"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.
“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.
“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.
“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.
“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.
"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.
“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.
“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.
“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.
"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.
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.
“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.
"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 Ghosh
Shilpi 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.
“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 Sison
Ray 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:
Learn 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 Lux
Ingrid 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.
"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:
“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.