Center of Excellence in Regulatory Science and Innovation
The Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) is a 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 Office of Regulatory Science and Innovation supports CERSIs at Yale-Mayo and the following sites:
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.
Recent News and Updates
The Yale-Mayo Clinic CERSI was pleased to have Molly Jeffery, PhD, Scientific Director of Emergency Medicine Research, Department of Health Sciences Research, Mayo Clinic, present results from the CERSI project “Characterization and analysis of high incidence of potentially unsafe prescribing of some Extended-Release opioid analgesics using Natural Language Processing (NLP) of Electronic Health Record clinical notes” at the FDA’s Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee on August 3, 2018.
Click here to view the recording.