Tala Fakhouri

Tala H. Fakhouri, Ph.D., M.P.H., is a leader in artificial intelligence, data science, and pharmaceutical regulation. Fakhouri serves as vice president of consulting for AI and digital policy, real-world research at Parexel. Previously, she was 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.

Fakhouri holds a Ph.D. in oncological sciences from the Huntsman Cancer Institute at the University of Utah, an M.P.H. in epidemiologic and biostatistical methods from Johns Hopkins University School of Public Health, and completed a postdoctoral fellowship in molecular biology and genetics at Harvard University.

During her tenure at the FDA, Fakhouri contributed to the agency's approach to AI in drug development. She led AI policy efforts in drug development, drafted the center's first AI guidance, and established the CDER AI Council. She also contributed to policy development on real-world evidence and digital health technologies, including leading the publication of the FDA's first real-world evidence guidance. Her work emphasized that AI models must be credible and trustworthy for their specific context of use, requiring scrutiny of training data and rigorous evaluation of model performance.

Before joining the FDA, Fakhouri worked in public health research. She served as senior health scientist and chief statistician for the CDC's National Health and Nutrition Examination Survey, where she provided leadership on epidemiologic, statistical, and methodological issues and led efforts to improve study design and participant recruitment. Her previous roles include serving as an Epidemic Intelligence Service officer at the CDC, deputy lead for health surveys at ICF Macro, and contributor to cross-agency efforts such as the Cancer Moonshot. She has authored more than 30 government reports, peer-reviewed publications, and book chapters.

Fakhouri has been appointed to the Federal Committee for Statistical Methodology in recognition of her leadership in statistical methods. At Parexel, she brings experience in regulatory affairs, AI-driven drug development, real-world data analytics, and digital health technology, with a record of developing regulatory frameworks and fostering collaborations between regulators, industry, and global stakeholders. She is known for her ability to communicate complex topics around AI and AI policy and has appeared at industry forums, including the Financial Times US Pharma and Biotech Summit and the American Society of Health-System Pharmacists Midyear Clinical Meeting.