Off Script: A Pharma Manufacturing Podcast

Pharma Manufacturing
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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!

  1. 9 HR AGO

    AI and the Future of Drug Development

    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.

    24 min

  2. 30/12/2025

    Predictive Maintenance for a Modern Cold Chain

    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.

    15 min

  3. 23/12/2025

    Building a Future for Curative Cell Therapies: Part Two

    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.

    14 min

  4. 16/12/2025

    Building a Future for Curative Cell Therapies: Part One

    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.

    17 min

  5. 09/12/2025

    Modular Flow Chemistry and the Future of Continuous Manufacturing

    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.

    17 min

  6. 25/11/2025

    The Economics Behind U.S. Generic Drug Manufacturing: Part Two

    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. 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.

    16 min

  7. 20/11/2025

    The Economics Behind U.S. Generic Drug Manufacturing: Part One

    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.

    16 min

  8. 11/11/2025

    CGT Manufacturing Challenges and Opportunities

    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.

    19 min
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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!

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