PharmaSource Podcast

“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 trilogue negotiations underway, she argues the window for meaningful reform is open — but not indefinitely.
In the latest PharmaSource podcast episode, Elisabeth breaks down what the CMA is designed to achieve, where the friction points lie, and what success would actually look like for European patients and the generics and biosimilar industry by 2030.
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“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 Center (APIIC), brings decades of experience in fine and specialty chemicals to one of the most pressing challenges in US healthcare: rebuilding domestic pharmaceutical manufacturing from the ground up. Before joining APIIC, Charlie held engineering and business leadership roles across chemical intermediates, specialty chemicals, and API production — giving him a front-row view of how the US gradually ceded control of its medicine supply to overseas producers.
In the latest PharmaSource podcast episode, Charlie explains how APIIC is taking a fundamentally different approach to reshoring — one that works with existing US capacity, leverages advanced manufacturing technology, and de-risks participation for CDMOs and API manufacturers through a public-private funding model.Full article

“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 and pharma, including senior roles at Novartis.
In the latest PharmaSource podcast episode, Daniel explains why radiopharmaceutical supply chains require fundamentally different approaches than traditional pharma—and how companies are building resilience into networks where every minute counts and safety stock doesn’t exist.
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“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, Bristol Myers Squibb, and CEPI, where he served as Executive Director and Head of Manufacturing and Supply Chain. Today, through Global BioVax Solutions, he advises global health organizations and investors on development, manufacturing, and supply chain strategy and technology transfer for vaccines and biologics
In this episode of the PharmaSource podcast, Anand reflected on how recent U.S. policy shifts are compounding disruptions across the global vaccine ecosystem—and why COVID exposed structural weaknesses that remain unresolved. His analysis connects policy, manufacturing realities, and long-term health security in ways that challenge simplistic narratives about reshoring and self-sufficiency. He provides his framework for building resilient regional manufacturing capacity that can withstand future crises.
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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, commercial and intellectual property partner at Keystone Law, has spent over 20 years navigating the complex world of pharmaceutical contract negotiations. His experience includes overseeing facilities across Singapore, Spain, Switzerland, and the US at Lonza and working in the cell and gene therapy space at Ascend.
In this episode of the PharmaSource podcast, Gerry explains why getting CDMO contract negotiations right is crucial for building successful partnerships. He shares practical strategies for accelerating deal timelines, avoiding common pitfalls, and structuring agreements that work for both biotechs and CDMOs from the very first conversation.
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