Hope in a Dose: CGT Podcast | Ep. 5 | Early Phase Challenges in Advanced Therapies

Host: Louise Kearney, Head of Cell and Gene Therapy, Strategy and Delivery at Fortrea

Participant: Frederick Derosier

Description: Cell and gene therapy (CGT) trials are rewriting the rules of early-phase research. Unlike traditional first-in-human studies, these programs involve patients—not healthy volunteers—and often target rare or ultra-rare genetic diseases. That means smaller populations, complex logistics, and long-term follow-up requirements that can span decades.

In this episode of Early Phase Challenges in Advanced Therapies, we explore the unique challenges of designing and delivering early-phase CGT trials—from patient recruitment and dosing to regulatory oversight and global coordination.