.jpg "Mei Sheng Duh, MPH, ScD photo")
Chief Epidemiologist and Managing Principal
Analysis Group, Inc., Boston, MA, USA
Dr. Duh, Chief Epidemiologist at Analysis Group, specializes in real-world evidence (RWE) generation for product registration, post-approval safety studies, and health economics and outcomes research (HEOR) of pharmaceuticals, vaccines, and regenerative biotherapeutics. She has led multiple projects for new molecular entity approvals and product label expansion applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), as well as health technology assessment (HTA) research for submissions to national payers such as the Centers for Medicare and Medicaid Services (CMS) in the US and the UK’s National Institute for Health and Care Excellence (NICE). Her extensive research has appeared in over 250 peer-reviewed publications.
Her work also extends to pharmaceutical liability litigation and securities fraud litigation related to adverse drug events that allegedly led to product recalls, market withdrawals, black box warnings, and FDA limited access programs.
Dr. Duh is also an adjunct in the biostatistics department at the Harvard T.H. Chan School of Public Health. She served as a chairperson of drug safety and epidemiology for the Drug Information Association (DIA) and was an adjunct assistant professor of pharmacoeconomics and pharmacoepidemiology at Massachusetts College of Pharmacy and Allied Health Sciences. Dr. Duh was appointed to an expert panel convened by the Foundation for the National Institutes of Health’s (FNIH’s) Observational Medical Outcomes Partnership (OMOP). She has served as a peer reviewer for several journals, including PharmacoEconomics, the American Journal of Health-System Pharmacy, Chest, Pharmacoepidemiology and Drug Safety, the American Journal of Kidney Diseases, and Therapeutics and Clinical Risk Management. Dr. Duh is also an elected member of the American Society of Hematology (ASH) and a member of the American Society of Clinical Oncology (ASCO), the International Society of Pharmacoepidemiology (ISPE), and the International Society of Pharmacoeconomics and Outcomes Research (ISPOR).
