Sebastian Schneeweiss, M.D., Sc.D.
Title Professor of Medicine Institution Brigham and Women's Hospital Address Brigham and Women's Hospital General Medicine 1620 Tremont St Boston MA 02120
ORCID
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Title
Professor in the Department of Epidemiology
Institution
Harvard T.H. Chan School of Public Health
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
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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.
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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.
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R01AR080194
(SCHNEEWEISS, SEBASTIAN G.)
Apr 1, 2022 - Dec 31, 2026
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.
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R01MH122427
(Lauren Moran/Sebastian Schneeweiss)
Jun 30, 2020 - Jun 30, 2025
Risk Factors for Psychosis and Mania with Prescription Amphetamine Use
Role: Site Principal Investigator
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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
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R01HL141505
(SCHNEEWEISS, SEBASTIAN G.;WANG, SHIRLEY)
Apr 1, 2019 - Mar 31, 2024
Randomized Cardiovascular Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE)
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HHSF223201810146C
(Jessica Franklin/Sebastian Schneeweiss)
Oct 1, 2018 - Sep 30, 2023
U.S. Food and Drug Administration
Predicting findings of ongoing phase IV RCTs with real world data analyses: An assessment to support FDA’s regulatory decision making
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HHSF223201710186C
(Sebastian Schneeweiss)
Sep 30, 2017 - Sep 30, 2021
U.S. Food and Drug Administration
Effectiveness research with Real World Data to support FDA’s regulatory decision making: A Real World Evidence Demonstration Project
Role: Principal Investigator
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R01LM012594
(Joshua Lin)
Sep 30, 2017 - Sep 30, 2020
Improving comparative effectiveness research through electronic health records continuity cohorts
Role: Co-Principal Investigator
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JLAF
(Shirley Wang)
Jun 30, 2017 - Jun 30, 2019
John and Laura Arnold Foundation
Evaluating Reproducibility and Robustness of Real World Evidence from Large Healthcare Databases (REPEAT pilot study)
Role: Co-Principal Investigator
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FDA-09-SOL-223-00112
(Richard Platt)
Sep 30, 2014 - Sep 30, 2019
U.S. Food and Drug Administration
The US Mini Sentinel System
Role: Co-Investigator; Co-Chair of the Methods Core
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PCORI
(Kenneth Mandel)
Sep 1, 2014 - Sep 30, 2020
Patient-Centered Outcomes Research Institute
A Scalable Collaborative Infrastructure for a Learning Health System (SCILHS)
Role: Co-Principal Investigator
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PCORI
(Sebastian Schneeweiss)
Aug 15, 2013 - Mar 10, 2018
Patient-Centered Outcomes Research Institute
Causal Inference for Effectiveness Research using Secondary Data
Role: Principal Investigator
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HHSA 29020050016I
(Sebastian Schneeweiss)
Sep 30, 2010 - Sep 30, 2013
The BWH DEcIDE Methods Research Center
Role: Principal Investigator
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RC4HL106376
(SCHNEEWEISS, SEBASTIAN G.)
Sep 22, 2010 - Aug 31, 2013
Assessment of Treatment Effects in High-Dimensional, Routine Care Claims Data
Role: Principal Investigator
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R01LM010213
(SCHNEEWEISS, SEBASTIAN G.)
Sep 30, 2009 - Sep 29, 2013
Analyzing Complex Healthcare Data to Determine Causality of Observed Drug Effects
Role: Principal Investigator
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RC1LM010351
(SCHNEEWEISS, SEBASTIAN G.)
Sep 30, 2009 - Mar 29, 2012
"Stopping Rules" for Drug Safety Monitoring Using Healthcare Databases
Role: Principal Investigator
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RC1RR028231
(SCHNEEWEISS, SEBASTIAN G.)
Sep 24, 2009 - Aug 31, 2012
Effectiveness studies with securely pooled healthcare data and adjusted analyses
Role: Principal Investigator
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U01MH079175
(SCHNEEWEISS, SEBASTIAN G.)
Aug 29, 2007 - Mar 30, 2012
Impact of Medicare Drug Coverage on Antidepressant Quality and Outcomes
Role: Principal Investigator
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U01MH078708
(SCHNEEWEISS, SEBASTIAN G.)
Sep 26, 2006 - Apr 30, 2012
Antidepressant Use and Suicidality: Comparative Safety in Children and Adults
Role: Principal Investigator
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U01MH069772
(SCHNEEWEISS, SEBASTIAN G.)
Mar 1, 2004 - Feb 28, 2009
Remibursement Limits, Antidepressants, and Outcomes
Role: Principal Investigator
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R01AG021950
(SCHNEEWEISS, SEBASTIAN G.)
Sep 1, 2003 - Feb 29, 2008
Effects of income-based drug charges on older Patients
Role: Principal Investigator
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R03AG019463
(SCHNEEWEISS, SEBASTIAN G.)
Aug 15, 2001 - Sep 30, 2002
Evaluating Drug Benefit Policy Changes in the Elderly
Role: Principal Investigator
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R01HS010881
(SCHNEEWEISS, SEBASTIAN G.)
Sep 30, 2000 - Jun 30, 2008
Consequences of Drug Cost Sharing:A New Randomized Trial
Role: Principal Investigator
Bibliographic
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