Sebastian Schneeweiss, MD, ScD
PROFESSOR OF MEDICINE AND EPIDEMIOLOGY AT HARVARD MEDICAL SCHOOL AND CHIEF OF THE DIVISION OF PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS IN THE DEPARTMENT OF MEDICINE, BRIGHAM AND WOMEN’S HOSPITAL, HARVARD MEDICAL SCHOOL & BRIGHAM & WOMEN'S HOSPITAL
Sebastian Schneeweiss is Professor of Medicine and Epidemiology at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine, Brigham and Women’s Hospital. His research is funded by multiple NIH, PCORI, and FDA grants and focuses on the comparative effectiveness and safety of biopharmaceuticals. He has developed analytic methods to improve the validity of epidemiologic studies using complex healthcare databases particularly for newly marketed medical products. Bundling such improved methods into a rapid-cycle analytics framework is the overarching theme of his research. His work is published in >300 articles, many of them in high-ranking journals. He is Aetion Inc.’s Science Lead of an evidence platform that enables rapid-cycle analytics for healthcare databases. Dr. Schneeweiss is Director of the Harvard-Brigham Drug Safety Research Center funded by FDA/CDER and Methods Lead of the FDA Sentinel program. He is voting consultant to the FDA Drug Safety and Risk Management Advisory Committee and 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. He received his medical training at the University of Munich Medical School and his doctoral degree in Pharmacoepidemiology from Harvard.
2:15 PM - 3:15 PM (PDT)
Monday, June 13
Regulatory guidance to support submission of high validity and relevance of real-world evidence …