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Welcome to the PharmaSource podcast: the pharma and biotech podcast that explores the latest trends, challenges, and commercial opportunities shaping the biopharma manufacturing and outsourcing.
In each episode we'll be speaking with top executives, researchers, and outsourcing experts, who share their perspectives on topics such as building a smarter, more sustainable supply chain, how to partner with CDMOs, digital transformation, procurement and external manufacturing strategies, and plenty more besides.
Make sure to subscribe for your regular dose of pharma insight.
In each episode we'll be speaking with top executives, researchers, and outsourcing experts, who share their perspectives on topics such as building a smarter, more sustainable supply chain, how to partner with CDMOs, digital transformation, procurement and external manufacturing strategies, and plenty more besides.
Make sure to subscribe for your regular dose of pharma insight.
184 Episodes
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“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
![[Exclusive] Society of Professional Pharmaceutical Consultants Launches - Interview with Ray Sison](https://s3.castbox.fm/7e/d8/06/985de3dbbde8a4d5fdaf5c7647ab089b8f_scaled_v1_400.jpg "[Exclusive] Society of Professional Pharmaceutical Consultants Launches - Interview with Ray Sison")
“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
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