PharmaSource Podcast

“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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