The Center of Excellence in Regulatory Science and Innovation (CERSI) is funded by an initial $1 million grant from the U.S. Food and Drug Administration. The center focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.
This center is a collaborative partnership between the University of Maryland, College Park, and the University of Maryland, Baltimore. Researchers from both campuses work with FDA staff to support the development of new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.
Collectively, the FDA, industry, and academic scientists all recognize the need for new tools in order to ensure safety and development efficiency in the evaluation of new drugs and medical devices.
The University of Maryland's CERSI draws upon the expertise of researchers from both the College Park and Baltimore campuses to create new mechanisms for scientific exchange, education and training, and regulatory science research in order to meet the needs for these new tools.
Center researchers will assist the FDA in driving innovation in medical product development, as well as in advancing laboratory, population, behavioral and manufacturing sciences.
The UM CERSI focuses on three key FDA priorities:
- improving pre-clinical assessments of the safety and efficacy of new drugs and devices;
- ensuring readiness to evaluate innovative and emerging technologies; and
- harnessing diverse data through information sciences to improve health outcomes;
- addressing minority health and health disparities.
Through the UM CERSI, researchers are addressing pre-clinical assessment focusing on membrane transporters in drug development. Membrane transporters allow nutrients and drugs to move throughout the body. However, these doorways can be the basis for drug-to-drug interactions. Ensuring readiness to evaluate innovative and emerging technologies will contribute to the scientific underpinning of two device-related product areas: laser-based therapeutic devices and tissue engineering constructs. Harnessing diverse data through information sciences to improve health outcomes is an important goal, as well as focusing on patient prescriber agreements (PPAs) of prescription opioid analgesic drugs. PPAs are contracts between prescribers and their patients to identify expectations of the prescriber and the patient.
The center also sponsors seminars and workshops, as well as an open public forum to promote regulatory science exchange, bringing together a network of experts from academia, industrial consortia and FDA scientists.
The center’s co-principal investigators are Dr. William Bentley, the Robert E. Fischell Distinguished Professor of Engineering and founding chair of the Fischell Department of Bioengineering at the University of Maryland’s Clark School of Engineering, and Dr. James Polli, the Shangraw/Noxell Endowed Chair in Pharmaceutical Sciences at the University of Maryland’s School of Pharmacy.