Sebastian Schneeweiss

Chief / Professor

Sebastian Schneeweiss is Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine of the Brigham and Women’s Hospital. He is a Professor of Medicine at Harvard Medical School and Professor in Epidemiology at the Harvard T.H. Chan School of Public Health.

Dr. Schneeweiss studies the comparative effectiveness and safety of biopharmaceuticals and develops methods to reach causal conclusions from analyzing complex healthcare databases (Duke-Margolis video, NASEM video). He focuses on newly marketed medications and how real-world evidence can be generated expeditiously at highest quality without compromising the accuracy of findings. He applies data-adaptive algorithms to large healthcare databases to improve confounding control supporting causal inference and calibrates RWE against randomized trials (ICPE video).  Automatization of this analytics in order to generate new evidence in rapid cycles is part of his focus. Disease areas of interest include cardiovascular, antithrombotic therapy, rheumatology, mental health, dermatology, oncology, and others. He teaches courses in principled database analytics in pharmacoepidemiology at Harvard and in Europe.

He is Principal Investigator of the FDA/CDER-funded Sentinel Innovation Center at Harvard, Duke University, Vanderbilt University, and the University of Washington (Sentinel video).  Dr. Schneeweiss is Past President of the International Society for Pharmacoepidemiology and is Fellow of the American College of Epidemiology, the American College of Clinical Pharmacology, and the International Society for Pharmacoepidemiology. He is voting consultant to the FDA Drug Safety and Risk Management Advisory Committee and past inaugural member of the Methods Committee of the Patient-Centered Outcomes Research Institute.

He received his medical training at the University of Munich Medical School and his masters and doctoral degrees in Pharmacoepidemiology from Harvard.


Current Courses Taught

EPI286 Database Analytics in Pharmacoepidemiology (Fall 2023) – This course is intended primarily for graduate students considering a career in the pharmaceutical/biotech industry, pharmaceutical benefits management, or in national regulatory bodies. Students will learn to design, implement and interpret pharmacoepidemiologic studies using longitudinal healthcare databases. (Dr. Huybrechts, Dr. Schneeweiss)

EPI253 Effectiveness Research with Longitudinal Healthcare Databases (Summer 2023) – The target audience consists of researchers working in academia, medical product industry, health plans, government institutions, regulatory agencies, who have access to large longitudinal healthcare databases. They may use healthcare databases to evaluate the effectiveness of medical interventions and care patterns, to understand the comparative effectiveness and safety of medical products, to test the impact of coverage changes, or to monitor the outcome of risk-sharing arrangements. (Dr. Desai, Dr. Schneeweiss, Dr. Rome)

AISC 624 Medications and Evidence (October 2022) - Prescription drugs are the most commonly used and effective interventions in all of medicine. This course integrates clinical, epidemiological, and policy perspectives exposing students to cutting-edge developments on how evidence on medications is generated and used in health care. It will present several perspectives: initial assessment by the FDA based on pre-approval trials, measuring effectiveness and safety in routine care based on epidemiologic studies, their important clinical role in preventing and treating disease, factors affecting patient adherence, balancing benefits and risks in prescribing, coverage by public and private payers, and drug pricing and cost-effectiveness. (Drs. Schneeweiss, Avorn, Kesselheim, Choudhry, Lauffenburger)