M. Khair ElZarrad Ph.D., MPH, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)

M. Khair ElZarrad Ph.D., MPH Dr. ElZarrad is the Deputy Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Prior to joining the FDA, he served as Acting Director of the Clinical and Healthcare Research Policy Division with the Office of Science Policy at the National Institutes of Health (NIH). At NIH he worked on policies related to human subject protections; the design, conduct, and oversight of clinical research; and enhancing quality assurance programs at pharmaceutical development and production facilities. Dr. ElZarrad currently leads multiple projects focused on exploring the potential utility of real-world evidence, innovative clinical trial designs, and the integration of technological advances in pharmaceutical development. He earned a doctoral degree in medical sciences with a focus on cancer metastases from the University of South Alabama, as well as a master’s degree in public health from the Johns Hopkins Bloomberg School of Public Health.

Session

9:50 AM - 10:15 AM

Update on FDA's Real-World Evidence Program

This session will cover the main elements of the framework for FDA’s real-world evidence program and will describe ongoing demonstration projects and collaborations. The emerging and evolving role of technological innovations in facilitating the use of real-world data will be discussed and highlighted. Examples of activities focused on the utilization of AI to support the development of therapeutics will be provided.

  • M. Khair ElZarrad Ph.D., MPH

    M. Khair ElZarrad Ph.D., MPH Deputy Director, Office of Medical Policy Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)


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