Tala H. Fakhouri, PhD, MPH

Tala H. Fakhouri, PhD, MPH is Vice President Consulting: AI & Digital Policy, Real-World Research.

Most recently, she served as Associate Director for Data Science and Artificial Intelligence at the FDA’s Center for Drug Evaluation and Research (CDER), where she led AI policy efforts in drug development. Her work included drafting CDER’s first AI guidance, establishing the CDER AI Council, and advancing regulatory science initiatives to ensure responsible AI use. She also contributed to policy development on real-world evidence and digital health technologies, including leading the publication of FDA’s first RWE guidance. In 2023, she was appointed to the Federal Committee for Statistical Methodology for her leadership in statistical methods.

Prior to FDA, Dr. Fakhouri held senior roles at CDC, including Chief Statistician for NHANES, and has authored over 30 publications. She holds a PhD in Oncological Sciences from the Huntsman Cancer Institute at the University of Utah, a MPH in Epidemiologic and Biostatistical Methods from the Johns Hopkins Bloomberg School of Public Health, and a postdoctoral fellowship in molecular biology and genetics from Harvard University. She earned her BSc in Medical Technology from the Jordan University of Science and Technology.