Dr. Mei Sheng Duh, MPH, ScD, specializes in regulatory real-world evidence (RWE) generation for product registration, post-approval safety and efficacy studies, and health economics and outcomes research (HEOR) of pharmaceuticals, vaccines, and regenerative biotherapeutics. Dr. Duh has led numerous projects for new molecular entity and 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 payer authorities, 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 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 publishes widely authorizing over 300 articles in peer-reviewed journals. Dr. Duh is an adjunct researcher in the biostatistics department at the Harvard T.H. Chan School of Public Health. She holds a Doctor of Science degree in Pharmacoepidemiology from the Harvard School of Public Health and a Master of Public Health from Yale Medical School.