Off Script: A Pharma Manufacturing Podcast

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.

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.

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.

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.

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.

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:

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.

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.

Building on insights from CRB’s Horizons: Life Sciences 2025 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.

If you missed Part One, catch our discussion on the rise of continuous manufacturing and its growing adoption across large pharma.

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.