PharmaSource Podcast

"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 intelligence, strategic partnerships, pricing, and product direction, making him one of the industry's sharpest observers of where life sciences manufacturing technology stands and the distance it still needs to travel.In the latest PharmaSource podcast episode, Matt maps the digital manufacturing journey contract development and manufacturing organizations (CDMOs) must take, from eliminating paper on the shop floor to achieving the industry's most coveted goal: golden batch and real-time release.Read more

“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 coordination, including final device assembly and primary container management, the boundaries of what a fill/finish partner is expected to deliver are shifting.In the latest PharmaSource podcast episode, Steven Kaufman — who has spent over 20 years in the drug delivery device space and now advises biotech companies and CDMOs on combination product strategy — breaks down where the complexity really lies, why fill/finish capacity remains so tight, and what smart companies are doing differently to protect their programs.Read more.

"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, joined the PharmaSource podcast to discuss the company's new purpose-built sterile injectable facility opening in Q2 2026 in Sittingbourne, Kent. The 11,000-square-foot site features a 2,000-square-foot GMP Grade A/C/D clean room suite engineered to achieve less than 1% material losses, well below the industry standard of approximately 10%.In this episode, Peter and David explain the engineering decisions behind the low-waste design, how the facility's end-to-end capabilities simplify outsourcing for biotech, academia, and research clients, and what it takes to build a sterile manufacturing site that meets 2023 EU GMP Annex One standards.Read more.

“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, scaling the largest cash pharmacy in the U.S. at Chewy, and now leading supply chain security for a 130-member industry consortium. His verdict: the infrastructure isn’t keeping up.In the latest PharmaSource podcast episode, Ryan explains why GLP-1 demand and the rise of direct-to-consumer platforms such as TrumpRX have become the stress test pharma’s supply chain never prepared for—and what manufacturers need to do before the system breaks.

“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 experience spanning CMC strategy, external manufacturing, and digital transformation. He spent more than a decade at Takeda leading oncology and biologics supply chain operations, served as Executive Director of Value Chain Leadership at Moderna, and now advises organizations at Azure Biopharma Consulting on adopting AI-driven solutions.In a recent PharmaSource podcast episode, Mike shares concrete use cases for digital twins, explains how to build them without deep technical expertise, and addresses the GXP compliance, data confidentiality, and human-centered challenges that will define pharma AI adoption.Watch the video to accompany this episode here

“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-time-in-full delivery routinely exceeds 99%, Gijs has spent years transforming pharmaceutical supply chain approaches, achieving employee engagement scores above 80% while dramatically improving supply reliability.Gijs Vissers, Head of Supply Chain and Procurement at Nordic Pharma, brings over 20 years of supply chain and procurement experience across fast-moving consumer goods, telecommunications, and pharmaceuticals, including senior roles at Heineken, Bavaria, and DSM before joining Nordic Pharma as Head of Supply Chain and Procurement. His career trajectory reflects a deliberate shift from commercial functions to operational excellence, driven by his Lean Six Sigma training and a conviction that the industry’s greatest asset is its people, not its processes.In this episode, Gijs shared his approach to rebuilding pharmaceutical supply chains from the ground up, moving from reactive vendor management to strategic CDMO partnerships anchored in transparency, long-term forecasting, and patient-centric objectives.Read more.

"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.Christoffer covers health, pharma, and life sciences policy from Brussels, with over five years of experience as a policy advisor to Danish MEPs inside the European Parliament. His close proximity to both legislative process and industry reaction gives him a well-informed perspective on the real-world consequences of US drug pricing reform on European markets.In this episode of the PharmaSource podcast, Christoffer explains why Trump's Most-Favored-Nation (MFN) executive order, signed in May 2025, is not just an American story, and why pharmaceutical executives, market access teams, and patient advocates across Europe need to be paying close attention right now.Read more.

“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 CenterAnd 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

“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 biologicsIn 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.⁠Read more⁠.

“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 biologics, ADCs, small molecules, and sterile manufacturing.In this PharmaSource podcast episode, Reza shares his framework for helping biotechs de-risk their external manufacturing strategy, navigate geopolitical supply chain challenges, and make phase-appropriate decisions that balance speed with resource constraints.Read the full article

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 podcast, Gil Roth, President of the Pharma and Biopharma Outsourcing Association (PBOA), explains how pharma companies are impacted by policy changes, and how CDMOs are building flexibility into capital planning, manufacturing infrastructure, and customer contracts to survive chaos that makes forecasting impossible.Gil Roth is speaking at CDMO Live Europe and CDMO Live Americas

“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 traditional drugs where marketing drives commercial success, radiopharmaceuticals demand something entirely different: flawless service delivery.As co-founder and head of systems and logistics at Firm, a design consultancy specialising in radiopharmaceutical services, Kostja has identified why operational excellence—not clinical superiority—will determine market winners.In the latest PharmaSource podcast episode, he explains why radiopharmaceutical companies must become service-centric organisations to succeed and how a lack of standardisation and suitable technology creates barriers to scale.