John Concato, MD, FACP, MS, MPH

Dr. Concato joined the Food and Drug Administration (FDA) in 2019, and from 2020-2024 he was Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER). In this position he developed, coordinated, and implemented medical policy programs and strategic initiatives, with a focus on real-world evidence (RWE). These efforts include overseeing RWE guidance development and demonstration projects, as well as engaging external stakeholders and participating in the review of RWE submissions, all in support of the agency’s evaluation of RWE as mandated by the 21st Century Cures Act. Prior to joining FDA, Dr. Concato was an investigator, mentor, administrator, and clinician at Yale School of Medicine and Veterans Affairs (VA) Connecticut Healthcare System from 1992 to 2019. Based on his education and training as an internist and epidemiologist, he acquired extensive experience in methodological and applied topics involving study design and data analysis in patient-oriented research. Dr. Concato’s work spans a range of topics in patient care, methodology, and health policy, and he held various administrative positions with leadership responsibilities. Examples of accomplishments include research evaluating the effectiveness of screening programs and other topics, launching the Million Veteran Program genomic biobank, and comparing results of real-world studies and randomized trials to inform ongoing discussions of real-world data and real-world evidence. Dr. Concato was also Founding Director of the VA Clinical Epidemiology Research Center. He continues to collaborate with Yale School of Medicine, including the National Clinician Scholars Program.