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FDA hemorrhaging staff while promising to fast-track advanced modalities. BIOSECURE Act signed into law with five-year phase-out timelines. Tariffs creating 50% cost increases on manufacturing equipment. Most Favored Nation deals cutting prices. Cell and gene therapy facilities closing despite scientific promise. Welcome to 2026 pharma manufacturing. In the latest episode of the PharmaSource podcast, Gil Roth, President of the Pharma and Biopharma Outsourcing Association (PBOA), explains how pharma companies are impacted by policy changes, and how CDMOs are building flexibility into capital planning, manufacturing infrastructure, and customer contracts to survive chaos that makes forecasting impossible.Gil Roth is speaking at CDMO Live Europe and CDMO Live Americas

Fresh from External Manufacturing Leaders in snowy Boston, in this episode we are sharing insights from senior biopharma executives confronting an impossible challenge: how do you reshore when there's nowhere to reshore to? Highlights of the event include why biotechs built on Chinese manufacturing economics are scrambling, why US capacity for ADCs and sterile fill-finish is completely tied up, and how manual operations are threatening American competitiveness. Plus: the 2026 strategies leaders are actually implementing, from AI-powered Digital Twins to creative redundancy plays. Thanks to Aenova Group for co-hosting ExM Leader Boston with us. Download the full report here: https://pharmasource.global/content/resources/exm-leaders-boston-26/

“There are 437 active clinical trials in radiopharmaceuticals, and 100 companies developing them. If your logistics are not better, there is no other differentiator. You need to compete by experience.” When Kostja Paschalidis and his co-founders left their roles developing one of the leading radiopharmaceutical products, they recognised a fundamental shift in pharmaceutical manufacturing. Unlike traditional drugs where marketing drives commercial success, radiopharmaceuticals demand something entirely different: flawless service delivery. As co-founder and head of systems and logistics at Firm, a design consultancy specialising in radiopharmaceutical services, Kostja has identified why operational excellence—not clinical superiority—will determine market winners. In the latest PharmaSource podcast episode, he explains why radiopharmaceutical companies must become service-centric organisations to succeed and how a lack of standardisation and suitable technology creates barriers to scale.

“We’re not trying to be everything for everyone. Our specialized focus has been very exciting for me.” Franco Negron, CEO of Simtra BioPharma Solutions, has transformed a 65-year sterile manufacturing legacy into an independent CDMO since the company’s carve-out from Baxter International (Baxter) in October 2023. Franco has led over $500 million in capital investments to double capacity and create mirrored capabilities across sites in Indiana, US, and Halle/Westfalen, Germany. Franco brings industry experience from Procter & Gamble, Johnson & Johnson, Novartis, and Patheon, which became part of Thermo Fisher Scientific, where he helped shape integrated CDMO strategies. In this PharmaSource podcast, recorded at CPHI 2025, Franco explains how Simtra is navigating supply chain challenges, tariff uncertainties, and injectable manufacturing complexity, from GLP-1s to antibody drug conjugates. Read more.

“Process chemistry alone is no longer the whole story—it needs to be connected with engineering solutions, digital tools, and data utilization.” Stefan Randl, Chief Scientific Officer at Siegfried, joined the Swiss-based CDMO in January 2025 after 16 years at Evonik, where he led innovation management for healthcare, ran drug substance operations in the US, and headed sales across Asia. Read more.

“Biotechs need flexibility and have limited budgets, while big pharma looks for long-term partnerships, reliability, scalability, and new technologies.” Luis Berrade, Senior Director of Global Biologics Testing Sales at Charles River Laboratories, has spent his career helping pharmaceutical and biotech companies bring therapies to market faster and safer. With a PhD in medicinal chemistry and experience spanning both contract manufacturing and testing services, Luis now leads Charles River’s global biologics testing commercial strategy, working with companies of all sizes to navigate the complex regulatory landscape. In an episode of the PharmaSource podcast, Luis shares his insights on when sponsors should start thinking about testing strategy, common mistakes that create bottlenecks, and how emerging technologies like next-generation sequencing are reshaping the biologics testing landscape. Read more.

PharmaSource analysis of 732 industry announcements reveals massive investment in U.S. capacity, with partnerships dominating the news cycle and advanced therapy manufacturing reaching industrial scale The pharmaceutical contract manufacturing landscape underwent a fundamental readjustment in 2025, marked by record investment flows, accelerated U.S. reshoring, and a decisive shift toward integrated technology platforms. In this episode, PharmaSource's very own Tamnna Thakur sits down with Editor Dora Wells to break down the year's most significant trends. From the $18.48 billion that poured into U.S. facilities to WuXi Biologics' 20 announcements despite regulatory headwinds. They analyze what the 732 tracked announcements reveal about where the industry is heading. Read more.

“Twenty years ago, who knew that ADCs and next-generation bioconjugates were going to be so exciting, so successful?” Campbell Bunce, Chief Scientific Officer at Abzena, reflects on the strategic positioning that has placed his company at the forefront of one of pharma’s fastest-growing segments. Campbell leads a global team spanning discovery, development, and GMP manufacturing at Abzena, where he has spent nearly a decade building the company’s capabilities in complex modalities. His background as an immunologist, combined with 18 years in biotech before joining Abzena, gives him a unique perspective on translating scientific innovation into commercial manufacturing reality. In this conversation on the PharmaSource podcast, Campbell discusses Abzena’s strategic focus on antibody-drug conjugates (ADCs) and bioconjugates, the company’s approach to proprietary platform development, and how the CDMO is responding to increased demand driven by geopolitical manufacturing shifts and clinical successes in the space. Read more.

“When I walked into the tech transfer, we were a million dollars over budget, six months behind schedule, and struggling to make a single successful batch,” says Amy Gamber. Amy Gamber, Executive Director, Lifecycle Lead at Kyverna Therapeutics, specializes in crisis recovery for late-stage biotech and cell and gene therapy programs. With 20+ years of CMC leadership experience at Atara Biotherapeutics, CSL Seqirus, and Amgen, she’s built a career fixing what others couldn’t. In this PharmaSource podcast interview, Amy shares how to identify warning signs before minor issues become million-dollar problems, strategies for rescuing failing tech transfers, and what it takes to restart a manufacturing facility dormant for two years. Full article

“We have to be transparent down to the last person in the organization, what the organization is doing, and where the issues are. We have to celebrate wins. We have to talk about the good things people do.” Markus Sieger serves as CEO of Polpharma Group, one of Central and Eastern Europe’s largest pharmaceutical manufacturers. With 25 years at the company, and 10  years as CEO, he has transformed the Polish generic and OTC medicines manufacturer into a regional powerhouse producing 400 million packages annually across Poland, Kazakhstan, and Western European markets. Markus will step down as CEO of Polpharma Group in January 2026, transitioning to the company’s supervisory board. In this conversation, Markus reflects on building Polpharma’s market leadership through culture transformation and digital-first operations, the challenges that shaped his leadership journey, and the evolution of Europe’s generic medicines industry. Read more.

“Our goal is to be recognized for exceptional reliability in our services and manufacturing, while helping our customers bring the most innovative medicines to market.” Dr. Michael Quirmbach, CEO and President of CordenPharma, has overseen remarkable growth at the full-service CDMO since joining in 2014. Under his leadership, the company has tripled its workforce to 3,000 employees and increased revenue from €245 million to nearly €1 billion while expanding capabilities across peptides, injectables, and high-potency oncology products. Michael, who holds a PhD in chemistry and began his career as a scientist before transitioning to business leadership, brings 25 years of CDMO experience to his role. In a recent PharmaSource podcast recorded at CPHI, he discussed CordenPharma’s €900 million expansion in peptide manufacturing, the company’s strategy for complex modalities, and how AI is transforming pharmaceutical manufacturing operations. Read more.

"If you can't demonstrate international quality standards, nobody is going to take a chance on a million-dollar batch to save a few dollars on their manufacturing. It just won't happen." Eric Langer is President of BioPlan Associates, where he has systematically documented the evolution of the biomanufacturing industry since the early 2000s. In the latest PharmaSource podcast episode, Eric explains why biopharmaceutical outsourcing budgets are projected to surge 11% in 2025, the cost of talent constraints, and the rise of complex modalities like cell and gene therapies. He shares critical insights from BioPlan's 22nd annual report on what manufacturers must prioritize to succeed in an increasingly competitive landscape. Read more.

“The world can change overnight. We have to accept volatility as part of the world we live in.” Peter DeYoung, CEO of Piramal Global Pharma, has spent 13 years with the Piramal Group, navigating the complexities of pharmaceutical manufacturing across consulting, investing, and operating roles. His engineering background and cross-continental experience position him to lead a billion-dollar pharma operation spanning CDMO services, complex hospital generics, and consumer healthcare. In this PharmaSource podcast interview, Peter explains how Piramal competes for mindshare as pharma companies reassess their manufacturing footprints, why geographic flexibility matters more than ever, and how the company measures success through customer delight rather than satisfaction. Read more.

"We are not in a transient moment - this will affect industry profitability for decades. The previous era of rule-based international trade is gone" Frank Binder, Managing Director at GSCA (Global Supply Chain Advisors) and former Head of Supply Chain at Santen and Celgene, has watched the pharmaceutical supply chain undergo unprecedented disruption in 2025. The wave of US tariff announcements, regulatory complexity, and forced regionalization has created what he calls a fundamental shift in how the industry must operate. Read full article

“We became an analytical powerhouse before we started offering integrated process development and manufacturing. That’s what differentiates us.” Sigma Mostafa, Chief Scientific Officer, and Katie Edgar, Chief Business Officer at KBI Biopharma, explain how technical depth in analytics and proprietary cell line technology create competitive advantage in an increasingly crowded CDMO market. Sigma brings 15 years of experience with KBI, joining as Director of Process Development in 2010 and advancing through the company’s exponential growth. Katie leads business strategy, focusing on long-term partnerships and proactive risk mitigation for customers ranging from virtual biotech startups to global pharmaceutical companies. In this PharmaSource podcast recorded live at CPHI Frankfurt 2025, Sigma and Katie reveal how KBI’s analytical foundation, combined with high-touch customer relationships and digital integration tools, supports molecules from early development through commercial manufacturing. Full article