Comment from Jordan Despanie

Summary: Dr. Jordan Despanie supports the establishment of the Expedited Investigational New Drug (IND) Acceleration Pilot Program to accelerate First-in-Human timelines and maintain U.S. biopharmaceutical competitiveness. The commenter proposes a five-pillar regulatory architecture involving Bayesian clinical trial design, AI-driven preclinical de-risking, an "Architecture of Trust" for AI governance, site-specific infrastructure, and alignment with late-stage incentives.