Off Script: A Pharma Manufacturing Podcast

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 S...

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 acc...

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 o...

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 Ce...

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 Manufact...

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 s...

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. J...

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 Kirs...

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, coo...

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 ne...

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 episo...

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 bala...

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 h...

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 le...

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 Par...

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-pa...