Medical Affairs Unscripted

In this episode, Peg Crowley-Nowick speaks with Joseph Elassal, MD, MBA, Chief Medical Officer of Ankyra Therapeutics, about the strategic, operational, and financial realities of leading clinical development from pre-IND through proof of concept and toward commercialization.
 
Drawing on experience across large pharma, biotech partnerships, and early-phase oncology, Joe shares a practical roadmap for new and aspiring CMOs. They discuss how to prioritize essential capabilities, including clinical operations, regulatory strategy, biostatistics, and pharmacovigilance, while determining the right time to introduce Medical Affairs. The conversation outlines how to scale teams at critical inflection points such as IND clearance, Phase 2 proof of concept, and advancement into Phase 3.
 
The episode also examines investor and board expectations, CRO selection, capital efficiency, cash runway management, and the performance metrics CMOs are ultimately judged on—from disciplined milestone execution to generating meaningful clinical data.
This episode offers actionable insight for biotech founders, clinical development leaders, medical affairs professionals, and emerging CMOs navigating the path from early development to launch.

How Medical Affairs leaders can move their organizations from a supporting role to a strategic driver—through accountability, insight translation, and the smart use of AI.
In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick speaks with Greg Carpenter, Global Medical Strategy Leader in General Medicine at Sanofi, for a candid conversation on how Medical Affairs must evolve to remain relevant—and indispensable—in a rapidly changing industry. The discussion focuses on how Medical Affairs leaders can increase their strategic impact across pharma and biopharma organizations. Drawing on experience across commercial, quality, and Medical Affairs functions, Carpenter outlines why broader career paths, business acumen, and accountability are essential to creating Medical Affairs value.
The conversation examines how Medical Affairs can move beyond data delivery to translate medical insights into strategy, strengthen cross-functional collaboration, and better support physicians and patients. The episode concludes with a practical discussion on AI in Medical Affairs, including how AI is being used today to improve insights, content development, and efficiency—while reinforcing the importance of human judgment and leadership.

Medical Affairs Unscripted welcomes Dr. Jeff Humphrey—an experienced CMO with three decades across Bristol Myers Squibb, Pfizer, Bayer, Kyowa Kirin, and multiple biotechs—to discuss why the Target Product Profile (TPP) is the foundation of effective drug development. He shares a clear framework for "starting with the end in mind," from scientific fit and standards of care to regulatory precedent, investor expectations, and the smart use of AI. Humphrey also underscores the importance of working with patient-first KOLs and reminds listeners that poorly planned development can waste years of people's lives and millions of dollars.

Medical Affairs isn't a downstream function—it's the throughline connecting science, story, and strategy from development through commercialization. This episode features Howard Rutman, MD, MBA, Chief Medical Officer at Xalud Therapeutics and Peg Crowley-Nowick, PhD, MBA discussing the critical role of early Medical Affairs engagement. Key topics include how early Medical Affairs involvement speeds patient enrollment and data generation, qualities to seek in the first Medical Affairs hire, the value a lean team can bring to BioTech, and the importance of evidence plans that support physician and market access needs.  The podcast emphasizes Medical Affairs as a continuous link from development to commercialization.

In this episode of Medical Affairs Unscripted, host Peg Crowley-Nowick talks with Shera Gruen, SVP of Strategy Consulting at Lumanity, about the power of collaboration between medical and commercial teams in pharma. Drawing on her 20 years of industry experience leading commercial teams, Shera shares lessons on aligning science with strategy, preparing for launch success, and managing uncertainty. From cross-functional teamwork to scenario planning and external partnerships, this conversation offers practical insights for anyone involved in bringing new therapies to market — and shows how collaboration can turn complex challenges into opportunities for impact.