Fast-Tracking First-in-Human: Navigating ATMP Regulatory Hurdles
Bringing a Cell or Gene Therapy from the lab to its First-in-Human (FIH) trial is an exciting milestone—but getting there can feel like navigating a regulatory maze. The promise of these therapies to cure previously untreatable diseases is immense, but the journey is filled with potential pitfalls. Understanding the key regulatory requirements early can make the difference between a smooth transition to the clinic and costly delays. So, how can CGT companies chart a clear path through this complex process?