Yale-Mayo FDA Center for Excellence in Regulatory Science and Innovation

Ross, Joseph

Abstract

The Centers for Excellence in Regulatory Science and Innovation (CERSI) program allows the U.S. Food and Drug Administration (FDA) to form extramural partnerships to create infrastructure for knowledge generation, conduct research to address key gaps in knowledge, and develop tools to support regulatory decision-making and the overall mission of the FDA. The Yale-Mayo CERSI will 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 take advantage of 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. Over the 5-year award, the Yale-Mayo CERSI will pursue the following specific aims:
Specific Aim 1. Establish a joint Center for Excellence in Regulatory Science and Innovation that bridges across the campuses of Yale University and the Mayo Clinic, leveraging the strengths of both institutions to create a novel partnership to support the FDA's regulatory mission.
Specific Aim 2. Provide and support high-quality mentorship and training in regulatory science research and affairs at Yale University and the Mayo Clinic, strengthening regulatory science at both institutions and encouraging regulatory career development.
Specific Aim 3. Provide and support high-quality scientific exchange and learning in select regulatory science and affairs issues at the FDA and across the CERSI network, strengthening both and coordinating educational efforts to optimize program efficiency and impact.
Specific Aim 4. Conduct high-quality, high-impact regulatory science research in collaboration with the FDA that enhances efforts to take advantage of real-world data sources and other existing data, builds capacity and develops advanced analytic methods to leverage these data sources, and applies this knowledge to ensure patient-centered care, in part through shared decision-making.
Specific Aim 5. Build collaborations among the Yale-Mayo CERSI, the CERSI network, FDA, industry and other stakeholders, including the pursuit of opportunities for acquisition of non-federal funding to leverage FDA funding and support the CERSI program.

Public Health Relevance

The Centers for Excellence in Regulatory Science and Innovation (CERSI) program allows the FDA to form extramural partnerships to create infrastructure for knowledge generation, conduct research to address key gaps in knowledge, and develop tools to support regulatory decision-making and the overall mission of the FDA. The Yale-Mayo CERSI will 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 take advantage of 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.