John Concato

John Concato, MD, is an **Adjunct Professor of General Internal Medicine** at Yale School of Medicine and **Associate Director for Real-World Evidence Analytics** at the FDA's Center for Drug Evaluation and Research (CDER). His work bridges academic research and regulatory policy, focusing on real-world evidence (RWE) to inform drug development and medical policy. He holds advanced degrees including an MPH from Yale and an MD from New York University.

Education & Training

• MD, New York University, 1985
• MS, Environmental Health, New York University, 1981
• MPH, Public Health, Yale University, 1991
• Fellowship, Yale School of Medicine, 1991

Research Interests

Dr. Concato leads initiatives in RWE applications for regulatory decisions, including FDA guidance development and demonstration projects. His research spans epidemiology, veteran health studies (e.g., Gulf War Illness), and clinical trial methodologies. He collaborates on large-scale programs like the Million Veteran Program, analyzing genomic and clinical data to address complex health questions.

Publications & Grants

His recent work emphasizes RWE's role in drug approval, sensitivity analysis in observational studies, and pandemic-era clinical trial adaptations. He has contributed to over 170 publications and holds grants for Gulf War veteran genomic studies and PTSD trajectory analyses. Collaborators include institutions like FDA, VA, and academic partners worldwide.

Labs/Teams

He directs FDA's RWE Analytics team and collaborates with Yale's clinical research groups on projects such as the Million Veteran Program, leveraging multi-omics and clinical data to advance precision medicine.