In this episode of The Chain, Richard Bonneau, PhD, and Marcel Hop, PhD, of Genentech interview Tala Fakhouri, PhD, of the FDA on her thoughts on the discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biologic Products” and the evolving role of AI/ML to create models and inform decisions in biopharmaceutical development and regulatory submissions. Dr. Fakhouri also discusses the impact AI/ML models could have on clinical trial conduct, patient enrollment, patient selection, and data interpretation. She also talks about the next steps to get the right processes in place and why transparency is important to establish trust with patients about AI/ML tools.