John Concato MD

Summary

• Dr. Concato is an Adjunct Professor of Medicine at Yale School of Medicine. He joined the FDA in 2019 and from 2020-2024 was an Associate Director for the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), overseeing Real-World Evidence Analytics. He worked with other CDER offices, FDA centers, and external entities to promote understanding of, and opportunities related to, use of real-world data (RWD) and real-world evidence (RWE). His duties included directing CDER’s RWE Program, serving as Chair of RWE Subcommittee, supporting Agency processes related to RWD/RWE, and interacting with interested parties.
  
  Under Dr. Concato’s leadership, CDER published eight guidance documents on RWD/RWE during 2021-2024, representing a first-generation portfolio of recommendations on data sources, study design, and regulatory considerations. In parallel, more than 25 research projects were funded to improve the reliability or use of RWD, better understand study designs that generate RWE, or develop specific methodological “tools.” He led initiatives leading to a new Advancing RWE Program and the first CDER RWE Annual Report. His presentations and publications are cited frequently.
  
  Dr. Concato was previously an investigator, mentor, administrator, and clinician at Yale School of Medicine and Veterans Affairs (VA) Connecticut Healthcare System from 1992-2019. As an internist and epidemiologist, he acquired experience in methodological and applied topics involving study design and data analysis in patient-oriented research and medical product evaluation. His work included research evaluating the effectiveness of screening programs and other topics, launching the Million Veteran Program genomic biobank, comparing results of non-interventional studies and randomized trials to inform ongoing discussions of real-world data and evidence, and serving as the founding director of the VA Clinical Epidemiology Research Center.