In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, Senior Advisor, Medical Affairs Consulting at Lumanity, welcomes Dr. Jeff Humphrey—an oncologist and seasoned CMO with nearly 30 years of experience across Bristol Myers Squibb, Pfizer, Bayer, Kyowa Kirin, and multiple emerging biotechs—for a deeply practical discussion on why the Target Product Profile (TPP) is the true foundation of modern drug development. Drawing on more than a dozen INDs and 11 global submissions and approvals, Humphrey lays out a clear, replicable framework for “starting with the end in mind,” especially in resource-constrained settings where every decision matters.
Together they discuss how early alignment on scientific fit, standard-of-care mapping, competitive dynamics, regulatory precedent, and market return prevents teams from drifting off course. As Humphrey notes, without a grounded TPP, organizations “set themselves up to wander and do either the wrong trial—or the right trial in the wrong way,” a misstep that can cost years of people’s lives and millions of dollars.
The conversation also explores the growing role of AI in accelerating early analysis, the shift in investor expectations post-COVID, and why choosing patient-first KOLs is essential for unbiased strategic guidance. Peg and Jeff dive into how a disciplined TPP shapes Phase 1 inclusion criteria, supports evidence planning long before pivotal studies, strengthens fundraising narratives, and ultimately reduces avoidable clinical and operational risk.
This episode offers candid, experience-based guidance for medical affairs leaders, aspiring CMOs, biotech founders, and anyone responsible for charting a development path that is scientifically sound, commercially viable, and anchored in patient impact.
Episode guest
Jeff Humphrey, MD
Chief Medical Officer, Voro Therapeutics
