PharmaSource Podcast

“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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"Strategic partnerships — what a buzzword this has become in our industry." Kaan Fabian-Kekec and Clarita Havermeier at Simon-Kucher, unveiled exclusive new research at the start of CDMO Live Europe 2026.
The research by Simon-Kucher and PharmaSource draws on 120+ senior executives across pharma and CDMOs globally. It reveals many areas of goal alignment, but highlights an execution gap as late-phase CDMOs are meeting established pharma's expectations just 44% of the time. The widest gaps are not quality or timelines. It's pricing and supply resilience.Listen to this recording from CDMO Live Europe 2026 and read the article