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Sebastian Schneeweiss, M.D., Sc.D.

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Overview
Sebastian Schneeweiss is Professor of Medicine and Epidemiology at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics of the Department of Medicine, Brigham and Women’s Hospital, a world-leading research and training center.

His research is funded by multiple NIH, PCORI, BWF, and FDA grants and focuses on the comparative effectiveness and safety of biopharmaceuticals. He has developed analytic methods to improve the scientific validity of epidemiologic analyses using complex longitudinal healthcare databases particularly for newly marketed medical products. Applying such methods in rapid analysis cycles for sequential medication effectiveness monitoring and rapid response analyses is the overarching theme of his research. He is Aetion Inc.’s co-founder and Science Advisor were he develops a range of rapid-cycle analytics platforms for healthcare database networks around the world.

Dr. Schneeweiss is PI of the Sentinel Innovation Center funded by FDA/CDER were he is a voting consultant to the FDA Drug Safety and Risk Management Advisory Committee. He was an inaugural member of the Methods Committee of the Patient-Centered Outcomes Research Institute. He 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.

At Harvard he teaches courses on Database Analytics for Pharmacoepidemiology (EPI286) and on Effectiveness Research in Longitudinal Healthcare Databases (EPI253), Medications and Evidence (AISC604) among others.

He received his medical training at the University of Munich Medical School and his doctoral degree from Harvard.

Research
The research activities and funding listed below are automatically derived from NIH ExPORTER and other sources, which might result in incorrect or missing items. Faculty can login to make corrections and additions.
  1. 75F40122C00181 (Shirley Wang/Sebastian Schneeweiss) Oct 1, 2022 - Oct 1, 2026
    US Food and Drug Administration
    Calibrating RWE studies in oncology against randomized trials
    Role Description: To expand a previously tested process for using RWE to support effectiveness claims for oncology drugs and empirically demonstrate the process with 12 suitable oncology trials across 4 cancers and 4 EHR data sources.
    Role: M-PI
  2. 75F40122C00154 (Sebastian Schneeweiss/Shirley Wang) Oct 1, 2022 - Oct 1, 2025
    US Food and Drug Administration
    Real-world evidence to support labeling expansions for effectiveness claims using a two-stage trial emulation process
    Role Description: To design a two-stage process for using real-world evidence (RWE) to support labeling expansions for effectiveness claims that is aligned with regulatory requirements and demonstrate and empirically test such a process with historical and ongoing RCTs for supplemental indications.
    Role: M-PI
  3. R01AR080194 (SCHNEEWEISS, SEBASTIAN G.) Apr 1, 2022 - Dec 31, 2026
    NIH/NIAMS
    New approaches to safety monitoring of novel systemic treatments for atopic dermatitis in clinical practice and underrepresented populations
    Role Description: Dermatology has experienced the emergence of targeted immuno-modulating drugs that have unprecedented efficacy in treating recalcitrant atopic dermatitis. We will generate directly applicable clinical insights on the safe and targeted use of new immuno-modulating drugs to treat AD by leveraging existing claims data sources with added EHR data and using novel methods for causal inference. The expedited evidence generation via the proposed prospective monitoring system will efficiently close knowledge gaps for optimal IMD use in patients with AD, including underrepresented and high-risk patients.
    Role: PI
  4. R01MH122427 (Lauren Moran/Sebastian Schneeweiss) Jun 30, 2020 - Jun 30, 2025
    NIH/NIMH
    Risk Factors for Psychosis and Mania with Prescription Amphetamine Use
    Role: Site Principal Investigator
  5. HHS 75F40119F19002 (Sebastian Schneeweiss) Sep 30, 2019 - Sep 30, 2024
    US Food and Drug Administration
    Sentinel Innovation Center
    Role Description: Improve methodologies to study medication safety with unstructured and structured healthcare data in quasi-real-time.
    Role: Principal Investigator

Bibliographic
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Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number UL1TR002541.