Claim OwnershipOff Script: A Pharma Manufacturing Podcast
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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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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.
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.
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 discussed how hydrogenation was implemented to bridge the gap between two of the company’s core hazardous chemistries: nitration and phosgenation.
Learn more about Valsynthese: https://www.valsynthese.ch/
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.
The good — Thermo Fisher opens center to boost cell therapy development
The bad — FDA cites Aurobindo plant after Raleigh inspection
The ugly — Trump probes pharma imports as tariff threat looms
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Novartis to invest $23B in U.S. manufacturing and R&D, including seven new sites
The bad — U.S. urged to invest $15B to counter China’s biotech rise
The ugly — Trump signals ‘major’ tariffs on pharma, urging manufacturing shift back to U.S.
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