"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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