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FDA Selects GU for New Regulatory Science and Innovation Center

October 26, 2011 – Strengthening the science and training needed to improve the way drugs, food, medical devices and other products are reviewed and evaluated is the goal of a new partnership between Georgetown and the U.S. Food and Drug Administration (FDA).

The partnership establishes a Georgetown Center of Excellence in Regulatory Science and Innovation (CERSI). The center is supported by an FDA investment with an initial $1 million grant, which is potentially part of a three-year funding program for improving drug development and manufacturing.

Experts in science, medicine and law at Georgetown University Medical Center (GUMC) and Georgetown University Law Center will lead the new center.

Dr. Ira Shoulson

Dr. Ira Shoulson

Fostering Innovation

“[The award] will further enable us to interface substantively with the FDA to share in education, training, professional development and scientific exchange as well as fostering innovation and applied research toward unmet public health needs,” says Dr. Ira Shoulson, a professor of neurology who will serve as principal CERSI investigator.

Shoulson is also director of GUMC’s Program for Regulatory Science and Medicine.

The co-principal investigators are Kenneth Dretchen, professor and chair of pharmacology and physiology at GUMC, and Lawrence Gostin, the Linda D. and Timothy J. O’Neill Professor of Global Health Law at the Law Center.

Kenneth Dretchen

Kenneth Dretchen

Teamwork and Sharing

Working closely with FDA scientists, Georgetown CERSI researchers will assist the FDA with advancing laboratory, population, behavioral, computational and manufacturing sciences to increase the efficiency of quality medical product development.

“We have been most gratified by the success of our teamwork and sharing,” Shoulson of his Georgetown colleagues. “We also look forward to working with our academic colleagues at the University of Maryland and its newly established CERSI to advance the applied discipline of regulatory science.”

The federal agency chose to pilot two Centers of Excellence in the Washington, D.C. area to allow for the greatest possible face-to-face collaboration and training with FDA staff.

Lawrence Gostin

Lawrence Gostin

Important Functions

“The very concept of regulatory science assumes sound regulation, which is the FDA’s mission,” Gostin says. “The regulation of food and drugs is one of the most important functions of government as the public comes to rely on the FDA to ensure the safety and quality of food, vaccines and medical products.”

He adds that providing for a safe supply of food and effective drugs is becoming ever more challenging as the U.S. imports more products to America, and as the FDA’s budget is strained.

“It is therefore vital to encompass law and ethics to inform us as we move forward,” he says. “Sharing knowledge and training opportunities will benefit both the FDA and academia.”

Critical Investment

Dretchen also lauded the partnership.

“CERSI will provide incredible educational opportunities as both teachers and learners in regulatory science for personnel at Georgetown University and the FDA,” he says.

The FDA’s chief scientist, Dr. Jesse L. Goodman, says the partnership represents a “critical, necessary and creative investment – one that will benefit not just FDA and academia, but also American consumers and industry.”

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