Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, he seeks to develop and implement policies related to drug development and regulatory review. His responsibilities related to real-world evidence (RWE) include developing internal Agency processes, interacting with external stakeholders, coordinating demonstration projects and guidance development, and serving as Chair of the RWE Subcommittee. Dr. Concato joined FDA after a >25-year career at Yale School of Medicine and the U.S. Department of Veterans Affairs (VA), where he was a clinician, educator, independent investigator, research center director, Professor of Medicine, and one of two founding principal investigators of the Million Veteran Program genomic mega-biobank. He has a B.E. degree from The Cooper Union, M.D. & M.S. degrees from New York University, and an M.P.H. degree from Yale University.