Off Script: A Pharma Manufacturing Podcast

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 collab...

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 GrayMatt...

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 Busines...

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 episod...

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...

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...

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...

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 constraint...

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...

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 matu...

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 bal...

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...

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...

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 phar...

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 manufact...

Large biopharma companies in recent months have pledged billions of dollars in capital expenditures for U.S. manufacturing and R&D facilities. What if it’s not accurate? Greg Slabodkin Read by Brittany Duncan  https://www.pharmamanufacturing.com/editors-review/article/55314470/editors-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbers  

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 Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/sector/contract-manufacturing/article/55314756/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-medications  

  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  

  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  

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 Slabodkin Read by Brittany Duncan  https://www.pharmamanufacturing.com/all-articles/article/55302441/hikmas-planned-1b-us-investment-comes-at-critical-time-for-generic-medicines-supply  

While macroeconomic uncertainty weighs on the sector, there are glimmers of hope in some areas of pharmaceutical outsourcing and services. Greg Slabodkin Read 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  

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 Slabodkin Read by Brittany Duncan

While the pharmaceutical industry has been slow to adopt continuous manufacturing, it appears to be gaining momentum. Greg Slabodkin Read by Brittany Duncan  Enjoy the article Here: https://www.pharmamanufacturing.com/all-articles/article/55295669/flow-state-the-evolving-shape-of-continuous-manufacturing  

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&D Chemist at Valsynthese, the fine chemicals division of Société Suisse des Explosifs Holding (SSE). Dr. Mantilli dis...

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.