GUMC Regulatory Science & Medicine Program to "Follow the Science" in Decision-Making

Posted in News Release

Washington, D.C.Georgetown University Medical Center announces the establishment of the Program for Regulatory Science and Medicine (GU PRSM), and has named Ira Shoulson, M.D., as director. Shoulson, an internationally recognized neurologist and member of the Institute of Medicine, joined GUMC in January to lead the innovative program. The GU PRSM will be a key component of a new affiliation formed last month between GUMC and the U.S. Food and Drug Administration that combines strengths and resources to stimulate innovation in regulatory science, ethics, education, and training.

The GU PRSM, dubbed “GU prism,” appears to be a first-of-its-kind academic program. It is designed to advance regulatory science and medicine by creating specialized interdisciplinary opportunities for biomedical research, bioethics, law, informatics, and many other fields critical to regulatory science.

The implications of such a program could dramatically impact the regulatory process at government, industry, and academic levels, says Howard J. Federoff, M.D., Ph.D., executive vice president for health sciences at GUMC and executive dean of its School of Medicine.

“It essentially will study how the regulatory process overseeing drugs, devices, biological products and food can be strengthened by application of evidence-based science,” he says. “Regulatory science and medicine hold great promise for scholarship, innovation and application to improve the safety and effectiveness of new treatments affecting public health.”

Early in its development, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products, and the GU-PRSM will meet this goal in a number of ways, according to Shoulson.

“Many in the regulatory community, as well as in academia and industry, realize that in these times of very complex biomedical research, evidence-based science should be the foundation upon which regulations are based and put into practice,” Shoulson says.

He explains that the regulatory process at the FDA and other governmental agencies have been moving forward for decades based on statutes and policies largely uninformed by science. He likened regulatory work to cases based on law and precedence – “does this new application for treatment look like others that have been approved?” A stronger scientific approach, however, can develop a body of evidence that can inform and be updated with new evidence, Shoulson says.

“The goal of this pioneering program is to make the regulatory process more efficient and scientifically valid,” he says. “This body of scientific basis then can inform regulatory policy making as well as biomedical research and development.”

There is also a great, unmet need to educate and train a cadre of individuals who will work in government, industry and academia to advance the field, Shoulson says. “Most professionals in the field of regulatory science come from a background in laboratory research, medicine, pharmacy, bioethics and law. There are no integrated educational programs designed specifically to train future regulators who will be responsible for developing and overseeing new and effective treatments and ensuring the safety of food products.”

This program will foster research in this new field across the Georgetown University (GU) campus and between GU and governmental agencies, industry, and other universities, Shoulson says. Future goals of the program include the development of a graduate school educational component and organizing international symposia on regulatory science and medicine.

Shoulson brings decades of experience building extensive collaborations to this new GUMC program, according to Federoff. Nearly 25 years ago, he created a new way to do research, by bringing together hundreds of investigators across the globe to rigorously test prospective new medications. His method of fostering collaborative research, which is at the core of academic neurology clinical trials worldwide, is considered a model for cooperative clinical research and the development of new treatments.

In addition, Shoulson’s collaborative research in Huntington’s disease and Parkinson’s disease resulted in several new drugs—many ushered by him through all aspects of research and development.
Shoulson came to GUMC from the University of Rochester School of Medicine & Dentistry. He received a B.A. at the University of Pennsylvania and earned his M.D. at the University of Rochester. Shoulson completed fellowship training at the National Institutes of Health and served as a public policy fellow in the United States Senate. He is board certified in internal medicine and neurology.

About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC’s mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis — or “care of the whole person.” The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Georgetown Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO). In fiscal year 2009-2010, GUMC accounted for 79 percent of Georgetown University’s extramural research funding.