Developments in Postmarketing Safety Surveillance of Medical Products: Reflections from the FDA Sentinel Innovation Center
Join us on Wednesday, January 28th for a Department of Epidemiology seminar featuring Dr. Rishi Desai discussing Developments in Postmarketing Safety Surveillance of Medical Products: Reflections from the FDA Sentinel Innovation Center.
Abstract: The U.S. Food and Drug Administration (FDA) Sentinel Initiative—launched in 2008 under the FDA Amendments Act as the first national active-surveillance system for medical-product safety—has grown from a proof-of-concept pilot into the nation’s flagship regulatory grade evidence generation engine for pressing drug safety questions. In 2019, the FDA the US Food and Drug Administration prioritized more extensive electronic health records (EHR) integration to the existing claims-based Sentinel Distributed Databases and methodological innovations leveraging cutting edge data science approaches. This talk will provide an overview of the progress made by Sentinel’s Innovation Center in various domains including data infrastructure, information extraction, computable phenotyping, and confounding adjustment. Exemplary case studies will be discussed to highlight challenges and opportunities in applying the methodological innovations to inferential studies of medication safety.
Bio: Dr. Alpa V. Patel earned her Bachelor of Science from the University of Florida, her Master of Public Health in Epidemiology from the Rollins School of Public Health at Emory University, and her Doctoral degree in Preventive Medicine with a concentration in Epidemiology from the Keck School of Medicine at the University of Southern California. She is the Senior Vice President of Population Science at the American Cancer Society and serves as the principal investigator of the Cancer Prevention Studies (CPS) II and 3, two long-term, large-scale, epidemiologic cohort studies established by the American Cancer Society. Combined, these two cohorts include over 1.5 million participants with a variety of over 400,000 biologic samples (such as blood, buccal cells, saliva, stool, and tumor tissue). Additionally, as the co-Principal Investigator, Dr. Patel and team launched the largest ever cancer cohort of Black women in the U.S. aimed to enroll at least 100,000 Black women to understand the multi-level drivers of cancer risk and outcomes in this population. Dr. Patel is a recognized leader in cancer epidemiology with particular emphases on the role of physical inactivity, obesity, sedentary behavior and cancer as well as risk assessment and blood-based markers of cancer detection. She has published nearly 300 scientific articles and book chapters, and her research has contributed significantly to national and international cancer prevention guidelines, such as the US Physical Activity Guidelines for Health and the American Cancer Society’s Nutrition and Physical Activity Guidelines for both cancer prevention and cancer survivorship.
Speaker Information
Rishi Desai, MS, PhD
Organizers
ⓘ Harvard Chan School hosts a diverse array of speakers, invited to share both scholarly research and personal perspectives. They do not speak for the School, and hosting them does not imply endorsement of their views, organizations, or employers.