How Biotechs Can De-Risk External Manufacturing, Navigate Geopolitical Challenges, and Plan for Capacity Constraints – Dr. Reza Oliyai

“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.

“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.