Welcome to the PharmaSource podcast: the pharma and biopharma podcast that explores the latest trends, challenges, and commercial opportunities shaping the industry. In each episode we'll be speaking with top executives, researchers, policy makers and other experts, who share their perspectives on the essential issues you need to know about. From the latest breakthroughs in drug development and manufacturing, to the impact of healthcare policy on drug pricing, we cover it all. Make sure to subscribe for your regular dose of pharma insight.

"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.

“We invest emotionally and intellectually in their journey—when their product reaches patients, that's our success too.”Janet Hoogstraate, CEO of NorthX Biologics, brings ~30 years of pharmaceutical experience spanning from preclinical development to GMP production for marketed products, with leadership roles at Valneva and AstraZeneca. Her experience from both the CDMO and sponsor sides contributes to NorthX's approach to developing advanced biologics in extended collaboration with the innovative product companies.The contract development and manufacturing organization (CDMO) landscape is evolving beyond transactional relationships toward integrated partnerships. In this podcast, recorded at Nordic Life Science Days (NLSDays) in Gothenburg, Janet outlines how CDMOs can function as strategic partners rather than service vendors, sharing insights from an interactive workshop on growing CDMO relationships alongside clinical development.Read more.

“The differentiator in our business isn't the equipment and the facility—it's the scientists working with customers to create assays and solve complex scientific challenges.”Leon Wyszkowski has spent nearly three decades in drug development, including 20 years at Thermo Fisher Scientific in roles spanning clinical services, CDMO operations, and now analytical services. His perspective on the evolution from internal pharma operations to service provider offers insights into how the industry's approach to outsourcing has matured.In this conversation, Leon discusses Thermo Fisher's expansion in the Nordics, the company's partnership with AstraZeneca's BioVenture Hub, and why trust remains the fundamental factor when biotechs and pharma companies evaluate analytical service partners.Read more.

“This cluster has such a long history—it's about chemistry meeting innovation, trading roots, and an open mindset. That unique mix created something remarkable.”Dr. Christof Klöpper, CEO of Basel Area Business & Innovation, brings a rare combination of academic rigour and practical experience to understanding biotech ecosystems. With a doctorate focused on innovation processes in biotechnology from the University of Basel and years leading the region's business development efforts, he has helped Basel emerge as one of Europe's most concentrated life sciences superclusters—home to over 800 companies and 33,000 professionals.Read more

"It costs about $2.5 billion to bring a drug to the market, and only about 30% of those actually succeed or meet their commercial goals when they get to the market."Manufacturing leaders typically focus on the technical challenges directly in front of them—process validation, tech transfer timelines, capacity utilization. But understanding the commercial landscape offers critical intelligence for strategic planning: which therapeutic areas will drive demand, what modalities require capacity investment, and how market access pressures reshape make-versus-buy decisions.Ryan Quigley, CEO of Inizio—a $1.6 billion commercialization services company working with over 700 pharma and biotech clients—offers a window into the commercial trends that ultimately determine manufacturing requirements. His perspective spans both sponsor and service provider roles, including experience at Abbott, AbbVie, and UDG Healthcare.In this PharmaSource podcast episode, Ryan shares his perspective on pipeline composition, which therapeutic areas will drive the most growth, how regulatory and pricing pressures are reshaping strategic decisions, and why flexibility has become the industry's most valuable currency.Read more

“The key word is curiosity. That curiosity helps you to question and improve not only yourself, but also your processes, your systems, and how you interact with different stakeholders.”Jeroen Janssens, External Manufacturing Technical Operations Lead at MSD, provides insights through a technical lens on how one of the world's largest pharmaceutical companies approaches biologics manufacturing partnerships. With over 15 years of experience spanning validation engineering to director-level leadership, he oversees manufacturing of 11 biologics across Europe and Asia whilst pioneering AI-powered solutions for complex manufacturing challenges.In the latest PharmaSource podcast episode, Jeroen explains how curiosity-driven leadership, strategic CDMO partnerships, and emerging technologies are reshaping external manufacturing excellence at MSD.Read article

“We have strong scientific foundations and manufacturing excellence. Now we're creating the ecosystem to help biotechs scale and compete globally,” says Federico Vigano, Board Member of Assobiotec.Federico Vigano, Country Manager for Vertex in Italy and Greece, brings extensive pharmaceutical leadership experience from roles at AstraZeneca, Boehringer Ingelheim and GSK. As a board member of Assobiotec, the Italian Association for the Development of Biotechnology representing over 100 companies and research institutes, he coordinates therapeutic areas including access, orphan drugs, advanced therapies, and clinical research.In the latest episode, Federico outlines Italy's ambitious plans to leverage its manufacturing heritage while addressing key barriers to help biotech companies scale from research excellence to commercial success. Read more

“CDMOs are partners with deep, extensive technical expertise that can be leveraged strategically—not just a restaurant where you pick from a menu.”Marta Kijanka, founder of MK Bioconsultancy, is a strategic project manager and CMC consultant who guides early-stage biotech companies through the complexities of manufacturing development, from discovery through regulatory readiness. With her career spanning academia, biotech leadership, CDMO operations, and now strategic consulting, Marta brings a 360-degree perspective to one of the industry's most critical partnerships.In the latest PharmaSource podcast episode, Marta explains why successful CMC programs require more than technical competence. She shares frameworks for building productive CDMO partnerships, avoiding common analytical bottlenecks, and creating alignment between scientific, operational, and business teams. Her insights are particularly valuable for companies preparing for Phase 1 and Phase 2 trials, where CMC planning directly impacts investor confidence and valuation.Read more

“The complexity is there's an antibody component, linker-payloads with highly potent toxic agents that need high containment, and linking a biologic with a highly potent small molecule – it's inherently challenging.”Dr. Harch Ooi, VP of Manufacturing and Chemistry at IsoBio Inc., brings 17 years of specialized expertise in antibody-drug conjugate (ADC) manufacturing and external partnerships from Seagen (acquired by Pfizer in 2023). There, he contributed to the development and manufacturing of SGD-1006, the vedotin linker-payload that is used in Adcetris, Padcev, Tivdak, Polivy (from Genentech/Roche), and Emrelis (from Abbvie). Over the years, Dr. Ooi has witnessed the field's dramatic transformation, from a single approved ADC in 2000 to a robust pipeline of 15 approved therapies today.In the latest podcast episode, Harch explains why mastering ADC outsourcing strategy is crucial for biotechnology companies navigating this complex modality. He shares practical insights on CDMO selection, safety protocols, and operational strategies that drive success from early development through commercial launch.Read more

"Sweden has been ranked the European Union's innovation leader for the fifth or sixth year in a row, and we're second globally. We have 4,000 life science companies—a remarkably high number for a country of 10 million people."Dr Marjo Puumalainen, International Director of SwedenBIO, brings extensive life science experience from both startup environments and academic research. Having previously served as Chief Scientific Officer at a CRISPR-based antivirals startup and completed her PhD in Switzerland, she now dedicates her role to strengthening Sweden's international presence through fostering partnerships, investments and global collaborations.In the latest PharmaSource podcast episode, Marjo explains why Sweden consistently ranks as Europe's innovation leader, how the Nordic countries collaborate rather than compete, and what makes the region attractive for international life science investment. With Nordic Life Science Days (NLS Days) taking place 13-14 October in Gothenburg, she shares insights into Sweden's unique ecosystem and the opportunities it presents for global biotech partnerships.Read full article

Carole Delauney warns that sterile injectable manufacturing “is not just fill-finish”—a misconception that can cost biotech companies millions and even derail entire drug development programs. She notes, “This is unfortunately not commonly recognized in the industry, but it is a very important topic.”Carole Delauney, a sterile injectable manufacturing expert with nearly two decades of technical expertise in contract manufacturing, has worked exclusively in sterile fill-finish since 2008. Her background in sales and business development has positioned her as what she calls a “solution provider” for complex manufacturing challenges.In a recent podcast, Carole explains why understanding sterile injectable complexity is crucial for CDMOs and biotech companies navigating a market projected to grow from $14.4 billion in 2024 to $33.7 billion by 2035 (Source: Roots Analysis). Her insights reveal critical best practices for avoiding costly mistakes and building successful manufacturing partnerships.Full article

“Siloed procurement is a big problem. We've recently worked with a client where a CDMO was selected simply because it could start two weeks before another. Ultimately, that led to about an 18-month delay in the project altogether.”Matthew Holt, Co-founder and Managing Director at Collaborative Sourcing, brings extensive pharmaceutical procurement expertise, from supply planning operations to managing large CMO networks. His consultancy now supports pharmaceutical companies ranging from biotech startups to established pharma giants.In the latest PharmaSource podcast episode, Matthew explains why getting CDMO selection right is crucial for project success and how a collaborative approach can prevent costly mistakes that derail timelines and budgets.Read the full article

"Outsourcing is about giving the things you don't excel at to someone who does them exceptionally well. That's what speeds development and delivery," says Kindeva's CEO, Milton Boyer.Milton brings nearly 30 years of pharmaceutical manufacturing experience as a contract manufacturer. He spent the first half of his career in drug substances and APIs, and the latter half in sterile drug product manufacturing before leading Kindeva's transformation into a multi-platform drug delivery CDMO.In this exclusive interview from Kindeva's new MDI Hub and UK headquarters at Charnwood Campus in Loughborough, Milton explains why strategic partnerships, sustainability initiatives, and specialized capabilities are driving the next wave of pharmaceutical outsourcing growth.

“A strategic partnerships is not a transactional relationship – it's a partnership that should last. If we incentivise through co-investments and risk sharing, the partner can grow their business while enabling us to achieve cost and volume targets.” – Shilpi GhoshShilpi Ghosh, who leads Roche's global CDMO operations, brings extensive expertise from chemical engineering and supply chain leadership across multiple continents. She oversees commercial aspects of Roche's external manufacturing strategy, managing relationships with multiple external manufacturers globally.In the latest PharmaSource podcast episode, Shilpi explains why getting CDMO relationship management right is a key strategy for driving down costs, improving operational efficiency, and building sustainable partnerships that deliver results from early development through commercial launch.Read more

“Pharma consulting right now is an overgrown patch of weeds. Everybody's just doing their own thing. It's the Wild West compared to what it could be – an English garden.” – Ray SisonRay Sison, founder of SCxCMC exclusively speaks to the PharmaSource podcast about the launch of the Society of Professional Pharmaceutical Consultants (SOPPhC)In the latest PharmaSource podcast episode, Ray explains why he believes the pharmaceutical consulting industry desperately needs professional standards, ethical guidelines, and professional trade organization to better serve biotech clients and create sustainable working conditions for consultants. He announces the new society designed to address these critical industry gaps.Read the full article

In this episode Luke Bilton, Co-Founder of PharmaSource, shares a special announcement about CDMO Live Europe 2026 (May 19-21, Rotterdam World Trade Center). Following a sold-out inaugural event that facilitated over 1,200 targeted meetings, this pharmaceutical outsourcing event is doubling in size in 2026.Key topics covered:Why the £200+ billion CDMO sector needed a dedicated European platformNew learning tracks for External Manufacturing Strategy and Drug Development & CMCHands-on training sessions including Strategic Partnership development and Biotech CMC BootcampExpanded PartnerMatch concierge system connecting pharma companies with more than 80 CDMOsLearn more about CDMO Live Europe here

“The idea is to get the information in real time. And for that, you would go and see what systems you have at hand, what system your CMO is using, and find a joint, so called ‘Safe Space', which serves both sides.” – Ingrid LuxIngrid Lux serves as Lead Quality Disposition in Oncology & Small Molecule External Supply Europe at Takeda, bringing extensive experience from her previous 16 years at Sandoz. Her expertise spans pharmaceutical quality management, with a particular focus on cross-functional collaboration and external manufacturing partnerships.In the latest PharmaSource podcast episode, Ingrid shares valuable insights on managing quality across external manufacturing networks, creating effective partnerships with CDMOs, and navigating the evolving landscape of pharmaceutical quality oversight in an increasingly complex global environment.Full article here

"Sustainability isn't just about doing the right thing. It's about making smarter, more cost effective decisions that are really building stronger, more reliable supply chains."Christiane Walker, Product Development Team Lead at Intelsius, believes the pharmaceutical industry stands at a critical juncture where environmental responsibility and operational excellence must converge.Christiane Walker leads the product development team at Intelsius, managing cross-functional teams that design innovative and sustainable packaging solutions. With four years at the company, she brings deep expertise in temperature-controlled transport packaging, working with pharmaceutical clients across global markets to optimise their cold chain operations.In the latest PharmaSource podcast episode, Christiane explains how pharmaceutical companies can simultaneously reduce their carbon footprint, cut operational costs, and improve supply chain resilience through strategic adoption of sustainable packaging technologies and connected digital systems.

Link to the CDMO News Analysis download:CDMO News Analysis Tracker“CMC topics are often taken a bit late in development. The biggest pitfall is not only it's going to cost you more, but it's going to cause delays to your programme. The more you push it, the bigger are the costs and potentially the delays.”Marine Joly-Battaglini, CMC consultant and founder of PharmDev, specialises in CMC regulatory strategy for pharmaceutical companies at all stages of development. With a decade of experience in CMC development at Galderma and a master's degree in regulatory affairs, she has built her career around preventing the costly mistakes that derail pharmaceutical development programmes.In the latest PharmaSource podcast episode, Marine reveals the strategic framework that successful biotechs use to navigate manufacturing partnerships, avoid development pitfalls, and position their products for commercial success. Her approach challenges conventional wisdom about when to engage with CMC planning and demonstrates how early strategic thinking prevents expensive delays down the development pathway.Full article

“The greatest opportunity at Teva is our innovative pipeline. We're really leaning in on our innovative pipeline as an integral part of our pivot to growth strategy.”This is the ambitious vision of Dr Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer at Teva Pharmaceuticals.He speaks about the company's strategic transformation from generics powerhouse to innovative biopharmaceutical leader - including how strategic partnerships and a matrix organisational approach are driving Teva's remarkable 10 consecutive quarters of growth. He shares best practices on leveraging generics expertise for innovation, building successful partnerships across multiple therapeutic areas, and creating synergies between different business portfolios.Full article here

“We need to strive to be an easy client. Being an easy client with clear goals and internal alignment is key for successful long-term relationships with CMOs. Equally important is how we manage internally – how we align internally and bring that one message to the CMOs.”Felipe Furiati, Senior Director External Supply Operations at Grünenthal, manages external supply operations across a €2 billion portfolio whilst leading crisis management and M&A integration activities.Felipe brings a distinctive background to external manufacturing, having started as a pharmacist in QA at Johnson & Johnson, spent time in management consulting at Bain & Company, and returned to pharmaceutical operations with experience spanning both technical and strategic functions.In the latest PharmaSource podcast episode, Felipe shares practical insights on building strategic partnerships without volume leverage, implementing product-centric supply chain management, and using digital tools for supplier selection – approaches that are particularly relevant for mid-sized pharmaceutical companies navigating complex supplier networks and geopolitical uncertainty.

"We are seeing a doubling or tripling of applications from the United States. You can really feel that shift already. People have been offered jobs and professorships and are already here in Heidelberg."Dr. Julia Schaft, Managing Director at BioRN Cluster Management GmbH, reveals the significant increase in American scientists exploring opportunities in Germany's Rhine-Neckar biotech hub as researchers seek new environments that support their work.Julia brings over a decade of international experience, including 11 years in Australia working with human embryonic stem cells, before returning to Germany to drive innovation at the intersection of industry and academia. She also serves as spokesperson for bioDeutschland's Working Group of BioRegions.In the latest PharmaSource podcast episode, Julia explains how changing dynamics are creating new opportunities for European life science clusters and what this means for the global biotech landscape.https://pharmasource.global/content/podcast/the-heidelberg-advantage-biorn/

HHS Secretary's unprecedented move to terminate 22 federal mRNA contracts sends shockwaves through biotech sector and raises critical questions about U.S. pandemic preparednessThe pharmaceutical industry woke up to a fundamentally altered landscape this week as Health and Human Services Secretary Robert F. Kennedy Jr. announced the termination of $500 million in federal funding for mRNA vaccine development. The decision, which affects 22 active projects across major pharmaceutical companies including Pfizer, Moderna, and Sanofi, represents the most significant policy reversal in vaccine development funding in recent memory.In this episode, we speak to Ben Locwin Vice President at Reliant Life Sciences, about what why mRNA therapeutics are so an important - not just to vaccines but also to cancer, genetic disorders and other therapeutic areas.Read the article

"When you are seeing great results in your research lab, you think that everything has been done. But then when you try to humanise your drug, a new adventure starts, because the CMC process is very difficult. In my opinion, it's as difficult as demonstrating efficacy." - Mari Carmen ÁlvarezMari Carmen Álvarez PhD. is the Managing Director of Tetraneuron, a pioneering Spanish biotech developing novel gene therapies for neurodegenerative diseases. With nearly two decades in biotech leadership, she founded Valencia University's first biotech spin-off and brings expertise spanning innovation management, business development, and fundraising from seed to Series A.In the latest PharmaSource podcast episode, Mari Carmen explains why scaling gene therapy development requires more than strong science, how to navigate the complex CDMO ecosystem, and what she learned from a previous biotech failure that shaped her approach to leadership and patient impact.Full interview: https://pharmasource.global/content/podcast/from-lab-to-patient-how-tetraneurons-gene-therapy-approach-is-tackling-alzheimers-disease/

“From Tokyo to Boston, we knew people had to see and feel the future we were building together. That is how you create lasting change.”Amber Meriwether, Director of Corporate Strategy at Astellas Pharma, has orchestrated one of the industry's most dramatic supplier rationalisations whilst navigating complex cultural dynamics across seven global locations.In the latest PharmaSource podcast episode, Amber reveals how effective supplier rationalisation transcends traditional cost-cutting approaches, requiring sophisticated change management, cultural intelligence, and the ability to forge consensus amongst diverse scientific teams spanning multiple continents and research modalities.https://pharmasource.global/content/podcast/how-astellas-procurement-cut-their-supplier-base-by-95-while-building-global-consensus/

"Current revenue scale is $1.3 billion. We anticipate it will grow to $5 billion, just in five years' time. We've committed to invest about two-thirds of Fujifilm's entire annual capex in this business."Toshihisa “Toshi” Iida, Chairman of FUJIFILM Biotechnologies Group and Board Director at FUJIFILM Corporation, reveals how 89 years of healthcare heritage drives the company's ambitious CDMO expansion strategy.Toshihisa brings 34 years of experience at Fujifilm, having witnessed the company's transformation from the golden age of photographic film through the digital revolution to its current position as a major biotechnology manufacturer. His journey spans international marketing, European operations, and now leading the Life Sciences strategy for the 91-year-old corporation.In this exclusive podcast interview, Toshihisa explains how Fujifilm's unique modular manufacturing approach and zero-defect philosophy position the company to achieve unprecedented growth whilst delivering scalability, speed and resilience to pharmaceutical partners worldwide.Full article: https://pharmasource.global/content/podcast/from-film-to-pharma-inside-fujifilm-biotechnologies-5-billion-growth-strategy/

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).Download the full CDMO Live report

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.Download the full CDMO Live Report

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 2025The 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.Download the full CDMO Live report

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.Download the full CDMO Live report

“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 VenturesKerstin 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.Read the full article:https://pharmasource.global/content/podcast/building-biotechs-from-first-principles-deep-science-ventures-formula-for-science-based-innovation/

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.Read more

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).Download the full 50 page report

“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.Full interview

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 PlayersThe 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."Download the full report

“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.Read more

"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.Read article

“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.Read more

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 ConnectionRob 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."Download the full report

“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.Read more

CDMO Live 2025 Highlights: How Bayer, Boehringer Ingelheim, and Leo Pharma are rebuilding manufacturing strategiesComplexity 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 productionAI 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."Download the full report

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."Download the full CDMO Live Report

“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 ResilienceHer 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.Read the full article

“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 2025Read the full article

“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 manufacturingJulien 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.Read the article

“AI doesn't have to be the first port of call. Many organisations still need to focus on the paper-to-glass journey before they can think about more advanced technologies” Vishnu Dwadasi, Director of Life Sciences at West Monroe, brings extensive experience across pharmaceutical operations, consulting and business development from both the sponsor and CDMO sides. His career path through companies including Catalent, BioDuro, PII and now West Monroe has given him unique insights into the evolving pharmaceutical outsourcing landscape.In the latest PharmaSource podcast episode, Vishnu shares his perspective on how private equity investments are reshaping the CDMO landscape, post-merger integration challenges, and the realistic pace of digital transformation within pharmaceutical manufacturing organisations.Read the article

“Our goal is to be more than a service provider. We aim to be a strategic partner that grows with our clients from bench to bedside.” – Dr. Jim LiDr. Jim Li, President of CMC Solutions at BioDuro, brings extensive experience as a chemist and pharmaceutical industry veteran, having held leadership positions at global companies including Pfizer and Henkel before joining BioDuro to build up and manage the company's CMC business.In the latest PharmaSource podcast episode, Jim explains how BioDuro's integrated CRDMO model creates higher value outcomes for clients while balancing cost considerations with speed to market.Read the full article

“Managing hundreds of products across multiple species requires a different approach to network strategy than human pharma,” explains Bernhard Boehm, Head of External Manufacturing for Animal Health at Boehringer Ingelheim.Bernhard Boehm leads external manufacturing for animal health as VP of 3PM at Boehringer Ingelheim, bringing nearly 20 years of pharmaceutical experience across regulatory, quality, R&D, and site management roles before transitioning to animal health five years ago.Ahead of CDMO Live, Bernhard explains how animal health manufacturing differs fundamentally from human pharmaceuticals, requiring specific strategies to manage a complex portfolio across multiple species while facing tighter margins and diverse customer needs.Read Boehringer Ingelheim's Six Strategic Approaches to External Manufacturing Networks