Yale University-Mayo Clinic CERSI

Center of Excellence in Regulatory Science and Innovation

Overview

The Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) is a recently established joint effort between Yale University, Mayo Clinic, and the U.S. Food and Drug Administration (FDA) to create infrastructure for regulatory science knowledge generation, conduct research to address key gaps in knowledge, and develop tools to support regulatory decision-making and the overall mission of FDA.

The FDA is tasked with the complex regulatory mission of protecting public health by assuring safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food, and products that emit radiation. In addition, the FDA is responsible for regulating the manufacturing, marketing and distribution of tobacco products, for advancing public health by helping to speed innovations that make medicines more effective, safe, and affordable, and for helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve health.

The Yale-Mayo CERSI aims to create an infrastructure to support and enhance several areas of focus in the FDA strategic plan for regulatory science, including to stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes, harness diverse data through information sciences to improve health outcomes, and strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products. The Yale-Mayo CERSI will use routinely-collected, real-world data sources, other existing clinical trial data, and genomic and biobank data in order to inform regulatory decision-making, build FDA capacity and capability to deploy advanced analytic methods, and disseminate the knowledge generated to ensure patient-centered regulatory decision-making, better-informed regulators, manufacturers, clinicians and patients, and support shared decision-making.

The Yale-Mayo CERSI builds upon the numerous ongoing regulatory science-related programs across both campuses, including the Yale School of Public Health Regulatory Affairs program, the Solomon Center for Health Law and Policy at Yale Law School, the Institution for Social and Policy Studies (ISPS) - Health at Yale, the Collaboration for Research Integrity and Transparency (CRIT), the Yale University Center for Biomedical and Interventional Technology (CBIT), the Yale Tobacco Center of Regulatory Science (TCORS), the Yale Interdisciplinary Center for Bioethics, the Kern Center for the Science of Health Care Delivery , the Mayo Clinic Center for Individualized Medicine (CIM), and the Mayo Clinic Center for Innovation.

More information coming soon on:

  • Advisory Board
  • Seminar Series
  • Research Projects¬†

Recent News and Updates

Now accepting applications for CERSI Scholars Program! 

The Yale-Mayo Clinic CERSI is pleased to announce that applications are currently being accepted for the CERSI Scholars Program to support regulatory science research that addresses the mission of the FDA. Eligible individuals for these Awards include students and trainees, including post-graduate fellows, at Yale University and the Mayo Clinic. Applications will be accepted until April 17, 2017 at 5:00 p.m. 

Click here for application details.