Michele Jonsson Funk, PhD, FISPE is Head of Epidemiology at Epividian. Michele trained in epidemiology at the University of North Carolina at Chapel Hill where she went on to serve as a member of the faculty for 22 years. Beginning in 2018, Michele led UNC’s doctoral training program in pharmacoepidemiology – one of the largest and most well-regarded worldwide. With more than 150 peer-reviewed publications, her scholarship includes applied research on the use, safety, and effectiveness of medications as well as contributions to the methods used to reduce bias in observational settings. She is widely recognized for leadership in epidemiologic methods, teaching, and public health service.
As Director of the UNC Center for Pharmacoepidemiology (2018-2026), Michele partnered with AbbVie, Astellas, Boehringer Ingelheim, GlaxoSmithKline, Merck, Sarepta, Takeda, and UCB to provide them with expert guidance on data resources, study designs and analytic tools for analyzing non-randomized studies. She served on the CIOMS Working Group XIII on Real-World Data and Real-World Evidence in Regulatory Decision Making, FDA Advisory Committees, and as a consultant to the FDA.
Michele has contributed to research on reducing measurement error in studies using claims data, methods for generalizing estimates from clinical trials to real-world populations, quantifying differences in treatment effects between potentially important subgroups, design considerations in externally controlled trials, avoiding immortal time bias due to data linkage, and assessing potential bias due to unmeasured confounders. Her applied research has drawn on data from Medicare, Merative’s MarketScan data, the Carolina Data Warehouse for Health (CDW-H) – an electronic medical record warehouse, and linked data sources such as insurance claims with EHR and multi-institutional EHR in the National Clinical Cohort Collaborative (N3C). She has experience in numerous therapeutic areas beyond HIV and infectious diseases. Her research has been funded through competitive contracts and grants from FDA, NIH, CDC, PCORI, Reagan-Udall Foundation, and AHRQ.
Michele has been a member of the OPERA Epidemiological and Clinical Advisory Board since 2017, providing guidance on our research agenda. As our new Head of Epidemiology, she leads an experienced epidemiology team at Epividian.