Dr. Sebastian Schneeweiss is a distinguished leader in pharmaceutical outcomes research and drug safety methodology. He serves as Professor of Medicine and Epidemiology at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics within the Department of Medicine at Brigham and Women's Hospital. His academic foundation includes medical training at the University of Munich Medical School followed by doctoral studies in Pharmacoepidemiology at Harvard University. Dr. Schneeweiss has established a world-leading research center focused on advancing methodologies for evaluating medical product safety and effectiveness in real-world settings. His institutional leadership positions have positioned him at the forefront of translating methodological innovations into practical applications for regulatory science.
Dr. Schneeweiss has pioneered advanced analytic methods to improve the scientific validity of epidemiologic analyses using complex longitudinal healthcare databases, particularly for newly marketed medical products. His research program focuses on comparative effectiveness and safety of biopharmaceuticals, with scholarly contributions exceeding 400 publications that have transformed how regulatory agencies utilize real-world evidence. As Principal Investigator of the FDA/CDER-funded Sentinel Innovation Center and former Methods Lead of the FDA Sentinel program, he has developed rapid-cycle analytics platforms that enable transparent and timely regulatory decision-making. His methodological innovations apply data-adaptive algorithms to enhance confounding control and causal inference while calibrating real-world evidence against randomized trial findings. This work has been consistently supported by major funding from NIH, PCORI, Arnold Foundation, IMI, and FDA, demonstrating the high impact and relevance of his research to public health.
Beyond his methodological contributions, Dr. Schneeweiss has provided significant leadership as Past President of the International Society for Pharmacoepidemiology and as a voting consultant to the FDA Drug Safety and Risk Management Advisory Committee. He is widely recognized as a Fellow of the American College of Epidemiology, the American College of Clinical Pharmacology, and the International Society for Pharmacoepidemiology, reflecting his substantial influence across multiple disciplines. As an educator, he teaches influential courses at Harvard on Database Analytics for Pharmacoepidemiology and Effectiveness Research in Longitudinal Healthcare Databases, shaping the next generation of researchers in the field. Dr. Schneeweiss co-founded Aetion Inc. where he serves as Science Advisor, developing rapid-cycle analytics platforms for healthcare database networks worldwide. His current research continues to advance the science of real-world evidence generation with applications spanning cardiovascular medicine, rheumatology, mental health, dermatology, and oncology, ensuring his ongoing impact on pharmaceutical regulation and patient care.
