Breaking the Death Spiral: How to Rescue Failing CDMO Relationships Before It’s Too Late

“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

“Despite the volatility, the industry is getting some positive energy and renewed confidence”Jeremie Trochu, Chief Executive Officer at Ardena, has spent two decades building and scaling businesses across the biopharma sector. He was part of the leadership team that transformed Catalent from a private equity spinoff into a publicly traded global CDMO, where he led multiple successful acquisitions and integrations. Since joining Ardena as CEO in 2024, he has been steering the company through one of the most volatile periods in pharmaceutical manufacturing history.In a recent PharmaSource podcast episode, Jeremie explains how CDMOs can build resilient partnerships, when to specialize versus diversify, and what it takes to earn a seat at the table with pharma and biotech clients.Read more.

"Life has not become simpler and easier. It's become more complex. Success requires acknowledging this complexity early and building flexibility into every aspect of the business model.”Renée Aguiar-Lucander is the CEO of Hansa Biopharma, appointed in April 2025. Renée brings rich expertise from seven years leading Calliditas Therapeutics through a dual NASDAQ listing and the first approved drug for IgA nephropathy, plus extensive healthcare investment experience at Omega Funds and 3i Group.Speaking to PharmaSource at Nordic Life Science Days (NLSDays), Renée shares candid insights on the investment climate that's reshaped biotech over the past few years, the structural challenges facing European companies, and what early-stage biotechs need to focus on to survive an increasingly selective funding environment.Read more.

“Poland is no longer an emerging market. It’s a partnering market.”Dr. Magdalena Kulczycka, founder of the Biotech Innovation Institute, is a molecular biologist with experience spanning academia, entrepreneurship, and venture capital. Her institute fosters biotech growth from lab to market through consulting, venture building, and business development, with particular focus on Poland’s life sciences sector and the broader Central and Eastern European region.Poland’s biotech sector has undergone substantial transformation over the last few decades, evolving from a centrally planned system to one of Europe’s more dynamic innovation economies. This evolution creates opportunities for pharmaceutical companies and contract development and manufacturing organizations (CDMOs) seeking European partnerships. Speaking to PharmaSource at Nordic Life Science Days (NLSDays) in Gothenburg, Magdalena outlines why Poland merits attention from international partners and how organizations can successfully navigate this market.Read more.