Tala H. Fakhouri, Ph.D., M.P.H., is the Vice President Consulting: AI & Digital Policy, Real-World Research and will consult in these three key innovation areas. Most recently, Dr. Fakhouri was the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). In this role, Dr. Fakhouri led a team focused on advancing medical policy related to the use of AI in drug development. Her work included overseeing FDA’s AI policy efforts in drug development, engaging with external stakeholders, and driving regulatory science initiatives to ensure the responsible and effective use of AI across the drug development lifecycle. During her FDA tenure, she led the development of the first draft CDER AI Guidance, established the CDER AI Council, and contributed to the development of policy on real-world evidence and digital health technologies, including leading the publication of the first RWE guidance for FDA. Her leadership in statistical methodology has been recognized through her selection to serve on the Federal Committee for Statistical Methodology in 2023. Dr. Fakhouri holds a Ph.D. in Oncological Sciences from the Huntsman Cancer Institute at the University of Utah.