PharmaSource Podcast

“We became an analytical powerhouse before we started offering integrated process development and manufacturing. That’s what differentiates us.”

Sigma Mostafa, Chief Scientific Officer, and Katie Edgar, Chief Business Officer at KBI Biopharma, explain how technical depth in analytics and proprietary cell line technology create competitive advantage in an increasingly crowded CDMO market.

Sigma brings 15 years of experience with KBI, joining as Director of Process Development in 2010 and advancing through the company’s exponential growth. Katie leads business strategy, focusing on long-term partnerships and proactive risk mitigation for customers ranging from virtual biotech startups to global pharmaceutical companies.

In this PharmaSource podcast recorded live at CPHI Frankfurt 2025, Sigma and Katie reveal how KBI’s analytical foundation, combined with high-touch customer relationships and digital integration tools, supports molecules from early development through commercial manufacturing.

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“Despite the volatility, the industry is getting some positive energy and renewed confidence”

Jeremie Trochu, Chief Executive Officer at Ardena, has spent two decades building and scaling businesses across the biopharma sector. He was part of the leadership team that transformed Catalent from a private equity spinoff into a publicly traded global CDMO, where he led multiple successful acquisitions and integrations. Since joining Ardena as CEO in 2024, he has been steering the company through one of the most volatile periods in pharmaceutical manufacturing history.

In a recent PharmaSource podcast episode, Jeremie explains how CDMOs can build resilient partnerships, when to specialize versus diversify, and what it takes to earn a seat at the table with pharma and biotech clients.

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"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.

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“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.

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“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.

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“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.

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“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.

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"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.

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“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.

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“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