The U.S. Food and Drug Administration (FDA) has renewed its funding for the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) under a new five-year, up to $50 million cooperative agreement.

M-CERSI is a partnership between the University of Maryland, Baltimore (UMB) and the University of Maryland, College Park (UMCP) and is led by James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics in the Department of Pharmaceutical Sciences (PSC) at UMSOP, and William Bentley, PhD, the Robert E. Fischell Distinguished Professor and director of the Robert E. Fischell Institute for Biomedical Devices at UMCP. The FDA’s Office of Regulatory Science and Innovation collaborates with M-CERSI on its activities.

“The renewal of M-CERSI demonstrates the impact and innovation that the center has had on regulatory science and recognition from the FDA of that work,” said Sarah L.J. Michel, PhD, interim dean and professor of the school and a principal investigator of two projects funded by M-CERSI.

M-CERSI is one of only five FDA-funded CERSIs in the country and is the oldest CERSI, established in 2011.

“We are honored by the FDA’s decision to renew M-CERSI for another five years and reinforce its commitment to advancing regulatory science,” Polli said. “M-CERSI has continued to establish great partnerships with UMCP, the FDA, and pharmaceutical industry partners. Our work in evaluating the safety and efficacy of new drugs, biologics, and medical devices will continue to benefit society and health care as a whole.”

Since the last funding renewal in 2018, M-CERSI has continued its mission of modernizing and improving the ways in which drugs, biologics, and medical devices are reviewed and evaluated. It has supported research projects and hosted conferences and workshops on topics related to its priority areas.

“I am truly excited that our efforts to bridge disciplines and campuses to develop the science that underpins regulatory practice have been recognized, not only by our students, faculty and staff, but also by the FDA,” Bentley said. “It is my hope that the next five years will bring us to even greater heights as a nexus for health-related activities between the campuses and the FDA.”

M-CERSI is currently collaborating with the FDA on approximately 30 research projects across several FDA product centers, such as those for drugs, biologics, medical devices, and tobacco. Examples include:

• Maureen Kane, PhD, professor of PSC and director of the school’s Mass Spectrometry Center, is leading an investigation to develop diagnostic biomarkers for traumatic brain injury.
• Danya Qato, PhD, PharmD, MPH, an associate professor in the Department of Practice, Sciences, and Health Outcomes Research, is leveraging data-informed models to identify optimal opioid use disorder treatment trajectories.
• Stephen Jay, PhD, associate professor of bioengineering at UMCP, is working to apply additive manufacturing for continuous production of extracellular vesicle products.
• Sarah Murthi, MD, professor of surgery at the University of Maryland School of Medicine (UMSOM), and Amitabh Varshney, dean of the College of Computer, Mathematical and Natural Sciences and professor of computer science at UMCP, are assessing safety and performance issues with extended reality tele-mentoring of image-guided, clinically important procedures.

“Generous funding support through M-CERSI has allowed for rich interdisciplinary research and multi-sectoral engagement between regulators and health services researchers,” Qato said. “M-CERSI has also helped enhance the relevance of basic science research and health services research to regulatory policy.”

There have been 76 M-CERSI workshops since 2012, with almost 25,000 attendees. Recent topics have included quantitative systems pharmacology-informed rare disease drug development, artificial intelligence for precision medicine, biosimilars, and co-processed active pharmaceutical ingredients. Many workshops have resulted in reports to guide subsequent research aims.

M-CERSI also holds an annual student competition, America’s Got Regulatory Science Talent, to promote student interest in regulatory science. A group of clinical laboratory science graduate students at UMSOM took the top prize at the 11th Annual America’s Got Regulatory Science Talent competition in February 2023.