PharmaSource Podcast

"There are not that many European CDMOs with commercial expertise in cell therapy - who understand the regulatory requirements and production challenges when you have to manufacture large quantities on a regular basis. This is why we ended up with a very short list of two or three potential suppliers."

CellProthera's recent announcement of its manufacturing partnership with SEQENS for Phase III trials marks a pivotal moment in the French biotech's journey from research lab to commercial reality. The eight-month technology transfer process now underway represents years of strategic planning and hard-won lessons about scaling cell therapy manufacturing.

In an exclusive interview, Matthieu De Kalbermatten, CEO of CellProthera, reveals the detailed selection process that led to choosing CELLforCURE by SEQENS as their manufacturing partner. His insights offer a rare glimpse into how biotechs navigate the complex transition from early development to commercial-scale production.

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“My ambition for being a CDMO is that there will always be technical challenges, but I want to be transparent about the challenge and provide options to a customer.”

Hanns-Christian Mahler, CEO of ten23 health, brings 15 years of sponsor-side experience to his current role leading a sterile product CDMO focused on drug product development, manufacturing and testing. His unique perspective from both sides of the outsourcing relationship provides valuable insights into building successful partnerships.

In the latest PharmaSource podcast episode recorded at CDMO Live 2025, Hanns explains why transparency, realistic planning and early development integration are essential strategies for avoiding costly manufacturing failures and building sustainable relationships.

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Leaders from the Pharmaceutical Supply Chain Initiative (PSCI) and Manufacture 2030 outlined the mounting pressure on contract manufacturers to address sustainability at CDMO Live 2025, with major pharma companies now making emissions reduction a prerequisite for business relationships.

The Climate-Healthcare Connection

Rob Williams, Senior Director of Sustainable Procurement at AstraZeneca and Chair of PSCI, opened with a stark reality check about healthcare's environmental impact. "Healthcare contributes 5% of global emissions. That's actually more than aviation, which is often pointed out as being one of the poster children of the problem we're creating," Williams revealed.

The connection between climate change and healthcare is becoming increasingly clear, with WHO recognising climate impacts as a major health issue. "Whether it's increased temperatures, whether it's intensity of storms, whether it's flooding... all of those organisations recognise that as the climate is changing, it's presenting impacts on human health," Williams explained.

Martin Chilcott, CEO and founder of Manufacture 2030, added critical context: "It's not just the headline acts of malaria and cholera that we're talking about moving with temperature changes, but also it's the migration patterns... 120 million people on the move because of the unlivability of the world in which they exist."

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“Nobody knows exactly what will happen, so making yourself anxious about unknowns doesn’t help. You must be prepared for multiple scenarios, ready and flexible to react quickly when changes do occur.”

Maik Talarczyk, Director of PMO Office and Strategy in External Manufacturing Operations at Sandoz, brings extensive expertise in managing external manufacturing relationships and strategic operations for one of the world’s largest generic pharmaceutical companies, with over 20,000 employees worldwide.

In this episode recorded at CDMO Live 2025 in Rotterdam, Maik shares how Sandoz navigates tremendous complexity and uncertainty in pharmaceutical manufacturing while managing hundreds of external partners. His insights reveal a methodical approach to preparedness, partnership management, and strategic planning in an increasingly unpredictable global landscape.

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CDMO Live 2025 Highlights: How Bayer, Boehringer Ingelheim, and Leo Pharma are rebuilding manufacturing strategies

• Complexity Challenge: With thousands of SKUs to manage (Bayer handles 5,000+, half outsourced), companies struggle with aging portfolios and aggressive commercial expansion.
• Geopolitical Reshuffling: A staggering 62% of pharma companies are restructuring their manufacturing footprints in response to global tensions.
• Different Resilience Approaches:

- Boehringer Ingelheim (family-owned) maintains dual sourcing despite higher costs

- Leo Pharma focuses on strategic partnerships for smaller-volume products

- Bayer's "Project Martini" shifts from Euro-centric to regional production

• AI Adoption: Still early days, but promising applications in contract management, document processing, and predictive maintenance are emerging.
• Sustainability Shift: While not top priority, sustainability is increasingly viewed as both an ethical necessity and long-term cost reducer.

Bottom Line: The industry is moving from pure cost optimization to balancing affordability with resilience. As Blue Jet Healthcare's MD put it: "resilience is becoming as important as costs."

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Gil Roth, president of the Pharma and Biopharma Outsourcing Association (PBOA), delivered a stark assessment of the uncertain regulatory and trade environment facing US drug manufacturers under Donald Trump's administration at CDMO Live 2025.

In a presentation characterised by its unflinching candour, Roth outlined the key challenges confronting contract manufacturers, from rapidly changing tariff policies to mass layoffs at the FDA. His central message was bracingly simple: "Nobody knows anything. You need to be focused on flexibility and optionality."

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“Over 90% of people you meet in life sciences are going to be dealing with failure every day. You have to normalize failure in this industry to get the success you want,” says Beth Benatti Kennedy, discussing the unique pressures facing pharmaceutical professionals.

Beth Benatti Kennedy brings more than two decades of experience as a leadership and resilience executive coach, working with major pharmaceutical companies including Takeda, Nautilus Biotechnology, and Pfizer. Beth is also the author of Career Recharge and co-author of ReThink Resilience

Her insights into preventing burnout have become increasingly relevant as the industry faces mounting pressures from accelerated development timelines and regulatory complexity. In this interview with PharmaSource, Beth shares critical strategies for building resilience.

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“The pharmaceutical industry is very good at being reactive. If something happens, they have very clear processes, but they’re not so good anticipating change.”

David Schneider, Founder & CEO of Qualifyze, brings more than a decade of experience working in investment banking (JP Morgan), Fortune 500 companies (BASF), and management consulting (McKinsey). He now leads Qualifyze, a company transforming supply risk management in the pharmaceutical industry.

With operations across Frankfurt, Barcelona, and now Jersey City, Qualifyze serves around 1,400 pharmaceutical companies globally and has inspected over 4,000 production sites worldwide.

In the latest PharmaSource podcast, David and Qualifyze’s Chief Product Officer Martin Lehmann discuss how data-driven approaches can help pharmaceutical supply chains adapt to geopolitical pressures and uncertainty.

Meet the Qualifyze team at CDMO Live 2025

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“In Big Pharma, innovation is often stifled because the bureaucracy and mindset completely kills creativity and intuition needed for discovery. That’s why they now prefer to allocate their early-phase resources to smaller biotechs,” explains Julien Laizé, sharing candid insights about the delicate balance between innovation and compliance in vaccine manufacturing

Julien Laizé serves as Director of External Manufacturing CTM at Valneva, a French-based specialty vaccine company developing and commercialising vaccines for infectious diseases. With previous roles at Novo Nordisk and Eli Lilly, Julien brings unique perspectives on managing external manufacturing across both big pharma and biotech environments, particularly in navigating the tension between innovation and regulatory compliance.

Ahead of CDMO Live next week, Julien shares his experiences in fostering innovation while maintaining rigorous quality standards, and explains why the industry’s greatest discoveries often come from embracing calculated risks.

Listen to the full episode here and join Julien and other ExM leaders at CDMO Live 2025, 7-8 May, Rotterdam.

“We are privately owned by a Trust, which means all our profits are reinvested in the company. This translates to steady growth – maybe slower compared to other service providers, but we’re quite proud of that steady growth,” explains Franciane Chevot, Senior Business Development Manager at Almac.

With 55 years of industry experience, approximately 7,500 employees, and 18 facilities worldwide across Europe, North America, and Asia, Almac has established a global footprint. However, it’s their ownership structure that truly differentiates them.

This reinvestment approach has allowed Almac to take a long-term view of business development rather than focusing on short-term gains, creating stability that benefits both the company and its clients.Ahead of CDMO Live, Franciane shares how Almac’s unique ownership structure, scientific expertise, and customer-centric approach have positioned the CDMO as a trusted partner for pharmaceutical and biotech companies across the drug development lifecycle.

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