Regulatory Focus™ > News Articles > Two New Centers of Regulatory Science Excellence Launched by FDA

Two New Centers of Regulatory Science Excellence Launched by FDA

Posted 07 May 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is throwing its support behind two new scientific programs intended to advance the state of regulatory science in the US.

Under an agreement announced on 5 May 2014, Johns Hopkins University and the University of California at San Francisco/Stanford University will join two other universities working with FDA as "Centers of Excellence in Regulatory Science and Innovation" (CERSI).

The programs are part of an effort by FDA to bring new tools and efficiencies to the way products are developed, evaluated, manufactured and used.

Since joining FDA, Commissioner Margaret Hamburg has been a strong proponent of regulatory science at the agency, calling it essential to allowing regulators to promote innovation while at the same time protecting patients.

"Frankly, these days, at least in Washington, you are far more likely to hear the word "regulatory" linked to the phrase "job-killing" than to "science," quipped Hamburg in an April 2012 speech. "But believe me, this is a short-sighted view."

"In my view, regulatory science is the critical link-the bridge-between cutting-edge discoveries and real-world diagnostics, treatments, and cures," Hamburg added. "A robust field of regulatory science can enable us to use our knowledge of biological pathways and gene variants to help identify promising new drug candidates and new potential targets for treatment."

For companies, regulators and patients alike, the appeal of regulatory science is relatively straightforward: Faster approval times, more robust approval decisions, cheaper development, more effective treatments and safer products.

And while some of these scientific advancements will come from industry or FDA itself, the agency has been looking specifically to academia to help spur some of those advancements.

FDA has already established centers of excellence at the University of Maryland, which is near FDA's Maryland headquarters, and Georgetown University, and seeded them with $2 million in funding to get started. It's also started a "virtual" center of excellence with the state of Arkansas, where the agency's National Center for Toxicological Research (NCTR) is located.

The addition of Johns Hopkins and the UCSF-Stanford teams will allow the agency to work on "leading-edge research focused on FDA science priority areas," FDA wrote in a statement. Both programs will be overseen by FDA's Office of Regulatory Science and Innovation (ORSI).

But each will focus on a separate set of issues, FDA confirmed.

Johns Hopkins will focus on clinical evaluations, social and behavioral science and food safety, while UCSF-Stanford will focus on toxicology, clinical studies, and harnessing diverse data through information sciences to improve health outcomes

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