This session will explore the critical gap between AI/ML-driven therapeutic discovery and current regulatory expectations for causality proof. Through the lens of Turing Biosciences' experience filing 32 FDA applications for AI-discovered therapeutics, we will discuss how sponsors can bridge this divide — achieving faster, more cost-effective regulatory success.
Learning Objectives:
Understand how OOPD’s evolving practices impact AI/ML-driven therapeutics.
Understand why predictive discovery alone is not yet sufficient for regulatory acceptance.
Learn strategies to translate AI-driven discoveries into regulator-trusted evidence.
Identify how to accelerate approvals while positioning pipelines for future regulatory modernization.
