Dr. Annette Stemhagen
Chief Science Officer
Dr. Annette Stemhagen is an epidemiologist with more than 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the Senior Vice President of Safety, Epidemiology, Registries and Risk Management within United BioSource, where she provides strategic consultative services to pharmaceutical, biotech, and medical device clients.
Dr. Stemhagen has specific expertise in safety surveillance and design, implementation, and analysis of epidemiologic studies, registries, large streamlined safety studies, and actual use and observational studies for products in Phase IIIb and post approval. She has designed and evaluated risk assessment studies, including more than 50 regulatory-mandated, long-term global safety studies. She has designed risk intervention programs, risk management evaluation studies, Risk Minimization Action Plans (RiskMAPs), Risk Evaluation and Mitigation Strategies (REMS), and risk minimization programs for EU Risk Management Plans 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. In 2004, Dr. Stemhagen was appointed as the first Industry Representative to the FDA Drug Safety and Risk Management Advisory Committee.