb2d</guid>
                                    <description><![CDATA[Generics, which make up approximately 90% of prescription volume in the U.S., are produced primarily in India as Hikma looks to onshore production of these critical drugs.

<a href='https://www.pharmamanufacturing.com/55247313'>Greg Slabodkin</a>

Read by Brittany Duncan 

<a href='https://www.pharmamanufacturing.com/all-articles/article/55302441/hikmas-planned-1b-us-investment-comes-at-critical-time-for-generic-medicines-supply'>https://www.pharmamanufacturing.com/all-articles/article/55302441/hikmas-planned-1b-us-investment-comes-at-critical-time-for-generic-medicines-supply</a> 
]]></description>
                                                            <content:encoded><![CDATA[Generics, which make up approximately 90% of prescription volume in the U.S., are produced primarily in India as Hikma looks to onshore production of these critical drugs.

<a href='https://www.pharmamanufacturing.com/55247313'>Greg Slabodkin</a><br>
<br>
Read by Brittany Duncan <br>
<br>
<a href='https://www.pharmamanufacturing.com/all-articles/article/55302441/hikmas-planned-1b-us-investment-comes-at-critical-time-for-generic-medicines-supply'>https://www.pharmamanufacturing.com/all-articles/article/55302441/hikmas-planned-1b-us-investment-comes-at-critical-time-for-generic-medicines-supply</a> 
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/nuk4m879k4pqbugn/Hikma_Read_Mixdown_1b2b6u.mp3" length="9706565" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Generics, which make up approximately 90% of prescription volume in the U.S., are produced primarily in India as Hikma looks to onshore production of these critical drugs.

Greg SlabodkinRead by Brittany Duncan https://www.pharmamanufacturing.com/all-articles/article/55302441/hikmas-planned-1b-us-investment-comes-at-critical-time-for-generic-medicines-supply 
]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>404</itunes:duration>
                <itunes:episode>87</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Editor’s (re)View: Is the biopharma industry’s glass half empty or half full?</title>
        <itunes:title>Editor’s (re)View: Is the biopharma industry’s glass half empty or half full?</itunes:title>
        <link>https://pharmamanu.podbean.com/e/editor-s-review-is-the-biopharma-industry-s-glass-half-empty-or-half-full/</link>
                    <comments>https://pharmamanu.podbean.com/e/editor-s-review-is-the-biopharma-industry-s-glass-half-empty-or-half-full/#comments</comments>        <pubDate>Tue, 01 Jul 2025 14:26:14 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/c9da4515-2c24-3e97-81ed-fc925e041260</guid>
                                    <description><![CDATA[While macroeconomic uncertainty weighs on the sector, there are glimmers of hope in some areas of pharmaceutical outsourcing and services.


<a href='https://www.pharmamanufacturing.com/home/contact/55247313/greg-slabodkin'>Greg Slabodkin</a>

Read by Brittany Duncan 

Read Article Here: <a href='https://www.pharmamanufacturing.com/editors-review/article/55299879/editors-review-is-the-biopharma-industrys-glass-half-empty-or-half-full'>https://www.pharmamanufacturing.com/editors-review/article/55299879/editors-review-is-the-biopharma-industrys-glass-half-empty-or-half-full</a> 

]]></description>
                                                            <content:encoded><![CDATA[While macroeconomic uncertainty weighs on the sector, there are glimmers of hope in some areas of pharmaceutical outsourcing and services.


<a href='https://www.pharmamanufacturing.com/home/contact/55247313/greg-slabodkin'>Greg Slabodkin</a><br>
<br>
Read by Brittany Duncan <br>
<br>
Read Article Here: <a href='https://www.pharmamanufacturing.com/editors-review/article/55299879/editors-review-is-the-biopharma-industrys-glass-half-empty-or-half-full'>https://www.pharmamanufacturing.com/editors-review/article/55299879/editors-review-is-the-biopharma-industrys-glass-half-empty-or-half-full</a> 

]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/r444md5agujkhwxh/Pharma_Mid_Year_Mixdown_1a896q.mp3" length="6916071" type="audio/mpeg"/>
        <itunes:summary><![CDATA[While macroeconomic uncertainty weighs on the sector, there are glimmers of hope in some areas of pharmaceutical outsourcing and services.


Greg SlabodkinRead by Brittany Duncan Read Article Here: https://www.pharmamanufacturing.com/editors-review/article/55299879/editors-review-is-the-biopharma-industrys-glass-half-empty-or-half-full 

]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>287</itunes:duration>
                <itunes:episode>86</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Life sciences manufacturers overwhelmingly embrace smart tech: global survey</title>
        <itunes:title>Life sciences manufacturers overwhelmingly embrace smart tech: global survey</itunes:title>
        <link>https://pharmamanu.podbean.com/e/life-sciences-manufacturers-overwhelmingly-embrace-smart-tech-global-survey/</link>
                    <comments>https://pharmamanu.podbean.com/e/life-sciences-manufacturers-overwhelmingly-embrace-smart-tech-global-survey/#comments</comments>        <pubDate>Thu, 26 Jun 2025 11:26:33 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/583c8395-bed8-38ee-997b-a5ebc602c457</guid>
                                    <description><![CDATA[<p>Smart manufacturing is “nearly universal” with 95% of manufacturers saying they are using or evaluating smart technology, according to a new survey from Rockwell Automation.
</p>


<a href='https://www.pharmamanufacturing.com/home/contact/55247313/greg-slabodkin'>Greg Slabodkin</a>

Read by Brittany Duncan

]]></description>
                                                            <content:encoded><![CDATA[<p>Smart manufacturing is “nearly universal” with 95% of manufacturers saying they are using or evaluating smart technology, according to a new survey from Rockwell Automation.<br>
</p>


<a href='https://www.pharmamanufacturing.com/home/contact/55247313/greg-slabodkin'>Greg Slabodkin</a><br>
<br>
Read by Brittany Duncan

]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/qz26qpu9yaacyctu/Pharma_Read_1_bbc14.mp3" length="7229534" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Smart manufacturing is “nearly universal” with 95% of manufacturers saying they are using or evaluating smart technology, according to a new survey from Rockwell Automation.


Greg SlabodkinRead by Brittany Duncan

]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>300</itunes:duration>
                <itunes:episode>85</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Flow state: The evolving shape of continuous manufacturing</title>
        <itunes:title>Flow state: The evolving shape of continuous manufacturing</itunes:title>
        <link>https://pharmamanu.podbean.com/e/flow-state-the-evolving-shape-of-continuous-manufacturing/</link>
                    <comments>https://pharmamanu.podbean.com/e/flow-state-the-evolving-shape-of-continuous-manufacturing/#comments</comments>        <pubDate>Mon, 23 Jun 2025 14:11:24 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/51b3e997-4a37-3545-9bda-1f8343def9a2</guid>
                                    <description><![CDATA[While the pharmaceutical industry has been slow to adopt continuous manufacturing, it appears to be gaining momentum.


<a href='https://www.pharmamanufacturing.com/home/contact/55247313/greg-slabodkin'>Greg Slabodkin</a>

Read by Brittany Duncan 

Enjoy the article Here: <a href='https://www.pharmamanufacturing.com/all-articles/article/55295669/flow-state-the-evolving-shape-of-continuous-manufacturing'>https://www.pharmamanufacturing.com/all-articles/article/55295669/flow-state-the-evolving-shape-of-continuous-manufacturing</a> 

]]></description>
                                                            <content:encoded><![CDATA[While the pharmaceutical industry has been slow to adopt continuous manufacturing, it appears to be gaining momentum.


<a href='https://www.pharmamanufacturing.com/home/contact/55247313/greg-slabodkin'>Greg Slabodkin</a><br>
<br>
Read by Brittany Duncan <br>
<br>
Enjoy the article Here: <a href='https://www.pharmamanufacturing.com/all-articles/article/55295669/flow-state-the-evolving-shape-of-continuous-manufacturing'>https://www.pharmamanufacturing.com/all-articles/article/55295669/flow-state-the-evolving-shape-of-continuous-manufacturing</a> 

]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/eiv97rr5fkueu5mf/Pharma_Read_1_9kdbm.mp3" length="21877320" type="audio/mpeg"/>
        <itunes:summary><![CDATA[While the pharmaceutical industry has been slow to adopt continuous manufacturing, it appears to be gaining momentum.


Greg SlabodkinRead by Brittany Duncan Enjoy the article Here: https://www.pharmamanufacturing.com/all-articles/article/55295669/flow-state-the-evolving-shape-of-continuous-manufacturing 

]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>911</itunes:duration>
                <itunes:episode>84</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] Hydrogenation: Bridging the gap between nitration and phosgenation</title>
        <itunes:title>[Solutions Spotlight] Hydrogenation: Bridging the gap between nitration and phosgenation</itunes:title>
        <link>https://pharmamanu.podbean.com/e/solutions-spotlight-hydrogenation-bridging-the-gap-between-nitration-and-phosgenation/</link>
                    <comments>https://pharmamanu.podbean.com/e/solutions-spotlight-hydrogenation-bridging-the-gap-between-nitration-and-phosgenation/#comments</comments>        <pubDate>Mon, 12 May 2025 09:02:52 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/94f0eae7-6ee8-3db6-bec7-19304056ec28</guid>
                                    <description><![CDATA[<p>Hydrogenation can serve as a critical link in chemical synthesis, particularly between nitration and phosgenation. When integrated strategically, it helps enable safer, more efficient production processes.</p>
<p>To better understand this connection, we spoke with Dr. Luca Mantilli, R&amp;D Chemist at Valsynthese, the fine chemicals division of Société Suisse des Explosifs Holding (SSE). Dr. Mantilli discussed how hydrogenation was implemented to bridge the gap between two of the company’s core hazardous chemistries: nitration and phosgenation.</p>
<p>Learn more about Valsynthese: <a href='https://www.valsynthese.ch/'>https://www.valsynthese.ch/</a></p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Hydrogenation can serve as a critical link in chemical synthesis, particularly between nitration and phosgenation. When integrated strategically, it helps enable safer, more efficient production processes.</p>
<p>To better understand this connection, we spoke with Dr. Luca Mantilli, R&amp;D Chemist at Valsynthese, the fine chemicals division of Société Suisse des Explosifs Holding (SSE). Dr. Mantilli discussed how hydrogenation was implemented to bridge the gap between two of the company’s core hazardous chemistries: nitration and phosgenation.</p>
<p>Learn more about Valsynthese: <a href='https://www.valsynthese.ch/'>https://www.valsynthese.ch/</a></p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/bznesa54544qnjrn/VALSYNTHESEV2_1_bek4m.mp3" length="21911949" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Hydrogenation can serve as a critical link in chemical synthesis, particularly between nitration and phosgenation. When integrated strategically, it helps enable safer, more efficient production processes.
To better understand this connection, we spoke with Dr. Luca Mantilli, R&amp;D Chemist at Valsynthese, the fine chemicals division of Société Suisse des Explosifs Holding (SSE). Dr. Mantilli discussed how hydrogenation was implemented to bridge the gap between two of the company’s core hazardous chemistries: nitration and phosgenation.
Learn more about Valsynthese: https://www.valsynthese.ch/]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1095</itunes:duration>
                <itunes:episode>83</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Editor’s (re)View: BMS, Merck, Roche see manufacturing flexibility as key to dealing with tariffs</title>
        <itunes:title>Editor’s (re)View: BMS, Merck, Roche see manufacturing flexibility as key to dealing with tariffs</itunes:title>
        <link>https://pharmamanu.podbean.com/e/editor-s-review-bms-merck-roche-see-manufacturing-flexibility-as-key-to-dealing-with-tariffs/</link>
                    <comments>https://pharmamanu.podbean.com/e/editor-s-review-bms-merck-roche-see-manufacturing-flexibility-as-key-to-dealing-with-tariffs/#comments</comments>        <pubDate>Wed, 30 Apr 2025 13:00:46 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/ac5c6d0e-9b23-3ba3-bbfc-118032719926</guid>
                                    <description><![CDATA[<p>The three Big Pharma companies on their earnings calls this week tried to reassure investors that they have the global footprints to mitigate the effects of tariffs.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>The three Big Pharma companies on their earnings calls this week tried to reassure investors that they have the global footprints to mitigate the effects of tariffs.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/kfci38reai3rtsz5/OFFSCRIOT4_3086nin.mp3" length="5337255" type="audio/mpeg"/>
        <itunes:summary><![CDATA[The three Big Pharma companies on their earnings calls this week tried to reassure investors that they have the global footprints to mitigate the effects of tariffs.]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>266</itunes:duration>
                <itunes:episode>82</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Thermo Fisher opens cell therapy center, FDA cites Aurobindo site, Trump probes pharma imports ahead of tariffs  [The good, the bad, the ugly]</title>
        <itunes:title>Thermo Fisher opens cell therapy center, FDA cites Aurobindo site, Trump probes pharma imports ahead of tariffs  [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/thermo-fisher-opens-cell-therapy-center-fda-cites-aurobindo-site-trump-probes-pharma-imports-ahead-of-tariffs-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/thermo-fisher-opens-cell-therapy-center-fda-cites-aurobindo-site-trump-probes-pharma-imports-ahead-of-tariffs-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 21 Apr 2025 12:46:14 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/203947ea-f9cd-3b1c-b437-711980fa8b29</guid>
                                    <description><![CDATA[<p>The good — Thermo Fisher opens center to boost cell therapy development
The bad — FDA cites Aurobindo plant after Raleigh inspection
The ugly — Trump probes pharma imports as tariff threat looms</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>The good — Thermo Fisher opens center to boost cell therapy development<br>
The bad — FDA cites Aurobindo plant after Raleigh inspection<br>
The ugly — Trump probes pharma imports as tariff threat looms</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/6wjcchbeukjtfcuz/TGTBTU4_217g6ih.mp3" length="5082300" type="audio/mpeg"/>
        <itunes:summary><![CDATA[The good — Thermo Fisher opens center to boost cell therapy developmentThe bad — FDA cites Aurobindo plant after Raleigh inspectionThe ugly — Trump probes pharma imports as tariff threat looms]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>253</itunes:duration>
                <itunes:episode>81</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Novartis to invest $23B in US sites, US urged to invest $15B in biotech counter to China, Trump warns of major pharma tariffs [The good, the bad, the ugly]</title>
        <itunes:title>Novartis to invest $23B in US sites, US urged to invest $15B in biotech counter to China, Trump warns of major pharma tariffs [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/novartis-to-invest-23b-in-us-sites-us-plans-15b-biotech-counter-to-china-trump-warns-of-major-pharma-tariffs-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/novartis-to-invest-23b-in-us-sites-us-plans-15b-biotech-counter-to-china-trump-warns-of-major-pharma-tariffs-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 14 Apr 2025 07:18:36 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/822531ee-03b8-34b8-a61a-b93e3fa59aa2</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:</p>
<p>The good — Novartis to invest $23B in U.S. manufacturing and R&amp;D, including seven new sites
The bad — U.S. urged to invest $15B to counter China’s biotech rise
The ugly — Trump signals ‘major’ tariffs on pharma, urging manufacturing shift back to U.S.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:</p>
<p>The good — Novartis to invest $23B in U.S. manufacturing and R&amp;D, including seven new sites<br>
The bad — U.S. urged to invest $15B to counter China’s biotech rise<br>
The ugly — Trump signals ‘major’ tariffs on pharma, urging manufacturing shift back to U.S.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/4bjxmhe6p2uwj6h2/TGTBTU4136ilks.mp3" length="5022218" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Novartis to invest $23B in U.S. manufacturing and R&amp;D, including seven new sitesThe bad — U.S. urged to invest $15B to counter China’s biotech riseThe ugly — Trump signals ‘major’ tariffs on pharma, urging manufacturing shift back to U.S.]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>250</itunes:duration>
                <itunes:episode>80</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Cellares, Cabaletta validate automated CAR T production, FDA warns Aspen over sterility issues, rejects Hengrui, Elevar cancer combo again [The good, the bad, the ugly]</title>
        <itunes:title>Cellares, Cabaletta validate automated CAR T production, FDA warns Aspen over sterility issues, rejects Hengrui, Elevar cancer combo again [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/cellarescabalettavalidate-automated-car-tproductionfdawarns-aspen-over-sterility-issuesrejects-hengrui-elevarcancer-combo-againthe-goodthe-bad-the-ug/</link>
                    <comments>https://pharmamanu.podbean.com/e/cellarescabalettavalidate-automated-car-tproductionfdawarns-aspen-over-sterility-issuesrejects-hengrui-elevarcancer-combo-againthe-goodthe-bad-the-ug/#comments</comments>        <pubDate>Wed, 26 Mar 2025 14:29:05 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/f86ede6e-8cf4-3463-8dff-ec777a8d7dea</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:</p>
<p>The good — Cellares, Cabaletta validate automated CAR T production
The bad — FDA warns Aspen over sterility issues
The ugly — FDA rejects Hengrui, Elevar cancer combo again</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:</p>
<p>The good — Cellares, Cabaletta validate automated CAR T production<br>
The bad — FDA warns Aspen over sterility issues<br>
The ugly — FDA rejects Hengrui, Elevar cancer combo again</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/ks6iy8fb78v2uida/PM_OffScript_TGTBTU_32625_mixdown65gpi.mp3" length="4777684" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Cellares, Cabaletta validate automated CAR T productionThe bad — FDA warns Aspen over sterility issuesThe ugly — FDA rejects Hengrui, Elevar cancer combo again]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>198</itunes:duration>
                <itunes:episode>79</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Axplora expands ADC capacity, Merck KGaA CDMO business slump, FDA issues a warning letter to Granules India [The good, the bad, the ugly]</title>
        <itunes:title>Axplora expands ADC capacity, Merck KGaA CDMO business slump, FDA issues a warning letter to Granules India [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/axplora-expands-adc-capacity-merck-kgaa-cdmo-business-slump-fda-issues-a-warning-letter-to-granules-india-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/axplora-expands-adc-capacity-merck-kgaa-cdmo-business-slump-fda-issues-a-warning-letter-to-granules-india-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 17 Mar 2025 05:10:18 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/ce441d33-c300-35ab-8fb5-f799e4b2efbb</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:</p>
<p>The good — Axplora expands its antibody-drug conjugate (ADC) manufacturing capacity to support growing demand.</p>
<p>The bad — Merck KGaA’s CDMO business reports a decline</p>
<p>The ugly — The FDA issues a warning letter to Granules India over manufacturing violations</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:</p>
<p>The good — Axplora expands its antibody-drug conjugate (ADC) manufacturing capacity to support growing demand.</p>
<p>The bad — Merck KGaA’s CDMO business reports a decline</p>
<p>The ugly — The FDA issues a warning letter to Granules India over manufacturing violations</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/whs7s2xa3crcfmpk/PM_OffScript_TGTBTU_31425_mixdown9bv7f.mp3" length="5405614" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Axplora expands its antibody-drug conjugate (ADC) manufacturing capacity to support growing demand.
The bad — Merck KGaA’s CDMO business reports a decline
The ugly — The FDA issues a warning letter to Granules India over manufacturing violations]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>224</itunes:duration>
                <itunes:episode>78</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Eli Lilly expands manufacturing to boost supply, FDA blocks imports from two Indian API makers, ICU Medical recalls potassium chloride injection bags over labeling error [The good, the bad, the ugly]</title>
        <itunes:title>Eli Lilly expands manufacturing to boost supply, FDA blocks imports from two Indian API makers, ICU Medical recalls potassium chloride injection bags over labeling error [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/eli-lillyexpands-manufacturing-toboostsupply-fda-blocksimports-from-two-indian-api-makersicumedical-recallspotassiumchlorideinjectionbagsoverlabel/</link>
                    <comments>https://pharmamanu.podbean.com/e/eli-lillyexpands-manufacturing-toboostsupply-fda-blocksimports-from-two-indian-api-makersicumedical-recallspotassiumchlorideinjectionbagsoverlabel/#comments</comments>        <pubDate>Tue, 25 Feb 2025 13:18:35 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/9c0e722f-bc41-3067-a572-3c99ec28821d</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:</p>
<p>The good — Eli Lilly expands manufacturing to boost supply</p>
<p>The bad — FDA blocks imports from two Indian API makers over manufacturing violations</p>
<p>The ugly — ICU Medical recalls potassium chloride injection bags over labeling error</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:</p>
<p>The good — Eli Lilly expands manufacturing to boost supply</p>
<p>The bad — FDA blocks imports from two Indian API makers over manufacturing violations</p>
<p>The ugly — ICU Medical recalls potassium chloride injection bags over labeling error</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/kwmd9vb3z98733x2/PM_OffScript_TGTBTU_22525_mixdownbsh6g.mp3" length="5657992" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Eli Lilly expands manufacturing to boost supply
The bad — FDA blocks imports from two Indian API makers over manufacturing violations
The ugly — ICU Medical recalls potassium chloride injection bags over labeling error]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>234</itunes:duration>
                <itunes:episode>77</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Novartis boosts Slovenia investment to $3.6B, Trump tariffs could unsettle biopharma FDI, FDA warns Global Calcium, blocks US imports [The good, the bad, the ugly]</title>
        <itunes:title>Novartis boosts Slovenia investment to $3.6B, Trump tariffs could unsettle biopharma FDI, FDA warns Global Calcium, blocks US imports [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/novartis-boostssloveniainvestmentto36btrump-tariffscouldunsettlebiopharmafdifda-warnsglobal-calciumblocks-usimportsthe-goodthe-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/novartis-boostssloveniainvestmentto36btrump-tariffscouldunsettlebiopharmafdifda-warnsglobal-calciumblocks-usimportsthe-goodthe-bad-the-ugly/#comments</comments>        <pubDate>Tue, 18 Feb 2025 14:10:08 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/2ac1b7bc-aa64-33ff-b001-64c2cdeea110</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Novartis boosts Slovenia investment to $3.6B</p>
<p>The bad — Trump tariffs unsettle biopharma FDI</p>
<p>The ugly — FDA warns Global Calcium, blocks US imports</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Novartis boosts Slovenia investment to $3.6B</p>
<p>The bad — Trump tariffs unsettle biopharma FDI</p>
<p>The ugly — FDA warns Global Calcium, blocks US imports</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/7u9x2wk6cs4yyxqn/PM_OffScript_TGTBTU_21825_mixdown80kdk.mp3" length="6383842" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Novartis boosts Slovenia investment to $3.6B
The bad — Trump tariffs unsettle biopharma FDI
The ugly — FDA warns Global Calcium, blocks US imports]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>264</itunes:duration>
                <itunes:episode>76</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA approves Opdivo subcutaneous version, Marinus Pharmaceuticals sells operations, Novo Nordisk pushes back against compounding pharmacies [The good, the bad, the ugly]</title>
        <itunes:title>FDA approves Opdivo subcutaneous version, Marinus Pharmaceuticals sells operations, Novo Nordisk pushes back against compounding pharmacies [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-approves-opdivosubcutaneous-versionmarinuspharmaceuticalssells-operations-novo-nordisk-pushes-back-against-compounding-pharmaciesthegoodthebad/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-approves-opdivosubcutaneous-versionmarinuspharmaceuticalssells-operations-novo-nordisk-pushes-back-against-compounding-pharmaciesthegoodthebad/#comments</comments>        <pubDate>Tue, 07 Jan 2025 14:20:24 -0600</pubDate>
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                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Opdivo subcutaneous version</p>
<p>The bad — Marinus Pharmaceuticals sells operations</p>
<p>The ugly — Novo Nordisk pushes back against compounding pharmacies </p>
<p> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Opdivo subcutaneous version</p>
<p>The bad — Marinus Pharmaceuticals sells operations</p>
<p>The ugly — Novo Nordisk pushes back against compounding pharmacies </p>
<p> </p>
]]></content:encoded>
                                    
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        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — FDA approves Opdivo subcutaneous version
The bad — Marinus Pharmaceuticals sells operations
The ugly — Novo Nordisk pushes back against compounding pharmacies 
 ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>199</itunes:duration>
                <itunes:episode>74</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
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    <item>
        <title>EU approves Novo-Catalent acquisition, CDMO National Resilience announces layoffs, FDA investigates blood cancer reports in gene therapy patients [The good, the bad, the ugly]</title>
        <itunes:title>EU approves Novo-Catalent acquisition, CDMO National Resilience announces layoffs, FDA investigates blood cancer reports in gene therapy patients [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/eu-approves-novo-catalentacquisition-cdmo-national-resilience-announces-layoffs-fda-investigatesbloodcancer-reportsin-gene-therapy-patientsthegoodthe/</link>
                    <comments>https://pharmamanu.podbean.com/e/eu-approves-novo-catalentacquisition-cdmo-national-resilience-announces-layoffs-fda-investigatesbloodcancer-reportsin-gene-therapy-patientsthegoodthe/#comments</comments>        <pubDate>Fri, 13 Dec 2024 13:36:33 -0600</pubDate>
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                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — EU approves Novo-Catalent acquisition</p>
<p>The bad — CDMO National Resilience announces layoffs</p>
<p>The ugly — FDA investigates blood cancer reports in gene therapy patients</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — EU approves Novo-Catalent acquisition</p>
<p>The bad — CDMO National Resilience announces layoffs</p>
<p>The ugly — FDA investigates blood cancer reports in gene therapy patients</p>
]]></content:encoded>
                                    
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        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — EU approves Novo-Catalent acquisition
The bad — CDMO National Resilience announces layoffs
The ugly — FDA investigates blood cancer reports in gene therapy patients]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>178</itunes:duration>
                <itunes:episode>73</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA approves Imkeldi oral solution, Alector axes workforce, Novartis announcnes layoffs [The good, the bad, the ugly]</title>
        <itunes:title>FDA approves Imkeldi oral solution, Alector axes workforce, Novartis announcnes layoffs [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-approves-imkeldi-oral-solution-alector-axes-workforce-novartis-announcnes-layoffs-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-approves-imkeldi-oral-solution-alector-axes-workforce-novartis-announcnes-layoffs-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 09 Dec 2024 07:09:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/1f54bb90-847a-3e93-b64c-593b0e2ed1c6</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Imkeldi oral solution</p>
<p>The bad — Alector axes workforce</p>
<p>The ugly — Novartis announcnes layoffs</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Imkeldi oral solution</p>
<p>The bad — Alector axes workforce</p>
<p>The ugly — Novartis announcnes layoffs</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/6sss8bujafdk697e/PM_OffScript_TGTBTU_124_mixdown8bsgn.mp3" length="4653221" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — FDA approves Imkeldi oral solution
The bad — Alector axes workforce
The ugly — Novartis announcnes layoffs]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>192</itunes:duration>
                <itunes:episode>72</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA grants Regenxbio accelerated path for Duchenne, Neurogene reports death in Rett trial, Halozyme drops Evotec bid [The good, the bad, the ugly]</title>
        <itunes:title>FDA grants Regenxbio accelerated path for Duchenne, Neurogene reports death in Rett trial, Halozyme drops Evotec bid [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-grants-regenxbio-accelerated-path-for-duchenne-neurogene-reports-death-in-rett-trial-halozyme-drops-evotec-bid-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-grants-regenxbio-accelerated-path-for-duchenne-neurogene-reports-death-in-rett-trial-halozyme-drops-evotec-bid-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Tue, 26 Nov 2024 14:57:59 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/02a2df1e-a465-37d6-b21f-d14a54596a3b</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA grants Regenxbio accelerated approval pathway for Duchenne gene therapy</p>
<p>The bad —  Neurogene reports patient death in Rett syndrome gene therapy trial</p>
<p>The ugly —  Halozyme withdraws acquisition proposal for Evotec</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA grants Regenxbio accelerated approval pathway for Duchenne gene therapy</p>
<p>The bad —  Neurogene reports patient death in Rett syndrome gene therapy trial</p>
<p>The ugly —  Halozyme withdraws acquisition proposal for Evotec</p>
]]></content:encoded>
                                    
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        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — FDA grants Regenxbio accelerated approval pathway for Duchenne gene therapy
The bad —  Neurogene reports patient death in Rett syndrome gene therapy trial
The ugly —  Halozyme withdraws acquisition proposal for Evotec]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>199</itunes:duration>
                <itunes:episode>71</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>PTC secures FDA nod, Kronos Bio halts CDK9 development, Marinus slashes 45% of workforce amid setbacks [The good, the bad, the ugly]</title>
        <itunes:title>PTC secures FDA nod, Kronos Bio halts CDK9 development, Marinus slashes 45% of workforce amid setbacks [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/ptc-secures-fda-nod-kronos-bio-halts-cdk9-development-marinus-slashes-45-of-workforce-amid-setbacks-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/ptc-secures-fda-nod-kronos-bio-halts-cdk9-development-marinus-slashes-45-of-workforce-amid-setbacks-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Thu, 21 Nov 2024 11:28:01 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/f3a7d507-4658-3636-abd2-7a19b695082e</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — PTC secures FDA nod for brain-targeted gene therapy </p>
<p>The bad —  Kronos Bio halts CDK9 development</p>
<p>The ugly —  Marinus slashes 45% of workforce amid setbacks</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — PTC secures FDA nod for brain-targeted gene therapy </p>
<p>The bad —  Kronos Bio halts CDK9 development</p>
<p>The ugly —  Marinus slashes 45% of workforce amid setbacks</p>
]]></content:encoded>
                                    
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        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — PTC secures FDA nod for brain-targeted gene therapy 
The bad —  Kronos Bio halts CDK9 development
The ugly —  Marinus slashes 45% of workforce amid setbacks]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>193</itunes:duration>
                <itunes:episode>70</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Ascendis, Novo ink partnership, Court blocks Sun Pharma launch, FDA moves to delist phenylephrine [The good, the bad, the ugly]</title>
        <itunes:title>Ascendis, Novo ink partnership, Court blocks Sun Pharma launch, FDA moves to delist phenylephrine [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/ascendis-novo-ink-partnership-court-blocks-sun-pharma-launch-fda-moves-to-delist-phenylephrine-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/ascendis-novo-ink-partnership-court-blocks-sun-pharma-launch-fda-moves-to-delist-phenylephrine-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Thu, 14 Nov 2024 09:57:32 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/da633fcb-d3ec-34f9-8dfb-981b4a35bc5f</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Ascendis, Novo ink partnership</p>
<p>The bad — Court blocks Sun Pharma launch</p>
<p>The ugly — FDA moves to delist phenylephrine</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Ascendis, Novo ink partnership</p>
<p>The bad — Court blocks Sun Pharma launch</p>
<p>The ugly — FDA moves to delist phenylephrine</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/czqm44qacjx7zbxy/PM_OffScript_TGTBTU_1113_mixdownaxxsa.mp3" length="5194362" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Ascendis, Novo ink partnership
The bad — Court blocks Sun Pharma launch
The ugly — FDA moves to delist phenylephrine]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>215</itunes:duration>
                <itunes:episode>69</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>MilliporeSigma expands ADC manufacturing, EU fines Teva, AZ exec under investigation in China  [The good, the bad, the ugly]</title>
        <itunes:title>MilliporeSigma expands ADC manufacturing, EU fines Teva, AZ exec under investigation in China  [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/milliporesigma-expands-adc-manufacturing-eu-fines-teva-az-exec-under-investigation-in-china-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/milliporesigma-expands-adc-manufacturing-eu-fines-teva-az-exec-under-investigation-in-china-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Wed, 06 Nov 2024 06:36:00 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/b606e867-f8f4-3f8e-b5ec-b758f8a290ac</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — MilliporeSigma expands ADC manufacturing </p>
<p>The bad — EU fines Teva</p>
<p>The ugly — AZ exec under investigation</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — MilliporeSigma expands ADC manufacturing </p>
<p>The bad — EU fines Teva</p>
<p>The ugly — AZ exec under investigation</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/26tdsaiut5w87s3a/PM_OffScript_TGTBTU_114_mixdownbbvbp.mp3" length="4279763" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — MilliporeSigma expands ADC manufacturing 
The bad — EU fines Teva
The ugly — AZ exec under investigation]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>177</itunes:duration>
                <itunes:episode>68</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Extended Release] Antibiotic resistance crisis and the global efforts against superbugs</title>
        <itunes:title>[Extended Release] Antibiotic resistance crisis and the global efforts against superbugs</itunes:title>
        <link>https://pharmamanu.podbean.com/e/extended-release-antibiotic-resistance-crisis-and-the-global-efforts-against-superbugs/</link>
                    <comments>https://pharmamanu.podbean.com/e/extended-release-antibiotic-resistance-crisis-and-the-global-efforts-against-superbugs/#comments</comments>        <pubDate>Wed, 30 Oct 2024 10:42:28 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/8b1c2462-8001-30a1-814c-e63c43fbccbf</guid>
                                    <description><![CDATA[<p>Join senior editor Andrea Corona and Emily Wheeler, Director of Infectious Disease Policy at the Biotechnology Innovation Organization (BIO), as they discuss the urgency of tackling antimicrobial resistance and the coordinated global efforts needed to save the struggling market of antibiotics. </p>
<p>Extended Release is an Off Script series to revisit conversations with our sources and explore new developments, gain deeper insights, and provide updates on the impact of their work. </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join senior editor Andrea Corona and Emily Wheeler, Director of Infectious Disease Policy at the Biotechnology Innovation Organization (BIO), as they discuss the urgency of tackling antimicrobial resistance and the coordinated global efforts needed to save the struggling market of antibiotics. </p>
<p>Extended Release is an<em> Off Script</em> series to revisit conversations with our sources and explore new developments, gain deeper insights, and provide updates on the impact of their work. </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/in2f98vgj354rags/PM_OffScript_ExtendedRelease_AMR_Oct_mixdown.mp3" length="21605285" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join senior editor Andrea Corona and Emily Wheeler, Director of Infectious Disease Policy at the Biotechnology Innovation Organization (BIO), as they discuss the urgency of tackling antimicrobial resistance and the coordinated global efforts needed to save the struggling market of antibiotics. 
Extended Release is an Off Script series to revisit conversations with our sources and explore new developments, gain deeper insights, and provide updates on the impact of their work. ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>899</itunes:duration>
                <itunes:episode>67</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Nucleus RadioPharma expands production with new sites, FDA issues CRL to Camurus' hormone disorder drug, NHS rejects Eli Lilly's Alzheimer's drug over cost [The good, the bad, the ugly]</title>
        <itunes:title>Nucleus RadioPharma expands production with new sites, FDA issues CRL to Camurus' hormone disorder drug, NHS rejects Eli Lilly's Alzheimer's drug over cost [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/nucleus-radiopharmaexpands-production-with-new-sitesfda-issuescrlto-camurushormonedisorder-drugnhs-rejects-elilillys-alzheimersdrugovercostthegoodthe/</link>
                    <comments>https://pharmamanu.podbean.com/e/nucleus-radiopharmaexpands-production-with-new-sitesfda-issuescrlto-camurushormonedisorder-drugnhs-rejects-elilillys-alzheimersdrugovercostthegoodthe/#comments</comments>        <pubDate>Mon, 28 Oct 2024 15:55:18 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/014abe40-8391-3725-b9ac-a0a009ee5bd6</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Nucleus RadioPharma expands production with new sites </p>
<p>The bad — FDA issues CRL to Camurus' hormone disorder drug </p>
<p>The ugly —  NHS rejects Alzheimer's drug over cost concerns </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Nucleus RadioPharma expands production with new sites </p>
<p>The bad — FDA issues CRL to Camurus' hormone disorder drug </p>
<p>The ugly —  NHS rejects Alzheimer's drug over cost concerns </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/xqs3ukju6zfr2iyh/PM_OffScript_TGTBTU_1028_mixdown_1_9u45f.mp3" length="4594332" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Nucleus RadioPharma expands production with new sites 
The bad — FDA issues CRL to Camurus' hormone disorder drug 
The ugly —  NHS rejects Alzheimer's drug over cost concerns ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>190</itunes:duration>
                <itunes:episode>66</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA approves AbbVie 24-hour Parkinson’s treatment, Sage Therapeutics axes workforce, FDA halts Novavax's COVID-flu vax trials [The good, the bad, the ugly]</title>
        <itunes:title>FDA approves AbbVie 24-hour Parkinson’s treatment, Sage Therapeutics axes workforce, FDA halts Novavax's COVID-flu vax trials [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-approves-abbvie-24-hour-parkinson-s-treatment-sage-therapeutics-axes-workforce-fda-halts-novavaxs-covid-flu-vax-trials-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-approves-abbvie-24-hour-parkinson-s-treatment-sage-therapeutics-axes-workforce-fda-halts-novavaxs-covid-flu-vax-trials-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 21 Oct 2024 15:13:04 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/6fe62616-227f-3d2a-acde-2f58e5e651d5</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves AbbVie 24-hour Parkinson’s treatment </p>
<p>The bad — Sage Therapeutics axes workforce </p>
<p>The ugly — FDA halts Novavax's COVID-flu vaccine trials </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves AbbVie 24-hour Parkinson’s treatment </p>
<p>The bad — Sage Therapeutics axes workforce </p>
<p>The ugly — FDA halts Novavax's COVID-flu vaccine trials </p>
]]></content:encoded>
                                    
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        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — FDA approves AbbVie 24-hour Parkinson’s treatment 
The bad — Sage Therapeutics axes workforce 
The ugly — FDA halts Novavax's COVID-flu vaccine trials ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>170</itunes:duration>
                <itunes:episode>65</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Roche gets FDA nod for breast cancer combo, Kezar’s lupus drug trial on hold, Zealand Pharma’s hypoglycemia drug rejected over manufacturing [The good, the bad, the ugly]</title>
        <itunes:title>Roche gets FDA nod for breast cancer combo, Kezar’s lupus drug trial on hold, Zealand Pharma’s hypoglycemia drug rejected over manufacturing [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/rochegetsfdanod-for-breastcancer-combo-kezars-lupus-drug-trial-on-hold-zealandpharma-shypoglycemia-drug-rejected-over-manufacturingthegoodthebadthe/</link>
                    <comments>https://pharmamanu.podbean.com/e/rochegetsfdanod-for-breastcancer-combo-kezars-lupus-drug-trial-on-hold-zealandpharma-shypoglycemia-drug-rejected-over-manufacturingthegoodthebadthe/#comments</comments>        <pubDate>Mon, 14 Oct 2024 16:37:15 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/e792cf59-56c4-3062-a51d-ade7a90a3776</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Roche snags breast cancer FDA nod </p>
<p>The bad — FDA places clinical hold on Kezar lupus nephritis drug trial </p>
<p>The ugly — FDA rejects Zealand Pharma hypoglycemia drug over manufacturing reinspection </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Roche snags breast cancer FDA nod </p>
<p>The bad — FDA places clinical hold on Kezar lupus nephritis drug trial </p>
<p>The ugly — FDA rejects Zealand Pharma hypoglycemia drug over manufacturing reinspection </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/5e5xq3z6qc838e5i/PM_OffScript_TGTBTU_1014_mixdown8v2cg.mp3" length="4302804" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Roche snags breast cancer FDA nod 
The bad — FDA places clinical hold on Kezar lupus nephritis drug trial 
The ugly — FDA rejects Zealand Pharma hypoglycemia drug over manufacturing reinspection ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>178</itunes:duration>
                <itunes:episode>64</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Gilead inks deal with generics manufacturers to expand HIV drug access, J&amp;J announces layoffs, Amgen sued for hiding $10.7B tax bill  [The good, the bad, the ugly]</title>
        <itunes:title>Gilead inks deal with generics manufacturers to expand HIV drug access, J&amp;J announces layoffs, Amgen sued for hiding $10.7B tax bill  [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/gilead-inks-deal-with-genericsmanufacturersto-expandhiv-drug-accessjjannounceslayoffsamgensuedforhiding-107b-tax-billthe-goodthe-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/gilead-inks-deal-with-genericsmanufacturersto-expandhiv-drug-accessjjannounceslayoffsamgensuedforhiding-107b-tax-billthe-goodthe-bad-the-ugly/#comments</comments>        <pubDate>Mon, 07 Oct 2024 15:25:22 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/f965043a-dd8a-3e5e-be6b-1ba9a250434e</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Gilead inks deal with generics manufacturers to expand HIV drug access </p>
<p>The bad — J&amp;J announces layoffs at New Brunswick headquarters </p>
<p>The ugly — Amgen sued for hiding $10.7B tax bill </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Gilead inks deal with generics manufacturers to expand HIV drug access </p>
<p>The bad — J&amp;J announces layoffs at New Brunswick headquarters </p>
<p>The ugly — Amgen sued for hiding $10.7B tax bill </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/sx9ziwhg4bpp7h8y/PM_OffScript_TGTBTU_107_mixdown9vpbu.mp3" length="5795309" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Gilead inks deal with generics manufacturers to expand HIV drug access 
The bad — J&amp;J announces layoffs at New Brunswick headquarters 
The ugly — Amgen sued for hiding $10.7B tax bill ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>240</itunes:duration>
                <itunes:episode>63</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA approves BMS schizophrenia drug, bluebird bio announces layoffs, J&amp;J talc subsidiary files for bankruptcy [The good, the bad, the ugly]</title>
        <itunes:title>FDA approves BMS schizophrenia drug, bluebird bio announces layoffs, J&amp;J talc subsidiary files for bankruptcy [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-approves-bms-schizophrenia-drug-bluebird-bio-announces-layoffs-jj-talc-subsidiary-files-for-bankruptcy-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-approves-bms-schizophrenia-drug-bluebird-bio-announces-layoffs-jj-talc-subsidiary-files-for-bankruptcy-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 30 Sep 2024 15:09:25 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/61bb0de0-cfd8-3b9d-80e9-a523fae12f4b</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good —FDA approves BMS schizophrenia drug </p>
<p>The bad — bluebird bio announces layoffs </p>
<p>The ugly —J&amp;J talc subsidiary files for bankruptcy</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good —FDA approves BMS schizophrenia drug </p>
<p>The bad — bluebird bio announces layoffs </p>
<p>The ugly —J&amp;J talc subsidiary files for bankruptcy</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/up7wpzgjqeybxhiy/PM_OffScript_TGTBTU_930_mixdown7rmos.mp3" length="5251080" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good —FDA approves BMS schizophrenia drug 
The bad — bluebird bio announces layoffs 
The ugly —J&amp;J talc subsidiary files for bankruptcy]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>217</itunes:duration>
                <itunes:episode>62</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Extended Release] Schizophrenia treatment barriers, KarXT, and the future of neuroscience</title>
        <itunes:title>[Extended Release] Schizophrenia treatment barriers, KarXT, and the future of neuroscience</itunes:title>
        <link>https://pharmamanu.podbean.com/e/extended-release-schizophrenia-treatment-barriers-karxt-and-the-future-of-neuroscience/</link>
                    <comments>https://pharmamanu.podbean.com/e/extended-release-schizophrenia-treatment-barriers-karxt-and-the-future-of-neuroscience/#comments</comments>        <pubDate>Thu, 26 Sep 2024 09:19:56 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/a980e504-7ba6-37cd-9748-06bc7aab3683</guid>
                                    <description><![CDATA[<p>Join senior editor Andrea Corona and Sam Clark, CEO and founder of Terran Biosciences, for a discussion on KarXT's landmark approval, schizophrenia treatment barriers, prodrugs, and more. </p>
<p>Extended Release is an Off Script series that allows us to revisit conversations with our sources to explore new developments, gain deeper insights, and provide updates on the impact of their work. Each episode goes beyond the initial story, offering a richer understanding of key topics and ongoing innovations in the pharma industry.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join senior editor Andrea Corona and Sam Clark, CEO and founder of Terran Biosciences, for a discussion on KarXT's landmark approval, schizophrenia treatment barriers, prodrugs, and more. </p>
<p>Extended Release is an Off Script series that allows us to revisit conversations with our sources to explore new developments, gain deeper insights, and provide updates on the impact of their work. Each episode goes beyond the initial story, offering a richer understanding of key topics and ongoing innovations in the pharma industry.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/ir4rqqypfffhm23h/PodcastExtendedrelese27pxy9.mp3" length="20976243" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join senior editor Andrea Corona and Sam Clark, CEO and founder of Terran Biosciences, for a discussion on KarXT's landmark approval, schizophrenia treatment barriers, prodrugs, and more. 
Extended Release is an Off Script series that allows us to revisit conversations with our sources to explore new developments, gain deeper insights, and provide updates on the impact of their work. Each episode goes beyond the initial story, offering a richer understanding of key topics and ongoing innovations in the pharma industry.]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1048</itunes:duration>
                <itunes:episode>61</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Novo Nordisk shares phase 2a obesity trial data, Achilles Therapeutics ends TIL-based therapy, Express Scripts sues FTC [The good, the bad, the ugly]</title>
        <itunes:title>Novo Nordisk shares phase 2a obesity trial data, Achilles Therapeutics ends TIL-based therapy, Express Scripts sues FTC [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/novo-nordisk-shares-phase-2a-obesity-trial-data-achilles-therapeutics-ends-til-based-therapy-express-scripts-sues-ftc-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/novo-nordisk-shares-phase-2a-obesity-trial-data-achilles-therapeutics-ends-til-based-therapy-express-scripts-sues-ftc-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 23 Sep 2024 14:49:59 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/ff50e294-1c3c-3d74-ac03-48da306b2b99</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Novo Nordisk shares phase 2a trial data for obesity treatment </p>
<p>The bad — Achilles Therapeutics to discontinue TIL-based therapy </p>
<p>The ugly — Express Scripts files lawsuit against FTC </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Novo Nordisk shares phase 2a trial data for obesity treatment </p>
<p>The bad — Achilles Therapeutics to discontinue TIL-based therapy </p>
<p>The ugly — Express Scripts files lawsuit against FTC </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/577z7qjddkfg72x8/PM_OffScript_TGTBTU_923_mixdown87xcp.mp3" length="4938978" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Novo Nordisk shares phase 2a trial data for obesity treatment 
The bad — Achilles Therapeutics to discontinue TIL-based therapy 
The ugly — Express Scripts files lawsuit against FTC ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>204</itunes:duration>
                <itunes:episode>60</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight]  Optimizing contamination control in pharma facilities</title>
        <itunes:title>[Solutions Spotlight]  Optimizing contamination control in pharma facilities</itunes:title>
        <link>https://pharmamanu.podbean.com/e/solutions-spotlight-optimizing-contamination-control-in-pharma-facilities/</link>
                    <comments>https://pharmamanu.podbean.com/e/solutions-spotlight-optimizing-contamination-control-in-pharma-facilities/#comments</comments>        <pubDate>Thu, 19 Sep 2024 12:00:13 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/d05de379-e31c-355e-9597-6ccdb968da79</guid>
                                    <description><![CDATA[<p class="p1">Drugmakers face stringent regulations to ensure that products remain free from contaminants that could compromise safety and efficacy. Effective contamination control requires meticulous monitoring of environmental conditions, rigorous testing of products, and implementation of robust cleaning and sterilization procedures.</p>
<p class="p1">To better understand these challenges, we sat down with Emily Alkandry, analytical services and quality control manager and Gabrielle Wilson, sterility assurance program manager at Saint-Gobain Life Sciences about the importance of comprehensive contamination control strategies for ensuring product quality and regulatory compliance.</p>
<p class="p1">Learn more about Saint-Gobain Life Sciences: <a href='https://www.lifesciences.saint-gobain.com/'>https://www.lifesciences.saint-gobain.com/</a></p>
]]></description>
                                                            <content:encoded><![CDATA[<p class="p1">Drugmakers face stringent regulations to ensure that products remain free from contaminants that could compromise safety and efficacy. Effective contamination control requires meticulous monitoring of environmental conditions, rigorous testing of products, and implementation of robust cleaning and sterilization procedures.</p>
<p class="p1">To better understand these challenges, we sat down with Emily Alkandry, analytical services and quality control manager and Gabrielle Wilson, sterility assurance program manager at Saint-Gobain Life Sciences about the importance of comprehensive contamination control strategies for ensuring product quality and regulatory compliance.</p>
<p class="p1">Learn more about Saint-Gobain Life Sciences: <a href='https://www.lifesciences.saint-gobain.com/'>https://www.lifesciences.saint-gobain.com/</a></p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/xtnc7qjxc4g3gevh/New_Pharma_mixdown7505z.mp3" length="18078669" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Drugmakers face stringent regulations to ensure that products remain free from contaminants that could compromise safety and efficacy. Effective contamination control requires meticulous monitoring of environmental conditions, rigorous testing of products, and implementation of robust cleaning and sterilization procedures.
To better understand these challenges, we sat down with Emily Alkandry, analytical services and quality control manager and Gabrielle Wilson, sterility assurance program manager at Saint-Gobain Life Sciences about the importance of comprehensive contamination control strategies for ensuring product quality and regulatory compliance.
Learn more about Saint-Gobain Life Sciences: https://www.lifesciences.saint-gobain.com/]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>752</itunes:duration>
                <itunes:episode>59</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Roche wins FDA approval for subcutaneous cancer immunotherapy, Moderna to cut $1.1B in R&amp;D expenses, Teva settles $80M opioid case with Baltimore [The good, the bad, the ugly]</title>
        <itunes:title>Roche wins FDA approval for subcutaneous cancer immunotherapy, Moderna to cut $1.1B in R&amp;D expenses, Teva settles $80M opioid case with Baltimore [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/rochewinsfdaapproval-for-subcutaneouscancer-immunotherapy-modernato-cut-11b-in-rdexpensestevasettles80m-opioidcasewithbaltimorethegoodthebadtheugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/rochewinsfdaapproval-for-subcutaneouscancer-immunotherapy-modernato-cut-11b-in-rdexpensestevasettles80m-opioidcasewithbaltimorethegoodthebadtheugly/#comments</comments>        <pubDate>Mon, 16 Sep 2024 13:26:24 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/a7a18508-a597-3bef-b68d-cbd3eaa041d7</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Roche snags FDA nod for subcutaneous cancer immunotherapy </p>
<p>The bad — Moderna to cut R&amp;D expenses by $1.1B </p>
<p>The ugly — Teva reaches $80M opioid settlement with Baltimore </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Roche snags FDA nod for subcutaneous cancer immunotherapy </p>
<p>The bad — Moderna to cut R&amp;D expenses by $1.1B </p>
<p>The ugly — Teva reaches $80M opioid settlement with Baltimore </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/xvxbkvkju6bb9rzk/PM_OffScript_TGTBTU_916_mixdown6pgnq.mp3" length="5177532" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Roche snags FDA nod for subcutaneous cancer immunotherapy 
The bad — Moderna to cut R&amp;D expenses by $1.1B 
The ugly — Teva reaches $80M opioid settlement with Baltimore ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>214</itunes:duration>
                <itunes:episode>58</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Pfizer, Valneva share phase 2 Lyme vax data, IN8bio axes workforce, AstraZeneca employees detained in China [The good, the bad, the ugly]</title>
        <itunes:title>Pfizer, Valneva share phase 2 Lyme vax data, IN8bio axes workforce, AstraZeneca employees detained in China [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/pfizer-valneva-share-phase-2-lyme-vax-data-in8bio-axes-workforce-astrazeneca-employees-detained-in-china-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/pfizer-valneva-share-phase-2-lyme-vax-data-in8bio-axes-workforce-astrazeneca-employees-detained-in-china-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 09 Sep 2024 14:41:35 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/8b08e97b-fe9a-3f2d-9619-8426ecba65e5</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Pfizer, Valneva share phase 2 positive Lyme vax data </p>
<p>The bad — IN8bio axes workforce, halts trial </p>
<p>The ugly — AstraZeneca employees detained in China </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Pfizer, Valneva share phase 2 positive Lyme vax data </p>
<p>The bad — IN8bio axes workforce, halts trial </p>
<p>The ugly — AstraZeneca employees detained in China </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/utqdus96djradca7/PM_OffScript_TGTBTU_99_mixdown9q72r.mp3" length="6073877" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Pfizer, Valneva share phase 2 positive Lyme vax data 
The bad — IN8bio axes workforce, halts trial 
The ugly — AstraZeneca employees detained in China ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>252</itunes:duration>
                <itunes:episode>57</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA approves Illumina cancer biomarker test, BioMarin reveals more layoffs, FDA hits API maker Global Calcium with 483 [The good, the bad, the ugly]</title>
        <itunes:title>FDA approves Illumina cancer biomarker test, BioMarin reveals more layoffs, FDA hits API maker Global Calcium with 483 [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-approves-illumina-cancer-biomarker-test-biomarin-reveals-more-layoffs-fda-hits-api-maker-global-calcium-with-483-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-approves-illumina-cancer-biomarker-test-biomarin-reveals-more-layoffs-fda-hits-api-maker-global-calcium-with-483-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Tue, 03 Sep 2024 15:40:20 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/e511aa92-c61f-3659-9c07-114d38a05b26</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Illumina cancer biomarker test </p>
<p>The bad — BioMarin reveals more layoffs </p>
<p>The ugly — FDA hits API maker Global Calcium with 483 </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Illumina cancer biomarker test </p>
<p>The bad — BioMarin reveals more layoffs </p>
<p>The ugly — FDA hits API maker Global Calcium with 483 </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/agqxzrw76f6bn3cw/PM_OffScript_TGTBTU_93_mixdownbqsj0.mp3" length="5079215" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — FDA approves Illumina cancer biomarker test 
The bad — BioMarin reveals more layoffs 
The ugly — FDA hits API maker Global Calcium with 483 ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>210</itunes:duration>
                <itunes:episode>56</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Pharma’s new age of longevity</title>
        <itunes:title>Pharma’s new age of longevity</itunes:title>
        <link>https://pharmamanu.podbean.com/e/pharma-s-new-age-of-longevity/</link>
                    <comments>https://pharmamanu.podbean.com/e/pharma-s-new-age-of-longevity/#comments</comments>        <pubDate>Wed, 28 Aug 2024 12:43:40 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/a6aac9bc-37fc-3f1c-b78c-28748e4f0305</guid>
                                    <description><![CDATA[<p>The concept of healthspan has recently gained new attention in the pharma industry and rightfully so, given the surprisingly large chasm in the U.S. between average years lived (77.5) and average years lived in good health (63.9). Facing a growing demographic of unhealthy seniors, a handful of innovative biotechs are reframing the longevity discussion: Rather than treat the symptoms of aging one disease at a time, what if we could instead focus on the root causes, enabling treatment of multiple chronic diseases simultaneously? </p>
<p>During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, discussing the compelling new research and novel genetic medicines that may help close the gap between healthspan and lifespan.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>The concept of healthspan has recently gained new attention in the pharma industry and rightfully so, given the surprisingly large chasm in the U.S. between average years lived (77.5) and average years lived in good health (63.9). Facing a growing demographic of unhealthy seniors, a handful of innovative biotechs are reframing the longevity discussion: Rather than treat the symptoms of aging one disease at a time, what if we could instead focus on the root causes, enabling treatment of multiple chronic diseases simultaneously? </p>
<p>During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, discussing the compelling new research and novel genetic medicines that may help close the gap between healthspan and lifespan.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/t3z6m8bf99dfpy4h/PM_OffScript_Episode4_2024_v2_mixdown.mp3" length="6159531" type="audio/mpeg"/>
        <itunes:summary><![CDATA[The concept of healthspan has recently gained new attention in the pharma industry and rightfully so, given the surprisingly large chasm in the U.S. between average years lived (77.5) and average years lived in good health (63.9). Facing a growing demographic of unhealthy seniors, a handful of innovative biotechs are reframing the longevity discussion: Rather than treat the symptoms of aging one disease at a time, what if we could instead focus on the root causes, enabling treatment of multiple chronic diseases simultaneously? 
During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, discussing the compelling new research and novel genetic medicines that may help close the gap between healthspan and lifespan.]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>255</itunes:duration>
                <itunes:episode>55</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Emergent donates 50k doses of mpox vaccine to Africa, FDA rejects Regeneron blood cancer bispecific antibody, China indicts Astellas exec for espionage [The good, the bad, the ugly]</title>
        <itunes:title>Emergent donates 50k doses of mpox vaccine to Africa, FDA rejects Regeneron blood cancer bispecific antibody, China indicts Astellas exec for espionage [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/emergent-donates-50kdoses-ofmpoxvaccine-toafrica-fda-rejectsregeneronblood-cancer-bispecificantibodychinaindicts-astellas-exec-for-espionage-the-goo/</link>
                    <comments>https://pharmamanu.podbean.com/e/emergent-donates-50kdoses-ofmpoxvaccine-toafrica-fda-rejectsregeneronblood-cancer-bispecificantibodychinaindicts-astellas-exec-for-espionage-the-goo/#comments</comments>        <pubDate>Mon, 26 Aug 2024 15:42:17 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/1142b38e-34c9-30cf-b038-82b9575d35ec</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Emergent donates 50,000 doses of mpox vaccine to Africa </p>
<p>The bad — FDA rejects Regeneron blood cancer bispecific antibody </p>
<p>The ugly — China indicts Astellas exec for espionage </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Emergent donates 50,000 doses of mpox vaccine to Africa </p>
<p>The bad — FDA rejects Regeneron blood cancer bispecific antibody </p>
<p>The ugly — China indicts Astellas exec for espionage </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/6j2hax95zkcrqdib/PM_OffScript_TGTBTU_826_mixdownar6wq.mp3" length="5326409" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Emergent donates 50,000 doses of mpox vaccine to Africa 
The bad — FDA rejects Regeneron blood cancer bispecific antibody 
The ugly — China indicts Astellas exec for espionage ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>221</itunes:duration>
                <itunes:episode>54</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA approves Ascendis drug, Lykos PTSD treatment rejected, Novartis bid blocked [The good, the bad, the ugly]</title>
        <itunes:title>FDA approves Ascendis drug, Lykos PTSD treatment rejected, Novartis bid blocked [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-approves-ascendis-drug-lykos-ptsd-treatment-rejected-novartis-bid-blocked-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-approves-ascendis-drug-lykos-ptsd-treatment-rejected-novartis-bid-blocked-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 19 Aug 2024 13:25:38 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/48681f2e-dc36-3ca4-814a-8b6da31ffc12</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Ascendis hypoparathyroidism drug </p>
<p>The bad — FDA rejects Lykos MDMA PTSD drug </p>
<p>The ugly — Judge blocks Novartis bid to stop generic blockbuster heart drug </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Ascendis hypoparathyroidism drug </p>
<p>The bad — FDA rejects Lykos MDMA PTSD drug </p>
<p>The ugly — Judge blocks Novartis bid to stop generic blockbuster heart drug </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/4kdbvjc9a26hqbuh/PM_OffScript_TGTBTU_819_mixdown7qyna.mp3" length="4863395" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — FDA approves Ascendis hypoparathyroidism drug 
The bad — FDA rejects Lykos MDMA PTSD drug 
The ugly — Judge blocks Novartis bid to stop generic blockbuster heart drug ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>201</itunes:duration>
                <itunes:episode>53</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Amneal's Parkinson's pill approved, Novo Nordisk withdraws Wegovy approval expansion bid, FDA delays BeiGene Tevimbra decision [The good, the bad, the ugly]</title>
        <itunes:title>Amneal's Parkinson's pill approved, Novo Nordisk withdraws Wegovy approval expansion bid, FDA delays BeiGene Tevimbra decision [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/amneals-parkinsons-pill-approved-novo-nordisk-withdraws-wegovy-approval-expansion-bid-fda-delays-beigene-tevimbra-decision/</link>
                    <comments>https://pharmamanu.podbean.com/e/amneals-parkinsons-pill-approved-novo-nordisk-withdraws-wegovy-approval-expansion-bid-fda-delays-beigene-tevimbra-decision/#comments</comments>        <pubDate>Mon, 12 Aug 2024 12:49:14 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/cb063ab7-49a4-3ccc-bec4-3d75d3b46faa</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly.</p>
<p>Up this week:  </p>
<p>The good — Amneal gets FDA nod for Parkinson’s pill </p>
<p>The bad — Novo Nordisk withdraws bid for Wegovy label expansion in heart failure </p>
<p>The ugly — FDA delays decision on BeiGene Tevimbra as a first-line therapy </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly.</p>
<p>Up this week:  </p>
<p>The good — Amneal gets FDA nod for Parkinson’s pill </p>
<p>The bad — Novo Nordisk withdraws bid for Wegovy label expansion in heart failure </p>
<p>The ugly — FDA delays decision on BeiGene Tevimbra as a first-line therapy </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/i5v9vsp3xccg5i3m/PM_OffScript_TGTBTU_812_mixdown7e2qk.mp3" length="4313981" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly.
Up this week:  
The good — Amneal gets FDA nod for Parkinson’s pill 
The bad — Novo Nordisk withdraws bid for Wegovy label expansion in heart failure 
The ugly — FDA delays decision on BeiGene Tevimbra as a first-line therapy ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>179</itunes:duration>
                <itunes:episode>52</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA approves Adaptimmune therapy, halts vTv diabetes program; Sanofi sues Sarepta over Duchenne patents [The good, the bad, the ugly]</title>
        <itunes:title>FDA approves Adaptimmune therapy, halts vTv diabetes program; Sanofi sues Sarepta over Duchenne patents [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-approves-adaptimmune-therapy-halts-vtv-diabetes-program-sanofi-sues-sarepta-over-duchenne-patents/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-approves-adaptimmune-therapy-halts-vtv-diabetes-program-sanofi-sues-sarepta-over-duchenne-patents/#comments</comments>        <pubDate>Mon, 05 Aug 2024 15:56:17 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/11dcb8ea-55f0-31c7-8440-e594f05220f2</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Adaptimmune engineered cell therapy 
The bad — FDA puts clinical hold on vTv Therapeutics diabetes program 
The ugly — Sanofi sues Sarepta over manufacturing patents for Duchenne gene therapy </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Adaptimmune engineered cell therapy <br>
The bad — FDA puts clinical hold on vTv Therapeutics diabetes program <br>
The ugly — Sanofi sues Sarepta over manufacturing patents for Duchenne gene therapy </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/5xd85htwqenwvhv5/PM_OffScript_TGTBTU_85_mixdown6ay0k.mp3" length="5739094" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — FDA approves Adaptimmune engineered cell therapy The bad — FDA puts clinical hold on vTv Therapeutics diabetes program The ugly — Sanofi sues Sarepta over manufacturing patents for Duchenne gene therapy ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>238</itunes:duration>
                <itunes:episode>51</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA approves Sun Pharma hair loss drug, FDA issues warning letter to Brassica, EMA rejects Eisai-Biogen Alzheimer's drug [The good, the bad, the ugly]</title>
        <itunes:title>FDA approves Sun Pharma hair loss drug, FDA issues warning letter to Brassica, EMA rejects Eisai-Biogen Alzheimer's drug [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-approves-sun-pharma-hair-loss-drug-fda-issues-warning-letter-to-brassica-ema-rejects-eisai-biogen-alzheimers-drug-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-approves-sun-pharma-hair-loss-drug-fda-issues-warning-letter-to-brassica-ema-rejects-eisai-biogen-alzheimers-drug-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 29 Jul 2024 12:36:15 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/80f33084-d0f1-3e53-acb0-584d32c3e60f</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Sun Pharma hair loss drug 
The bad — FDA issues harsh warning letter to Indian CDMO Brassica 
The ugly — EMA issues negative opinion on Eisai-Biogen Alzheimer's drug </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA approves Sun Pharma hair loss drug <br>
The bad — FDA issues harsh warning letter to Indian CDMO Brassica <br>
The ugly — EMA issues negative opinion on Eisai-Biogen Alzheimer's drug </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/hi457t5nxesue8v9/PodcastJul29.mp3" length="4528504" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — FDA approves Sun Pharma hair loss drug The bad — FDA issues harsh warning letter to Indian CDMO Brassica The ugly — EMA issues negative opinion on Eisai-Biogen Alzheimer's drug ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>226</itunes:duration>
                <itunes:episode>50</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Genentech's oral weight loss drug shows promise; FDA denies accelerated approval for Agenus' cancer drug; Orexo's opioid overdose drug rejected again [The good, the bad, the ugly]</title>
        <itunes:title>Genentech's oral weight loss drug shows promise; FDA denies accelerated approval for Agenus' cancer drug; Orexo's opioid overdose drug rejected again [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/genentechs-oral-weight-loss-drug-showspromise-fda-deniesaccelerated-approvalforagenus-cancerdrugorexos-opioidoverdosedrugrejected-againthegoodthebad/</link>
                    <comments>https://pharmamanu.podbean.com/e/genentechs-oral-weight-loss-drug-showspromise-fda-deniesaccelerated-approvalforagenus-cancerdrugorexos-opioidoverdosedrugrejected-againthegoodthebad/#comments</comments>        <pubDate>Mon, 22 Jul 2024 15:36:49 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/921454dc-2cdb-3723-9229-d0f0c4147d07</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Genentech's oral weight loss drug shows promise 
The bad — FDA denies accelerated approval for Agenus' cancer drug 
The ugly — Orexo's opioid overdose drug rejected again </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Genentech's oral weight loss drug shows promise <br>
The bad — FDA denies accelerated approval for Agenus' cancer drug <br>
The ugly — Orexo's opioid overdose drug rejected again </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/mbh3eawe776rgsjy/PM_OffScript_TGTBTU_722_mixdowna996s.mp3" length="5185649" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Genentech's oral weight loss drug shows promise The bad — FDA denies accelerated approval for Agenus' cancer drug The ugly — Orexo's opioid overdose drug rejected again ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>215</itunes:duration>
                <itunes:episode>49</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Pfizer advances obesity pill, FDA rejects Novo insulin, FTC releases PBM report [The good, the bad, the ugly]</title>
        <itunes:title>Pfizer advances obesity pill, FDA rejects Novo insulin, FTC releases PBM report [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/pfizer-advances-obesity-pill-fda-rejects-novo-insulin-ftc-releases-pbm-report-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/pfizer-advances-obesity-pill-fda-rejects-novo-insulin-ftc-releases-pbm-report-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 15 Jul 2024 15:05:34 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/c3769194-75f4-3941-b0bd-6e32e8d063c1</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Pfizer advances once-daily obesity pill 
The bad — FDA rejects Novo Nordisk once-weekly insulin 
The ugly — FTC releases long-awaited report on PBMs </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Pfizer advances once-daily obesity pill <br>
The bad — FDA rejects Novo Nordisk once-weekly insulin <br>
The ugly — FTC releases long-awaited report on PBMs </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/8dtk8qca33dktrw7/PM_OffScript_TGTBTU_715_mixdown710t5.mp3" length="5015909" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Pfizer advances once-daily obesity pill The bad — FDA rejects Novo Nordisk once-weekly insulin The ugly — FTC releases long-awaited report on PBMs ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>208</itunes:duration>
                <itunes:episode>48</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Lilly Alzheimer’s drug gets full approval, Rocket gene therapy rejected, Eisai, BMS end ADC partnership [The good, the bad, the ugly]</title>
        <itunes:title>Lilly Alzheimer’s drug gets full approval, Rocket gene therapy rejected, Eisai, BMS end ADC partnership [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/eli-lilly-alzheimer-s-drug-granted-full-approval-rocket-gene-therapy-is-rejected-eisai-and-bms-end-adc-partnership-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/eli-lilly-alzheimer-s-drug-granted-full-approval-rocket-gene-therapy-is-rejected-eisai-and-bms-end-adc-partnership-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 08 Jul 2024 09:26:41 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/3ea5f4ae-b902-3305-9f15-d586ff29ae3a</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA grants Eli Lilly Alzheimer’s drug full approval 
The bad — FDA rejects Rocket gene therapy 
The ugly — Eisai, BMS end ADC partnership </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — FDA grants Eli Lilly Alzheimer’s drug full approval <br>
The bad — FDA rejects Rocket gene therapy <br>
The ugly — Eisai, BMS end ADC partnership </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/cz9g2spd6wbzdcf6/PM_OffScript_TGTBTU_78_mixdownak7ly.mp3" length="5397886" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — FDA grants Eli Lilly Alzheimer’s drug full approval The bad — FDA rejects Rocket gene therapy The ugly — Eisai, BMS end ADC partnership ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>224</itunes:duration>
                <itunes:episode>47</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] Streamlining oral dose packaging design</title>
        <itunes:title>[Solutions Spotlight] Streamlining oral dose packaging design</itunes:title>
        <link>https://pharmamanu.podbean.com/e/solutions-spotlight-streamlining-oral-dose-packaging-design/</link>
                    <comments>https://pharmamanu.podbean.com/e/solutions-spotlight-streamlining-oral-dose-packaging-design/#comments</comments>        <pubDate>Wed, 03 Jul 2024 12:04:49 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/8c939673-1e79-3565-9619-2b8a7f587b08</guid>
                                    <description><![CDATA[<p class="p2">By integrating a Quality by Design (QbD) approach, developers can design robust packaging from the outset,  drastically reducing development time and costs. Understanding how moisture affects a product is key, allowing developers to use industry-accepted and validated models to predict and address potential stability issues early in the design phase, thereby reducing the need for prolonged probe stability testing and potential reformulations or packaging redesign. </p>
<p class="p2">To understand more about the issues at hand, senior editor Andrea Corona recently spoke with Adrian Possumato, president and Chris Gilmor, director of sales, at Sanner of America.</p>
<p>Learn more about Sanner of America: <a href='https://www.sanner-group.com/'>https://www.sanner-group.com/</a></p>
<p> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p class="p2">By integrating a Quality by Design (QbD) approach, developers can design robust packaging from the outset,  drastically reducing development time and costs. Understanding how moisture affects a product is key, allowing developers to use industry-accepted and validated models to predict and address potential stability issues early in the design phase, thereby reducing the need for prolonged probe stability testing and potential reformulations or packaging redesign. </p>
<p class="p2">To understand more about the issues at hand, senior editor Andrea Corona recently spoke with Adrian Possumato, president and Chris Gilmor, director of sales, at Sanner of America.</p>
<p>Learn more about Sanner of America: <a href='https://www.sanner-group.com/'>https://www.sanner-group.com/</a></p>
<p> </p>
]]></content:encoded>
                                    
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        <itunes:summary><![CDATA[By integrating a Quality by Design (QbD) approach, developers can design robust packaging from the outset,  drastically reducing development time and costs. Understanding how moisture affects a product is key, allowing developers to use industry-accepted and validated models to predict and address potential stability issues early in the design phase, thereby reducing the need for prolonged probe stability testing and potential reformulations or packaging redesign. 
To understand more about the issues at hand, senior editor Andrea Corona recently spoke with Adrian Possumato, president and Chris Gilmor, director of sales, at Sanner of America.
Learn more about Sanner of America: https://www.sanner-group.com/
 ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1917</itunes:duration>
                <itunes:episode>44</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Verona wins COPD nod, FDA rejects Merck-Daiichi ADC, Glenmark recalls potassium chloride capsules [The good, the bad, the ugly]</title>
        <itunes:title>Verona wins COPD nod, FDA rejects Merck-Daiichi ADC, Glenmark recalls potassium chloride capsules [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/verona-wins-fda-nod-for-copd-fda-issues-crl-to-merck-daiichi-adc-glenmark-recalls-potassium-chloride-capsules-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/verona-wins-fda-nod-for-copd-fda-issues-crl-to-merck-daiichi-adc-glenmark-recalls-potassium-chloride-capsules-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 01 Jul 2024 11:19:45 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/6337f909-878f-3bf3-869f-f3437b59d555</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Verona wins FDA nod for COPD 
The bad — FDA issues CRL to Merck-Daiichi lung cancer ADC 
The ugly — Glenmark recalls 114 batches of potassium chloride capsules </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  </p>
<p>The good — Verona wins FDA nod for COPD <br>
The bad — FDA issues CRL to Merck-Daiichi lung cancer ADC <br>
The ugly — Glenmark recalls 114 batches of potassium chloride capsules </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/vp7evj8hx3ypvayt/PM_OffScript_TGTBTU_71_mixdown_1_6dgnl.mp3" length="5342104" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  
The good — Verona wins FDA nod for COPD The bad — FDA issues CRL to Merck-Daiichi lung cancer ADC The ugly — Glenmark recalls 114 batches of potassium chloride capsules ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>222</itunes:duration>
                <itunes:episode>46</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Gilead HIV shot delivers zero infections, Takeda epilepsy drug misses endpoints, Lilly goes after counterfeiters [The good, the bad, the ugly]</title>
        <itunes:title>Gilead HIV shot delivers zero infections, Takeda epilepsy drug misses endpoints, Lilly goes after counterfeiters [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/gilead-twice-yearlyhiv-shot-delivers-zero-infectionstakeda-epilepsydrugmisses-endpoints-eli-lilly-goes-aftercounterfeiters%c2%a0thegoodthebadthe-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/gilead-twice-yearlyhiv-shot-delivers-zero-infectionstakeda-epilepsydrugmisses-endpoints-eli-lilly-goes-aftercounterfeiters%c2%a0thegoodthebadthe-ugly/#comments</comments>        <pubDate>Mon, 24 Jun 2024 13:58:17 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/279b62c1-db34-3fbd-a870-09dc17427058</guid>
                                    <description><![CDATA[<p class="p1">Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p class="p1">The good — Gilead twice-yearly HIV shot delivers zero infections in trial 
The bad — Takeda epilepsy drug misses endpoints in trials 
The ugly — Eli Lilly goes after counterfeiters </p>
]]></description>
                                                            <content:encoded><![CDATA[<p class="p1">Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p class="p1">The good — Gilead twice-yearly HIV shot delivers zero infections in trial <br>
The bad — Takeda epilepsy drug misses endpoints in trials <br>
The ugly — Eli Lilly goes after counterfeiters </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/vtrhr2kqnir5b9dg/PM_OffScript_TGTBTU_624_mixdown69ved.mp3" length="5197615" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
The good — Gilead twice-yearly HIV shot delivers zero infections in trial The bad — Takeda epilepsy drug misses endpoints in trials The ugly — Eli Lilly goes after counterfeiters ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>216</itunes:duration>
                <itunes:episode>45</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA backs Lilly Alzheimer’s drug; Pfizer Duchenne gene therapy fails; Talc plaintiffs seek J&amp;J bankruptcy restraining order  [The good, the bad, the ugly]</title>
        <itunes:title>FDA backs Lilly Alzheimer’s drug; Pfizer Duchenne gene therapy fails; Talc plaintiffs seek J&amp;J bankruptcy restraining order  [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-backs-lilly-alzheimer-s-drug-pfizer-duchenne-gene-therapy-fails-talc-plaintiffs-seek-jj-bankruptcy-restraining-order-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-backs-lilly-alzheimer-s-drug-pfizer-duchenne-gene-therapy-fails-talc-plaintiffs-seek-jj-bankruptcy-restraining-order-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Tue, 18 Jun 2024 14:32:08 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/882816f5-12ea-39af-92d6-d864d9a6bcc3</guid>
                                    <description><![CDATA[<p class="p1">Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p class="p1">The good — FDA AdComm backs Eli Lilly Alzheimer’s drug
The bad — Pfizer gene therapy fails phase 3 Duchenne trial
The ugly — Talc plaintiffs seek restraining order on J&amp;J bankruptcy tactic</p>
]]></description>
                                                            <content:encoded><![CDATA[<p class="p1">Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p class="p1">The good — FDA AdComm backs Eli Lilly Alzheimer’s drug<br>
The bad — Pfizer gene therapy fails phase 3 Duchenne trial<br>
The ugly — Talc plaintiffs seek restraining order on J&amp;J bankruptcy tactic</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/ba48e6g8nnc7nrwh/PM_OffScript_TGTBTU_618_mixdown_1_alrj2.mp3" length="6373321" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
The good — FDA AdComm backs Eli Lilly Alzheimer’s drugThe bad — Pfizer gene therapy fails phase 3 Duchenne trialThe ugly — Talc plaintiffs seek restraining order on J&amp;J bankruptcy tactic]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>265</itunes:duration>
                <itunes:episode>43</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>AZ's Tagrisso shines in phase 3 trial, BMS layoffs, FDA violations at Jiangsu Hengrui site  [The good, the bad, the ugly]</title>
        <itunes:title>AZ's Tagrisso shines in phase 3 trial, BMS layoffs, FDA violations at Jiangsu Hengrui site  [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/azs-tagrisso-shines-in-phase-3-trial-bms-to-let-go-of-863-workers-fda-finds-violations-at-jiangsu-hengrui-site-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/azs-tagrisso-shines-in-phase-3-trial-bms-to-let-go-of-863-workers-fda-finds-violations-at-jiangsu-hengrui-site-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 10 Jun 2024 14:07:18 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/2885b726-1206-3ce3-8e40-3931db0e6e9d</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good —  AstraZeneca’s Tagrisso delivers 84% progression-free survival in trial
The bad — BMS to let go of 863 employees at NJ site 
The ugly — FDA inspection uncovers multiple violations at Jiangsu Hengrui Pharmaceuticals site</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good —  AstraZeneca’s Tagrisso delivers 84% progression-free survival in trial<br>
The bad — BMS to let go of 863 employees at NJ site <br>
The ugly — FDA inspection uncovers multiple violations at Jiangsu Hengrui Pharmaceuticals site</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/aq4irvur893y34va/PM_OffScript_TGTBTU_610_mixdown65vfr.mp3" length="5407452" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
The good —  AstraZeneca’s Tagrisso delivers 84% progression-free survival in trialThe bad — BMS to let go of 863 employees at NJ site The ugly — FDA inspection uncovers multiple violations at Jiangsu Hengrui Pharmaceuticals site]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>224</itunes:duration>
                <itunes:episode>42</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>J&amp;J depression drug aces trial, Takeda plans layoffs, FDA delays review of Sanofi-Regeneron's Dupixent [The good, the bad, the ugly]</title>
        <itunes:title>J&amp;J depression drug aces trial, Takeda plans layoffs, FDA delays review of Sanofi-Regeneron's Dupixent [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/jj-depressiondrugaceslatestagetrial-takedaplanslayoffs-at-massachusettssites-fda-delays-reviewof-sanofiregenerons-dupixent-incopdthegoodthebadthe-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/jj-depressiondrugaceslatestagetrial-takedaplanslayoffs-at-massachusettssites-fda-delays-reviewof-sanofiregenerons-dupixent-incopdthegoodthebadthe-ugly/#comments</comments>        <pubDate>Mon, 03 Jun 2024 13:35:26 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/96d1c34f-c864-3990-8fb1-c7fc16760d55</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good — J&amp;J depression drug aces late-stage trial
The bad — Takeda plans layoffs at Massachusetts sites
The ugly —  FDA delays review of Sanofi-Regeneron's Dupixent in COPD</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good — J&amp;J depression drug aces late-stage trial<br>
The bad — Takeda plans layoffs at Massachusetts sites<br>
The ugly —  FDA delays review of Sanofi-Regeneron's Dupixent in COPD</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/ib9i7xuevhe8tp67/PM_OffScript_TGTBTU_63_mixdown_1_7uoqv.mp3" length="4908149" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
The good — J&amp;J depression drug aces late-stage trialThe bad — Takeda plans layoffs at Massachusetts sitesThe ugly —  FDA delays review of Sanofi-Regeneron's Dupixent in COPD]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>204</itunes:duration>
                <itunes:episode>41</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Mining pharma's reshoring rush</title>
        <itunes:title>Mining pharma's reshoring rush</itunes:title>
        <link>https://pharmamanu.podbean.com/e/mining-pharmas-reshoring-rush/</link>
                    <comments>https://pharmamanu.podbean.com/e/mining-pharmas-reshoring-rush/#comments</comments>        <pubDate>Wed, 29 May 2024 10:20:14 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/c4966f64-7328-3879-8bd8-50db6da464cd</guid>
                                    <description><![CDATA[<p class="p1">When the pandemic hit and Americans found themselves looking to China for critical medical supplies, the idea of reshoring — a concept that had drifted along the currents of the manufacturing sector for over a decade — embedded itself into pharma discourse with renewed luster.</p>
<p class="p1">During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, Mining pharma's reshoring rush, and discuss where the industry stands amid the U.S. movement to bring the manufacturing of generic drugs, APIs and ingredients home.</p>
<p class="p1"> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p class="p1">When the pandemic hit and Americans found themselves looking to China for critical medical supplies, the idea of reshoring — a concept that had drifted along the currents of the manufacturing sector for over a decade — embedded itself into pharma discourse with renewed luster.</p>
<p class="p1">During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, Mining pharma's reshoring rush, and discuss where the industry stands amid the U.S. movement to bring the manufacturing of generic drugs, APIs and ingredients home.</p>
<p class="p1"> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/skeah4hevnt9in79/PM_OffScript_2024ep3_v2_mixdown.mp3" length="6427001" type="audio/mpeg"/>
        <itunes:summary><![CDATA[When the pandemic hit and Americans found themselves looking to China for critical medical supplies, the idea of reshoring — a concept that had drifted along the currents of the manufacturing sector for over a decade — embedded itself into pharma discourse with renewed luster.
During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, Mining pharma's reshoring rush, and discuss where the industry stands amid the U.S. movement to bring the manufacturing of generic drugs, APIs and ingredients home.
 ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>267</itunes:duration>
                <itunes:episode>40</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA approves biosim to Regeneron Eylea, Evotec exits gene therapy, J&amp;J reports deaths in radioligand trial [The good, the bad, the ugly]</title>
        <itunes:title>FDA approves biosim to Regeneron Eylea, Evotec exits gene therapy, J&amp;J reports deaths in radioligand trial [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-approves-biosim-to-regeneron-eylea-evotec-exits-gene-therapy-jj-reports-deaths-in-radioligand-trial-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-approves-biosim-to-regeneron-eylea-evotec-exits-gene-therapy-jj-reports-deaths-in-radioligand-trial-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Tue, 28 May 2024 12:02:04 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/37a9d29f-5109-31b6-b772-646a8ba3c1a3</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good —  FDA approves first interchangeable biosims to Regeneron Eylea 
The bad — Evotec exits gene therapy
The ugly —  J&amp;J reports deaths in early-stage radioligand trial</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good —  FDA approves first interchangeable biosims to Regeneron Eylea <br>
The bad — Evotec exits gene therapy<br>
The ugly —  J&amp;J reports deaths in early-stage radioligand trial</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/827qvzw7a2axysn5/PM_OffScript_TGTBTU_528_mixdown7qvg4.mp3" length="5051664" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
The good —  FDA approves first interchangeable biosims to Regeneron Eylea The bad — Evotec exits gene therapyThe ugly —  J&amp;J reports deaths in early-stage radioligand trial]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>210</itunes:duration>
                <itunes:episode>39</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>FDA approves Amgen's T-cell engager for lung cancer, BioMarin announces layoffs, FDA delays Ascendis drug review [The good, the bad, the ugly]</title>
        <itunes:title>FDA approves Amgen's T-cell engager for lung cancer, BioMarin announces layoffs, FDA delays Ascendis drug review [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/fda-approves-amgens-t-cell-engager-for-lung-cancer-biomarin-announces-layoffs-fda-delays-ascendis-drug-review-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/fda-approves-amgens-t-cell-engager-for-lung-cancer-biomarin-announces-layoffs-fda-delays-ascendis-drug-review-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 20 May 2024 10:56:20 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/466ba997-0fd1-3133-9377-c3f4fd9ceca0</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good —   FDA approves Amgen T-cell engager for small cell lung cancer 
The bad — BioMarin announces 170 layoffs 
The ugly — FDA delays review of Ascendis hypoparathyroidism drug</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good —   FDA approves Amgen T-cell engager for small cell lung cancer <br>
The bad — BioMarin announces 170 layoffs <br>
The ugly — FDA delays review of Ascendis hypoparathyroidism drug</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/djz6kgwhpyacg6m4/PM_OffScript_TGTBTU_520_mixdownad96g.mp3" length="5514282" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
The good —   FDA approves Amgen T-cell engager for small cell lung cancer The bad — BioMarin announces 170 layoffs The ugly — FDA delays review of Ascendis hypoparathyroidism drug]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>229</itunes:duration>
                <itunes:episode>38</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Vertex submits NDA for CF drug, MacroGenics reports ADC prostate cancer trial patient deaths, FTC extends review of Novo-Catalent deal [The good, the bad, the ugly]</title>
        <itunes:title>Vertex submits NDA for CF drug, MacroGenics reports ADC prostate cancer trial patient deaths, FTC extends review of Novo-Catalent deal [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/vertex%c2%a0submitsnda-for-cfdrugmacrogenics-reports-adcprostatecancer-trial-patientdeaths-ftc-extendsreview-ofnovocatalentdeal%c2%a0thegoodthebad/</link>
                    <comments>https://pharmamanu.podbean.com/e/vertex%c2%a0submitsnda-for-cfdrugmacrogenics-reports-adcprostatecancer-trial-patientdeaths-ftc-extendsreview-ofnovocatalentdeal%c2%a0thegoodthebad/#comments</comments>        <pubDate>Mon, 13 May 2024 10:36:52 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/3c6c12d5-73b1-3ab2-9c34-d9ba8c90e095</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good —  Vertex submits NDA for CF drug
The bad — MacroGenics reports patient deaths in prostate cancer ADC trial 
The ugly — FTC extends review of Novo-Catalent deal</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good —  Vertex submits NDA for CF drug<br>
The bad — MacroGenics reports patient deaths in prostate cancer ADC trial <br>
The ugly — FTC extends review of Novo-Catalent deal</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/rpuuinrs38upx369/PM_OffScript_TGTBTU_513_mixdown_1_b1kr5.mp3" length="6107101" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
The good —  Vertex submits NDA for CF drugThe bad — MacroGenics reports patient deaths in prostate cancer ADC trial The ugly — FTC extends review of Novo-Catalent deal]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>254</itunes:duration>
                <itunes:episode>37</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Neurocrine wins FDA nod for 'sprinkle' Ingrezza, Moderna-Metagenomi deal ends, Emergent's layoffs [The good, the bad, the ugly]</title>
        <itunes:title>Neurocrine wins FDA nod for 'sprinkle' Ingrezza, Moderna-Metagenomi deal ends, Emergent's layoffs [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/neurocrine-wins-fda-nod-for-sprinkle-ingrezza-formulation-moderna-and-metagenomi-deal-ends-emergent-announces-layoffs-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/neurocrine-wins-fda-nod-for-sprinkle-ingrezza-formulation-moderna-and-metagenomi-deal-ends-emergent-announces-layoffs-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 06 May 2024 12:13:31 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/f02234d8-7a5f-3027-9263-605fa382fdeb</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good — Neurocrine wins FDA nod for 'sprinkle' Ingrezza formulation 
The bad — Moderna, Metagenomi end gene editing collab
The ugly — Emergent announces layoffs, closes sites </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: </p>
<p>The good — Neurocrine wins FDA nod for 'sprinkle' Ingrezza formulation <br>
The bad — Moderna, Metagenomi end gene editing collab<br>
The ugly — Emergent announces layoffs, closes sites </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/mkc8pvnqp86n43sn/PM_TheGoodTheBadTheUgly_56_MM_mixdown7xyqw.mp3" length="5242752" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
The good — Neurocrine wins FDA nod for 'sprinkle' Ingrezza formulation The bad — Moderna, Metagenomi end gene editing collabThe ugly — Emergent announces layoffs, closes sites ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>217</itunes:duration>
                <itunes:episode>36</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Novartis wins rare cancer pediatric indication, BMS layoffs, McKinsey under fire [The good, the bad, the ugly]</title>
        <itunes:title>Novartis wins rare cancer pediatric indication, BMS layoffs, McKinsey under fire [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/novartis-wins-rare-cancer-pediatric-indication-bms-layoffs-mckinsey-under-fire-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/novartis-wins-rare-cancer-pediatric-indication-bms-layoffs-mckinsey-under-fire-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 29 Apr 2024 14:39:53 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/92f74b3f-b071-3b97-a9c9-55182c0318aa</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Novartis wins rare cancer pediatric indication for Lutathera
The bad — BMS unveils cost-saving initiative, layoffs
The ugly — McKinsey under fire for alleged role in opioid crisis  </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Novartis wins rare cancer pediatric indication for Lutathera<br>
The bad — BMS unveils cost-saving initiative, layoffs<br>
The ugly — McKinsey under fire for alleged role in opioid crisis  </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/v6t9jnuzay2fnbuz/PM_TheGoodTheBadTheUgly_429_MM_mixdownarwdy.mp3" length="6402331" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Novartis wins rare cancer pediatric indication for LutatheraThe bad — BMS unveils cost-saving initiative, layoffsThe ugly — McKinsey under fire for alleged role in opioid crisis  ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>266</itunes:duration>
                <itunes:episode>35</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>GSK antibiotic hits phase 3 goals, Genentech-Adaptimmune collab ends, Par Pharma recall [The good, the bad, the ugly]</title>
        <itunes:title>GSK antibiotic hits phase 3 goals, Genentech-Adaptimmune collab ends, Par Pharma recall [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/gsk-antibiotic-hits-phase-3-goals-genentech-adaptimmune-t-cell-collab-ends-par-pharmaceutical%c2%a0recall-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/gsk-antibiotic-hits-phase-3-goals-genentech-adaptimmune-t-cell-collab-ends-par-pharmaceutical%c2%a0recall-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Mon, 22 Apr 2024 15:15:43 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/d423dd2c-fb1e-305b-9a27-266899646549</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — GSK antibiotic hits phase 3 goals in gonorrhea
The bad — Genentech ends $3B Adaptimmune T-cell collab
The ugly — Par Pharmaceutical recalls Treprostinil injection for potential contamination</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — GSK antibiotic hits phase 3 goals in gonorrhea<br>
The bad — Genentech ends $3B Adaptimmune T-cell collab<br>
The ugly — Par Pharmaceutical recalls Treprostinil injection for potential contamination</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/6cw2wjv6v3bzjpvz/PM_TheGoodTheBadTheUgly_422_MM_mixdown9ogk0.mp3" length="6014773" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — GSK antibiotic hits phase 3 goals in gonorrheaThe bad — Genentech ends $3B Adaptimmune T-cell collabThe ugly — Par Pharmaceutical recalls Treprostinil injection for potential contamination]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>250</itunes:duration>
                <itunes:episode>34</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>BMS schizophrenia drug shines, Novartis axes jobs, Lilly compounding suit dismissed  [The good, the bad, the ugly]</title>
        <itunes:title>BMS schizophrenia drug shines, Novartis axes jobs, Lilly compounding suit dismissed  [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/bms-schizophrenia-drug-shines-novartis-axes-jobs-lilly-compounding-suit-dismissed-the-good-bad-and-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/bms-schizophrenia-drug-shines-novartis-axes-jobs-lilly-compounding-suit-dismissed-the-good-bad-and-ugly/#comments</comments>        <pubDate>Mon, 22 Apr 2024 15:14:23 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/d1fe0d72-0925-37a3-84d6-03ea937e3788</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — BMS schizophrenia drug shines in phase 3 trial
The bad — Novartis to axe 680 jobs
The ugly — Lilly compounding suit dismissed</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — BMS schizophrenia drug shines in phase 3 trial<br>
The bad — Novartis to axe 680 jobs<br>
The ugly — Lilly compounding suit dismissed</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/ksnrje3c33n3yw3q/PM_TheGoodTheBadTheUgly_415_MM_mixdown_1_6khl9.mp3" length="7245775" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — BMS schizophrenia drug shines in phase 3 trialThe bad — Novartis to axe 680 jobsThe ugly — Lilly compounding suit dismissed]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>301</itunes:duration>
                <itunes:episode>33</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>2024 election's impact on manufacturing</title>
        <itunes:title>2024 election's impact on manufacturing</itunes:title>
        <link>https://pharmamanu.podbean.com/e/2024-elections-impact-on-manufacturing/</link>
                    <comments>https://pharmamanu.podbean.com/e/2024-elections-impact-on-manufacturing/#comments</comments>        <pubDate>Fri, 12 Apr 2024 12:23:05 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/be21822b-8bfd-3281-b2f4-fbaae2e67448</guid>
                                    <description><![CDATA[<p>Politics, whether we like them or not, weigh heavy on manufacturing’s future.</p>
<p>In case you haven’t heard, it is an election year! Which means, global trade, regulations, immigration, national security and taxation will all be part of the national discourse, and all of those topics touch on manufacturing in one way or another.</p>
<p>During this podcast, we will share a discussion courtesy of our sister brand, IndustryWeek, as part of their livestream program, Production Pulse. The broadcast features insights from Pharma Manufacturing’s chief content director Karen Langhauser as well as from editors on Machine Design and Food Processing.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Politics, whether we like them or not, weigh heavy on manufacturing’s future.</p>
<p>In case you haven’t heard, it is an election year! Which means, global trade, regulations, immigration, national security and taxation will all be part of the national discourse, and all of those topics touch on manufacturing in one way or another.</p>
<p>During this podcast, we will share a discussion courtesy of our sister brand, IndustryWeek, as part of their livestream program, Production Pulse. The broadcast features insights from Pharma Manufacturing’s chief content director Karen Langhauser as well as from editors on Machine Design and Food Processing.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/yhvyxdqqmnrefkuu/PM_OffScript_ProductionPulse_48_MM_v2_mixdown8vbkw.mp3" length="47468349" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Politics, whether we like them or not, weigh heavy on manufacturing’s future.
In case you haven’t heard, it is an election year! Which means, global trade, regulations, immigration, national security and taxation will all be part of the national discourse, and all of those topics touch on manufacturing in one way or another.
During this podcast, we will share a discussion courtesy of our sister brand, IndustryWeek, as part of their livestream program, Production Pulse. The broadcast features insights from Pharma Manufacturing’s chief content director Karen Langhauser as well as from editors on Machine Design and Food Processing.]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1977</itunes:duration>
                <itunes:episode>32</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Basilea grabs FDA nod, Verve halts gene editing trial, Amylyx pulls ALS drug [The good, the bad, the ugly]</title>
        <itunes:title>Basilea grabs FDA nod, Verve halts gene editing trial, Amylyx pulls ALS drug [The good, the bad, the ugly]</itunes:title>
        <link>https://pharmamanu.podbean.com/e/the-good-the-bad-the-ugly-editors-review-week-of-april-1/</link>
                    <comments>https://pharmamanu.podbean.com/e/the-good-the-bad-the-ugly-editors-review-week-of-april-1/#comments</comments>        <pubDate>Mon, 08 Apr 2024 09:40:01 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/76df1283-002a-3142-9754-62f3c3a73499</guid>
                                    <description><![CDATA[<p>Editor's Review: Week of April 1
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Basilea Pharmaceutica receives FDA approval for its IV antibiotic
The bad — Verve Therapeutics halts gene editing trial, again
The ugly — Amylyx removes ALS treatment from market</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Editor's Review: Week of April 1<br>
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Basilea Pharmaceutica receives FDA approval for its IV antibiotic<br>
The bad — Verve Therapeutics halts gene editing trial, again<br>
The ugly — Amylyx removes ALS treatment from market</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/vxna94/PM_TheGoodTheBadTheUgly_48_MM_mixdownag79k.mp3" length="5473512" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Editor's Review: Week of April 1Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Basilea Pharmaceutica receives FDA approval for its IV antibioticThe bad — Verve Therapeutics halts gene editing trial, againThe ugly — Amylyx removes ALS treatment from market]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>227</itunes:duration>
                <itunes:episode>31</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[The good, the bad, the ugly] Editor's Review week of March 25</title>
        <itunes:title>[The good, the bad, the ugly] Editor's Review week of March 25</itunes:title>
        <link>https://pharmamanu.podbean.com/e/the-good-the-bad-the-ugly-editors-review-week-of-march-25/</link>
                    <comments>https://pharmamanu.podbean.com/e/the-good-the-bad-the-ugly-editors-review-week-of-march-25/#comments</comments>        <pubDate>Mon, 01 Apr 2024 11:14:18 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/ee6e4ce8-9505-3266-ba1e-59b01ee8e911</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — FDA approves Akebia Therapeutics' Vafseo anemia drug
The bad — Bristol Myers Squibb's Crohn's disease drug disappoints 
The ugly — FDA rejects Regeneron Pharmaceuticals lymphoma treatment </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — FDA approves Akebia Therapeutics' Vafseo anemia drug<br>
The bad — Bristol Myers Squibb's Crohn's disease drug disappoints <br>
The ugly — FDA rejects Regeneron Pharmaceuticals lymphoma treatment </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/6ia5h7/PM_TheGoodTheBadTheUgly_41_MM_mixdownapult.mp3" length="5418312" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves Akebia Therapeutics' Vafseo anemia drugThe bad — Bristol Myers Squibb's Crohn's disease drug disappoints The ugly — FDA rejects Regeneron Pharmaceuticals lymphoma treatment ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>225</itunes:duration>
                <itunes:episode>30</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[The good, the bad, the ugly] Editor's Review week of March 18</title>
        <itunes:title>[The good, the bad, the ugly] Editor's Review week of March 18</itunes:title>
        <link>https://pharmamanu.podbean.com/e/the-good-the-bad-the-ugly-editors-review-week-of-march-18/</link>
                    <comments>https://pharmamanu.podbean.com/e/the-good-the-bad-the-ugly-editors-review-week-of-march-18/#comments</comments>        <pubDate>Mon, 25 Mar 2024 10:24:12 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/84787118-c35e-3b0f-a20d-246839f09dec</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Orchard gene therapy wins first FDA nod for rare pediatric disease
The bad — Abiomed recalls heart pump instructions due to perforation risks 
The ugly — J&amp;J files lawsuit against a former employee for allegedly taking over 1,000 files to Pfizer</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Orchard gene therapy wins first FDA nod for rare pediatric disease<br>
The bad — Abiomed recalls heart pump instructions due to perforation risks <br>
The ugly — J&amp;J files lawsuit against a former employee for allegedly taking over 1,000 files to Pfizer</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/rv7fwt/PM_TheGoodTheBadTheUgly_325_MM_mixdownaww6i.mp3" length="7959741" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Orchard gene therapy wins first FDA nod for rare pediatric diseaseThe bad — Abiomed recalls heart pump instructions due to perforation risks The ugly — J&amp;J files lawsuit against a former employee for allegedly taking over 1,000 files to Pfizer]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>331</itunes:duration>
                <itunes:episode>29</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[The good, the bad, the ugly] Editor's Review week of March 11</title>
        <itunes:title>[The good, the bad, the ugly] Editor's Review week of March 11</itunes:title>
        <link>https://pharmamanu.podbean.com/e/tktktktk/</link>
                    <comments>https://pharmamanu.podbean.com/e/tktktktk/#comments</comments>        <pubDate>Mon, 18 Mar 2024 09:36:18 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/338cf5eb-2b57-3f35-bc6f-4432cf349d98</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Madrigal wins first FDA nod for NASH
The bad — Acadia abandons plans to expand pimavanserin indications 
The ugly — BIO backs BIOSECURE Act, boots WuXi</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Madrigal wins first FDA nod for NASH<br>
The bad — Acadia abandons plans to expand pimavanserin indications <br>
The ugly — BIO backs BIOSECURE Act, boots WuXi</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/7sqr7n/PM_TheGoodTheBadTheUgly_318_MM_mixdowna1rsv.mp3" length="5636823" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Madrigal wins first FDA nod for NASHThe bad — Acadia abandons plans to expand pimavanserin indications The ugly — BIO backs BIOSECURE Act, boots WuXi]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>234</itunes:duration>
                <itunes:episode>28</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[The good, the bad, the ugly] Editor's Review week of March 4</title>
        <itunes:title>[The good, the bad, the ugly] Editor's Review week of March 4</itunes:title>
        <link>https://pharmamanu.podbean.com/e/the-good-the-bad-the-ugly-editors-review-week-of-march-4/</link>
                    <comments>https://pharmamanu.podbean.com/e/the-good-the-bad-the-ugly-editors-review-week-of-march-4/#comments</comments>        <pubDate>Mon, 11 Mar 2024 10:57:55 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/286e6675-3548-3824-a7fa-225998ed268e</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Boehringer Ingelheim to cap out-of-pocket inhaler prices
The bad — Amylyx ALS drug falls short in phase 3 trial
The ugly — FDA delays Eli Lilly Alzheimer's drug decision with last-minute AdComm</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Boehringer Ingelheim to cap out-of-pocket inhaler prices<br>
The bad — Amylyx ALS drug falls short in phase 3 trial<br>
The ugly — FDA delays Eli Lilly Alzheimer's drug decision with last-minute AdComm</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/mkj95b/PM_TheGoodTheBadTheUgly_311_MM_v2_mixdown60n8f.mp3" length="6155287" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Boehringer Ingelheim to cap out-of-pocket inhaler pricesThe bad — Amylyx ALS drug falls short in phase 3 trialThe ugly — FDA delays Eli Lilly Alzheimer's drug decision with last-minute AdComm]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>256</itunes:duration>
                <itunes:episode>27</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[The good, the bad, the ugly] Editor's Review week of February 29</title>
        <itunes:title>[The good, the bad, the ugly] Editor's Review week of February 29</itunes:title>
        <link>https://pharmamanu.podbean.com/e/the-good-the-bad-the-ugly-editors-review-week-of-february-29/</link>
                    <comments>https://pharmamanu.podbean.com/e/the-good-the-bad-the-ugly-editors-review-week-of-february-29/#comments</comments>        <pubDate>Tue, 05 Mar 2024 09:31:26 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/2c20e1ff-59ed-3f73-b77c-661785cf4f3c</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Iovance has launches Amtagvi
The bad — FDA rejected Theratechnologies HIV instramuscular injection
The ugly — BioMarin receives a subpoena from the DOJ</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:</p>
<p>The good — Iovance has launches Amtagvi<br>
The bad — FDA rejected Theratechnologies HIV instramuscular injection<br>
The ugly — BioMarin receives a subpoena from the DOJ</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/fafpzz/PM_TheGoodTheBadTheUgly_34_MM_v2_mixdownaxh7t.mp3" length="4516170" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Iovance has launches AmtagviThe bad — FDA rejected Theratechnologies HIV instramuscular injectionThe ugly — BioMarin receives a subpoena from the DOJ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>187</itunes:duration>
                <itunes:episode>26</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[The good, the bad, the ugly] Editor's Review week of February 23</title>
        <itunes:title>[The good, the bad, the ugly] Editor's Review week of February 23</itunes:title>
        <link>https://pharmamanu.podbean.com/e/editors-review-february-23-the-good-the-bad-the-ugly/</link>
                    <comments>https://pharmamanu.podbean.com/e/editors-review-february-23-the-good-the-bad-the-ugly/#comments</comments>        <pubDate>Fri, 01 Mar 2024 12:29:01 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/d00348f4-d193-3c2d-931f-9adb8befab81</guid>
                                    <description><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: 
The good — Amtagvi approval
The bad — Rapt clinical hold
The ugly — Novavax and Gavi settlement </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: <br>
The good — Amtagvi approval<br>
The bad — Rapt clinical hold<br>
The ugly — Novavax and Gavi settlement </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/mhx87r/PM_TheGoodTheBadTheUgly_228_MM_mixdown84f1p.mp3" length="5649951" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Amtagvi approvalThe bad — Rapt clinical holdThe ugly — Novavax and Gavi settlement ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>235</itunes:duration>
                <itunes:episode>25</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Raising a modern CDMO</title>
        <itunes:title>Raising a modern CDMO</itunes:title>
        <link>https://pharmamanu.podbean.com/e/raising-a-modern-cdmo/</link>
                    <comments>https://pharmamanu.podbean.com/e/raising-a-modern-cdmo/#comments</comments>        <pubDate>Tue, 27 Feb 2024 07:51:40 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/8c9d9b35-2f9b-3286-ab32-629a6e1f0691</guid>
                                    <description><![CDATA[<p class="p1">Across the board, the pharma industry is facing sky-high pressures to bring drugs to market quickly, safely and affordably. Facing this daunting landscape, pharma companies are enlisting the help of focused contract manufacturers to shape their therapies from the ground up. CDMOs, who so often go unnamed and unsung, have now become integral to forging the future of pharma.</p>
<p class="p1">During this podcast, Chief Content Director Karen Langhauser will introduce you to the four promising CDMOs we’ve chosen to profile in our March issue — ten23 health, Cellares, INCOG BioPharma Services and Matica Biotechnology.</p>
<p class="p1">Launching a new company into a crowded contracting space isn’t for the faint of heart — it demands expertise, ingenuity and a willingness to embrace risk. Fortunately, a new generation of CDMOs are boldly positioning themselves to become pillars of pharmaceutical progress.</p>
]]></description>
                                                            <content:encoded><![CDATA[<p class="p1">Across the board, the pharma industry is facing sky-high pressures to bring drugs to market quickly, safely and affordably. Facing this daunting landscape, pharma companies are enlisting the help of focused contract manufacturers to shape their therapies from the ground up. CDMOs, who so often go unnamed and unsung, have now become integral to forging the future of pharma.</p>
<p class="p1">During this podcast, Chief Content Director Karen Langhauser will introduce you to the four promising CDMOs we’ve chosen to profile in our March issue — ten23 health, Cellares, INCOG BioPharma Services and Matica Biotechnology.</p>
<p class="p1">Launching a new company into a crowded contracting space isn’t for the faint of heart — it demands expertise, ingenuity and a willingness to embrace risk. Fortunately, a new generation of CDMOs are boldly positioning themselves to become pillars of pharmaceutical progress.</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/wzjp9u/PM_OffScript_2262024MM_v2_mixdownak9as.mp3" length="12796281" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Across the board, the pharma industry is facing sky-high pressures to bring drugs to market quickly, safely and affordably. Facing this daunting landscape, pharma companies are enlisting the help of focused contract manufacturers to shape their therapies from the ground up. CDMOs, who so often go unnamed and unsung, have now become integral to forging the future of pharma.
During this podcast, Chief Content Director Karen Langhauser will introduce you to the four promising CDMOs we’ve chosen to profile in our March issue — ten23 health, Cellares, INCOG BioPharma Services and Matica Biotechnology.
Launching a new company into a crowded contracting space isn’t for the faint of heart — it demands expertise, ingenuity and a willingness to embrace risk. Fortunately, a new generation of CDMOs are boldly positioning themselves to become pillars of pharmaceutical progress.]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>532</itunes:duration>
                <itunes:episode>24</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] Meeting today’s container closure integrity requirements</title>
        <itunes:title>[Solutions Spotlight] Meeting today’s container closure integrity requirements</itunes:title>
        <link>https://pharmamanu.podbean.com/e/spolight-solutions-meeting-today-s-container-closure-integrity-requirements/</link>
                    <comments>https://pharmamanu.podbean.com/e/spolight-solutions-meeting-today-s-container-closure-integrity-requirements/#comments</comments>        <pubDate>Thu, 21 Sep 2023 14:50:24 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/47e8939d-5570-33aa-8150-bcd07b4a9c07</guid>
                                    <description><![CDATA[<p>In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Derek Duncan Product Line Director, at Lighthouse Instruments to discuss the significance of CCI and the evolving landscape of CCI testing, regulatory guidance, and the unique considerations posed by innovative therapies with extreme storage and transport requirements. </p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/home/article/33011904/solutions-spotlight'>https://www.pharmamanufacturing.com/home/article/33011904/solutions-spotlight</a></p>
<p>Learn more about Lighthouse instruments: <a href='https://lighthouseinstruments.com/'>https://lighthouseinstruments.com/</a></p>
]]></description>
                                                            <content:encoded><![CDATA[<p>In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Derek Duncan Product Line Director, at Lighthouse Instruments to discuss the significance of CCI and the evolving landscape of CCI testing, regulatory guidance, and the unique considerations posed by innovative therapies with extreme storage and transport requirements. </p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/home/article/33011904/solutions-spotlight'>https://www.pharmamanufacturing.com/home/article/33011904/solutions-spotlight</a></p>
<p>Learn more about Lighthouse instruments: <a href='https://lighthouseinstruments.com/'>https://lighthouseinstruments.com/</a></p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/xuvwu7/Lighthouse_Instruments_podcast_v16gqnx.mp3" length="15961381" type="audio/mpeg"/>
        <itunes:summary><![CDATA[In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Derek Duncan Product Line Director, at Lighthouse Instruments to discuss the significance of CCI and the evolving landscape of CCI testing, regulatory guidance, and the unique considerations posed by innovative therapies with extreme storage and transport requirements. 
Read the transcript: https://www.pharmamanufacturing.com/home/article/33011904/solutions-spotlight
Learn more about Lighthouse instruments: https://lighthouseinstruments.com/]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>996</itunes:duration>
                <itunes:episode>23</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] Ensuring quality during a syringe surge</title>
        <itunes:title>[Solutions Spotlight] Ensuring quality during a syringe surge</itunes:title>
        <link>https://pharmamanu.podbean.com/e/off-script/</link>
                    <comments>https://pharmamanu.podbean.com/e/off-script/#comments</comments>        <pubDate>Wed, 09 Aug 2023 15:07:14 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/0278fbac-a957-3ff6-8400-f86c7131c156</guid>
                                    <description><![CDATA[<p>In this latest episode of Off Script: A Pharma Manufacturing Podcast, Karen Langhauser is joined by Veronica Ghidotti Product Manager, Visual Inspection Systems at Stevanato Group, to discuss how pharma markets have shifted towards drugs that require syringes and vials — which are historically difficult to inspect — and how new automatic inspection solutions can help. </p>
<p>Read the transcript: <a href='https://pharmamanufacturing.com/33009598'>https://pharmamanufacturing.com/33009598</a></p>
<p>Learn more about Stevanato Group: <a href='https://www.stevanatogroup.com/en/'>https://www.stevanatogroup.com/en/</a></p>
]]></description>
                                                            <content:encoded><![CDATA[<p>In this latest episode of Off Script: A Pharma Manufacturing Podcast, Karen Langhauser is joined by Veronica Ghidotti Product Manager, Visual Inspection Systems at Stevanato Group, to discuss how pharma markets have shifted towards drugs that require syringes and vials — which are historically difficult to inspect — and how new automatic inspection solutions can help. </p>
<p>Read the transcript: <a href='https://pharmamanufacturing.com/33009598'>https://pharmamanufacturing.com/33009598</a></p>
<p>Learn more about Stevanato Group: <a href='https://www.stevanatogroup.com/en/'>https://www.stevanatogroup.com/en/</a></p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/etjkrq/Pharma_SPAMI_Podcast_July_20238q8vq.mp3" length="12750604" type="audio/mpeg"/>
        <itunes:summary><![CDATA[In this latest episode of Off Script: A Pharma Manufacturing Podcast, Karen Langhauser is joined by Veronica Ghidotti Product Manager, Visual Inspection Systems at Stevanato Group, to discuss how pharma markets have shifted towards drugs that require syringes and vials — which are historically difficult to inspect — and how new automatic inspection solutions can help. 
Read the transcript: https://pharmamanufacturing.com/33009598
Learn more about Stevanato Group: https://www.stevanatogroup.com/en/]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>795</itunes:duration>
                <itunes:episode>22</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] Overcoming drug formulation challenges</title>
        <itunes:title>[Solutions Spotlight] Overcoming drug formulation challenges</itunes:title>
        <link>https://pharmamanu.podbean.com/e/solutions-spotlight-overcoming-drug-formulation-challenges/</link>
                    <comments>https://pharmamanu.podbean.com/e/solutions-spotlight-overcoming-drug-formulation-challenges/#comments</comments>        <pubDate>Thu, 19 Jan 2023 14:18:32 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/ca6e3ee7-a646-3ca2-bd53-b913219aed5d</guid>
                                    <description><![CDATA[<p>In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Daniel Price, director and head of excipients, solid applications at <a href='https://www.emdmillipore.com/US/en'>MilliporeSigma</a>, to discuss his work driving innovation in the fields of 3d printing of oral solid dosage forms, next generation pharmaceutical manufacturing, oral delivery of novel modalities and predictive formulation, and how these innovations can help overcome today's drug formulation challenges.  </p>
<p>Read the transcript: <a href='https://pharmamanufacturing.com/21438233'>https://pharmamanufacturing.com/21438233</a></p>
]]></description>
                                                            <content:encoded><![CDATA[<p>In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Daniel Price, director and head of excipients, solid applications at <a href='https://www.emdmillipore.com/US/en'>MilliporeSigma</a>, to discuss his work driving innovation in the fields of 3d printing of oral solid dosage forms, next generation pharmaceutical manufacturing, oral delivery of novel modalities and predictive formulation, and how these innovations can help overcome today's drug formulation challenges.  </p>
<p>Read the transcript: <a href='https://pharmamanufacturing.com/21438233'>https://pharmamanufacturing.com/21438233</a></p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/h965ee/2210_PHOS_Millipore_2-for_reviewbe4bo.mp3" length="15277818" type="audio/mpeg"/>
        <itunes:summary><![CDATA[In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Daniel Price, director and head of excipients, solid applications at MilliporeSigma, to discuss his work driving innovation in the fields of 3d printing of oral solid dosage forms, next generation pharmaceutical manufacturing, oral delivery of novel modalities and predictive formulation, and how these innovations can help overcome today's drug formulation challenges.  
Read the transcript: https://pharmamanufacturing.com/21438233]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1423</itunes:duration>
                <itunes:episode>21</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] Bringing pharma’s asset management into the digital age</title>
        <itunes:title>[Solutions Spotlight] Bringing pharma’s asset management into the digital age</itunes:title>
        <link>https://pharmamanu.podbean.com/e/solutions-spotlight-bringing-pharma-s-asset-management-into-the-digital-age/</link>
                    <comments>https://pharmamanu.podbean.com/e/solutions-spotlight-bringing-pharma-s-asset-management-into-the-digital-age/#comments</comments>        <pubDate>Wed, 26 Oct 2022 15:51:13 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/3393aa3f-8084-38bc-867c-2383283ee942</guid>
                                    <description><![CDATA[<p>For those in the pharmaceutical industry, the recent challenge has been in figuring out how to extend the digital capability of our everyday lives into pharma asset management. How do you bring all of a plant's activities and the data behind them into one place? Furthermore, if you could do that, what benefits would it bring to asset management? Karen Langhauser is joined by Ethan Smith, general manager of Life Sciences for Nuvolo, to get a better understanding of how pharma can bring its asset management into the digital age.</p>
<p>Learn more about Nuvolo: <a href='https://www.nuvolo.com/'>https://www.nuvolo.com/</a></p>
<p>Read the transcript: <a href='https://pharmamanufacturing.com/21436830'>https://pharmamanufacturing.com/21436830</a> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>For those in the pharmaceutical industry, the recent challenge has been in figuring out how to extend the digital capability of our everyday lives into pharma asset management. How do you bring all of a plant's activities and the data behind them into one place? Furthermore, if you could do that, what benefits would it bring to asset management? Karen Langhauser is joined by Ethan Smith, general manager of Life Sciences for Nuvolo, to get a better understanding of how pharma can bring its asset management into the digital age.</p>
<p>Learn more about Nuvolo: <a href='https://www.nuvolo.com/'>https://www.nuvolo.com/</a></p>
<p>Read the transcript: <a href='https://pharmamanufacturing.com/21436830'>https://pharmamanufacturing.com/21436830</a> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/ikxmr4/PHOS_2209_Nuvolo_V2.mp3" length="16752636" type="audio/mpeg"/>
        <itunes:summary><![CDATA[For those in the pharmaceutical industry, the recent challenge has been in figuring out how to extend the digital capability of our everyday lives into pharma asset management. How do you bring all of a plant's activities and the data behind them into one place? Furthermore, if you could do that, what benefits would it bring to asset management? Karen Langhauser is joined by Ethan Smith, general manager of Life Sciences for Nuvolo, to get a better understanding of how pharma can bring its asset management into the digital age.
Learn more about Nuvolo: https://www.nuvolo.com/
Read the transcript: https://pharmamanufacturing.com/21436830 ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1523</itunes:duration>
                <itunes:episode>20</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] How to overcome challenges in ophthalmic formulations</title>
        <itunes:title>[Solutions Spotlight] How to overcome challenges in ophthalmic formulations</itunes:title>
        <link>https://pharmamanu.podbean.com/e/how-to-overcome-challenges-in-ophthalmic-formulations/</link>
                    <comments>https://pharmamanu.podbean.com/e/how-to-overcome-challenges-in-ophthalmic-formulations/#comments</comments>        <pubDate>Mon, 17 Oct 2022 18:19:10 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/ae9b48e8-9b1a-3325-9de0-a9e6b500fd31</guid>
                                    <description><![CDATA[<p>Ophthalmic drug formulation and manufacturing brings with it unique challenges and regulatory requirements. To discuss methods to overcome these challenges, Pharma Manufacturing Senior Editor Andrea Corona speaks with Smita Rajput, field marketing manager at MilliporeSigma. </p>
<p>Learn more about MilliporeSigma: <a href='https://www.emdmillipore.com/US/en'>https://www.emdmillipore.com/US/en</a> </p>
<p>Read the transcript: <a href='https://pharmamanufacturing.com/21436478'>https://pharmamanufacturing.com/21436478</a> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Ophthalmic drug formulation and manufacturing brings with it unique challenges and regulatory requirements. To discuss methods to overcome these challenges, Pharma Manufacturing Senior Editor Andrea Corona speaks with Smita Rajput, field marketing manager at MilliporeSigma. </p>
<p>Learn more about MilliporeSigma: <a href='https://www.emdmillipore.com/US/en'>https://www.emdmillipore.com/US/en</a> </p>
<p>Read the transcript: <a href='https://pharmamanufacturing.com/21436478'>https://pharmamanufacturing.com/21436478</a> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/sqb7jq/PHOS_2208_millipore-2.mp3" length="9767352" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Ophthalmic drug formulation and manufacturing brings with it unique challenges and regulatory requirements. To discuss methods to overcome these challenges, Pharma Manufacturing Senior Editor Andrea Corona speaks with Smita Rajput, field marketing manager at MilliporeSigma. 
Learn more about MilliporeSigma: https://www.emdmillipore.com/US/en 
Read the transcript: https://pharmamanufacturing.com/21436478 ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>861</itunes:duration>
                <itunes:episode>19</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] How digitalization can provide a competitive advantage</title>
        <itunes:title>[Solutions Spotlight] How digitalization can provide a competitive advantage</itunes:title>
        <link>https://pharmamanu.podbean.com/e/how-digitalization-can-provide-a-competitive-advantage/</link>
                    <comments>https://pharmamanu.podbean.com/e/how-digitalization-can-provide-a-competitive-advantage/#comments</comments>        <pubDate>Fri, 17 Jun 2022 14:05:30 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/04a08dda-2659-3366-9e26-b83e121de9b1</guid>
                                    <description><![CDATA[<p>The digitalization journey for pharmaceutical manufacturing can reap many benefits and there are many choices to be made in terms of these technologies and how to deploy them. In this episode, Andrea Corona talks about how digitalization is delivering a competitive advantage and assembly and inspection with Veronica Ghidotti and Fabio Bertacchini from Stevanato Group.</p>
<p>Learn more about Stevanato Group: <a href='https://www.stevanatogroup.com/en/'>https://www.stevanatogroup.com/en/</a></p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/how-digitalization-can-provide-a-competitive-advantage'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/how-digitalization-can-provide-a-competitive-advantage</a> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>The digitalization journey for pharmaceutical manufacturing can reap many benefits and there are many choices to be made in terms of these technologies and how to deploy them. In this episode, Andrea Corona talks about how digitalization is delivering a competitive advantage and assembly and inspection with Veronica Ghidotti and Fabio Bertacchini from Stevanato Group.</p>
<p>Learn more about Stevanato Group: <a href='https://www.stevanatogroup.com/en/'>https://www.stevanatogroup.com/en/</a></p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/how-digitalization-can-provide-a-competitive-advantage'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/how-digitalization-can-provide-a-competitive-advantage</a> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/dqk3d8/PHOS_2206_Stevanto-For_review8nm8c.mp3" length="11494799" type="audio/mpeg"/>
        <itunes:summary><![CDATA[The digitalization journey for pharmaceutical manufacturing can reap many benefits and there are many choices to be made in terms of these technologies and how to deploy them. In this episode, Andrea Corona talks about how digitalization is delivering a competitive advantage and assembly and inspection with Veronica Ghidotti and Fabio Bertacchini from Stevanato Group.
Learn more about Stevanato Group: https://www.stevanatogroup.com/en/
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/how-digitalization-can-provide-a-competitive-advantage ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>909</itunes:duration>
                <itunes:episode>18</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] Stop the stall: The time is now for predictive maintenance in pharma</title>
        <itunes:title>[Solutions Spotlight] Stop the stall: The time is now for predictive maintenance in pharma</itunes:title>
        <link>https://pharmamanu.podbean.com/e/stop-the-stall-the-time-is-now-for-predictive-maintenance-in-pharma/</link>
                    <comments>https://pharmamanu.podbean.com/e/stop-the-stall-the-time-is-now-for-predictive-maintenance-in-pharma/#comments</comments>        <pubDate>Tue, 24 May 2022 13:05:51 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/b413ba52-d644-3983-800d-82e3d57d487b</guid>
                                    <description><![CDATA[<p>Predictive maintenance can help pharma companies can capture enormous value. Digital solutions can help eliminate downtime, reduce maintenance costs and maximize productivity, ultimately unlocking the capacity that is necessary to get the highest quality product to patients who need them most. Senior editor Andrea Corona discusses this with Zach Gilulah, pharma machine health lead at <a href='https://www.augury.com/'>Augury</a></p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/stop-the-stall-the-time-is-now-for-predictive-maintenance-in-pharma'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/stop-the-stall-the-time-is-now-for-predictive-maintenance-in-pharma</a> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Predictive maintenance can help pharma companies can capture enormous value. Digital solutions can help eliminate downtime, reduce maintenance costs and maximize productivity, ultimately unlocking the capacity that is necessary to get the highest quality product to patients who need them most. Senior editor Andrea Corona discusses this with Zach Gilulah, pharma machine health lead at <a href='https://www.augury.com/'>Augury</a></p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/stop-the-stall-the-time-is-now-for-predictive-maintenance-in-pharma'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/stop-the-stall-the-time-is-now-for-predictive-maintenance-in-pharma</a> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/x4a4er/PHOS_SS_2205_AuguryWIntro.mp3" length="19513823" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Predictive maintenance can help pharma companies can capture enormous value. Digital solutions can help eliminate downtime, reduce maintenance costs and maximize productivity, ultimately unlocking the capacity that is necessary to get the highest quality product to patients who need them most. Senior editor Andrea Corona discusses this with Zach Gilulah, pharma machine health lead at Augury
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/stop-the-stall-the-time-is-now-for-predictive-maintenance-in-pharma ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>740</itunes:duration>
                <itunes:episode>17</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] A groundbreaking approach to BET testing</title>
        <itunes:title>[Solutions Spotlight] A groundbreaking approach to BET testing</itunes:title>
        <link>https://pharmamanu.podbean.com/e/solutions-spotlight-a-groundbreaking-approach-to-bet-testing/</link>
                    <comments>https://pharmamanu.podbean.com/e/solutions-spotlight-a-groundbreaking-approach-to-bet-testing/#comments</comments>        <pubDate>Tue, 23 Nov 2021 11:31:13 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/4cefedb6-09f1-37e2-b176-56b4f296ba07</guid>
                                    <description><![CDATA[<p>Endotoxin testing serves a vital function in pharma quality control by ensuring that products are safe for patients. But the traditional approach to Bacterial Endotoxins Testing (BET) is an area ripe for disruption and improvements. Now, the Sievers Eclipse BET platform by Suez offers new levels of automation, compliance and sustainability, ushering in the next generation of BET.</p>
<p>Learn more about Suez: <a href='https://www.suezwatertechnologies.com/'>https://www.suezwatertechnologies.com/</a> </p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-a-groundbreaking-approach-to-bet-testing'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-a-groundbreaking-approach-to-bet-testing</a></p>
<p> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Endotoxin testing serves a vital function in pharma quality control by ensuring that products are safe for patients. But the traditional approach to Bacterial Endotoxins Testing (BET) is an area ripe for disruption and improvements. Now, the Sievers Eclipse BET platform by Suez offers new levels of automation, compliance and sustainability, ushering in the next generation of BET.</p>
<p>Learn more about Suez: <a href='https://www.suezwatertechnologies.com/'>https://www.suezwatertechnologies.com/</a> </p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-a-groundbreaking-approach-to-bet-testing'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-a-groundbreaking-approach-to-bet-testing</a></p>
<p> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/p22cyb/PHOS_SS_2111_Suez.mp3" length="36053127" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Endotoxin testing serves a vital function in pharma quality control by ensuring that products are safe for patients. But the traditional approach to Bacterial Endotoxins Testing (BET) is an area ripe for disruption and improvements. Now, the Sievers Eclipse BET platform by Suez offers new levels of automation, compliance and sustainability, ushering in the next generation of BET.
Learn more about Suez: https://www.suezwatertechnologies.com/ 
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-a-groundbreaking-approach-to-bet-testing
 ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1522</itunes:duration>
                <itunes:episode>16</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions spotlight] A better way to measure critical attributes in bioreactors</title>
        <itunes:title>[Solutions spotlight] A better way to measure critical attributes in bioreactors</itunes:title>
        <link>https://pharmamanu.podbean.com/e/solutions-spotlight-gas-analysis-mass-spectrometer-applications-in-fermentation-and-cell-culture-process/</link>
                    <comments>https://pharmamanu.podbean.com/e/solutions-spotlight-gas-analysis-mass-spectrometer-applications-in-fermentation-and-cell-culture-process/#comments</comments>        <pubDate>Tue, 26 Oct 2021 13:08:18 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/9450fde9-13d5-394c-a766-ac67896b915f</guid>
                                    <description><![CDATA[<p>In pharma, the use of gas analysis in fermentation bioreactors is critical for monitoring the health of a culture, and measuring small changes to oxygen and carbon dioxide concentrations at key phases of the process. Whether using continuous or batch fermentation for bacterial, microbial or mammalian cell culture expression, Thermo Fischer Scientific's gas analysis mass spectrometry product range provides precise off-gas analysis through every stage of fermentation. To learn more about the Prima BT and Prima PRO models, senior editor Meagan Parrish chats with Daniel Merriman, strategic marketing manager, <a href='https://www.thermofisher.com/us/en/home.html'>Thermo Fischer</a>.</p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-gas-analysis-mass-spectrometer-applications-in-fermentation-and-cell-culture-process'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-gas-analysis-mass-spectrometer-applications-in-fermentation-and-cell-culture-process</a> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>In pharma, the use of gas analysis in fermentation bioreactors is critical for monitoring the health of a culture, and measuring small changes to oxygen and carbon dioxide concentrations at key phases of the process. Whether using continuous or batch fermentation for bacterial, microbial or mammalian cell culture expression, Thermo Fischer Scientific's gas analysis mass spectrometry product range provides precise off-gas analysis through every stage of fermentation. To learn more about the Prima BT and Prima PRO models, senior editor Meagan Parrish chats with Daniel Merriman, strategic marketing manager, <a href='https://www.thermofisher.com/us/en/home.html'>Thermo Fischer</a>.</p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-gas-analysis-mass-spectrometer-applications-in-fermentation-and-cell-culture-process'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-gas-analysis-mass-spectrometer-applications-in-fermentation-and-cell-culture-process</a> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/beuwbj/PHOS_SS_2110_Thermo.mp3" length="20134694" type="audio/mpeg"/>
        <itunes:summary><![CDATA[In pharma, the use of gas analysis in fermentation bioreactors is critical for monitoring the health of a culture, and measuring small changes to oxygen and carbon dioxide concentrations at key phases of the process. Whether using continuous or batch fermentation for bacterial, microbial or mammalian cell culture expression, Thermo Fischer Scientific's gas analysis mass spectrometry product range provides precise off-gas analysis through every stage of fermentation. To learn more about the Prima BT and Prima PRO models, senior editor Meagan Parrish chats with Daniel Merriman, strategic marketing manager, Thermo Fischer.
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-gas-analysis-mass-spectrometer-applications-in-fermentation-and-cell-culture-process ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>797</itunes:duration>
                <itunes:episode>15</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] Special delivery: Lipid nanoparticles usher in new treatments</title>
        <itunes:title>[Solutions Spotlight] Special delivery: Lipid nanoparticles usher in new treatments</itunes:title>
        <link>https://pharmamanu.podbean.com/e/solutions-spotlight-special-delivery-lipid-nanoparticles-usher-in-new-treatments/</link>
                    <comments>https://pharmamanu.podbean.com/e/solutions-spotlight-special-delivery-lipid-nanoparticles-usher-in-new-treatments/#comments</comments>        <pubDate>Mon, 04 Oct 2021 14:50:37 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/a48a9d6b-ba8f-3a4f-bb79-f5688201c7be</guid>
                                    <description><![CDATA[<p>RNA-based vaccines have played a starring role in the ongoing COVID-19 pandemic and there is great potential for RNA to be applied to further indications. But nucleic acids are highly negatively charged and fragile and the right delivery systems are needed to protect RNA from degradation. One technology — lipid nanoparticles — has proven to enable the drug delivery of RNA-based therapeutics. Karen Langhauser and <a href='https://www.emdmillipore.com/US/en'>MilliporeSigma</a>’s Dr. Estelle Beguin discuss lipid nanoparticles and the role they will play in the success of emerging therapies and vaccines.</p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-special-delivery-lipid-nanoparticles-usher-in-new-treatments'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-special-delivery-lipid-nanoparticles-usher-in-new-treatments</a> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>RNA-based vaccines have played a starring role in the ongoing COVID-19 pandemic and there is great potential for RNA to be applied to further indications. But nucleic acids are highly negatively charged and fragile and the right delivery systems are needed to protect RNA from degradation. One technology — lipid nanoparticles — has proven to enable the drug delivery of RNA-based therapeutics. Karen Langhauser and <a href='https://www.emdmillipore.com/US/en'>MilliporeSigma</a>’s Dr. Estelle Beguin discuss lipid nanoparticles and the role they will play in the success of emerging therapies and vaccines.</p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-special-delivery-lipid-nanoparticles-usher-in-new-treatments'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-special-delivery-lipid-nanoparticles-usher-in-new-treatments</a> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/an8bgi/PHOS_SS_2019_Millipore_for_transcriptam6bp.mp3" length="22408193" type="audio/mpeg"/>
        <itunes:summary><![CDATA[RNA-based vaccines have played a starring role in the ongoing COVID-19 pandemic and there is great potential for RNA to be applied to further indications. But nucleic acids are highly negatively charged and fragile and the right delivery systems are needed to protect RNA from degradation. One technology — lipid nanoparticles — has proven to enable the drug delivery of RNA-based therapeutics. Karen Langhauser and MilliporeSigma’s Dr. Estelle Beguin discuss lipid nanoparticles and the role they will play in the success of emerging therapies and vaccines.
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-special-delivery-lipid-nanoparticles-usher-in-new-treatments ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>932</itunes:duration>
                <itunes:episode>14</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] Harnessing AI to improve workplace ergonomics</title>
        <itunes:title>[Solutions Spotlight] Harnessing AI to improve workplace ergonomics</itunes:title>
        <link>https://pharmamanu.podbean.com/e/solutions-spotlight-harnessing-ai-to-improve-workplace-ergonomics/</link>
                    <comments>https://pharmamanu.podbean.com/e/solutions-spotlight-harnessing-ai-to-improve-workplace-ergonomics/#comments</comments>        <pubDate>Mon, 09 Aug 2021 14:14:54 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/d45443ad-2c2c-3588-8248-9cc9111f7f95</guid>
                                    <description><![CDATA[<p>Poor ergonomics have been linked to a host of physical problems and can have an impact on workplace efficiency. Improving posture and physical habits has been linked to increased worker productivity and reduced errors. A reduction in injuries also saves money for companies, and helps businesses retain healthier and happier employees. However, many companies might overlook this aspect of workplace safety and this is where artificial intelligence can come to the rescue. Meagan Parrish and Blake McGowan, Director of Ergonomics Research for <a href='https://www.ehs.com/'>VelocityEHS</a>, discuss.</p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-harnessing-ai-to-improve-workplace-ergonomics'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-harnessing-ai-to-improve-workplace-ergonomics</a> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Poor ergonomics have been linked to a host of physical problems and can have an impact on workplace efficiency. Improving posture and physical habits has been linked to increased worker productivity and reduced errors. A reduction in injuries also saves money for companies, and helps businesses retain healthier and happier employees. However, many companies might overlook this aspect of workplace safety and this is where artificial intelligence can come to the rescue. Meagan Parrish and Blake McGowan, Director of Ergonomics Research for <a href='https://www.ehs.com/'>VelocityEHS</a>, discuss.</p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-harnessing-ai-to-improve-workplace-ergonomics'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-harnessing-ai-to-improve-workplace-ergonomics</a> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/efsiy3/PHOS_SS_Velocity_V2.mp3" length="24726386" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Poor ergonomics have been linked to a host of physical problems and can have an impact on workplace efficiency. Improving posture and physical habits has been linked to increased worker productivity and reduced errors. A reduction in injuries also saves money for companies, and helps businesses retain healthier and happier employees. However, many companies might overlook this aspect of workplace safety and this is where artificial intelligence can come to the rescue. Meagan Parrish and Blake McGowan, Director of Ergonomics Research for VelocityEHS, discuss.
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-harnessing-ai-to-improve-workplace-ergonomics ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1050</itunes:duration>
                <itunes:episode>13</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Is it time to call the dogs off drug testing?</title>
        <itunes:title>Is it time to call the dogs off drug testing?</itunes:title>
        <link>https://pharmamanu.podbean.com/e/is-it-time-to-call-the-dogs-off-drug-testing/</link>
                    <comments>https://pharmamanu.podbean.com/e/is-it-time-to-call-the-dogs-off-drug-testing/#comments</comments>        <pubDate>Wed, 16 Jun 2021 14:22:29 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/85a18f6f-7a59-394f-b93c-ef4c53deb067</guid>
                                    <description><![CDATA[<p>Many inside and outside of the pharma industry think so. Now, one group is putting pressure on the FDA and Congress to move pharma away from animal modeling in drug development.</p>
<p>Learn more about the White Coast Waste Project: https://www.whitecoatwaste.org/</p>
<p>Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/is-it-time-to-call-the-dogs-off-drug-testing</p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Many inside and outside of the pharma industry think so. Now, one group is putting pressure on the FDA and Congress to move pharma away from animal modeling in drug development.</p>
<p>Learn more about the White Coast Waste Project: https://www.whitecoatwaste.org/</p>
<p>Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/is-it-time-to-call-the-dogs-off-drug-testing</p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/mbfv2d/PHOS_2106_Pod_12_V3bs96f.mp3" length="33779765" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Many inside and outside of the pharma industry think so. Now, one group is putting pressure on the FDA and Congress to move pharma away from animal modeling in drug development.
Learn more about the White Coast Waste Project: https://www.whitecoatwaste.org/
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/is-it-time-to-call-the-dogs-off-drug-testing]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1347</itunes:duration>
                <itunes:episode>12</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Drugs down the drain</title>
        <itunes:title>Drugs down the drain</itunes:title>
        <link>https://pharmamanu.podbean.com/e/drugs-down-the-drain/</link>
                    <comments>https://pharmamanu.podbean.com/e/drugs-down-the-drain/#comments</comments>        <pubDate>Mon, 24 May 2021 14:05:30 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/84da7934-fa54-36cb-a105-ef6ff324db1c</guid>
                                    <description><![CDATA[<p>When doctors administer treatments to patients, some amount of drug is often left behind in the vial. What happens next? It gets tossed. Now, Congress is taking a closer look at this issue and considering new policies aimed at reducing this kind of medical waste.</p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/drugs-down-the-drain'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/drugs-down-the-drain</a> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>When doctors administer treatments to patients, some amount of drug is often left behind in the vial. What happens next? It gets tossed. Now, Congress is taking a closer look at this issue and considering new policies aimed at reducing this kind of medical waste.</p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/drugs-down-the-drain'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/drugs-down-the-drain</a> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/xn2nud/PHOS_2105_Episode_10bbjy4.mp3" length="48479037" type="audio/mpeg"/>
        <itunes:summary><![CDATA[When doctors administer treatments to patients, some amount of drug is often left behind in the vial. What happens next? It gets tossed. Now, Congress is taking a closer look at this issue and considering new policies aimed at reducing this kind of medical waste.
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/drugs-down-the-drain ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1992</itunes:duration>
                <itunes:episode>11</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] Elevating quality inspection with AI</title>
        <itunes:title>[Solutions Spotlight] Elevating quality inspection with AI</itunes:title>
        <link>https://pharmamanu.podbean.com/e/solution-spotlight-elevating-quality-inspection-with-ai/</link>
                    <comments>https://pharmamanu.podbean.com/e/solution-spotlight-elevating-quality-inspection-with-ai/#comments</comments>        <pubDate>Fri, 30 Apr 2021 13:41:30 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/bc8332cd-3e6a-3295-92e1-d3f0b7cecab3</guid>
                                    <description><![CDATA[<p>The importance of quality in pharma manufacturing can't be overstated. Fortunately, the industry has stepped up drug quality. While much of this can be attributed to better science and clearer guidance, technology improvements — like the application of AI to visual inspection equipment — have potential. Chief content director Karen Langhauser and Giacomo Girotto, vision inspection project manager for Stevanato Group discuss.</p>
<p>Learn more about Stevanato Group: <a href='https://www.stevanatogroup.com/en/'>https://www.stevanatogroup.com/en/</a></p>
<p>Read the full transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solution-spotlight-elevating-quality-inspection-with-ai'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solution-spotlight-elevating-quality-inspection-with-ai</a> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>The importance of quality in pharma manufacturing can't be overstated. Fortunately, the industry has stepped up drug quality. While much of this can be attributed to better science and clearer guidance, technology improvements — like the application of AI to visual inspection equipment — have potential. Chief content director Karen Langhauser and Giacomo Girotto, vision inspection project manager for Stevanato Group discuss.</p>
<p>Learn more about Stevanato Group: <a href='https://www.stevanatogroup.com/en/'>https://www.stevanatogroup.com/en/</a></p>
<p>Read the full transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solution-spotlight-elevating-quality-inspection-with-ai'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solution-spotlight-elevating-quality-inspection-with-ai</a> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/ekbgdq/PHOS2104_SS_Stevanato-V2.mp3" length="23513824" type="audio/mpeg"/>
        <itunes:summary><![CDATA[The importance of quality in pharma manufacturing can't be overstated. Fortunately, the industry has stepped up drug quality. While much of this can be attributed to better science and clearer guidance, technology improvements — like the application of AI to visual inspection equipment — have potential. Chief content director Karen Langhauser and Giacomo Girotto, vision inspection project manager for Stevanato Group discuss.
Learn more about Stevanato Group: https://www.stevanatogroup.com/en/
Read the full transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solution-spotlight-elevating-quality-inspection-with-ai ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>982</itunes:duration>
                <itunes:episode>10</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Inside the FDA’s fateful Alzheimer’s decision</title>
        <itunes:title>Inside the FDA’s fateful Alzheimer’s decision</itunes:title>
        <link>https://pharmamanu.podbean.com/e/inside-the-fda-s-fateful-alzheimer-s-decision/</link>
                    <comments>https://pharmamanu.podbean.com/e/inside-the-fda-s-fateful-alzheimer-s-decision/#comments</comments>        <pubDate>Fri, 19 Mar 2021 15:24:00 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/67fa10a0-c7fb-35e0-8728-23b8d6d55d25</guid>
                                    <description><![CDATA[<p>If Biogen’s controversial aducanumab is approved, it could become the best-selling drug of all time — and it’s a drug that has only shown modest efficacy. Here’s more on why the Alzheimer’s pipeline is primed for such a remarkable situation.</p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/inside-the-fdas-fateful-alzheimers-decision'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/inside-the-fdas-fateful-alzheimers-decision</a> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>If Biogen’s controversial aducanumab is approved, it could become the best-selling drug of all time — and it’s a drug that has only shown modest efficacy. Here’s more on why the Alzheimer’s pipeline is primed for such a remarkable situation.</p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/inside-the-fdas-fateful-alzheimers-decision'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/inside-the-fdas-fateful-alzheimers-decision</a> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/b9prfa/PHOS_2103_Episode_873zr4.mp3" length="34350035" type="audio/mpeg"/>
        <itunes:summary><![CDATA[If Biogen’s controversial aducanumab is approved, it could become the best-selling drug of all time — and it’s a drug that has only shown modest efficacy. Here’s more on why the Alzheimer’s pipeline is primed for such a remarkable situation.
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/inside-the-fdas-fateful-alzheimers-decision ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1289</itunes:duration>
                <itunes:episode>9</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Growing the biologic drug supply</title>
        <itunes:title>Growing the biologic drug supply</itunes:title>
        <link>https://pharmamanu.podbean.com/e/growing-the-biologic-drug-supply/</link>
                    <comments>https://pharmamanu.podbean.com/e/growing-the-biologic-drug-supply/#comments</comments>        <pubDate>Fri, 26 Feb 2021 12:03:51 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/effbeb69-0dcc-3f11-86b4-713d1ddfcd71</guid>
                                    <description><![CDATA[<p>The complex development and manufacturing processes needed to bring biologic drugs to market almost always translates into exorbitant prices, even after the drugs go off patent. Consequently, many areas of the world simply do not have access to the accepted standard of care. Chief content director Karen Langhauser sat down with the founders of Phylloceuticals to discuss how they plan to change this.</p>
<p>Learn more about Phylloceuticals at <a href='http://phylloceuticals.com.'>http://phylloceuticals.com. </a></p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/growing-the-biologic-drug-supply/'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/growing-the-biologic-drug-supply/ </a></p>
]]></description>
                                                            <content:encoded><![CDATA[<p>The complex development and manufacturing processes needed to bring biologic drugs to market almost always translates into exorbitant prices, even after the drugs go off patent. Consequently, many areas of the world simply do not have access to the accepted standard of care. Chief content director Karen Langhauser sat down with the founders of Phylloceuticals to discuss how they plan to change this.</p>
<p>Learn more about Phylloceuticals at <a href='http://phylloceuticals.com.'>http://phylloceuticals.com. </a></p>
<p>Read the transcript: <a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/growing-the-biologic-drug-supply/'>https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/growing-the-biologic-drug-supply/ </a></p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/gravft/PHOS_2102_Episode_7_V4a7gsb.mp3" length="40626039" type="audio/mpeg"/>
        <itunes:summary><![CDATA[The complex development and manufacturing processes needed to bring biologic drugs to market almost always translates into exorbitant prices, even after the drugs go off patent. Consequently, many areas of the world simply do not have access to the accepted standard of care. Chief content director Karen Langhauser sat down with the founders of Phylloceuticals to discuss how they plan to change this.
Learn more about Phylloceuticals at http://phylloceuticals.com. 
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/growing-the-biologic-drug-supply/ ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1705</itunes:duration>
                <itunes:episode>8</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Will the FDA keep moving at this breakneck pace?</title>
        <itunes:title>Will the FDA keep moving at this breakneck pace?</itunes:title>
        <link>https://pharmamanu.podbean.com/e/will-the-fda-keep-moving-at-this-breakneck-pace/</link>
                    <comments>https://pharmamanu.podbean.com/e/will-the-fda-keep-moving-at-this-breakneck-pace/#comments</comments>        <pubDate>Mon, 01 Feb 2021 11:27:35 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/0660372b-15b4-3852-889c-87b12eb3b3b6</guid>
                                    <description><![CDATA[<p>What has allowed the government to — for once — move at the speed of industry to help curb the pandemic? And will the FDA be able to maintain this pace once the pandemic winds down?</p>
<p>We caught up a long-time regulatory expert to find out.</p>
<p><a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/will-the-fda-keep-moving-at-this-breakneck-pace/'>Read the transcript.</a></p>
]]></description>
                                                            <content:encoded><![CDATA[<p>What has allowed the government to — for once — move at the speed of industry to help curb the pandemic? And will the FDA be able to maintain this pace once the pandemic winds down?</p>
<p>We caught up a long-time regulatory expert to find out.</p>
<p><a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/will-the-fda-keep-moving-at-this-breakneck-pace/'>Read the transcript.</a></p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/er3av8/2102_PHOS_Episode_67jc6y.mp3" length="35786500" type="audio/mpeg"/>
        <itunes:summary><![CDATA[What has allowed the government to — for once — move at the speed of industry to help curb the pandemic? And will the FDA be able to maintain this pace once the pandemic winds down?
We caught up a long-time regulatory expert to find out.
Read the transcript.]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1475</itunes:duration>
                <itunes:episode>7</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Pharma's wild ride through 2020</title>
        <itunes:title>Pharma's wild ride through 2020</itunes:title>
        <link>https://pharmamanu.podbean.com/e/pharmas-wild-ride-through-2020/</link>
                    <comments>https://pharmamanu.podbean.com/e/pharmas-wild-ride-through-2020/#comments</comments>        <pubDate>Wed, 30 Dec 2020 13:15:37 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/dd921e99-fdca-359d-a5d9-d9317648b905</guid>
                                    <description><![CDATA[<p>Pharma stepped up to the plate this year to deliver vaccines in record time and desperately needed therapeutics. Will these historic achievements change the industry's reputation in the eyes of the public? Chief Content Director, Karen Langhauser, and Senior Editor, Meagan Parrish, take a look back at pharma's accomplishments — and stumbles — during the pandemic.</p>
<p><a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/pharmas-wild-ride-through-2020'>Read the transcript .</a></p>
<p>Audio clips used:</p>
<p><a href='https://www.youtube.com/watch?v=eEHJNQV7cNw'>CNBC: </a><a href='https://www.youtube.com/watch?v=eEHJNQV7cNw'>"How pharmaceutical companies are responding to the coronavirus outbreak"</a></p>
<p><a href='https://www.youtube.com/watch?v=StsFJgGdGhQ'>CNA: </a><a href='https://www.youtube.com/watch?v=StsFJgGdGhQ'>"Pharmaceutical companies scramble to produce coronavirus vaccine"</a></p>
<p><a href='https://www.youtube.com/watch?v=ek3T8xiu1Fw'>CNBC: </a><a href='https://www.youtube.com/watch?v=ek3T8xiu1Fw'>"The Race To Develop A Coronavirus Vaccine"</a></p>
<p><a href='https://www.youtube.com/watch?v=RhXn8dKo5g8'>CBS News: </a><a href='https://www.youtube.com/watch?v=RhXn8dKo5g8'>"Trump to meet with pharmaceutical CEOs amid growing coronavirus outbreak"</a></p>
<p><a href='https://www.youtube.com/watch?v=C__Rsnrvy6w'>CNBC: </a><a href='https://www.youtube.com/watch?v=C__Rsnrvy6w'>"Trump meets with big pharma to tackle coronavirus"</a></p>
<p><a href='https://www.youtube.com/watch?v=RsgYEUQpQEo'>CBNC: </a><a href='https://www.youtube.com/watch?v=RsgYEUQpQEo'>"Moderna CEO Stephane Bancel on executive stock sales"</a></p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Pharma stepped up to the plate this year to deliver vaccines in record time and desperately needed therapeutics. Will these historic achievements change the industry's reputation in the eyes of the public? Chief Content Director, Karen Langhauser, and Senior Editor, Meagan Parrish, take a look back at pharma's accomplishments — and stumbles — during the pandemic.</p>
<p><a href='https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/pharmas-wild-ride-through-2020'>Read the transcript .</a></p>
<p>Audio clips used:</p>
<p><a href='https://www.youtube.com/watch?v=eEHJNQV7cNw'>CNBC: </a><a href='https://www.youtube.com/watch?v=eEHJNQV7cNw'>"How pharmaceutical companies are responding to the coronavirus outbreak"</a></p>
<p><a href='https://www.youtube.com/watch?v=StsFJgGdGhQ'>CNA: </a><a href='https://www.youtube.com/watch?v=StsFJgGdGhQ'>"Pharmaceutical companies scramble to produce coronavirus vaccine"</a></p>
<p><a href='https://www.youtube.com/watch?v=ek3T8xiu1Fw'>CNBC: </a><a href='https://www.youtube.com/watch?v=ek3T8xiu1Fw'>"The Race To Develop A Coronavirus Vaccine"</a></p>
<p><a href='https://www.youtube.com/watch?v=RhXn8dKo5g8'>CBS News: </a><a href='https://www.youtube.com/watch?v=RhXn8dKo5g8'>"Trump to meet with pharmaceutical CEOs amid growing coronavirus outbreak"</a></p>
<p><a href='https://www.youtube.com/watch?v=C__Rsnrvy6w'>CNBC: </a><a href='https://www.youtube.com/watch?v=C__Rsnrvy6w'>"Trump meets with big pharma to tackle coronavirus"</a></p>
<p><a href='https://www.youtube.com/watch?v=RsgYEUQpQEo'>CBNC: </a><a href='https://www.youtube.com/watch?v=RsgYEUQpQEo'>"Moderna CEO Stephane Bancel on executive stock sales"</a></p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/jrzs9m/2012_OffScript_Episode_5-V29wuap.mp3" length="35986626" type="audio/mpeg"/>
        <itunes:summary>Pharma stepped up to the plate this year to deliver vaccines in record time and desperately needed therapeutics. Will these historic achievements change the industry's reputation in the eyes of the public? Chief Content Director, Karen Langhauser, and Senior Editor, Meagan Parrish, take a look back at pharma's accomplishments — and stumbles — during the pandemic.</itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1393</itunes:duration>
                <itunes:episode>6</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Saving the shrinking pipeline for antibiotics</title>
        <itunes:title>Saving the shrinking pipeline for antibiotics</itunes:title>
        <link>https://pharmamanu.podbean.com/e/saving-the-shrinking-pipeline-for-antibiotics/</link>
                    <comments>https://pharmamanu.podbean.com/e/saving-the-shrinking-pipeline-for-antibiotics/#comments</comments>        <pubDate>Mon, 16 Nov 2020 13:57:56 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/7460f288-c6a1-3129-8477-dd7122543615</guid>
                                    <description><![CDATA[<p>The threat of superbugs hasn’t gone away and in many ways the pandemic has made this problem loom even larger. But a new organization called the <a href='https://amractionfund.com/'>AMR Action Fund</a> is working to infuse needed dollars and resources into the dwindling pipeline for needed antibiotics.</p>
<p><a href='https://bit.ly/36BxXPO'>Read the full transcript</a></p>
]]></description>
                                                            <content:encoded><![CDATA[<p>The threat of superbugs hasn’t gone away and in many ways the pandemic has made this problem loom even larger. But a new organization called the <a href='https://amractionfund.com/'>AMR Action Fund</a> is working to infuse needed dollars and resources into the dwindling pipeline for needed antibiotics.</p>
<p><a href='https://bit.ly/36BxXPO'>Read the full transcript</a></p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/tw8gwq/PHOS_2011_Pod_49kibp.mp3" length="42612165" type="audio/mpeg"/>
        <itunes:summary><![CDATA[The threat of superbugs hasn’t gone away and in many ways the pandemic has made this problem loom even larger. But a new organization called the AMR Action Fund is working to infuse needed dollars and resources into the dwindling pipeline for needed antibiotics.
Read the full transcript]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1779</itunes:duration>
                <itunes:episode>5</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Reaching undecided vaxxers: Can pharma simultaneously advance vaccines and public trust</title>
        <itunes:title>Reaching undecided vaxxers: Can pharma simultaneously advance vaccines and public trust</itunes:title>
        <link>https://pharmamanu.podbean.com/e/reaching-undecided-vaxxers-can-pharma-simultaneously-advance-vaccines-and-public-trust/</link>
                    <comments>https://pharmamanu.podbean.com/e/reaching-undecided-vaxxers-can-pharma-simultaneously-advance-vaccines-and-public-trust/#comments</comments>        <pubDate>Mon, 02 Nov 2020 07:46:22 -0600</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/e41dc95e-cbd3-32fe-b1d2-8a2ea43c9c50</guid>
                                    <description><![CDATA[<p>As several late-stage trials edge towards the finish line, skepticism surrounding vaccines continues to spread at a rate faster than the coronavirus itself — and drugmakers and health officials are scrambling to restore public trust. Pharma Manufacturing editors Karen Langhauser and Meagan Parrish discuss.</p>
<p>Read the transcript here: <a href='https://bit.ly/34PEeb6'>https://bit.ly/34PEeb6</a></p>
]]></description>
                                                            <content:encoded><![CDATA[<p>As several late-stage trials edge towards the finish line, skepticism surrounding vaccines continues to spread at a rate faster than the coronavirus itself — and drugmakers and health officials are scrambling to restore public trust. Pharma Manufacturing editors Karen Langhauser and Meagan Parrish discuss.</p>
<p>Read the transcript here: <a href='https://bit.ly/34PEeb6'>https://bit.ly/34PEeb6</a></p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/4qiaah/201102_PHOS_Episode_3a78ay.mp3" length="23803967" type="audio/mpeg"/>
        <itunes:summary><![CDATA[As several late-stage trials edge towards the finish line, skepticism surrounding vaccines continues to spread at a rate faster than the coronavirus itself — and drugmakers and health officials are scrambling to restore public trust. Pharma Manufacturing editors Karen Langhauser and Meagan Parrish discuss.
Read the transcript here: https://bit.ly/34PEeb6]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>912</itunes:duration>
                <itunes:episode>4</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>[Solutions Spotlight] Pharma’s drive towards more sustainable packaging</title>
        <itunes:title>[Solutions Spotlight] Pharma’s drive towards more sustainable packaging</itunes:title>
        <link>https://pharmamanu.podbean.com/e/solutions-spotlight-pharmas-drive-towards-more-sustainable-packaging/</link>
                    <comments>https://pharmamanu.podbean.com/e/solutions-spotlight-pharmas-drive-towards-more-sustainable-packaging/#comments</comments>        <pubDate>Thu, 29 Oct 2020 10:03:28 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/9a07ac7d-fdcf-32ab-9a11-ac6fd9a334c0</guid>
                                    <description><![CDATA[<p>Chief Content Director Karen Langhauser is joined by Richard Wood, Executive Director of Technical Solutions at <a href='https://www.softboxsystems.com/'>Softbox Systems. </a></p>
<p> </p>
<p>Read the full transcript: <a href='https://bit.ly/2JaQOsQ'>https://bit.ly/2JaQOsQ </a>Learn more: <a href='https://bit.ly/2G8oWo3'>https://bit.ly/2G8oWo3</a></p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Chief Content Director Karen Langhauser is joined by Richard Wood, Executive Director of Technical Solutions at <a href='https://www.softboxsystems.com/'>Softbox Systems. </a></p>
<p> </p>
<p>Read the full transcript: <a href='https://bit.ly/2JaQOsQ'>https://bit.ly/2JaQOsQ </a>Learn more: <a href='https://bit.ly/2G8oWo3'>https://bit.ly/2G8oWo3</a></p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/zeufgv/2010_PHOS_SS_Softbox_FINAL.mp3" length="19414742" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Chief Content Director Karen Langhauser is joined by Richard Wood, Executive Director of Technical Solutions at Softbox Systems. 
 
Read the full transcript: https://bit.ly/2JaQOsQ Learn more: https://bit.ly/2G8oWo3]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>814</itunes:duration>
                <itunes:episode>3</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
            </item>
    <item>
        <title>Pharma's next big hurdle — distributing vaccines</title>
        <itunes:title>Pharma's next big hurdle — distributing vaccines</itunes:title>
        <link>https://pharmamanu.podbean.com/e/pharmas-next-big-hurdle-%e2%80%94-distributing-vaccines/</link>
                    <comments>https://pharmamanu.podbean.com/e/pharmas-next-big-hurdle-%e2%80%94-distributing-vaccines/#comments</comments>        <pubDate>Mon, 19 Oct 2020 09:42:36 -0500</pubDate>
        <guid isPermaLink="false">pharmamanu.podbean.com/9e97dd8f-5c04-3508-85d0-cd646f4f8bd1</guid>
                                    <description><![CDATA[<p>It's been called the biggest logistical challenge of all time. What does pharma and the government need to do to quickly and successfully deliver COVID-19 vaccines into the waiting arms of Americans? Senior editor, Meagan Parrish, chats with PwC's Omar Chane to find out.</p>
<p>Read the full transcript here: <a href='https://bit.ly/3dJdhZs'>https://bit.ly/3dJdhZs</a> </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>It's been called the biggest logistical challenge of all time. What does pharma and the government need to do to quickly and successfully deliver COVID-19 vaccines into the waiting arms of Americans? Senior editor, Meagan Parrish, chats with PwC's Omar Chane to find out.</p>
<p>Read the full transcript here: <a href='https://bit.ly/3dJdhZs'>https://bit.ly/3dJdhZs</a> </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/7irsjv/2010_PHOS_Episode_27qjoa.mp3" length="48436387" type="audio/mpeg"/>
        <itunes:summary><![CDATA[It's been called the biggest logistical challenge of all time. What does pharma and the government need to do to quickly and successfully deliver COVID-19 vaccines into the waiting arms of Americans? Senior editor, Meagan Parrish, chats with PwC's Omar Chane to find out.
Read the full transcript here: https://bit.ly/3dJdhZs ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1983</itunes:duration>
                <itunes:episode>2</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
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    <item>
        <title>The United States of Generics</title>
        <itunes:title>The United States of Generics</itunes:title>
        <link>https://pharmamanu.podbean.com/e/the-united-states-of-generics/</link>
                    <comments>https://pharmamanu.podbean.com/e/the-united-states-of-generics/#comments</comments>        <pubDate>Mon, 05 Oct 2020 11:39:53 -0500</pubDate>
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                                    <description><![CDATA[<p>Should America reshore more generic drug manufacturing? Will it really keep our supply chains safe from disruptions? For our September cover story, we took a deep dive into these questions to untangle the arguments around reshoring generic drug production. Find out why we walked away so obsessed with Rosemary Gibson and why Phlow Corp. might be the company that settles the debate around reshoring once and for all. </p>
]]></description>
                                                            <content:encoded><![CDATA[<p>Should America reshore more generic drug manufacturing? Will it really keep our supply chains safe from disruptions? For our September cover story, we took a deep dive into these questions to untangle the arguments around reshoring generic drug production. Find out why we walked away so obsessed with Rosemary Gibson and why Phlow Corp. might be the company that settles the debate around reshoring once and for all. </p>
]]></content:encoded>
                                    
        <enclosure url="https://mcdn.podbean.com/mf/web/s2hh4w/2009_PHOS_Episode_1-v2-music_layer783pi.mp3" length="31142832" type="audio/mpeg"/>
        <itunes:summary><![CDATA[Should America reshore more generic drug manufacturing? Will it really keep our supply chains safe from disruptions? For our September cover story, we took a deep dive into these questions to untangle the arguments around reshoring generic drug production. Find out why we walked away so obsessed with Rosemary Gibson and why Phlow Corp. might be the company that settles the debate around reshoring once and for all. ]]></itunes:summary>
        <itunes:author>Pharma Manufacturing</itunes:author>
        <itunes:explicit>false</itunes:explicit>
        <itunes:block>No</itunes:block>
        <itunes:duration>1179</itunes:duration>
                <itunes:episode>1</itunes:episode>
        <itunes:episodeType>full</itunes:episodeType>
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