Building a CMC Strategy That Satisfies Regulators and Attracts Investors

“Projects quite often realize too late that their R&D process cannot just be copy-pasted from the lab into the manufacturing facility.”Dr. Jenny Prange is Head of Project Management at the Regenerative Medicine Technologies Platform (RMTP) at Wyss Zurich, an accelerator embedded within ETH Zurich and the University of Zurich. With a background spanning molecular biotechnology, a PhD in human physiology, and hands-on experience translating an advanced therapy medicinal product (ATMP) from bench to clinical trial at University Hospital Zurich, Jenny brings both scientific depth and manufacturing expertise to early-stage biotech projects.In this PharmaSource podcast episode, Jenny explains why the leap from academic research to GMP-ready clinical manufacturing is consistently underestimated, what it actually takes to build a robust CMC strategy, and how translational facilities like Wyss Zurich are filling a critical gap in the biotech development landscape.Read the full article.

Andrzej Hoczyk, External Supply Operations (ESO) Head at Polpharma, presented the case for treating large-scale tech transfer as a managed program rather than a series of parallel projects at CDMO Live Europe 2026, drawing on a five-year, 21-product sterile portfolio migration across five contract manufacturing sites.Read more.

"The quality of any relationship becomes most visible during times of challenge and pressure," says Frederik Krekeler.Frederik Krekeler is Head of Procurement for Bayer's Consumer Health business in North America, leading sourcing strategy and supplier partnerships across a critical global network. With over 20 years of supply chain leadership spanning Europe, Latin America, and North America, he is known for building strategic CDMO relationships that deliver both resilience and commercial performance.Ahead of CDMO Live Americas (20-21 October, Boston), Frederik shares the principles behind Bayer's approach to CDMO partnership management, covering the multi-year network reset of Project Martini, the innovation days and Negotiation Factory programs that keep suppliers engaged year-round. For anyone managing external manufacturing relationships in a rapidly evolving market, it's a practical and candid playbook.Read the article

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 episode of the PharmaSource podcast, Sid shares why raw material variability remains one of the industry’s most underestimated risks, what separates a technically proficient CDMO from one that is merely experienced, and why digital CMC transformation fails when it ignores people and process.Read the full article.

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 of External Manufacturing at Par Health; Mark Goemans, Chief Commercial Officer at Bora Biologics; and Thomas Thunnissen, Director of Procurement and Partnerships at Leyden Labs. The discussion moved through four stages of the partnership life cycle: initial negotiation, contract construction, governance, and risk-sharing.Read the full article here.

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 managing approximately 500 finished dose form (FDF) suppliers — a network Talarczyk describes as fragmented and expensive to run. The initial diagnosis was that 20% of suppliers accounted for 80% of sales. But the structural problem ran deeper: commercial and technical operations weren’t talking to each other. Country organizations understood top-line sales and margin. They did not see what was happening in technical operations.Read the full article

"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 ConnectToday 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 with Life Science Connect CEO Jon Howland to talk about what's been going on behind the scenes, and what this new chapter means to biopharma outsourcing media and events.Read more on PharmaSource

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.