How the BMC Achieves Clinical-to-Commercial Quality Continuity Across Its Biologics CDMO Platform

"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.