Explore every episode of the podcast PharmaSource Podcast

Container closure integrity (CCI) is a critical element of sterile product quality, but evaluating a CDMO’s CCI capabilities requires more than confirming that testing is available.

The appropriate approach depends on the drug product, container closure system, manufacturing process, lifecycle risks, and applicable regulatory requirements. For pharmaceutical companies selecting or qualifying a CDMO, understanding how a manufacturing partner approaches these variables can provide useful insight into the maturity of its overall quality program.

Oliver Stauffer, CEO of PTI (Packaging Technologies and Inspection), has more than two decades of experience in container closure integrity testing and quality risk assessment. In a recent PharmaSource podcast, he discussed several considerations for assessing CCI strategies across vials, prefilled syringes, autoinjectors, and other sterile product formats.

The discussion points to six areas sponsors should consider when evaluating a CDMO’s approach to container closure integrity.

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At CDMO Live Europe 2026, Giulio Cavalli, Principal Lead External Manufacturing, J&J Innovative Medicine; Neil Stevenson, Director, CMC Logic Consultancy; Marine Joly Battaglini, Founder, PharmDev; and Susan Reasoner, Chief Commercial Officer, BioDuro, examined how early-stage biotechs can avoid common selection mistakes, manage capacity concerns, and build CDMO relationships designed to last beyond Phase 1.

“Traditional staff augmentation says, ‘Here are the people you asked for.’ An outcome-led model says, ‘Here is the service or capability you asked for, and we are accountable and responsible for making it work.’” — Aisling Flanagan

Aisling Flanagan, Global SVP of Professional and Managed Services at Catalyx, leads people-based services for regulated manufacturing environments. She works alongside Mike Barrett, Catalyx’s director of sales and operations for the UK and Europe, who focuses on translating client needs into measurable delivery.

In this PharmaSource podcast interview, Aisling and Mike explain how pharmaceutical manufacturers can improve staffing outsourcing in pharma manufacturing by buying capability, capacity, and results instead of contractor headcount. Their recommendations cover supplier consolidation, GMP expertise, workforce retention, governance, and performance-based KPIs.

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Sponsored by Blue Jet Healthcare, this panel at CDMO Live Europe 2026 brought together Bernhard Boehm, Head of External Manufacturing Animal Health, Boehringer Ingelheim; Philip Coetzee, Director CMO Management, Daiichi Sankyo Europe; Fanny Eberhardt, Director Global Procurement, UCB; and Shiven Arora, Managing Director, Blue Jet Healthcare to debate how pharma companies are making network strategy decisions as cost pressures, geopolitical risk, and the limits of tech transfer collide.

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“AI is marketed as such an approachable, ubiquitous thing that everybody thinks they can vibe code it. Unfortunately, a lot of companies are starting to think that way,” says Kat Kozyrytska.

Kat Kozyrytska is a portfolio strategy and technology leader in life science technologies who has operated across organizations, including Sartorius and Thermo Fisher, and now advises across the life sciences ecosystem. Her work focuses on translating emerging technologies, including AI, automation, and digital capabilities, into portfolio strategy, partnerships, and business growth.

Ahead of CDMO Live Americas, Kat explains why many of the assumptions shaping AI adoption in drug discovery do not translate into biopharma manufacturing. She covers the evolving questions around intellectual property and learning rights, why building AI in-house may be the wrong long-term choice for many companies, and why manufacturers need to move from experimentation toward portfolio-level prioritization if AI is to deliver sustainable business value.

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“How good is your AI model? That’s the wrong question. The right question is: what does your AI model actually help your company do?”

Seungik Cho, founder of Sapiens Health, has spent the past year pulling apart the assumption in biomanufacturing that a better-predicting AI model means a better digital twin. His research argues the opposite: that optimizing AI for prediction accuracy can cause these systems to fail in CDMO environments.

Seungik Cho is the founder of Sapiens Health and Director of Strategic Operations at Nucleate. He’s finishing his B.S. in Biological Physics at Rice University, where his research explores the intersection between computational biology and multimodal AI. He describes his work as building AI systems that are “trustworthy and deployable,” not just accurate on a benchmark. His recent publications include work on longitudinal CT lesion prediction (IEEE ISBI 2026) and gene network analysis (IEEE BHI 2025).

In the latest PharmaSource podcast episode, Seungik explains why he believes CDMOs are pointing their AI investment in the wrong direction and lays out an alternative model built around diagnosis rather than prediction, explainability rather than confidence scores, and institutional memory rather than one-off forecasts.

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At CDMO Live Europe 2026, Dr. Olivier Aebischer, Deputy CEO at Interlabor Belp AG, demonstrated how a structured, dual-path analytical approach can identify manufacturing root causes in days, using two real contamination case studies from the lab’s operations.

“We can adjust and be flexible around equipment configuration, but we can’t be flexible around what is a clear communicator and an honest partner.”

Damien Perriman is Chief Commercial Officer at ExoZymes, a Nasdaq-listed company using AI-enhanced enzymes to produce pharmaceutical and nutraceutical compounds without living cells. He spent two decades commercializing biotechnologies at multiple companies, scaling up seven different technologies, before joining ExoZymes just over a year ago.

In the latest PharmaSource podcast episode, Damien explains how ExoZymes is running its first major CDMO selection process for a platform unlike anything most contract manufacturers have run before, and why the company is weighing communication and cultural fit as heavily as technical capability.

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“Rather than saying that there’s a gap from the industry, I think there’s a listening gap from our governments.”

Neha Dave is an independent EU Government Affairs Advisor based in Brussels, with more than 20 years of experience across the EU institutions, agency-side consulting at Weber Shandwick, and government affairs and public policy at MedTech Europe. She advises pharma and medtech companies on entering and navigating the European market, with policy expertise spanning pharmaceuticals, MDR/IVDR, clinical trials, and the single market.

In the latest PharmaSource podcast episode, Neha explains how EU regulation, particularly the environmental and sustainability agenda, is landing on contract manufacturers, which legislation is already in force, what arrives in the next 12 to 18 months, and what CDMOs should be doing now to prepare.

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Moderated by Raman Sehgal, Host of Molecule to Market, this opening panel at CDMO Live Europe 2026 brought together Melanie Wamsler, External Network Strategy Lead, Takeda, Rocco Paracchini, Vice President, Morpho, Kaan-Fabian Kekec, Partner, Simon-Kucher, and Kurt Nielsen, President, Longview Leader, to assess market conditions, capital discipline, geopolitical risk, and pricing in contract manufacturing.

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“There isn’t enough capacity for antibody-oligo conjugates out there today, full stop,” says Geoff Glass, CEO of Abzena. “And it’s really because of the volume requirements for the diseases.”

Geoff Glass is Chief Executive Officer of Abzena, the end-to-end, fully integrated CDMO and CRO for complex biologics and bioconjugates. He brings 30 years in life sciences, including at Patheon, Avadel, and Ncardia, and he chaired Abzena’s board before taking the CEO seat last year. He’s joined by Campbell Bunce, Abzena’s Chief Scientific Officer, who runs discovery through GMP manufacturing across the company’s San Diego, CA, Bristol, PA, and Cambridge, UK sites.

Antibody-oligonucleotide conjugates (AOCs) have moved from concept to late-stage development in just a few years, attracting major investment along the way. In the latest PharmaSource podcast, Geoff and Campbell walk through where the modality came from, manufacturing considerations compared to ADCs, and the broader geopolitical and capacity challenges in the US.

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“If you look at the employment numbers in the manufacturing sector, it’s been absolutely flat for two years. The political noise has not driven that big wave of reshoring that we were expecting.” After a decade of making the economic case for bringing manufacturing back to America, Rosemary Coates says the data tells a very different story from the press releases.

Rosemary Coates is Executive Director of the Reshoring Institute and President of global supply chain consultancy Blue Silk Consulting, with 35 years of experience across industries from healthcare to high tech. She has consulted for over 80 clients worldwide, served as an expert witness in major supply chain disputes, authored five books including the Amazon bestseller 42 Rules for Sourcing and Manufacturing in China, and was named one of the 100 Most Influential Women in Silicon Valley in 2024.

In the latest PharmaSource podcast episode, Rosemary explains what the data really says about reshoring to the US, why tariff volatility has frozen executive decision-making, and how pharmaceutical companies can build manufacturing strategies durable enough to survive an unstable world.

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“No one is going to care about your project as much as you do.” 

Steven Weissman is Vice President and Head of CMC at Cognition Therapeutics, a small pharma company outside New York City developing CT1812, a neurodegeneration candidate now through three Phase 2 trials in Alzheimer’s disease, Lewy body dementia, and dry AMD. He spent 18 years in the process chemistry groups at Merck before moving into the small pharma space, where he has managed CMC functions at Concert Pharmaceuticals, Lexicon, and now Cognition Therapeutics.

In the latest PharmaSource podcast, Steven explains how small biotechs can build a manufacturing supply chain from scratch, why cost of goods is a lever most teams pull too late, and what working on drugs that made it to market, and some that didn’t, taught him about when to invest in process development.

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“Digital collaboration is a competitive advantage for everyone — for CDMOs and CMOs, it’s not a question of if you’re going to do it, it’s when. So how do you get ready for it?”

At CDMO Live Europe 2026, Sham Afzalpurkar, CEO of Collabrix, presented a standards-based, AI-enabled framework for connecting sponsor-CDMO networks at scale, arguing that custom point-to-point integrations are structurally unsustainable as external manufacturing portfolios grow.

Read the full article here.

“When we go to an external partner, we need to show up as one single aligned organization. If we’re not aligned internally, the CMO ends up becoming the referee.”

In pharmaceutical manufacturing, the quality of a CDMO partnership is rarely determined by the contract alone. According to Sabrina Mattos, Senior Director of External Manufacturing for the Americas at Elanco, what truly separates high-performing partnerships from dysfunctional ones comes down to two factors: internal alignment and cultural intelligence.

Sabrina brings over 20 years of pharmaceutical industry experience spanning quality, supply chain, and operations leadership across Brazil, Europe, and North America. As a pharmacist who began her career as a QA representative at Eli Lilly in Brazil, she has progressed through site leadership and global roles to now oversee Elanco’s external manufacturing portfolio across the US, Canada, and Latin America — a hub spanning close to 50 CMO relationships.

In a recent PharmaSource Podcast conversation, Sabrina shared how Elanco structures its external manufacturing teams, navigates the cultural differences that shape partnerships across the Americas, and why getting internal alignment right before approaching a CDMO is non-negotiable.

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At CDMO Live Europe 2026, Jeff Mason, VP and Head of US Sales at Samsung Biologics, demonstrated a risk-based, parallel approach to dual-site technology transfer that delivered a first GMP batch at a second facility within 90 days of initiation.

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When relationships with contract manufacturers break down, the cause is rarely just the contract manufacturer. A panel of three sponsor-side executives examined the warning signs, the internal failures, and the governance models that determine whether a difficult relationship recovers or ends.

At CDMO Live Europe 2026, a session, moderated by Raman Sehgal of the Molecule to Market podcast, brought together three buyers: Stefan Bouckaert, a Quality and Operations Leader who spent 20 years at Johnson & Johnson overseeing 170 contract manufacturing organizations and 5,500 suppliers; Nick Wark, Head of External Manufacturing and Strategic Partnerships at Ferring Pharmaceuticals, overseeing several dozen contract manufacturers; and Oksana Vodovska, Business Development Manager at Sopharma, a regional generics company that selectively outsources alongside its own production facilities.

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“The least expensive CDMO on the first day of bidding may not be the optimum value CDMO three years later.”

Choosing a contract development and manufacturing organization is not about who quotes the lowest unit price. It’s mainly about who keeps your clinical timeline intact.

Prakash Savarirayan is a life sciences procurement leader with more than two decades of sourcing experience, over a dozen years of it in biopharma, including senior roles at Takeda (formerly Shire) and Roche’s Spark Therapeutics. He has led complex CDMO partnerships, supported M&A integrations, and built governance models across small molecules, biologics, and gene therapy, and now advises pharma and biotech clients in consulting capacity.

In the latest PharmaSource podcast episode, Prakash explains why getting CDMO selection right matters more than negotiating the lowest price, how procurement earned a strategic seat at the table, and why the right partner protects both patient safety and enterprise value.

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At CDMO Live Europe, Dr. Vijay Vittal Mathad, Chief Operating Officer of CRAMSN Research Park, outlined how a genuine end-to-end CDMO model reduces friction across the drug development lifecycle, from supply chain resilience to sustainability, drawing on 32 years of pharmaceutical development experience.

Read the full article here.

Leon Tian, Director of US Project Management, ProBio, walked through the cell line development, high-concentration formulation, and purification workflow, delivering a bispecific antibody tox batch from a single selected clone in 4 to 5 months at CDMO Live Europe 2026.

Speed is always a top priority in biologic CMC development — but most of the time, speed trades against quality or regulatory confidence. What I want to show today is that this trade-off is not necessary.”

ProBio’s client brought a demanding brief: a bispecific antibody project requiring a high-concentration formulation of approximately 120 mg/mL, produced from a single selected clone, with a tox batch delivered in 4 to 5 months. Tian called it a “mission impossible” scenario, then spent the session methodically explaining how ProBio’s platform addresses each part of that challenge.

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“Environmental Sustainability can be a substantial differentiator for CDMOs”

Jürgen Wieland, Development Environmental Sustainability Lead at Novartis, is engaged to integrate sustainability into development processes, including reducing the emissions of clinical trials.  Jürgen brings over 20 years of finance and controlling experience to his sustainability role at Novartis, where he’s responsible for embedding environmental considerations across R&D and clinical operations. Before joining Novartis in 2011, he served as CFO of an NGO bringing solar energy to rural East Africa.

In a recent PharmaSource podcast, Jürgen shares how pharmaceutical companies and their Contract, Development and Manufacturing Organization (CDMO) partners can reduce scope 3 emissions while improving operational efficiency—proving that sustainability and profitability are not mutually exclusive.

Read the full article here.

At CDMO Live Europe 2026, a panel of pharma and CDMO executives examined how supply chains must be redesigned for a world of sustained geopolitical pressure, regulatory fragmentation, and accelerating demand, and where contracts, governance, and visibility fit in.

This panel brought together Steve Leonard, COO, Meribel; Ryan Kelly, Interim CEO, Rx-360; Frank Binder, Managing Director, GSCA; and Maik Talarczyk, Head PMO ESO, Sandoz.

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“Projects quite often realize too late that their R&D process cannot just be copy-pasted from the lab into the manufacturing facility.”

Dr. Jenny Prange is Head of Project Management at the Regenerative Medicine Technologies Platform (RMTP) at Wyss Zurich, an accelerator embedded within ETH Zurich and the University of Zurich. With a background spanning molecular biotechnology, a PhD in human physiology, and hands-on experience translating an advanced therapy medicinal product (ATMP) from bench to clinical trial at University Hospital Zurich, Jenny brings both scientific depth and manufacturing expertise to early-stage biotech projects.

In this PharmaSource podcast episode, Jenny explains why the leap from academic research to GMP-ready clinical manufacturing is consistently underestimated, what it actually takes to build a robust CMC strategy, and how translational facilities like Wyss Zurich are filling a critical gap in the biotech development landscape.

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Andrzej Hoczyk, External Supply Operations (ESO) Head at Polpharma, presented the case for treating large-scale tech transfer as a managed program rather than a series of parallel projects at CDMO Live Europe 2026, drawing on a five-year, 21-product sterile portfolio migration across five contract manufacturing sites.

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"The quality of any relationship becomes most visible during times of challenge and pressure," says Frederik Krekeler.

Frederik Krekeler is Head of Procurement for Bayer's Consumer Health business in North America, leading sourcing strategy and supplier partnerships across a critical global network. With over 20 years of supply chain leadership spanning Europe, Latin America, and North America, he is known for building strategic CDMO relationships that deliver both resilience and commercial performance.

Ahead of CDMO Live Americas (20-21 October, Boston), Frederik shares the principles behind Bayer's approach to CDMO partnership management, covering the multi-year network reset of Project Martini, the innovation days and Negotiation Factory programs that keep suppliers engaged year-round. For anyone managing external manufacturing relationships in a rapidly evolving market, it's a practical and candid playbook.

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At CDMO Live Europe 2026, Dr. Adriana Kiedzierska-Mencfeld, Chief Executive Officer of Rezon Bio, drew on 11 years of leading operations at Polpharma Biologics to explain why biosimilar developers must address cost strategy in process development, long before any product reaches market.

“CMC was not usually a core part of the planning — it was more of an afterthought. Now that funding has tightened, that is changing.”

Siddhartha Jain, President of Shoolin Management Company, has spent two decades in biologics CMC across Novartis, Regeneron, Sanofi, and other major companies, contributing to the development and manufacturing of over 10 clinical and commercial molecules.

In this episode of the PharmaSource podcast, Sid shares why raw material variability remains one of the industry’s most underestimated risks, what separates a technically proficient CDMO from one that is merely experienced, and why digital CMC transformation fails when it ignores people and process.

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At CDMO Live Europe 2025, a panel of procurement and commercial leaders argued that the most consequential CDMO negotiations happen after the contract is signed, covering risk-sharing structures, governance discipline, and the conditions under which trust compounds or collapses.

The session was chaired by Matthew Holt, Co-Founder of Collaborative Sourcing, with panelists Salomon Engels, Head of External Manufacturing at Par Health; Mark Goemans, Chief Commercial Officer at Bora Biologics; and Thomas Thunnissen, Director of Procurement and Partnerships at Leyden Labs. The discussion moved through four stages of the partnership life cycle: initial negotiation, contract construction, governance, and risk-sharing.

Read the full article here.

Gil Roth, President of the Pharma & Biopharma Outsourcing Association (PBOA), walked CDMO Live Europe delegates through the full matrix of US policy pressures bearing on contract manufacturers, from Section 232 tariffs and most favored nation pricing to FDA workforce collapse and a stalled BioSecure Act.

Read the full article here.

At CDMO Live Europe 2026 Maik Talarczyk Head PMO External Supplier Operations, Sandoz, laid out the company’s three-year supplier network consolidation program, detailing a six-step make-vs-buy decision framework that reduced network complexity by 34% against its 2023 baseline.

Maik Talarczyk opened with a warning. “The fan is always on – and the shit is always flying.”

Sandoz entered 2024 managing approximately 500 finished dose form (FDF) suppliers — a network Talarczyk describes as fragmented and expensive to run. The initial diagnosis was that 20% of suppliers accounted for 80% of sales. But the structural problem ran deeper: commercial and technical operations weren’t talking to each other. Country organizations understood top-line sales and margin. They did not see what was happening in technical operations.

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"We saw what you guys built and made a decision pretty quickly: we didn't want to compete with that. We wanted to be part of it." Jon Howland, CEO, Life Science Connect

Today we are announcing that PharmaSource, CDMO Live and External Manufacturing Leaders will be joining forces with Life Science Connect to create a new events divison.

In this special episode, Luke Bilton sits down with Life Science Connect CEO Jon Howland to talk about what's been going on behind the scenes, and what this new chapter means to biopharma outsourcing media and events.

Read more on PharmaSource

Mike Schaefers, Chief Operating Officer at Simtra BioPharma, outlined what it takes to build durable CDMO partnerships in injectable manufacturing, why regional supply chains have become a permanent feature, and how early-phase collaboration directly shortens time to market.

"The challenge is not getting better biology. It's building a better system to carry the biology forward," says Richard van Rijnsoever.

Debby Vermeer and Richard van Rijnsoever are co-founders of ExpediteBio, a Netherlands-based venture focused on accelerating antibody and protein therapeutics from discovery to first-in-human study. Debby also co-leads the biologics workstream at Oncode Accelerator, a national initiative working to accelerate cancer therapy development, e.g., by building infrastructure in the Netherlands.

On the PharmaSource podcast, Debby and Richard spoke about the structural reasons biologics programs fail to reach patients, how their ASCEND framework addresses those failures, and what a more functional European biologics ecosystem could look like. Their conversation is a practical guide for biotech CEOs and CMC leaders navigating the most expensive stretch of early-stage drug development.

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“When your patient is your priority—getting them safe, highly pure, quality medicine—you’re aligned with the health agency. That alignment and engagement really help.”

Manda Pasarkar, Global Head of Regulatory Affairs CMC at Sanofi, has spent over 20 years mastering the intersection of chemistry and compliance—a rare combination that positions her at the forefront of pharmaceutical regulatory strategy.

Pasarkar progressed from scientist roles at Teva through regulatory positions at Bayer, and now leads regulatory strategy for Sanofi’s multi-billion dollar portfolio across biologics and small molecules, securing numerous drug marketing approvals in the US, EU, Japan, and China. She’s also a Distinguished Toastmaster (DTM)—a designation fewer than 1% of Toastmasters International members achieve.

In a recent PharmaSource podcast episode, Manda shared insights on navigating complex global regulatory landscapes, building productive agency relationships, leveraging ICH guidelines, working with CDMOs, and preparing for AI’s impact on regulatory CMC.

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A panel discussion with Cristoffer Frendesen, EU Correspondent at Dagens Pharma, and Gil Roth, President of the Pharma and Biopharma Outsourcing Association, at CDMO Live Europe 2026, examined how US pricing policy, European legislative fragmentation, and FDA staffing gaps are forcing the industry to rethink where and how it manufactures.

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“We have to stop treating manufacturing as the final step in vaccine development. In my opinion, it’s actually the linchpin of the entire system.”

In this episode of the PharmaSource podcast, Dora, PharmaSource’s Editor, brings together five leaders who collectively span R&D pipelines, capital markets, manufacturing operations, tech transfer, and on-the-ground work in low- and middle-income countries (LMICs). The panel includes Krish Ramanathan, Interim CEO of the Gates Medical Research Institute; Savant Ahmed, Chief Business Officer at Exela Pharma Sciences; Christopher Locher, CEO of Versatope Therapeutics; Kristopher Howard, Managing Director of NRL Enterprise Solutions; and Anand Ekambaram, Principal at Global BioVax Solutions and formerly Executive Director and Head of Manufacturing and Supply Chain at CEPI.

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"We want to outgrow the market, and we want to do it ethically." Christian Seufert, Head of Advanced Synthesis at Lonza and member of the executive committee, brings 20 years of experience from BASF's specialty chemical business. He leads a team applying 125 years of Lonza's chemistry expertise to manufacturing small molecules, highly potent APIs, and antibody-drug conjugates.

In the latest PharmaSource podcast episode, Christian explains the ‘One Lonza’ strategy that positions the company to capture growth across the fastest-expanding CDMO segments, particularly bioconjugation, while addressing the industry's most persistent operational challenges: speed, data accessibility, and supply chain resilience.

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"Strategic partnerships — what a buzzword this has become in our industry." Kaan Fabian-Kekec and Clarita Havermeier at Simon-Kucher, unveiled exclusive new research at the start of CDMO Live Europe 2026.

The research by Simon-Kucher and PharmaSource draws on 120+ senior executives across pharma and CDMOs globally. It reveals many areas of goal alignment, but highlights an execution gap as late-phase CDMOs are meeting established pharma's expectations just 44% of the time. The widest gaps are not quality or timelines. It's pricing and supply resilience.Listen to this recording from CDMO Live Europe 2026 and read the article

"A lot of biotech companies die because they run out of runway. And they might have been successful if they had another six or 12 months."

Baruch Harris, Chief Operating Officer at Pretzel Therapeutics, has spent over two decades navigating the business side of life sciences, from consulting and big pharma to early-stage biotech. With a PhD in biochemistry and deep experience in business development, investor relations, and corporate strategy, he has been key in guiding Pretzel from seed stage through a $72.5 million Series A and subsequent Series B financing.

In this episode of the PharmaSource podcast, Baruch shares the strategic decisions and creative financing structures that have kept Pretzel advancing its first-in-class mitochondrial biology pipeline, including a lead program currently wrapping up Phase 1 for rare mitochondrial depletion syndrome and an early-stage obesity asset. From spinout strategies to non-dilutive funding and the company's recent acquisition of Rome Therapeutics, his insights offer a practical roadmap for biotech leaders navigating today's capital-constrained environment.

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"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 Europe

Pharmaceutical 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.

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"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.

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“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.

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"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.

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“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.

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"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.

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"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.

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“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.

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“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.

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“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.

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"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.

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