Navigation Links
FDA awards Georgetown University a Center of Excellence in Regulatory Science & Innovation

WASHINGTON, D.C. -- Georgetown University today announces a partnership with the U.S. Food and Drug Administration (FDA) to establish a first of its kind 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 CERSI. Ira Shoulson, M.D., professor of neurology and director of GUMC's Program for Regulatory Science and Medicine, is principal investigator of the CERSI. Co-principal investigators include Kenneth L. Dretchen, Ph.D., professor and chairman 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.

The CERSI will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated, a major focus within the FDA as outlined in its strategic plan for "Advancing Regulatory Science at FDA." 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.

"The CERSI award provides us with an enormous opportunity to interact collegially and productively with FDA scientists and engage our students, staff and faculty in scientific applications as we strive for more effective product development and evaluation," says Shoulson. "It 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."

The CERSI is a large collaborative undertaking involving colleagues at the Medical Center, Law Center and also the School of Continuing Studies. "We have been most gratified by the success of our teamwork and sharing," Shoulson says of the effort to date. "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 very concept of regulatory science assumes sound regulation, which is the FDA's mission," explains Gostin, an expert in health law and bioethics. "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."

Gostin says that providing for a safe supply of food and effective drugs is becoming ever more challenging as the U.S. imports more of these 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. Sharing knowledge and training opportunities will benefit both the FDA and academia," he says.

The agency chose to pilot the Centers of Excellence in the capital region to allow for the greatest possible face-to-face collaboration and training with FDA staff.

"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, M.D, M.P.H. "The Centers of Excellence will create new scientific research, training and staff exchange opportunities for FDA and leading area institutions."

"CERSI will provide incredible educational opportunities as both teachers and learners in regulatory science for personnel at Georgetown University and the FDA. The awarded cooperative agreement should facilitate and expand already existing collaborative efforts between the two organizations," says GUMC's Dretchen.

"These partnerships will promote faster and better scientific approaches to product development, helping people in need and supporting biotech innovation," Goodman said.

Contact: Karen Mallet
Georgetown University Medical Center

Related medicine news :

1. USAID awards cooperative agreement to CONRAD for multipurpose prevention study
2. US Army awards $1.5 million for sleep research
3. Georgia Tech researchers receive 3 NSF Emerging Frontiers awards
4. 2 scientists at the University of Texas at Austin receive early career awards from White House
5. US Department of Defense awards University of South Florida $1.59 million for musculoskeletal research
6. University Hospitals Case Medical Center awarded 2011 fellowship awards for pain medicine, epilepsy
7. NCI awards $19.3m for multisite investigation of cancer disparities
8. Elsevier congratulates Dr. Charles Silverstein upon his receipt of 2 awards
9. NIH awards WSU researcher $1.39M to study chromatins role in cell division
10. BIDMC scientists receive Challenge Awards from Prostate Cancer Foundation
11. NIH awards WSU researcher $1.7 million to study non-alcoholic fatty liver disease
Post Your Comments:
(Date:10/12/2017)... Orleans, LA (PRWEB) , ... October 12, 2017 , ... ... centers in the U.S., announced today its plans to open a flagship location in ... will occupy the former Rooms To Go store next to Office Depot in the ...
(Date:10/12/2017)... ... 2017 , ... The American College of Medical Informatics (ACMI) will present the ... Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium ... a pioneer in the field of medical informatics, this prestigious award is presented to ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, ... a medical article to the newly revamped Cosmetic Town journal section, ... hair transplant procedure known as Follicular Unit Extraction (FUE). , Dr. ...
(Date:10/12/2017)... Wesley Chapel, FL (PRWEB) , ... October 12, 2017 , ... ... Chapel is holding a treadmill relay – Miles by Moonlight to raise money for ... by donating $300 or more. , Teams will work together to keep their ...
(Date:10/12/2017)... ... October 12, 2017 , ... In the United States, single-family ... some states—like New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, and California—the average ... extremely low property-tax rates, which contributes to the relatively lower cost of living ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... Labs announces the European launch of their new low volume, high ... in Cambridge, U.K on October 4th. The ... with unprecedented speed and sensitivity while using far less sample volume ... ... ...
(Date:9/27/2017)...  Commended for their devotion to personalized service, SMP Pharmacy ... one in the South Florida Business Journal,s 50 Fastest-Growing Companies, ... list, the national specialty pharmacy has found its niche.  To ... soon be honored by SFBJ as the 2017 Power Leader ... to receive his award in October, Bardisa said of the ...
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, ... complete response letter from the U.S. Food and Drug ... approval of sirukumab for the treatment of moderately to ... indicates additional clinical data are needed to further evaluate ... to severely active RA. ...
Breaking Medicine Technology: