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Welcome to the PharmaSource podcast: the pharma and biotech podcast that explores the latest trends, challenges, and commercial opportunities shaping the biopharma manufacturing and outsourcing.
In each episode we'll be speaking with top executives, researchers, and outsourcing experts, who share their perspectives on topics such as building a smarter, more sustainable supply chain, how to partner with CDMOs, digital transformation, procurement and external manufacturing strategies, and plenty more besides.
Make sure to subscribe for your regular dose of pharma insight.
In each episode we'll be speaking with top executives, researchers, and outsourcing experts, who share their perspectives on topics such as building a smarter, more sustainable supply chain, how to partner with CDMOs, digital transformation, procurement and external manufacturing strategies, and plenty more besides.
Make sure to subscribe for your regular dose of pharma insight.
223 Episodes
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“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 Chief Operating Officer and assumed the CEO role in 2024.In this episode of the PharmaSource podcast, Nicolas explains why supply reliability, digital standardization, and long-term partnership thinking are the strategic pillars that allow Delpharm to differentiate in an increasingly consolidated CDMO market — and why time to market is the single most important criterion any biotech should use when selecting a manufacturing partner.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.
"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 CDMO established in response to Canada’s effort to strengthen domestic biologics manufacturing capacity following the pandemic. There, Mohamad oversees quality systems across all biologics manufacturing operations, from early clinical through commercial scale.In this episode of the PharmaSource podcast, Mohamad explains why a risk-based, science-driven approach to quality is the defining factor that separates strong CDMO partners from the rest — and how the BMC has built its quality organization to deliver that across every stage of a program's lifecycle.Read more.
“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
“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 receptor agonist for Type 2 diabetes. Today, he leads AmbioPharm through a period of significant strategic expansion, anchored by a differentiated capability: hybrid peptide synthesis.In this episode of the PharmaSource podcast, Brian explains why hybrid synthesis is rapidly becoming the defining manufacturing advantage in the GLP-1 era, how AmbioPharm is building mirror-image facilities in Shanghai and South Carolina to de-risk customer supply chains, and why the company’s dual-continent footprint is an asset.Read more.
“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.
“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 29 years of pharmaceutical and biotech experience spanning marketing, drug development, and corporate strategy at major pharmaceutical companies. After launching a consulting practice focused on early-stage immuno-oncology biotechs, Raphaël co-founded NKILT Therapeutics.NKILT’s off-the-shelf allogeneic approach (as opposed to patient-specific autologous therapies) targets HLA-G, an immunosuppressive molecule expressed across major cancer types including colorectal, breast, prostate, and kidney cancers, providing access to substantially larger patient populations while improving manufacturing scalability and economics.His company’s 12-month IND delay exemplifies the systemic pressures that continue to threaten cell therapy innovation, and both sides of the CDMO-biotech relationship.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.
“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.Read the article
“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
“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.Read the 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.
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.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
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 one.Paul Broomhead, Head of Site at SGS CDMO Solutions in Wales, is leading an ambitious digital transformation. In this exclusive interview, Paul reveals why SGS is making a commitment to digital infrastructure, how the transformation creates competitive advantages for biotech sponsors, and what “digitally native” manufacturing actually means in practice for pharmaceutical development and commercialization.Read more
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
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, and how manual operations are threatening American competitiveness. Plus: the 2026 strategies leaders are actually implementing, from AI-powered Digital Twins to creative redundancy plays. Thanks to Aenova Group for co-hosting ExM Leader Boston with us.Download the full report here:https://pharmasource.global/content/resources/exm-leaders-boston-26/
“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.
![Supply Chain Resilience Through Geographic Redundancy [Simtra BioPharma Solutions CEO]](https://s3.castbox.fm/63/7b/97/44fff80f3a8d583a0c8a4a75c152ab9ffa_scaled_v1_400.jpg "Supply Chain Resilience Through Geographic Redundancy [Simtra BioPharma Solutions CEO]")
“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 create mirrored capabilities across sites in Indiana, US, and Halle/Westfalen, Germany.Franco brings industry experience from Procter & Gamble, Johnson & Johnson, Novartis, and Patheon, which became part of Thermo Fisher Scientific, where he helped shape integrated CDMO strategies.In this PharmaSource podcast, recorded at CPHI 2025, Franco explains how Simtra is navigating supply chain challenges, tariff uncertainties, and injectable manufacturing complexity, from GLP-1s to antibody drug conjugates.Read more.
“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.
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