Utilization of Real-World Data in Clinical Pharmacology – Regulatory Perspectives

While there is significant interest from both industry & regulatory agencies on applying Artificial Intelligence/Machine Learning (AI/ML), Real-World Evidence (RWE), and omics data to quantitative modeling for drug development applications, several challenges remain: these include the generalizability, interpretability and data requirement of such models. To help address these issues, US FDA published a series of guidance and held a series of workshops. The speaker is a key member of the Innovation and Partnership Program within the Office of Clinical Pharmacology (OCP). She specializes in AI/ML, Real-World Evidence (RWE), and omics data. Dr. Zhang has made significant contributions to several New Drug Application (NDA) reviews, particularly in assessing the reliability of AI/ML and RWD/RWE components used in clinical trials and drug development. She will systematically represent the current state-of-the-art of attitude and policy for how to use these methodologies to make better drug development and precision dosing for age-related special populations.