Off Script: A Pharma Manufacturing Podcast

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.

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.

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.

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.

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.

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.

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.  

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.

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.

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.

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.

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.

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: 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.

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.

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.