Sebastian Schneeweiss

Current Position

Title: Co-Founder & Senior Advisor Company: Aetion Inc. Also: Professor of Medicine and Epidemiology, Harvard Medical School; Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital Location: Boston, Massachusetts (based on Harvard Medical School and Brigham and Women's Hospital affiliations)

Professional Background

Sebastian Schneeweiss is a physician-pharmacoepidemiologist and healthcare data scientist with 25+ years of experience in analyzing complex longitudinal healthcare databases to assess the safety and efficacy of biopharmaceuticals. He received his medical training at Ludwig-Maximilians-University Munich (1992) and earned graduate degrees in epidemiology from Harvard School of Public Health (S.M. in 1994, Sc.D. in 2000). His career has bridged academic research at Brigham and Women's Hospital and Harvard with entrepreneurial innovation through his co-founding of Aetion, a real-world evidence analytics platform.

Schneeweiss is recognized globally as a leading methodologist in pharmacoepidemiology. His research focuses on developing analytical methods to improve the scientific validity of epidemiologic studies using healthcare databases, particularly for evaluating newly marketed medical products. He has published over 400 peer-reviewed articles with an H-index of 80 and has been cited by over 53,000 researchers. His work has been instrumental in advancing the FDA's regulatory use of real-world evidence (RWE) through the Sentinel Initiative and in shaping how payers and regulators evaluate drug safety and efficacy.

At Aetion, Schneeweiss has pivoted from purely academic research to building scalable technology platforms that democratize access to rapid-cycle analytics. He guides the company's strategic direction on real-world evidence methodologies while maintaining an active academic role teaching courses on database analytics, effectiveness research, and evidence interpretation at Harvard. This dual role positions him as both a rigorous methodologist and a pragmatist focused on translating evidence science into operational healthcare decision-making.

Career Timeline

Education

• M.D., Ludwig-Maximilians-University Munich (1992)
• S.M. (Master of Science) in Epidemiology, Harvard School of Public Health (1994)
• Sc.D. (Doctor of Science) in Pharmacoepidemiology, Harvard School of Public Health (2000)

Public Presence

Social Media

Note: Only publicly accessible profiles are documented. Profile on LinkedIn shows activity related to professional announcements and industry engagement.

Published Writings

• "Data Checks Before Registering Study Protocols for Health Care Database Analyses" — JAMA (May 2024)
• "The Future of Data-Rich Pharmacoepidemiology Studies: Transitioning to Large-Scale Linked Electronic Health Record + Claims Data" — American Journal of Epidemiology (2024)
• "The FDA Sentinel Real World Evidence Data Enterprise (RWE-DE)" — Pharmacoepidemiology and Drug Safety (October 2024, co-author)
• "Takeaways from the Framework for FDA's RWE Program: Implications for Biopharma" — Aetion Evidence Hub (featured)
• "Real-World Evidence of Treatment Effects: The Useful and the Misleading" — Invited commentary on RWE study design principles
• "Reproducibility of Real-World Evidence Studies Using Clinical Practice Data to Inform Regulatory and Coverage Decisions" — Nature Communications (2022, co-author)
• "RWE Studies on Treatments for Chronic Conditions" — Endocrine Reviews (with Elisabetta Patorno)
• "Concepts of Designing and Implementing Pharmacoepidemiology Studies on the Safety of Systemic Treatments in Dermatology Practice" — ScienceDirect (2023)
• Numerous course materials and teaching publications on database analytics and effectiveness research

Public Speaking

• "Real-World Evidence to Provide Supportive Evidence for Evaluating the Safety and Effectiveness of Therapeutic Products" — 2023 FDA Science Forum (video presentation available)
• "Calibrating Real-World Evidence Against RCT Evidence: Early Learnings from RCT-DUPLICATE" — Rethinking Clinical Trials (February 26, 2021)
• "Regulatory and Payer Evaluation of Real-World Evidence: A Roundtable Discussion" — International Society for Pharmacoepidemiology (October 2025)
• "In 5 Years, Rapid-Cycle Analytics Will Account for Majority of Analyses" — American Journal of Managed Care Interview Series
• "How Rapid-Cycle Analytics Can Evaluate Drug Safety, Efficacy" — AJMC Interview
• "How Rapid-Cycle Analytics Can Identify High-Risk, High-Cost Patients" — AJMC Interview
• "How Payers Can Benefit From Rapid-Cycle Analytics of Real-World Evidence" — AMCP Conference (2019)
• Multiple speaker appearances at The Effective Statistician Fall Conference and other academic/industry events
• Registered speaker with National Press Foundation for healthcare policy discussions

Communication Style

Tone: Authoritative yet accessible; technical but translation-focused; pragmatic visionary Recurring themes: Real-world evidence methodology and rigor; rapid-cycle analytics; regulatory science and FDA adoption; bias mitigation in observational studies; translating complex epidemiology into actionable insights for payers, regulators, and pharma Notable positions: Advocate for methodological transparency and principled study designs in RWE; proponent of rapid-cycle analytics as the future of drug safety monitoring; believer that RWE rigor can match randomized trials when properly designed; strong focus on minimizing confounding bias through propensity score methods and other advanced techniques

Schneeweiss communicates with the precision of an academic scientist combined with the clarity needed for business executives and policymakers. His interviews and articles demonstrate a pattern of breaking down complex pharmacoepidemiologic concepts into concrete examples that resonate with different audiences—regulators understand the scientific rigor, payers understand the operational efficiency gains, and pharmaceutical companies understand the competitive and regulatory implications. He frequently uses data-centric language ("calibrating evidence," "rapid-cycle analytics," "longitudinal healthcare databases") while maintaining enough accessible explanation that non-specialists grasp the core arguments. His writing style is direct and evidence-based; he avoids hyperbole and instead grounds claims in specific methodological principles and published evidence. His interviews suggest a conversational tone that reveals deep expertise without condescension—he explains why rapid-cycle analytics matters (speed and real-world applicability) alongside how they work (connecting software platforms directly to integrated healthcare data). As a co-founder, he demonstrates entrepreneurial language about platform scalability and adoption while remaining rooted in academic rigor, positioning Aetion's technology as enabling rather than replacing rigorous epidemiologic thinking.

Notable Achievements

• Co-founded Aetion (2014) — Built a real-world evidence analytics platform now serving healthcare organizations, pharmaceutical companies, and regulators globally
• 400+ peer-reviewed publications with an H-index of 80 and 53,815+ citations, establishing him as a prolific and highly-cited researcher in pharmacoepidemiology
• FDA Sentinel Innovation Center PI — Principal Investigator of FDA-funded center advancing methods for drug safety surveillance using healthcare databases
• Past President of the International Society for Pharmacoepidemiology — Leadership of the world's premier professional organization for pharmacoepidemiology
• Elected Fellow — American College of Epidemiology; American College of Clinical Pharmacology; International Society for Pharmacoepidemiology
• RCT-DUPLICATE Research Initiative — Led landmark project replicating findings from completed randomized controlled trials using real-world evidence, validating RWE methodology and predicting outcomes of ongoing Phase III/IV trials
• FDA Advisory Role — Voting consultant to the FDA Drug Safety and Risk Management Advisory Committee; advisor to EMA, CMS, PCORI, and NIH
• Teaching and Curriculum Development — Designed and teaches courses on database analytics (EPI286), effectiveness research (EPI253), and medications and evidence (AISC604) at Harvard; shaped training of next generation of pharmacoepidemiologists
• Methodologic Innovation — Developed analytical frameworks for propensity score adjustment, bias correction, and rapid-cycle analytics that are now industry standards

Key Relationships

• Aetion Leadership — Co-founder alongside other health technology leaders; continues to shape company strategy as Senior Advisor
• Harvard Medical School — Faculty position in Department of Medicine with teaching and mentorship responsibilities; affiliated with Harvard T.H. Chan School of Public Health and Harvard Biomedical Informatics PhD program
• Brigham and Women's Hospital — Chief of Pharmacoepidemiology Division; active clinical research leadership
• FDA/Sentinel — Formal advisor and voting consultant; plays role in shaping U.S. drug safety regulatory science
• PCORI (Patient-Centered Outcomes Research Institute) — Inaugural member of Methods Committee; advisor on research methodology standards
• International Society for Pharmacoepidemiology — Past President; continues prominent role in professional community leadership
• Academic Collaborators — Works with methodologists including Elisabetta Patorno and others at Harvard and nationally on epidemiologic methods papers
• Healthcare System Partners — Collaborations with integrated healthcare delivery systems contributing data to Aetion platform
• Industry Partnerships — Consulting and advisory relationships with pharmaceutical companies seeking to leverage RWE for regulatory and commercial strategy

Research Interests and Professional Focus

Schneeweiss's core professional agenda centers on three interconnected goals:

1. Advancing Real-World Evidence Rigor — Establishing RWE as scientifically valid for regulatory decision-making through methodological innovation and transparent study design
2. Enabling Rapid-Cycle Analytics — Building technology and methods that allow continuous monitoring and quick evaluation of drug safety and efficacy in real-world settings
3. Translating Evidence into Action — Bridging the gap between epidemiologic science and operational decision-making for FDA, payers, providers, and patients

His trajectory from pure academic research to technology entrepreneurship reflects a deliberate mission to scale impact beyond traditional peer-reviewed publications into tools that shape clinical practice and regulatory science in real time.