Senior Director, Epidemiology
Janssen Research & Development, United States
Rachael L. DiSantostefano, MS PhD, is a Senior Director in the Epidemiology Department within Janssen Pharmaceuticals, R&D, LLC. She has nearly 30 years of pharmaceutical research experience including 8 years at Janssen. Dr. DiSantostefano has worked in disciplines of epidemiology, biostatistics, and health outcomes. Currently, she supports Global Public Health and oversees the strategy and conduct of observational studies relating to drug safety, including benefit-risk assessment and risk-minimization activities.
Prior to Janssen, Rachael was employed at a pharmaceutical company where she was accountable for the observational research strategy, study design, and study execution for respiratory medications. This included descriptive studies, post-authorization safety studies (PASS), and Risk Evaluation and Mitigation Strategies (REMS). Dr. DiSantostefano has worked in other therapy areas, including immunology, oncology, neuroscience, and women’s health. She has extensive experience with health authority engagement including representing epidemiology at FDA Advisory Committee Meetings and EMA Oral Explanations.
Dr. DiSantostefano obtained a Doctor of Philosophy degree in Health Policy & Management and a Master’s of Science in Biostatistics from the UNC Gillings School of Global Public Health and a Bachelor’s degree is in Mathematics from Loyola University Maryland. She is an active member of the International Society for Pharmacoepidemiology (ISPE), particularly the Benefit-Risk Assessment, Communication, and Evaluation Special Interest Group or (BRACE-SIG) and the American Statistical Association (ASA) Biopharmaceutical Section. When requested, she is a reviewer for Pharmacoepidemiology and Drug Safety, Value in Health, The Patient, and the Journal of Asthma. Dr. DiSantostefano has published more than 45 manuscripts in the peer reviewed literature and presents her research at professional conferences.
Disclosure information not submitted.
Sunday, August 27, 2023
1:45 PM – 2:00 PM ADT
