The BioCentury Show
The BioCentury Show
BioCentury
Ep. 117 - C-Path's Klaus Romero on moving genetic medicines beyond one patient
29 minutes Posted Aug 21, 2026 at 1:00 am.
Introduction
Current Framework
Process-based Regulation
Overcoming Bottlenecks
Use of AI
Beyond Rare Diseases
0:00
29:57
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Show notes
The Critical Path Institute’s One to Millions Initiative is using individualized rare disease therapies as the starting point for a development framework that could eventually extend across all genetically defined diseases. The initiative seeks to bring form to FDA’s Plausible Mechanism Framework by standardizing how evidence and methods can be reused across therapies and patients. In conversation with Biopharma Analyst Dr. Tierney Baum on The BioCentury Show, C-Path CEO and CSO Klaus Romero ...