• Ross, Joseph Solomon (PI)
  • Shah, Nilay D (CoPI)

Project: Research project

Project Details


7. PROJECT SUMMARY/ABSTRACTThe Centers of Excellence in Regulatory Science and Innovation (CERSI) program allows the U.S. Food andDrug Administration (FDA) to form extramural partnerships that foster robust and innovative research todevelop new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products, supporting regulatory decision-making and the overall mission of the FDA. Over the pasttwo years, the Yale-Mayo Clinic CERSI has pursued a series of innovative research projects that leverageroutinely-collected, real-world data sources to assess the safety, efficacy, quality, and performance of FDA-regulated products, informing regulatory decision-making as well as manufacturers, clinicians, and patients insupport of patient-centered decision-making, along with providing and supporting high-quality mentorship andtraining in regulatory science. The Yale-Mayo Clinic CERSI will continue this work, conducting high-quality,high-impact regulatory science research in priority areas identified by the FDA to advance clinical and post-market surveillance of drugs and biologics, medical devices, and diagnostic tests, to develop and apply novelanalytics to leverage routinely-collected real-world data sources for medical product evaluation, and to fosterpatient-centered decision-making. Over the 5-year award, the Yale-Mayo Clinic CERSI will pursue thefollowing specific aims:Specific Aim 1. Strengthen existing extramural partnerships between FDA and the Yale-Mayo Clinic CERSI,bridging the campuses of Yale University and Mayo Clinic, and create and foster new relationships that supportthe FDA's regulatory mission.Specific Aim 2. Conduct high-quality, high-impact regulatory science in collaboration with FDA to develop newtools, standards, and approaches that provide timely assessments of the safety, efficacy, quality, andperformance of FDA-regulated products, thereby supporting regulatory decision-making.Specific Aim 3. Provide and support high-quality mentorship and training in regulatory science at YaleUniversity and Mayo Clinic, strengthening regulatory science at both institutions through educational effortsand scientific exchange with FDA scientists and across the CERSI network.Specific Aim 4. Foster collaboration among the Yale-Mayo Clinic CERSI, the CERSI network, FDA, industryand other key stakeholders, including pursuit of non-federal funding to better leverage FDA-relatedopportunities and support the CERSI program.

Effective start/end date9/30/168/31/23


  • U.S. Food and Drug Administration: $4,362,166.00


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