A panel of M&A advisors and consultants at CDMO Live 2025 explored how private equity investment has transformed the contract manufacturing sector, whilst examining current challenges from geopolitical uncertainty to market volatility.
The session, sponsored by TH Healthcare & Life Sciences, featured Kurt Nielsen (Managing Partner, Longview Leader LLC), Dirk Beyer (Managing Director, Raymond James), Asif Shahinsha (Executive Director, TH Healthcare & Life Sciences), and Vishnu Dwadasi (Director Life Sciences, West Monroe).
The biologics external manufacturing panel at CDMO Live 2025, sponsored by BSP Pharmaceuticals, brought together industry leaders to tackle the key challenges in scaling biological manufacturing amid geopolitical tensions, capacity constraints and evolving partnership models.
The panel featured Olaf Birkenmeier, Head of External Manufacturing at Polpharma Biologics; Julien Laizé, Director of External Manufacturing CTM at Valneva; Catherine Seigneur, Senior Director of External Manufacturing Business Lead at UCB; and Giorgio Salciarini, Head of Sales - Technical Business Development at BSP Pharmaceuticals.
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Joshi Venugopal, SVP and Head of Region for Novartis Gene Therapies, outlined three critical inflection points that will determine whether cell and gene therapy reaches its full potential at CDMO Live 2025
The cell and gene therapy industry finds itself squarely in the middle of a classic Gartner hype cycle, according to Novartis gene therapy chief Joshi Venugopal.
Speaking at CDMO Live 2025, Venugopal drew on Novartis's experience with the first two FDA-approved gene therapies to map where the industry stands today — and what it will take to reach the "plateau of productivity."
"We had the opportunity to be the pioneers in introducing these innovative medicines in several countries, and sense the opportunities and challenges first hand," Venugopal told delegates in Rotterdam.
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At CDMO Live 2025, industry leaders Elisabeth Stampa (Medicines for Europe), Elena Barboni (Flamma) and Agneta Larhed (RegSmart Life Science) discussed how Europe's stringent new regulations could reshape the continent's pharmaceutical manufacturing landscape.
Europe's pharmaceutical manufacturing sector faces an unprecedented challenge as new environmental regulations threaten to drive production offshore, whilst the Critical Medicines Act attempts to bring it back home. Industry leaders warn that razor-thin margins on generic medicines could lead to widespread product withdrawals if costs aren't carefully managed.
“When you’re building something at the edge of science, it’s crucial to start with the problem, not the solution. My team has created 15 pharma startups using this approach, and 14 are still alive.” – Kerstin Papenfuss, Director of Pharma at Deep Science Ventures
Kerstin Papenfuss serves as the Director of Pharma at Deep Science Ventures, where she leads the creation and development of novel therapeutics for unmet medical needs. With a PhD in Tumour Immunology from Imperial College London and an MBA from Bayes Business School, Kerstin brings over a decade of experience in oncology, signal transduction, and pharmaceutical markets to her role building science-based startups from scratch.
Kerstin explains why traditional approaches to biotech startup creation often fail and how working from first principles can lead to more successful, impactful ventures. Her experience spans working with entrepreneurs, academics, pharmaceutical companies, and disease charities to build companies that solve fundamental challenges in healthcare.
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The COVID-19 pandemic demonstrated how pharmaceutical manufacturing timelines can be dramatically compressed while maintaining quality. At CDMO Live 2025, Fabrice Le Garrec shared lessons from the Lonza-Moderna vaccine scale-up, where "timeline meant lives."
Here are his "10 Commandments" for fast-tracking emergency drug manufacturing.
Dpwnload the full CDMO Live 2025 Report
Simon Kucher opened CDMO Live 2025 in Rotterdam by unveiling brand new research developed in partnership with PharmaSource.
The comprehensive study, presented by Kaan-Fabian Kekec and Clarita Simon, mapped the evolving landscape of CDMO-sponsor partnerships based on insights from over 100 industry experts.
CDMO Live 2025, a panel sponsored by Lifecore Biomedical brought together industry quality leaders to discuss how quality management can become a strategic enabler rather than a compliance burden.
The panel featured Jackie Klecker (EVP Quality & Development Services, Lifecore Biomedical), Liesbeth Foesters (VP Head of External & Clinical Supply Quality, UCB), Stefan Bouckaert (Vice President External Supply Integration Quality, Johnson & Johnson), and Gwladys Mabonzo (Associate Director External Manufacturing Vaccines, MSD).
“We invest to meet the needs of the customer. What’s driving these investments are really the customer partnerships that we’re building to make these happen,” explains Arul Ramadurai, Chief Commercial Officer at Axplora.
Axplora, a global leader in API small molecule and ADC manufacturing, was formed through the merger of Farmabios, Novasep, and PharmaZell. With 2,400 employees across ten API manufacturing sites in Europe, India and the US, the company has recently accelerated its growth strategy with major investments in high-growth areas like GLP-1 peptides and antibody-drug conjugates (ADCs).
In a strategic leadership move to drive this expansion, the company appointed Martin Meeson as its new Chief Executive Officer in April 2024, succeeding Sylke Hassel.
In the latest episode of the PharmaSource podcast we interview Arul Ramadurai about the company strategy.
At CDMO Live 2025, a panel sponsored by Aizon explored how pharma companies are transforming external manufacturing operations through digital integration, with experts from sharing practical approaches to implementation.
The Digital Divide: Big Pharma vs Mid-Size Players
The panellists painted a stark contrast in digital maturity across the pharmaceutical manufacturing landscape. Dave O'Gara, pharmaceutical business consultant at Aizon with over 30 years experience at Novartis, outlined the current state of play.
"When you move into pharma and segregate into big pharma, they have digital strategies... When you move into the mid-range CDMOs and smaller CMOs, it's not so active," O'Gara explained, highlighting what he termed a "massive opportunity" for mid-size players.
Franziskus Kath, founder of Kath-Consulting and former VP of Emerging Technology for QA at Johnson & Johnson, confirmed this assessment: "The larger the companies, the more digital is already there... Most of them have been for the past eight to 10 years really tackling the topic."
From the CDMO perspective, Vishnu Dwadasi, Director of Life Sciences at West Monroe, described significant implementation challenges: "A lot of these companies are still very manual, so they have to move from paper to digital and then digital to eventually leveraging analytics and AI."
“Know your supply chain. Make sure you have it well mapped. The biggest thing that we’ve seen coming out of COVID was investments in technology – that’s what’s helping manufacturers respond to the unexpected.”
Ryan Kelly, Senior Director of Supply Chain Security and Brand Protection at Rx-360, delivered this stark assessment of pharmaceutical supply chain management during a live podcast recording at CDMO Live 2025 in Rotterdam.
Ryan brings extensive experience in pharmaceutical supply chain security from his role at Rx-360, a nonprofit consortium representing approximately 130 manufacturers, suppliers, distributors and contract logistics providers. His organisation focuses on safeguarding the quality and security of pharmaceutical supply chains through information sharing and collaborative risk management.
In this episode Ryan explains how pharmaceutical companies can build resilience against increasingly frequent supply chain disruptions whilst maintaining patient access to critical medications.
"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.
“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.
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."
“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.
CDMO Live 2025 Highlights: How Bayer, Boehringer Ingelheim, and Leo Pharma are rebuilding manufacturing strategies
- 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
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.
“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
“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.
