PharmaSource Podcast

At CDMO Live Europe 2026, Dr. Adriana Kiedzierska-Mencfeld , Chief Executive Officer of Rezon Bio, drew on 11 years of leading operations at Polpharma Biologics to explain why biosimilar developers must address cost strategy in process development, long before any product reaches market.

“CMC was not usually a core part of the planning — it was more of an afterthought. Now that funding has tightened, that is changing.” Siddhartha Jain, President of Shoolin Management Company, has spent two decades in biologics CMC across Novartis, Regeneron, Sanofi, and other major companies, contributing to the development and manufacturing of over 10 clinical and commercial molecules. In this ep...

At CDMO Live Europe 2025, a panel of procurement and commercial leaders argued that the most consequential CDMO negotiations happen after the contract is signed, covering risk-sharing structures, governance discipline, and the conditions under which trust compounds or collapses. The session was chaired by  Matthew Holt , Co-Founder of Collaborative Sourcing, with panelists  Salomon Engels , Head o...

Gil Roth, President of the Pharma & Biopharma Outsourcing Association (PBOA), walked CDMO Live Europe delegates through the full matrix of US policy pressures bearing on contract manufacturers, from Section 232 tariffs and most favored nation pricing to FDA workforce collapse and a stalled BioSecure Act. Read the full article here .

At CDMO Live Europe 2026  Maik Talarczyk  Head PMO External Supplier Operations, Sandoz, laid out the company’s three-year supplier network consolidation program, detailing a six-step make-vs-buy decision framework that reduced network complexity by 34% against its 2023 baseline. Maik Talarczyk opened with a warning. “The fan is always on – and the shit is always flying.” Sandoz entered 2024 manag...

"We saw what you guys built and made a decision pretty quickly: we didn't want to compete with that. We wanted to be part of it." Jon Howland, CEO, Life Science Connect Today we are announcing that PharmaSource, CDMO Live and External Manufacturing Leaders will be joining forces with Life Science Connect to create a new events divison. In this special episode, Luke Bilton sits down w...

Mike Schaefers,  Chief Operating Officer at Simtra BioPharma, outlined what it takes to build durable CDMO partnerships in injectable manufacturing, why regional supply chains have become a permanent feature, and how early-phase collaboration directly shortens time to market.

"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 Accelerato...

“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 str...

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. Read more.

“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 co...

"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. I...

"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...

"A lot of biotech companies die because they run out of runway. And they might have been successful if they had another six or 12 months." Baruch Harris , Chief Operating Officer at Pretzel Therapeutics, has spent over two decades navigating the business side of life sciences, from consulting and big pharma to early-stage biotech. With a PhD in biochemistry and deep experience in busines...

"Sustainability should be understood as carbon, cost, and safety together. When a process becomes more efficient, you frequently improve all three."— Celine Chen, VP and Head of PharmaBlock Europe Pharmaceutical sustainability is no longer a compliance exercise, but a commercial and strategic imperative. The greatest decarbonization opportunity does not just lie in renewable energy or fa...

"At Kindeva, we want to be viewed as a fully Annex 1 compliant facility and partner that can pivot when needed and supply uninterrupted to the patients that need it."  Tommy Shornak , Senior Vice President of Sterile Injectables at Kindeva, brings nearly 20 years of sterile manufacturing operations experience from organizations including AMRI, Thermo Fisher Scientific, and Gilead Science...

“The right CDMO is not the one with the biggest plant or the lowest price. It’s the one with the judgment, the systems, and the incentives to protect your molecule when complexity, scale, and scrutiny converge.” Alessio Piccoli , Chief Commercial Officer at  PI Health Sciences  (PIHS), a CDMO and CRO with discovery and process R&D capabilities in Jaipur and Hyderabad, India, and EU cGMP manufa...

"If you feel the rules are changing every five minutes, that's not going to help you — because this is a long-term industry." Jan Ramakers is an independent consultant with over two decades of experience tracking the fine chemicals and pharmaceutical ingredients market. A chemist by training, Jan has worked across pharma, agrochemicals, and the financial sector, spanning market intel...

“A 10% success rate means you have to be smart about every decision you make in the pipeline.” Nick Wigdahl , Director of PharmaGro, has spent his career navigating two worlds that rarely talk to each other: the operational complexity of big pharma and the portfolio discipline of family office investing. That combination, he argues, is exactly what mid-size life science companies need more of. Nic...

"The manufacturing process doesn't just produce the product — it determines what the product becomes."  Stephen Sullivan, Founder of Linville Bio, brings more than two decades of experience spanning developmental biology, clinical translation, and manufacturing strategy across organizations, including Novartis and the Global Alliance for iPSC Therapies. Most recently, he led the setu...

"If I have one more person talk to me about agentic AI and then realize they're still using paper batch records, I'm going to scream." That frustration captures the central tension in CDMO digital transformation today says Matt Lowe , Chief Strategy Officer at MasterControl. Matt has spent nearly two decades at MasterControl, rising to CSO with responsibility spanning competitive...

“Aligning development strategy early creates a real competitive advantage. When scalability and late-stage requirements are already considered during Phase I and II, you avoid gaps that cause delays further down the line.” Eike Cordts, Director Early Stage Development USA, Rottendorf Pharma, leads early stage development initiatives in North America for Rottendorf Pharma, a German CDMO with nearly...

“Capacity isn’t the biggest gap. It’s people. And nobody’s talking about it.” For pharma and biotech companies, manufacturing combination devices means coordinating not just fill/finish manufacturing but also primary container selection, device sourcing, final assembly, and serialization — often across multiple specialist partners.  As CDMOs expand their service offerings to take on more of that c...

“Don’t pick a CMO that just agrees with you.” Isabel Feuerstein is Head of Business Development for EU and Asia CMO at Novartis, where she shapes the company’s contract manufacturing strategy across key global markets. Mark Schiefermeier leads the manufacturing unit at DS Schaftenau, one of Novartis’ critical drug substance manufacturing facilities in Austria, overseeing technical execution and qu...

"Every milliliter lost translates to delayed timelines and increased costs." For early-phase biotech companies working with limited API batches, this is the central challenge of sterile injectable manufacturing. Peter Mollison, CEO and co-founder of Eramol, a UK-based pharmaceutical CMO, has built an entire facility around solving it. Peter Mollison and David Cox, Site Director at Eramol...