New CERSI Center Will Help Speed Drug & Medical Device Approvals 

The U.S. Food and Drug Administration (FDA) is giving UNC-Chapel Hill and Duke University $50 million over five years to establish a new research center focused on public health. 

Called the Research Triangle Center of Excellence in Regulatory Science and Innovation, or Triangle CERSI for short, it’s the newest of only five CERSI centers across the country. The center will also involve collaborations with NC State and NC Central (NCCU). 

The agency wants the new CERSI centers to work with FDA scientists to better inform and support the FDA’s needs. Specifically, they hope the centers will speed up the approval process for new medicines and medical devices. 

“We are delighted to be awarded the fifth national CERSI, which is a testament to the outstanding scientists at Carolina and Duke as well as our collaborating institutions, NC State and NCCU,” said Dr. Paul Watkins, director of the Institute for Drug Safety Sciences and a professor at UNC’s Eshelman School of Pharmacy.  

According to a release from UNC, “The center will support many joint research projects involving FDA scientists to better inform regulatory decisions and thereby improve publish health.” 

Triangle Universities Meet FDA Research Needs 

The FDA hopes the CERSI centers will work together to meet the FDA’s evolving needs to access the most current scientific knowledge. The centers will provide “essential new information as well as access to infrastructure and tools to shorten the drug and medical device development process, advance public health and inform regulatory decision-making and guidance documents.” 

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

In applying for the CERSI center, the universities’ grant application proposed 38 research projects, involving machine learning, pediatric pharmacology and population science. 

The important research conducted at UNC and Duke in fighting the COVID-19 pandemic is a good example of how the Research Triangle CERSI can help the FDA. 

“Preparation for the next pandemic is something the FDA is interested in, and fortunately, we have great expertise, to really help guide the agency to make the right decisions,” said Watkins. “They can ask for consultants, but there are areas where there are gaps in knowledge, and filling in those gaps is what this is designed to do.” 

PBS North Carolina and Sci NC appreciate the support of the NC Department of Natural and Cultural Resources.