FDA Awards UM a New Center for Regulatory Science

The University of Maryland has created a new Center of Excellence in Regulatory Science and Innovation (CERSI), funded by an initial $1 million grant from the U.S. Food and Drug Administration. The center will focus on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.

The new center will be a collaborative partnership between the University of Maryland, College Park, and the University of Maryland, Baltimore. Researchers from both campuses will work with FDA scientists to develop new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.

"Maryland's CERSI will draw from University of Maryland expertise on both the College Park and Baltimore campuses and create new mechanisms for scientific exchange, education and training, and regulatory science research," said William Bentley, the Robert E. Fischell Distinguished Professor of Engineering and founding chair of the Fischell Department of Bioengineering at the university's A. James Clark School of Engineering. Bentley and James Polli, the Shangraw/Noxell Endowed Chair in Pharmaceutical Sciences at the University of Maryland School of Pharmacy, are co-principal investigators on the initiative.

"Collectively, FDA, industry, and academic scientists all recognize the need for new tools in drug discovery and development, such as a series of new laboratory tests or software, in order to anticipate safety and efficacy of drugs in development," said Polli.

Center researchers will assist the FDA in driving innovation in medical product development, as well as in advancing laboratory, population, behavioral and manufacturing sciences.

"These partnerships represent a critical, necessary and creative investment - one that will benefit not just FDA and academia, but also American consumers and industry," said FDA Chief Scientist Jesse L. Goodman. "The Centers of Excellence will create new scientific research, training and staff exchange opportunities for FDA and leading area institutions."

The University of Maryland center will focus on three key FDA priorities: 1) improving pre-clinical assessments of the safety and efficacy of new drugs and devices; 2) ensuring readiness to evaluate innovative and emerging technologies; and 3) harnessing diverse data through information sciences to improve health outcomes. Maryland researchers will address pre-clinical assessment challenges related to membrane transporters in drug development, hepatotoxicity biomarkers and personalized medicine, as well as device evaluation related to optical imaging, materials such as nanostructured polymeric coatings for stents and grafts, and tissue engineering.

The new UMD/UMB center also will sponsor 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.

"This innovative new center will improve the lives of Americans," said Patrick O'Shea, vice president for research at the University of Maryland, College Park. "University of Maryland's researchers will help the FDA transform the way that drugs and devices are evaluated and influence how they are designed, developed, manufactured and brought to market."

The FDA also awarded $1 million to Georgetown University for a sister regulatory science and innovation center. According to the FDA, the agency chose to pilot the two centers in the Washington, D.C., area to allow for the greatest possible face-to-face collaboration and training with FDA staff.

Published October 26, 2011