Dr. Annette Stemhagen
Chief Science Officer
Annette Stemhagen, DrPH, FISPE is an epidemiologist with more than 35 years of public health research experience, including epidemiologic research and safety surveillance of pharmaceutical and biotechnology products, vaccines, and medical devices. She provides strategic consultative services with a focus on risk evaluation and mitigation strategies (REMS) and developing real-world evidence to meet regulatory and commercial objectives regarding product safety and value.
Dr. Stemhagen has specific expertise in the design, implementation, and analysis of epidemiologic studies, both observational and pragmatic, for products in Phase IIIb and post-approval. She has designed and evaluated risk assessment studies, including more than 60 regulatory-mandated, long-term global safety studies. She has also designed global risk minimization programs and risk management evaluation studies and developed REMS for more than 120 products.
Dr. Stemhagen is active in the International Society for Pharmacoepidemiology and the Drug Information Association. She served on the Board of Directors for each of these organizations. Dr. Stemhagen has held adjunct faculty appointments at the University of Pennsylvania Center for Epidemiology and Biostatistics in the School of Medicine, the Temple University School of Pharmacy, and the Drexel University School of Public Health. Dr. Stemhagen was appointed as the first Industry Representative to the FDA Drug Safety and Risk Management Advisory Committee. In addition to providing consultative services, Dr. Stemhagen has held positions within the government, academia, and the pharmaceutical industry focused on patient safety.