PharmaSource Podcast

"Sustainability should be understood as carbon, cost, and safety together. When a process becomes more efficient, you frequently improve all three."— Celine Chen, VP and Head of PharmaBlock EuropePharmaceutical sustainability is no longer a compliance exercise, but a commercial and strategic imperative. The greatest decarbonization opportunity does not just lie in renewable energy or facility upgrades, but inside the chemistry and process design of drug manufacturing itself, explains Celine Chen, VP and Head of PharmaBlock Europe, and David Ennis, Executive Advisor, PharmaBlock; Former VP Chemical Development, AstraZeneca. This episode of the PharmaSource explores why green chemistry must lead the pharmaceutical decarbonization agenda, what buyers should demand from CDMO partners, and how forward-thinking manufacturers are connecting carbon intelligence with process excellence.Read more.

"At Kindeva, we want to be viewed as a fully Annex 1 compliant facility and partner that can pivot when needed and supply uninterrupted to the patients that need it." Tommy Shornak, Senior Vice President of Sterile Injectables at Kindeva, brings nearly 20 years of sterile manufacturing operations experience from organizations including AMRI, Thermo Fisher Scientific, and Gilead Sciences. Since joining Kindeva in 2025, Tommy has been at the center of the company's investment strategy.In the latest PharmaSource podcast, Tommy explains why Kindeva's approach to sterile injectable CDMO services, anchored by a $200 million facility investment, a no-single-source supply policy, and a shift toward flexible commercial models, is designed to position the company as a one-stop partner for drug sponsors navigating an increasingly complex outsourcing landscape.Read more.

“The right CDMO is not the one with the biggest plant or the lowest price. It's the one with the judgment, the systems, and the incentives to protect your molecule when complexity, scale, and scrutiny converge.”Alessio Piccoli, Chief Commercial Officer at PI Health Sciences (PIHS), a CDMO and CRO with discovery and process R&D capabilities in Jaipur and Hyderabad, India, and EU cGMP manufacturing in Lodi, Italy – a site holding FDA, AIFA, and KFDA approvals. The organization is backed by PI Industries, a global life sciences powerhouse with over 80 years of legacy in turning complex science into scalable real-world outcomes.In this episode of the PharmaSource podcast, Alessio explains why the most consequential differentiator in CDMO selection is control. He shares how PIHS is building a model defined by scientific accountability, digital execution, and a partnership mindset that links development decisions to commercial reality.Read more.

"If you feel the rules are changing every five minutes, that's not going to help you — because this is a long-term industry."Jan Ramakers is an independent consultant with over two decades of experience tracking the fine chemicals and pharmaceutical ingredients market. A chemist by training, Jan has worked across pharma, agrochemicals, and the financial sector, spanning market intelligence, competitor analysis, and M&A due diligence.In this PharmaSource podcast episode, Jan explains why the API outsourcing market is at an inflection point shaped by geopolitical uncertainty, supply chain fragility, and the evolving race among CDMOs to differentiate. Drawing on career-long pattern recognition, he outlines what is actually happening on the ground versus what the industry often gets wrong.Read more.

“A 10% success rate means you have to be smart about every decision you make in the pipeline.”Nick Wigdahl, Director of PharmaGro, has spent his career navigating two worlds that rarely talk to each other: the operational complexity of big pharma and the portfolio discipline of family office investing. That combination, he argues, is exactly what mid-size life science companies need more of.Nick Wigdahl is Director of PharmaGro, a consultancy specializing in CMC, supply chain, market assessment, and portfolio management for mid-size pharmaceutical and CDMO companies. His background includes supply chain leadership roles at Roche and GSK, as well as investment and portfolio management experience with family offices in logistics and transportation.In the latest PharmaSource podcast episode, Nick explains why managing molecule uncertainty is one of the most underappreciated disciplines in pharma, and how companies that get it right make better investment decisions, optimize their portfolios, and build more resilient businesses.Read full article

"The manufacturing process doesn't just produce the product — it determines what the product becomes." Stephen Sullivan, Founder of Linville Bio, brings more than two decades of experience spanning developmental biology, clinical translation, and manufacturing strategy across organizations, including Novartis and the Global Alliance for iPSC Therapies. Most recently, he led the setup of a first-in-human trial for an iPSC-based cancer vaccine.In this PharmaSource podcast episode, Stephen discusses the manufacturing challenges involved in induced pluripotent stem cell (iPSC) therapies and why companies that treat it as a downstream operational problem rather than a core product design decision are setting themselves up to fail.Read more.

"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

“Aligning development strategy early creates a real competitive advantage. When scalability and late-stage requirements are already considered during Phase I and II, you avoid gaps that cause delays further down the line.”Eike Cordts, Director Early Stage Development USA, Rottendorf Pharma, leads early stage development initiatives in North America for Rottendorf Pharma, a German CDMO with nearly a century of expertise in oral solid dosage (OSD) forms. Having grown from 800 to over 1,400 employees in the past decade, Rottendorf Pharma recently formalized a strategic transatlantic partnership with Corealis Pharma, a Canadian early-phase OSD specialist. In this PharmaSource podcast episode, Eike explains the strategic thinking behind the alliance and what it means for pharmaceutical companies seeking an integrated development-to-commercialization pathway.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.

“Don't pick a CMO that just agrees with you.”Isabel Feuerstein is Head of Business Development for EU and Asia CMO at Novartis, where she shapes the company's contract manufacturing strategy across key global markets. Mark Schiefermeier leads the manufacturing unit at DS Schaftenau, one of Novartis' critical drug substance manufacturing facilities in Austria, overseeing technical execution and quality systems that underpin Novartis' external manufacturing commitments.In this episode of the PharmaSource podcast, Isabel and Mark explain why technical credibility, real transparency, and a willingness to challenge clients are the foundations of a high-performing CDMO relationship — and how Novartis is positioning its CMO business for the future of biologics.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.

“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.

“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.

“Biotechs need flexibility and have limited budgets, while big pharma looks for long-term partnerships, reliability, scalability, and new technologies.”Luis Berrade, Senior Director of Global Biologics Testing Sales at Charles River Laboratories, has spent his career helping pharmaceutical and biotech companies bring therapies to market faster and safer. With a PhD in medicinal chemistry and experience spanning both contract manufacturing and testing services, Luis now leads Charles River's global biologics testing commercial strategy, working with companies of all sizes to navigate the complex regulatory landscape.In an episode of the PharmaSource podcast, Luis shares his insights on when sponsors should start thinking about testing strategy, common mistakes that create bottlenecks, and how emerging technologies like next-generation sequencing are reshaping the biologics testing landscape.Read more.

PharmaSource analysis of 732 industry announcements reveals massive investment in U.S. capacity, with partnerships dominating the news cycle and advanced therapy manufacturing reaching industrial scaleThe pharmaceutical contract manufacturing landscape underwent a fundamental readjustment in 2025, marked by record investment flows, accelerated U.S. reshoring, and a decisive shift toward integrated technology platforms.In this episode, PharmaSource's very own Tamnna Thakur sits down with Editor Dora Wells to break down the year's most significant trends. From the $18.48 billion that poured into U.S. facilities to WuXi Biologics' 20 announcements despite regulatory headwinds. They analyze what the 732 tracked announcements reveal about where the industry is heading. Read more.

“Twenty years ago, who knew that ADCs and next-generation bioconjugates were going to be so exciting, so successful?”Campbell Bunce, Chief Scientific Officer at Abzena, reflects on the strategic positioning that has placed his company at the forefront of one of pharma's fastest-growing segments.Campbell leads a global team spanning discovery, development, and GMP manufacturing at Abzena, where he has spent nearly a decade building the company's capabilities in complex modalities. His background as an immunologist, combined with 18 years in biotech before joining Abzena, gives him a unique perspective on translating scientific innovation into commercial manufacturing reality.In this conversation on the PharmaSource podcast, Campbell discusses Abzena's strategic focus on antibody-drug conjugates (ADCs) and bioconjugates, the company's approach to proprietary platform development, and how the CDMO is responding to increased demand driven by geopolitical manufacturing shifts and clinical successes in the space.Read more.

“When I walked into the tech transfer, we were a million dollars over budget, six months behind schedule, and struggling to make a single successful batch,” says Amy Gamber.Amy Gamber, Executive Director, Lifecycle Lead at Kyverna Therapeutics, specializes in crisis recovery for late-stage biotech and cell and gene therapy programs. With 20+ years of CMC leadership experience at Atara Biotherapeutics, CSL Seqirus, and Amgen, she's built a career fixing what others couldn't.In this PharmaSource podcast interview, Amy shares how to identify warning signs before minor issues become million-dollar problems, strategies for rescuing failing tech transfers, and what it takes to restart a manufacturing facility dormant for two years.Full article

“We have to be transparent down to the last person in the organization, what the organization is doing, and where the issues are. We have to celebrate wins. We have to talk about the good things people do.”Markus Sieger serves as CEO of Polpharma Group, one of Central and Eastern Europe's largest pharmaceutical manufacturers. With 25 years at the company, and 10  years as CEO, he has transformed the Polish generic and OTC medicines manufacturer into a regional powerhouse producing 400 million packages annually across Poland, Kazakhstan, and Western European markets. Markus will step down as CEO of Polpharma Group in January 2026, transitioning to the company's supervisory board.In this conversation, Markus reflects on building Polpharma's market leadership through culture transformation and digital-first operations, the challenges that shaped his leadership journey, and the evolution of Europe's generic medicines industry.Read more.

“Our goal is to be recognized for exceptional reliability in our services and manufacturing, while helping our customers bring the most innovative medicines to market.” Dr. Michael Quirmbach, CEO and President of CordenPharma, has overseen remarkable growth at the full-service CDMO since joining in 2014. Under his leadership, the company has tripled its workforce to 3,000 employees and increased revenue from €245 million to nearly €1 billion while expanding capabilities across peptides, injectables, and high-potency oncology products. Michael, who holds a PhD in chemistry and began his career as a scientist before transitioning to business leadership, brings 25 years of CDMO experience to his role. In a recent PharmaSource podcast recorded at CPHI, he discussed CordenPharma's €900 million expansion in peptide manufacturing, the company's strategy for complex modalities, and how AI is transforming pharmaceutical manufacturing operations.Read more.

"If you can't demonstrate international quality standards, nobody is going to take a chance on a million-dollar batch to save a few dollars on their manufacturing. It just won't happen."Eric Langer is President of BioPlan Associates, where he has systematically documented the evolution of the biomanufacturing industry since the early 2000s. In the latest PharmaSource podcast episode, Eric explains why biopharmaceutical outsourcing budgets are projected to surge 11% in 2025, the cost of talent constraints, and the rise of complex modalities like cell and gene therapies. He shares critical insights from BioPlan's 22nd annual report on what manufacturers must prioritize to succeed in an increasingly competitive landscape.Read more.

“The world can change overnight. We have to accept volatility as part of the world we live in.”Peter DeYoung, CEO of Piramal Global Pharma, has spent 13 years with the Piramal Group, navigating the complexities of pharmaceutical manufacturing across consulting, investing, and operating roles. His engineering background and cross-continental experience position him to lead a billion-dollar pharma operation spanning CDMO services, complex hospital generics, and consumer healthcare.In this PharmaSource podcast interview, Peter explains how Piramal competes for mindshare as pharma companies reassess their manufacturing footprints, why geographic flexibility matters more than ever, and how the company measures success through customer delight rather than satisfaction.Read more.

"We are not in a transient moment - this will affect industry profitability for decades. The previous era of rule-based international trade is gone"Frank Binder, Managing Director at GSCA (Global Supply Chain Advisors) and former Head of Supply Chain at Santen and Celgene, has watched the pharmaceutical supply chain undergo unprecedented disruption in 2025. The wave of US tariff announcements, regulatory complexity, and forced regionalization has created what he calls a fundamental shift in how the industry must operate.Read full article

“We became an analytical powerhouse before we started offering integrated process development and manufacturing. That's what differentiates us.”Sigma Mostafa, Chief Scientific Officer, and Katie Edgar, Chief Business Officer at KBI Biopharma, explain how technical depth in analytics and proprietary cell line technology create competitive advantage in an increasingly crowded CDMO market.Sigma brings 15 years of experience with KBI, joining as Director of Process Development in 2010 and advancing through the company's exponential growth. Katie leads business strategy, focusing on long-term partnerships and proactive risk mitigation for customers ranging from virtual biotech startups to global pharmaceutical companies.In this PharmaSource podcast recorded live at CPHI Frankfurt 2025, Sigma and Katie reveal how KBI's analytical foundation, combined with high-touch customer relationships and digital integration tools, supports molecules from early development through commercial manufacturing.Full article

“Despite the volatility, the industry is getting some positive energy and renewed confidence”Jeremie Trochu, Chief Executive Officer at Ardena, has spent two decades building and scaling businesses across the biopharma sector. He was part of the leadership team that transformed Catalent from a private equity spinoff into a publicly traded global CDMO, where he led multiple successful acquisitions and integrations. Since joining Ardena as CEO in 2024, he has been steering the company through one of the most volatile periods in pharmaceutical manufacturing history.In a recent PharmaSource podcast episode, Jeremie explains how CDMOs can build resilient partnerships, when to specialize versus diversify, and what it takes to earn a seat at the table with pharma and biotech clients.Read more.

"Life has not become simpler and easier. It's become more complex. Success requires acknowledging this complexity early and building flexibility into every aspect of the business model.”Renée Aguiar-Lucander is the CEO of Hansa Biopharma, appointed in April 2025. Renée brings rich expertise from seven years leading Calliditas Therapeutics through a dual NASDAQ listing and the first approved drug for IgA nephropathy, plus extensive healthcare investment experience at Omega Funds and 3i Group.Speaking to PharmaSource at Nordic Life Science Days (NLSDays), Renée shares candid insights on the investment climate that's reshaped biotech over the past few years, the structural challenges facing European companies, and what early-stage biotechs need to focus on to survive an increasingly selective funding environment.Read more.

“Poland is no longer an emerging market. It's a partnering market.”Dr. Magdalena Kulczycka, founder of the Biotech Innovation Institute, is a molecular biologist with experience spanning academia, entrepreneurship, and venture capital. Her institute fosters biotech growth from lab to market through consulting, venture building, and business development, with particular focus on Poland's life sciences sector and the broader Central and Eastern European region.Poland's biotech sector has undergone substantial transformation over the last few decades, evolving from a centrally planned system to one of Europe's more dynamic innovation economies. This evolution creates opportunities for pharmaceutical companies and contract development and manufacturing organizations (CDMOs) seeking European partnerships. Speaking to PharmaSource at Nordic Life Science Days (NLSDays) in Gothenburg, Magdalena outlines why Poland merits attention from international partners and how organizations can successfully navigate this market.Read more.

“We invest emotionally and intellectually in their journey—when their product reaches patients, that's our success too.”Janet Hoogstraate, CEO of NorthX Biologics, brings ~30 years of pharmaceutical experience spanning from preclinical development to GMP production for marketed products, with leadership roles at Valneva and AstraZeneca. Her experience from both the CDMO and sponsor sides contributes to NorthX's approach to developing advanced biologics in extended collaboration with the innovative product companies.The contract development and manufacturing organization (CDMO) landscape is evolving beyond transactional relationships toward integrated partnerships. In this podcast, recorded at Nordic Life Science Days (NLSDays) in Gothenburg, Janet outlines how CDMOs can function as strategic partners rather than service vendors, sharing insights from an interactive workshop on growing CDMO relationships alongside clinical development.Read more.

“The differentiator in our business isn't the equipment and the facility—it's the scientists working with customers to create assays and solve complex scientific challenges.”Leon Wyszkowski has spent nearly three decades in drug development, including 20 years at Thermo Fisher Scientific in roles spanning clinical services, CDMO operations, and now analytical services. His perspective on the evolution from internal pharma operations to service provider offers insights into how the industry's approach to outsourcing has matured.In this conversation, Leon discusses Thermo Fisher's expansion in the Nordics, the company's partnership with AstraZeneca's BioVenture Hub, and why trust remains the fundamental factor when biotechs and pharma companies evaluate analytical service partners.Read more.

“This cluster has such a long history—it's about chemistry meeting innovation, trading roots, and an open mindset. That unique mix created something remarkable.”Dr. Christof Klöpper, CEO of Basel Area Business & Innovation, brings a rare combination of academic rigour and practical experience to understanding biotech ecosystems. With a doctorate focused on innovation processes in biotechnology from the University of Basel and years leading the region's business development efforts, he has helped Basel emerge as one of Europe's most concentrated life sciences superclusters—home to over 800 companies and 33,000 professionals.Read more

"It costs about $2.5 billion to bring a drug to the market, and only about 30% of those actually succeed or meet their commercial goals when they get to the market."Manufacturing leaders typically focus on the technical challenges directly in front of them—process validation, tech transfer timelines, capacity utilization. But understanding the commercial landscape offers critical intelligence for strategic planning: which therapeutic areas will drive demand, what modalities require capacity investment, and how market access pressures reshape make-versus-buy decisions.Ryan Quigley, CEO of Inizio—a $1.6 billion commercialization services company working with over 700 pharma and biotech clients—offers a window into the commercial trends that ultimately determine manufacturing requirements. His perspective spans both sponsor and service provider roles, including experience at Abbott, AbbVie, and UDG Healthcare.In this PharmaSource podcast episode, Ryan shares his perspective on pipeline composition, which therapeutic areas will drive the most growth, how regulatory and pricing pressures are reshaping strategic decisions, and why flexibility has become the industry's most valuable currency.Read more

“The key word is curiosity. That curiosity helps you to question and improve not only yourself, but also your processes, your systems, and how you interact with different stakeholders.”Jeroen Janssens, External Manufacturing Technical Operations Lead at MSD, provides insights through a technical lens on how one of the world's largest pharmaceutical companies approaches biologics manufacturing partnerships. With over 15 years of experience spanning validation engineering to director-level leadership, he oversees manufacturing of 11 biologics across Europe and Asia whilst pioneering AI-powered solutions for complex manufacturing challenges.In the latest PharmaSource podcast episode, Jeroen explains how curiosity-driven leadership, strategic CDMO partnerships, and emerging technologies are reshaping external manufacturing excellence at MSD.Read article

“We have strong scientific foundations and manufacturing excellence. Now we're creating the ecosystem to help biotechs scale and compete globally,” says Federico Vigano, Board Member of Assobiotec.Federico Vigano, Country Manager for Vertex in Italy and Greece, brings extensive pharmaceutical leadership experience from roles at AstraZeneca, Boehringer Ingelheim and GSK. As a board member of Assobiotec, the Italian Association for the Development of Biotechnology representing over 100 companies and research institutes, he coordinates therapeutic areas including access, orphan drugs, advanced therapies, and clinical research.In the latest episode, Federico outlines Italy's ambitious plans to leverage its manufacturing heritage while addressing key barriers to help biotech companies scale from research excellence to commercial success. Read more

“CDMOs are partners with deep, extensive technical expertise that can be leveraged strategically—not just a restaurant where you pick from a menu.”Marta Kijanka, founder of MK Bioconsultancy, is a strategic project manager and CMC consultant who guides early-stage biotech companies through the complexities of manufacturing development, from discovery through regulatory readiness. With her career spanning academia, biotech leadership, CDMO operations, and now strategic consulting, Marta brings a 360-degree perspective to one of the industry's most critical partnerships.In the latest PharmaSource podcast episode, Marta explains why successful CMC programs require more than technical competence. She shares frameworks for building productive CDMO partnerships, avoiding common analytical bottlenecks, and creating alignment between scientific, operational, and business teams. Her insights are particularly valuable for companies preparing for Phase 1 and Phase 2 trials, where CMC planning directly impacts investor confidence and valuation.Read more