FDA Tags UNC, Duke for Research Center

UNC, in partnership with Duke University, has been awarded up to $50 million from the Food and Drug Administration to establish a center that will work with FDA scientists to conduct research that will better inform and support the agency’s regulatory and approval processes.

The grant will create the Research Triangle Park Center of Excellence in Regulatory Science and Innovation. It outlines 38 projects that propose research into novel statistical methodology, machine learning and artificial intelligence, imaging, computer-based-modeling trials, pediatric pharmacology, population science, patient reported outcomes, safety assessment across the lifespan and other areas. Work performed at the Triangle CERSI will include collaborations with N.C. Central University and N.C. State University. The center will be one of five nationwide.

The center’s goal is to partner with the FDA to provide the agency access to current scientific research, as well as infrastructure and tools to shorten the drug and device development process, improve public health and inform regulatory decision making and guidance documents that complement and enhance other CERSIs.

Dr. Paul Watkins, the Howard Q. Ferguson Distinguished Professor of pharmacy at the UNC Eshelman School of Pharmacy and a professor in UNC’s School of Medicine and Gillings School of Global Public Health, is a co-principal investigator on the grant.

Joining Watkins as principal investigators from Duke University are:

  • Susan Halabi, the James B. Duke Distinguished Professor of biostatistics and bioinformatics and co-chief for the division of biostatics at the School of Medicine;
  • Robert Mentz, associate professor of medicine and population health sciences, chief of the heart failure section at the School of Medicine and a faculty member at the Clinical Research Institute; and
  • Ehsan Samei, the Marth Rice Distinguished Professor of radiology and chief imagining physicist for the Duke University Health System.

“We are delighted to be awarded the fifth national CERSI, which is a testament to the outstanding scientists at Carolina and Duke, along with our collaborating institutions N.C. State and NCCU,” Watkins told UNC media relations officials.

Plans call for the center to include a broad network of researchers, and national and international collaborators who bring together unique and diverse expertise and resources to support FDA regulatory actions.

Triangle CERSI will include faculty from UNC’s Eshelman School of Pharmacy, School of Medicine, Gillings School of Global Public Health, and School of Data Science and Society, and Duke University’s School of Medicine, Pratt School of Engineering, Center for Virtual Imaging Trials and Clinical Research Institute. Also joining the center will be faculty from NCCU’s College of Arts, Social Sciences and Humanities, Biomanufacturing Research Institute and Technology Enterprise, Julius L. Chambers Biomedical and Biotechnology Research Institute, and N.C. State University’s Colleges of Engineering and Veterinary Medicine.

Other CERSI centers have been established at the University of Maryland in College Park, Maryland; the University of California at San Francisco, in partnership with Stanford University; Yale University, in partnership with the Mayo Clinic; and at Johns Hopkins University in Baltimore.

— Laurie D. Willis ‘86

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