PharmaSource Podcast

“One day lost during a clinical phase is one day of peak sales that is lost — always.” Nicolas Ragot, Chief Executive Officer of Delpharm, brings over three decades of pharmaceutical manufacturing expertise, having started his career as a process engineer at Eli Lilly before progressing through technical and leadership roles at Procter & Gamble Pharma and GSK. He joined Delpharm in 2018 as Chi...

“We’re witnessing what I would consider the most structurally disruptive pharmaceutical moment I’ve seen in my career—and it’s being driven by consumers.” Ryan Kelly , Interim CEO and Senior Director of Supply Chain Security and Brand Protection at Rx-360, has seen pharma’s direct-to-consumer transformation from multiple angles—building pharmacy operations at Amazon during the PillPack acquisition...

"Sponsors don't want to know how many SOPs you have on the shelf. They're really looking to see if you have sound judgment to take care of their program."  Mohamad Ahmad , Vice President of Quality and Compliance at the Biologics Manufacturing Centre (BMC) Inc., brings extensive quality leadership experience across the pharmaceutical industry. The BMC is a Canadian non-profit CDM...

“The level of comfort with AI use in this space is pretty low right now.” Mike Boyson’s observation cuts to the heart of pharma’s AI dilemma. Hesitation is justified—but it shouldn’t paralyze action. His answer: build practical, compliant digital twins that operators can create in Claude without waiting for IT. Mike is a supply chain and pharmaceutical operations leader with over 20 years of exper...

“Drug candidates that previously would not have been considered feasible — they’re now on the table. Hybrid synthesis is opening the door to peptide drugs you’re going to need in larger quantities.”  Brian Gregg , CEO of AmbioPharm, has spent his career in the peptide contract development and manufacturing organization (CDMO) industry — including early work on exenatide, the first approved GLP-1 r...

“Our on-time-in-full delivery was 30%. In the beer industry, it’s around 99%. That was a big shock.” When Gijs Vissers joined the pharmaceutical industry, he saw that supply chain operations were often driven by fragmented processes, minimal performance tracking, and cost-focused supplier relationships that created more problems than solutions. Drawing on lessons from the beer industry, where on-t...

“CDMOs and Biotechs will both die,” warns NKILT Therapeutics CEO as he talks candidly about the funding crisis stalling cell therapy development, predicting widespread consolidation across biotechs and CDMOs unless the industry shifts toward risk-sharing partnership models that align manufacturing economics with capital constraints. Raphaël Ognar, CEO and co-founder of NKILT Therapeutics, brings 2...

"A high-level Pfizer manager went on record and said: if they had to choose between lowering prices in the US or not launching in France — they would not launch in France." Christoffer Frendesen , EU correspondent for Dagens Pharma and former European Parliament policy advisor, raises serious concerns about a policy shock that many in Brussels are still reluctant to confront directly. Ch...

“The wake-up call happened during COVID — we realized our dependency on basic medicines coming from outside Europe was dangerously high.” Elisabeth Stampa , CEO of Medichem and Vice President of Medicines for Europe, has been one of the pharmaceutical industry’s most outspoken advocates for the  Critical Medicines Act (CMA) . With the European Parliament having just published its position and tril...

“83% of the top 100 most prescribed generic medicines in the US have no domestic manufacturing source for their API.” —  Charles Lyon , VP Manufacturing, Procurement & Logistics, API Innovation Center And yet the capacity to produce these APIs already exists — sitting idle across US facilities operating at 50% or below. Charles Lyon, VP of Manufacturing and Procurement at the API Innovation Ce...

“Managing a radiopharmaceutical supply chain is like transporting a block of ice in the middle of summer under the scorching sun in the desert—you have no means to protect it or cover it, so it just continues melting.” Daniel Rossetto , Head & SVP of Supply Chain and External Manufacturing at ARTBIO, brings over 17 years of experience leading high-speed, agile supply networks across biotech an...

“If you take away funding from research and development, especially for diseases with pandemic potential, those programs will be delayed. We lose time, and some of that time can’t be recovered later with more funding.” Anand Ekambaram  has spent more than three decades at the intersection of vaccine development, manufacturing, and global supply chains. His career spans leadership roles at Merck, B...

Picture the scene: the Sales teams from a CDMO and Sponsor are delighted to have finalized the principles of a manufacturing deal, the relationship is off to a strong start, but now the dreaded ‘template’ is issued. Suddenly, everything comes to a grinding halt while the commercial and legal teams battle out the details within the development and manufacturing agreement (DMSA). Gerry Kennedy, comm...

“Intrinsically, there is nothing wrong with using Chinese CDMOs. But because of geopolitical issues, some large pharma want to have redundancy of that supply chain in the US.” Dr. Reza Oliyai , President and CEO of Oliyai Consulting Corporation, spent 28 years at Gilead Sciences rising from research scientist to SVP overseeing 1,700 people across seven sites and multiple modalities including biolo...

By 2028, SGS CDMO Solutions’ MHRA and FDA-inspected site in Wales will operate entirely without paper. For biotech and Pharmaceutical sponsors, this provides a better way to run development and manufacturing projects. “If it can’t be done digitally, then we don’t want to do it,” says Paul Broomhead, Head of Site. The result is a digitally native CDMO where data, processes, and decisions live in on...

FDA hemorrhaging staff while promising to fast-track advanced modalities. BIOSECURE Act signed into law with five-year phase-out timelines. Tariffs creating 50% cost increases on manufacturing equipment. Most Favored Nation deals cutting prices. Cell and gene therapy facilities closing despite scientific promise. Welcome to 2026 pharma manufacturing. In the latest episode of the PharmaSource podca...

Fresh from External Manufacturing Leaders in snowy Boston, in this episode we are sharing insights from senior biopharma executives confronting an impossible challenge: how do you reshore when there's nowhere to reshore to? Highlights of the event include why biotechs built on Chinese manufacturing economics are scrambling, why US capacity for ADCs and sterile fill-finish is completely tied up...

“There are 437 active clinical trials in radiopharmaceuticals, and 100 companies developing them. If your logistics are not better, there is no other differentiator. You need to compete by experience.” When  Kostja Paschalidis  and his co-founders left their roles developing one of the leading radiopharmaceutical products, they recognised a fundamental shift in pharmaceutical manufacturing. Unlike...

“We’re not trying to be everything for everyone. Our specialized focus has been very exciting for me.” Franco Negron , CEO of  Simtra BioPharma Solutions , has transformed a 65-year sterile manufacturing legacy into an independent CDMO since the company’s carve-out from Baxter International (Baxter) in October 2023. Franco has led over $500 million in capital investments to double capacity and cre...

“Process chemistry alone is no longer the whole story—it needs to be connected with engineering solutions, digital tools, and data utilization.” Stefan Randl , Chief Scientific Officer at Siegfried, joined the Swiss-based CDMO in January 2025 after 16 years at Evonik, where he led innovation management for healthcare, ran drug substance operations in the US, and headed sales across Asia. Read more...

“Biotechs need flexibility and have limited budgets, while big pharma looks for long-term partnerships, reliability, scalability, and new technologies.” Luis Berrade , Senior Director of Global Biologics Testing Sales at  Charles River Laboratories , has spent his career helping pharmaceutical and biotech companies bring therapies to market faster and safer. With a PhD in medicinal chemistry and e...

PharmaSource analysis of 732 industry announcements reveals massive investment in U.S. capacity, with partnerships dominating the news cycle and advanced therapy manufacturing reaching industrial scale The pharmaceutical contract manufacturing landscape underwent a fundamental readjustment in 2025, marked by record investment flows, accelerated U.S. reshoring, and a decisive shift toward integrate...

“Twenty years ago, who knew that ADCs and next-generation bioconjugates were going to be so exciting, so successful?” Campbell Bunce , Chief Scientific Officer at Abzena, reflects on the strategic positioning that has placed his company at the forefront of one of pharma’s fastest-growing segments. Campbell leads a global team spanning discovery, development, and GMP manufacturing at Abzena, where...

“When I walked into the tech transfer, we were a million dollars over budget, six months behind schedule, and struggling to make a single successful batch,” says  Amy Gamber . Amy Gamber, Executive Director, Lifecycle Lead at Kyverna Therapeutics, specializes in crisis recovery for late-stage biotech and cell and gene therapy programs. With 20+ years of CMC leadership experience at Atara Biotherap...

“We have to be transparent down to the last person in the organization, what the organization is doing, and where the issues are. We have to celebrate wins. We have to talk about the good things people do.” Markus Sieger  serves as CEO of Polpharma Group, one of Central and Eastern Europe’s largest pharmaceutical manufacturers. With 25 years at the company, and 10  years as CEO, he has transformed...