DURHAM, N.C. – Duke University and the University of North Carolina at Chapel Hill will receive up to $50 million over five years from the U.S. Food and Drug Administration. The money will be used to establish the Research Triangle Center of Excellence in Regulatory Science and Innovation. The center also includes collaborations with North Carolina State University and North Carolina Central University.

Triangle CERSI, the newest of five CERSIs nationally, will work with FDA scientists to perform scientific research to support the FDA’s needs.

The center is led by four principal investigators: Paul Watkins, M.D., Howard Q. Ferguson Distinguished Professor of Pharmacy at the UNC Eshelman School of Pharmacy and professor at the UNC School of Medicine and the UNC Gillings School of Global Public Health; Susan Halabi, Ph.D., James B. Duke Distinguished Professor of biostatistics and bioinformatics and co-chief for the division of biostatistics at Duke University School of Medicine; Robert Mentz, M.D., associate professor of medicine and population health sciences and chief of the heart failure section at Duke University School of Medicine and a Duke Clinical Research Institute faculty member; and Ehsan Samei, Ph.D., Reed and Martha Rice Distinguished Professor of Radiology at Duke University and chief imaging physicist for Duke University Health System.

They will co-lead the new Triangle CERSI and collaborate with regulators, academia, and industry stakeholders to meet the FDA’s need for the most current scientific knowledge.

“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 NC State and NCCU. This center will support many joint research projects involving FDA scientists to better inform regulatory decisions and thereby improve public health,” said Watkins. 

“We are uniquely positioned to leverage the tremendous strengths of Duke’s trial and observational research infrastructure, machine learning, statistical knowledge, in silico trials, and imaging expertise to answer meaningful questions for patients and other key stakeholders,” Mentz said.

The Triangle CERSI will include, but is not limited to, faculty from the UNC Eshelman School of Pharmacy, UNC School of Medicine, UNC Gillings School of Global Public Health, UNC School of Data Science and Society, Duke University School of Medicine, Duke University Pratt School of Engineering, Duke University’s Center for Virtual Imaging Trials, the Duke Clinical Research Institute, the Colleges of Engineering and Veterinary Medicine at N.C. State, the NCCU College of Health and Sciences, NCCU College of Arts, Social Sciences and Humanities, the NCCU Biomanufacturing Research Institute and Technology Enterprise  and the NCCU Julius L. Chambers Biomedical and Biotechnology Research Institute.

“The Triangle CERSI is a significant opportunity for our scholarly communities to curate and direct our intelligence towards addressing an important societal need for proficient and efficient regulatory approval and oversight,” Samei said.

The center will provide new infrastructure and tools to shorten the drug and device development process, to advance public health, and to inform regulatory decision making and guidance documents that complements and enhances other CERSIs.

“The Triangle CERSI will equip the FDA with tools to overcome the challenges of the 21st century drug and device development process in order to rapidly advance public health interests,” Halabi said.

The 38 projects proposed in the grant application include statistical methodology, machine learning and artificial intelligence, imaging, pediatric pharmacology, and safety assessments.