MSD External Manufacturing: How Technical Operations are Driving Digital Innovation

"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