Machine Learning for PK/PD Modeling in Drug Development How the US FDA MIDD paired pilot program helps sponsors Measuring metabolites in index clinical DDI studies Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters Key development considerations for cell therapies De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development