Panel: From Agentic AI to Regulatory Credibility: What Actually Accelerates Drug Development

Session details:

AI is compressing discovery-to-IND timelines, but speed only matters if outputs are credible, governable, and defensible with regulators. This panel examines where AI and NAMs have delivered real impact, how credibility frameworks are evolving, and what sponsors must document to translate AI outputs beyond research and into regulatory-facing decisions. 
 
Key discussion points 
Where AI has delivered measurable discovery-to-IND time savings 
FDA’s AI credibility framework and implications for sponsors 
NAMs (in silico, organoids, organ-on-chip): current regulatory acceptance 
Model validation, bias, drift, and documentation best practices 
Managing regulatory divergence across FDA, EMA, MHRA, and key Asian agencies