The pandemic has illustrated the difficulty in decision-making in the context of rapidly evolving scientific evidence. It has also highlighted the justifiable bias (in infrastructure, funding, and methodology) towards assessments of efficacy versus safety of potential treatments. Should we have waited to distribute SAR-COV2 vaccines until we completely understand their safety profile? Indeed, although medications are approved based on favorable risk-benefit, information on safety at the time of approval is fragmented, which is particularly true for assessments in vulnerable populations, including pregnant persons and their offspring. Using assessments in pregnancy as a case study, this presentation provides an overview of state-of-the art causal inference designs using non-experimental real-world settings to elucidate our understanding of medication risk. It will then introduce BOaches fOr Safe Therapeutics in Healthy Pregnancies (BOOST-HP), a new marriage of data mining, triage methods, and pharmacoepidemiologic study to accelerate evidence on medication safety to improve child and maternal health.

Almut Winterstein is Distinguished Professor and the Dr. Robert and Barbara Crisafi Chair for Medication Safety in the Department of Pharmaceutical Outcomes and Policy, Affiliate Distinguished Professor in Epidemiology, and the founding Director of the Center for Drug Evaluation and Safety at the University of Florida. Since 2019, she also serves as director of the Consortium for Medical Marijuana Clinical Outcomes Research, a state-funded consortium of 9 universities in Florida. Dr. Winterstein’s research interests center on the post-marketing evaluation of medications in pediatrics and pregnancy, infectious disease and psychiatry and the evaluation of policy surrounding medication use using real-world data. As expert in drug safety, she has chaired the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee from 2012-2018. Recognizing her contributions in pharmacoepidemiology, Dr. Winterstein was inducted as a fellow of the International Society of Pharmacoepidemiology in 2013 and served as president of the society from 2019-2020. In 2022, she was inducted in the Academy of Science, Engineering and Medicine in Florida. She received her pharmacy degree from Friedrich Wilhelm University in Bonn, Germany and her PhD in Pharmacoepidemiology from Humboldt University in Berlin. Dr. Winterstein has chaired more than two dozen PhD committees and received the UF-wide Dissertation Advisor/Mentoring award for her excellence in graduate training.