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FDA and the University of Maryland: Partnering on a New Center for Regulatory Science

FDA Chief Scientist Jesse L. Goodman on the Importance of the CERSI

The Fischell Department of Bioengineering was honored to welcome FDA Chief Scientist and Deputy Commissioner for Science and Public Health, Jesse L. Goodman, M.D., M.P.H., to the 2011 Fischell Festival as our Keynote speaker. Goodman discussed what the new partnership would mean for the approval processes applied to new drugs and biomedical devices.

Goodman's address introduced guests to the FDA’s new strategic plan for advancing regulatory science, and how building partnerships with academia and industry—like the establishment of the new CERSIs with the University of Maryland and Georgetown University—will be critical to advancing its goals.

Addressing the criticisms leveled against the agency, Goodman explained how difficult its job can be. "The FDA regulates products that relate to 25% of the nation’s economy," he told the audience, "so you can see how the potential to do good in terms of promoting innovation, to do harm if you unnecessarily slow it, or to do harm if you make decisions that allow unsafe products on the market, is tremendous."

The FDA's new strategic plan and vision, Goodman explained, is to speed innovation, improve decision making, and get safe and effective products to people in need by focusing on eight key areas: Modernizing toxicology by replacing animal testing with sophisticated human models, improving clinical trials through better prediction of long-term effects, improving manufacturing, preparedness for handling the evaluation of emerging technologies, compiling health data from multiple sources, food safety, addressing the threats of new and emerging diseases, and patient education.

"We have tremendous opportunities," Goodman concluded, "…but to really transform them into things that help people is going to require partnerships…We really welcome the University of Maryland and scientists present and future to join us in that."

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In 2011, the University of Maryland 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 is 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," says Fischell Department of Bioengineering professor and chair William E. 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," says 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," says 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," says 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.

To learn more about CERSI personnel, research and events, please visit cersi.umd.edu.