Simtra BioPharma CCO: “Manufacturing in the Region for the Region Is Here to Stay”

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 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.Read more.

“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.Read more.

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 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.Read more.

"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.Read the full article

"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

"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 business development, investor relations, and corporate strategy, he has been key in guiding Pretzel from seed stage through a $72.5 million Series A and subsequent Series B financing.In this episode of the PharmaSource podcast, Baruch shares the strategic decisions and creative financing structures that have kept Pretzel advancing its first-in-class mitochondrial biology pipeline, including a lead program currently wrapping up Phase 1 for rare mitochondrial depletion syndrome and an early-stage obesity asset. From spinout strategies to non-dilutive funding and the company's recent acquisition of Rome Therapeutics, his insights offer a practical roadmap for biotech leaders navigating today's capital-constrained environment.Read more.

"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 EuropePharmaceutical 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 facility upgrades, but inside the chemistry and process design of drug manufacturing itself, explains Celine Chen, VP and Head of PharmaBlock Europe, and David Ennis, Executive Advisor, PharmaBlock; Former VP Chemical Development, AstraZeneca. This episode of the PharmaSource explores why green chemistry must lead the pharmaceutical decarbonization agenda, what buyers should demand from CDMO partners, and how forward-thinking manufacturers are connecting carbon intelligence with process excellence.Read more.

"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 Sciences. Since joining Kindeva in 2025, Tommy has been at the center of the company's investment strategy.In the latest PharmaSource podcast, Tommy explains why Kindeva's approach to sterile injectable CDMO services, anchored by a $200 million facility investment, a no-single-source supply policy, and a shift toward flexible commercial models, is designed to position the company as a one-stop partner for drug sponsors navigating an increasingly complex outsourcing landscape.Read more.