Navigation Links
FDA awards Georgetown University a Center of Excellence in Regulatory Science & Innovation
Date:10/26/2011

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
km463@georgetown.edu
Georgetown University Medical Center
Source:Eurekalert

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:
*Name:
*Comment:
*Email:
(Date:1/16/2017)... Grove Village, IL (PRWEB) , ... January 16, ... ... and personal audio products, will demonstrate their groundbreaking GunSport•PRO® and EB15•LE® electronic earplugs ... and Convention Center in Las Vegas, Booth #2809. The SHOT Show is the ...
(Date:1/16/2017)... ... January 16, 2017 , ... As New York’s fastest growing ... MD to their medical staff, according to eye surgeon, Jeffrey Martin, MD, FACS, ... a division of SightMD. Dr. Giamos will practice primarily out of SightMD’s Riverhead, ...
(Date:1/16/2017)... , ... January 16, 2017 , ... St. Louisans are well-aware of the following facts ... This year’s influenza shot seems to be having no effect on keeping this particularly ... half of the people around are coughing, sneezing, or sniffling , These ...
(Date:1/16/2017)... ... January 16, 2017 , ... One thing common to all types of ... test for, as well. The money spent screening for and treating cancer in the ... screen patients for cancer more than in any other country that has an advanced ...
(Date:1/15/2017)... , ... January 15, 2017 , ... In this role, ... the United States for the asthma & allergy friendly mark. This certification program was ... test and identify consumer products to be more suitable for the 60+ million people ...
Breaking Medicine News(10 mins):
(Date:1/17/2017)... , January 17, 2017 ... 1):2-4 ; http://www.touchneurology.com/articles/tailored-temperature-management-neurocritical-care ... ... recently in European Neurological Review ... Catherine Amey reports that despite standard ...
(Date:1/17/2017)... January 17, 2017 Transparency Market Research has ... Acid, Sodium Benzoate, Benzyl Alcohol and Others) Market - Global Industry ... report, the global benzaldehyde derivative market was valued at ... 2.14 Bn by 2024, expanding at a CAGR of 5.1 % ... ...
(Date:1/17/2017)... DUBLIN and BUDAPEST, Hungary , ... ) and Gedeon Richter Plc. today announced positive results from ... trials evaluating the efficacy and safety of ulipristal acetate in ... drug application filing for ulipristal acetate is planned for the ... the favorable results of Venus II supporting the efficacy and ...
Breaking Medicine Technology: