Mei Sheng Duh
Sc.D., pharmaco-epidemiology, Harvard School of Public Health; M.P.H., chronic disease epidemiology, Yale Medical School; B.S., pharmacy, Kaohsiung Medical College
Summary of Experience:
Dr. Duh is a pharmacoepidemiologist specializing in the safety, health economics, and outcomes of pharmaceutical or biological agents and in mass tort drug safety litigations. She has conducted many medical records review studies, patient surveys, and analyses of claims data, clinical trials data, and MedWatch data to investigate adverse events, prevalence and incidence, resource utilization patterns, patient-reported outcomes, clinical comparative effectiveness, direct medical and indirect productivity costs, and cost-effectiveness associated with use of pharmaceuticals or biologics. Her work also includes mass tort personal injury claims associated with drug adverse events that lead to product recall, market withdrawal, black box warnings, and FDA limited access programs.
Dr. Duh served as a chairperson for Drug Information Association annual meetings and was an adjunct assistant professor of Pharmacoeconomics and Pharmacoepidemiology at Massachusetts College of Pharmacy and Allied Health Sciences in Boston. She is a visiting scholar in the biostatistics department and a guest lecturer in the epidemiology department, both at the Harvard University School of Public Health. Dr. Duh was appointed to an expert panel convened by the Foundation for the National Institutes of Health’s Observational Medical Outcomes Partnership (OMOP) to develop methodologies for studying drug-induced liver injuries on a national scale. She has served as a peer reviewer for several journals, including PharmacoEconomics, American Journal of Hospital-System Pharmacists, Chest, Pharmacoepidemiology and Drug Safety, Managed Care Interface, American Journal of Kidney Diseases, and Therapeutics and Clinical Risk Management. Dr. Duh also is an elected member of the American Society of Hematology, and a member of the International Society of Pharmacoepidemiology, and the International Society of Pharmacoeconomics and Outcomes Research.
SAFETY ISSUES AND REMS – TAKING RISK MANAGEMENT A STEP FURTHER
In this Q&A, Managing Principal Mei Sheng Duh discusses recent REMS developments.