FDA, federal agencies team up to develop technologies that predict drug safety

On Sept. 19, President Barack Obama announced that the U.S. National Institutes of Health (NIH) will collaborate with the U.S. Food and Drug Administration (FDA) and the Defense Advanced Research Projects Agency (DARPA) to develop cutting-edge technologies to predict drug safety.

Amy Swinderman
WASHINGTON, D.C.—On Sept. 19, President Barack Obamaannounced that the U.S. National Institutes of Health (NIH) will collaboratewith the U.S. Food and Drug Administration (FDA) and the Defense AdvancedResearch Projects Agency (DARPA) to develop cutting-edge technologies topredict drug safety.
 
 
The agencies will develop a chip to screen for safe andeffective drugs that is expected to be faster and more efficient than currentmethods.
 
In a statement released by the NIH, Dr. Francis Collins,director of the agency, said, "drug toxicity is one of the most common reasonswhy promising compounds fail. We need to know which ones are safe and effectivemuch earlier on in the process. This is an unprecedented opportunity to speeddevelopment of effective therapies, while saving time and money."
 
 
According to the NIH, the chip will be loaded with specificcell types that reflect human biology, and will be designed to allow multipledifferent readouts that can indicate whether a particular compound is likely tobe safe or toxic for humans.
 
According to the agencies, the new technology will bringtogether "the latest advances in engineering, biology, and toxicology to bearon this complex problem."
 
 
"We know the development pipeline has bottlenecks in it, andeveryone would benefit from fixing them," Collins stated. "What we need areentirely novel approaches to translational science, to take full advantage ofthe deluge of new biomedical discoveries that have been made in recent years."
 
 
DARPA researchers will concentrate their efforts onengineering platforms and the biology required for scientific proof of concept.The NIH's National Center for Advancing Translational Sciences (NCATS) willfocus on developing complementary microphysiological systems to mimic humanphysiology and pathology by taking advantage of recent advances in the field.Both agencies will work closely with the FDA throughout the process. The FDAwill provide scientific input to help ensure that the regulatory challenges ofreviewing drug safety and efficacy are considered before and duringdevelopment.
 
 
The NIH will commit up to $70 million for the project overthe next five years. DARPA is expected to commit a comparable amount to theeffort.
 
 
According to the collaborating parties, the project is anexample of the types of innovative projects that would be led by the proposedNCATS, which is intended to help identify barriers to progress and providescience-based solutions to reduce costs and the time required to develop newdrugs and diagnostics. The FDA will help determine how this new technology canbe utilized to assess drug safety, prior to approval for first-in-humanstudies.
 
 
As proposed, NCATS will study the steps in the process ofdiagnostics and therapeutics development, identify the bottlenecks andexperiment with innovative methods to streamline the process. By focusing ondeveloping innovative new tools and methods for therapeutics development, asopposed to developing therapeutics themselves, NCATS will enable others tobring safer and more effective medical products to market in less time. In thisway, NCATS will complement, and not compete with, the work of the privatesector and other NIH translational science efforts.
 
"The FDA is excited about this program to develop novel newplatforms that can be used to screen drugs for safety and efficacy, without theuse of animals and in a manner that better predicts what happens in people,"said Dr. Margaret A. Hamburg, commissioner of the FDA, in a statement. "Thischeaper, faster and more predictive approach to drug screening could speed thedevelopment and improve the evaluation of innovative medicines, bringing neededproducts to patients safer and faster."
 
 
The agencies are also seeking proposals from industry,government laboratories, academic institutions and other research organizationson how best to develop the chip.

Amy Swinderman

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