John Concato MD

Summary

• Dr. Concato is Professor (Adjunct) of Medicine at Yale School of Medicine in New Haven, CT. As a general internist and clinical epidemiologist, Dr. Concato’s full-time academic career (1992-2019) at Yale School of Medicine and the Department of Veterans Affairs (VA) included conducting clinical research as an independent investigator and later as a research center director; he was promoted to Professor of Medicine in 2007. Representative projects involved a range of topics in patient care, research methodology, and health policy. He published seminal comparisons of observational studies and randomized trials that informed discussions of evidence-based medicine and real-world evidence (RWE); he also served as one of two founding Principal Investigators of the VA Million Veteran Program genomic biobank. Based on his expertise regarding evidence generation, Dr. Concato was recruited to the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in 2019. As a regulator (2019-2024), he designed and implemented strategies and policies for medical product development. Under Dr. Concato’s leadership, accomplishments of FDA’s RWE Program included publishing eight guidance documents during 2021-2024, representing a first-generation portfolio of recommendations from FDA on data sources, study design, and regulatory considerations. Before retiring from federal service in December of 2024, he helped develop and was the Founding Director of the CDER Center for Real-World Evidence Innovation (CCRI).