Please join us on Thursday, 12/05/19 for our POP Research Seminar, held from 9:30am-11:00am in the Communicore Building, Room C1-07. We will be welcoming our guest speaker, Judy Staffa, Ph.D., R.Ph., as our seminar presenter.
Title: “Fundamental Challenges in the Pharmacoepidemiology of Prescription Opioid Abuse”
Judy Staffa, Ph.D., R.Ph., is the Associate Director for Public Health Initiatives at FDA, Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), where she is responsible for setting strategic direction for complex, multidisciplinary reviews related to opioid abuse – from a planning, scientific, and policy point of view. Prior to this role, Judy was the Director, Division of Epidemiology II, directing the regulatory review and research work of epidemiologists in CDER. She has spent her FDA career serving in various roles as the office has evolved over the years. While in the role of the Associate Director for Regulatory Research she assisted in building OSE’s epidemiologic research program, and prior to that she was an epidemiology reviewer and a drug utilization analyst team leader. Before joining FDA in 1999, Judy was a researcher at The Degge Group for ten years, conducting numerous pharmacoepidemiologic studies using both administrative claims data and electronic medical records data to investigate drug safety issues. Judy is a registered pharmacist who received her bachelor’s degree in pharmacy from the University of Connecticut. She practiced community pharmacy prior to receiving her training in public health. She holds a master’s degree in behavioral sciences from the Harvard School of Public Health, and a doctoral degree in epidemiology from the Johns Hopkins Bloomberg School of Public Health.
Dr. Staffa will provide an overview of the considerable challenges facing FDA epidemiologists when examining misuse of opioids as a drug safety issue. She will discuss the complexities of using basic epidemiologic principles, such as defining exposures, outcomes, confounders and populations of interest, and applying them to studying opioid misuse, particularly using “big data”. She will describe some of the current challenges emerging in this area, as well as outstanding research questions and data needs.