PharmaSource Podcast

"The challenge is not getting better biology. It's building a better system to carry the biology forward," says Richard van Rijnsoever.
Debby Vermeer and Richard van Rijnsoever are co-founders of ExpediteBio, a Netherlands-based venture focused on accelerating antibody and protein therapeutics from discovery to first-in-human study. Debby also co-leads the biologics workstream at Oncode Accelerator, a national initiative working to accelerate cancer therapy development, e.g., by building infrastructure in the Netherlands.
On the PharmaSource podcast, Debby and Richard spoke about the structural reasons biologics programs fail to reach patients, how their ASCEND framework addresses those failures, and what a more functional European biologics ecosystem could look like. Their conversation is a practical guide for biotech CEOs and CMC leaders navigating the most expensive stretch of early-stage drug development.
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“When your patient is your priority—getting them safe, highly pure, quality medicine—you’re aligned with the health agency. That alignment and engagement really help.”
Manda Pasarkar, Global Head of Regulatory Affairs CMC at Sanofi, has spent over 20 years mastering the intersection of chemistry and compliance—a rare combination that positions her at the forefront of pharmaceutical regulatory strategy.
Pasarkar progressed from scientist roles at Teva through regulatory positions at Bayer, and now leads regulatory strategy for Sanofi’s multi-billion dollar portfolio across biologics and small molecules, securing numerous drug marketing approvals in the US, EU, Japan, and China. She’s also a Distinguished Toastmaster (DTM)—a designation fewer than 1% of Toastmasters International members achieve.
In a recent PharmaSource podcast episode, Manda shared insights on navigating complex global regulatory landscapes, building productive agency relationships, leveraging ICH guidelines, working with CDMOs, and preparing for AI’s impact on regulatory CMC.
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A panel discussion with Cristoffer Frendesen, EU Correspondent at Dagens Pharma, and Gil Roth, President of the Pharma and Biopharma Outsourcing Association, at CDMO Live Europe 2026, examined how US pricing policy, European legislative fragmentation, and FDA staffing gaps are forcing the industry to rethink where and how it manufactures.
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“We have to stop treating manufacturing as the final step in vaccine development. In my opinion, it’s actually the linchpin of the entire system.”
In this episode of the PharmaSource podcast, Dora, PharmaSource’s Editor, brings together five leaders who collectively span R&D pipelines, capital markets, manufacturing operations, tech transfer, and on-the-ground work in low- and middle-income countries (LMICs). The panel includes Krish Ramanathan, Interim CEO of the Gates Medical Research Institute; Savant Ahmed, Chief Business Officer at Exela Pharma Sciences; Christopher Locher, CEO of Versatope Therapeutics; Kristopher Howard, Managing Director of NRL Enterprise Solutions; and Anand Ekambaram, Principal at Global BioVax Solutions and formerly Executive Director and Head of Manufacturing and Supply Chain at CEPI.
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"We want to outgrow the market, and we want to do it ethically." Christian Seufert, Head of Advanced Synthesis at Lonza and member of the executive committee, brings 20 years of experience from BASF's specialty chemical business. He leads a team applying 125 years of Lonza's chemistry expertise to manufacturing small molecules, highly potent APIs, and antibody-drug conjugates.
In the latest PharmaSource podcast episode, Christian explains the ‘One Lonza’ strategy that positions the company to capture growth across the fastest-expanding CDMO segments, particularly bioconjugation, while addressing the industry's most persistent operational challenges: speed, data accessibility, and supply chain resilience.
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