FDA awards GU $1 million grant, regulatory science center formed

November 10, 2011

Georgetown has recently been awarded a $1 million grant from the Food and Drug Administration to establish a Center of Excellence in Regulatory Science and Innovation, a partnership between the Medical Center, the Law Center, and the University as a whole.

Ira Shoulson, professor of neurology, director of GUMC’s Program for Regulatory Science and Medicine, and principal investigator for the CERSI, said the main goals of the center will be to establish programs in regulatory sciences and to support two innovative research projects.

“Regulatory Science is an emerging field of science that will enhance the knowledge base and better inform regulators like the FDA who have important public health responsibilities to ensure the safety and benefits of medical products and food quality,” Shoulson wrote in an email.

The collaboration between the FDA and the University is one of the things that makes the center truly innovative. It will foster a connection between the federal agency and the University that will prove to be beneficial to both sides, according to Shoulson.

Lawrence Gostin, the Linda D. and Timothy J. O’Neill Professor of Global Health Law at the Law Center, said the center will give “our faculty and students opportunities to learn from and interact with very experienced and senior FDA staff who will come lecture, teach and do seminars on our campus.”

The CERSI will have effects beyond Georgetown, delving into areas of research that will someday benefit the American people as a whole.

“Advancing regulatory sciences means advancing science and medicine to ensure better medical products, fewer adverse events for patients, and safer food,” Shoulson said.

Both Shoulson and Gostin stated that the center will have effects globally as well. Many of the food and drugs that reach the United States are imported from around the world.

“You really can’t protect Americans without looking to the world because a very large percentage of our food and drugs come from foreign countries,” Gostin said. “We have very little influence on the safety standards of those countries.”

The CERSI leaders hope to begin working on this issue soon. One of their current goals is to head an international symposium of scientists involved in regulatory science. They hope the symposium will allow scientists to discuss important issues surrounding regulatory science including standardizing scientific approaches and establishing research and education priorities.

“Because the GU CERSI is a new initiative and the field of RS is evolving, there will be ample opportunity to [continue to] shape the goals of the CERSI,” Shoulson said.


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