Dr. Mallika Mundkur

Mallika L. Mundkur, MD, MPH, is a physician-scientist who spent nearly a decade at the U.S. Food and Drug Administration, most recently as Deputy Chief Medical Officer in the Office of the Commissioner, where her work focused on real-world evidence, clinical policy, and novel regulatory pathways to streamline approvals in areas of unmet need. She established the FDA's first Agency-wide council on real-world evidence, led development of a modernized Sentinel 2.0 framework, and partnered with the Commissioner and the Agency's Chief AI Officer on a proposed framework for the Real-Time Clinical Trials initiative.

Dr. Mundkur trained at Harvard College, the University of Massachusetts Medical School, and the Harvard T.H. Chan School of Public Health. She completed her internal medicine residency at the University of Alabama at Birmingham, where she was selected as Chief Medical Resident, followed by fellowships in clinical informatics at the National Library of Medicine and in pharmacoepidemiology at Brigham and Women's Hospital and Harvard Medical School.

Dr. Mundkur advises, invests in, and provides regulatory counsel to biotechnology and medical device companies worldwide. She has a particular interest in women's health, where she works to close evidence gaps and advance innovation in areas that remain understudied, underdiagnosed, and undertreated. She maintains clinical practice as a volunteer internist in Virginia and teaches medical students at the George Washington University School of Medicine.