Dr. Tala H. Fakhouri is the Vice President Consulting, AI & Digital Policy, Real-World Research at Parexel. Previously, she was Associate Director for Data Science and AI at the FDA's CDER, leading AI policy efforts in drug development. In her most recent FDA role, she led the development of the first draft CDER AI Guidance, established the CDER AI Council, and contributed to real-world evidence and digital health technologies policies. Dr. Fakhouri also served as Senior Health Scientist and Chief Statistician for CDC's NHANES, focusing on epidemiologic and statistical issues. Her career includes roles as CDC Epidemic Intelligence Service Officer and deputy lead for health surveys at ICF International. She has authored numerous government reports and peer-reviewed publications. Dr. Fakhouri holds a PhD in Oncological Sciences from the University of Utah, an MPH from Johns Hopkins, and completed a postdoctoral fellowship at Harvard University. She earned her BSc in Medical Technology from Jordan University of Science and Technology.