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NIH Program Partners With FDA to Develop Regulatory Tools

Posted 24 July 2012 | By Alexander Gaffney, RAC 

A new project funded by the National Institutes of Health (NIH) could assist regulators by allowing the US Food and Drug Administration (FDA) to develop test chips to evaluate the toxicity of novel drug compounds without needing to first test them in human subjects.

The project-a series of 17 grants disbursed to medical and academic centers across the country-isn't, as first reported, intended to develop just a single chip capable of analyzing all toxicities. Rather, the grants are aimed at developing a litany of chip-based tests for each bodily organ.

Among the chips intended for development are ones for the circulatory system, the nervous system, the intestines, the brain and brain development, cardiac tissue, the liver and kidney. In a statement, NIH said FDA will "help explore how this new technology might be utilized to assess drug safety prior to approval for first-in-human studies.

NCATS' First Big Project

While the project was announced in 2011, the 24 July announcement ties specific projects to the more than $70 million in funding committed by NIH to the project over the coming five years. The project is also an unusual cooperation between NIH, FDA and the Defense Department's Defense Advanced Research Projects Agency (DARPA)-a skunkworks of sorts responsible numerous high-profile inventions including the predecessor to the internet.

In a statement, NCATS said it has already committed $9 million to the project, with NIH's Common Fund providing an additional $4 million. DARPA is conducting its own related projects, said the statement, but has committed to assisting several of NIH's grante-funded projects as well.

The project is also the first high-profile undertaking by NIH's newly-formed National Center for Advancing Translational Sciences (NCATS). The center has been focusing the majority of its energies and funding on projects to get pharmaceutical products past the infamous "valley of death"-so named because of the frequency at which promising drug candidates fail to make it from late-stage testing to market.

NCAT's activities have been lauded by both industry and other parts of the government. An April 2012 report by the White House's Office of Science and Technology (OST) commended the Center's activities on the development of the toxicity chips and recommended its partnership with FDA and DARPA continue. Industry, meanwhile, has already partnered with NCATS in an attempt to re-purpose advanced stage drug candidates for alternate treatment purposes. Participants in the program include Bristol-Myers Squibb, GlaxoSmithKline and Sanofi.

Read more:

NIH - NIH funds development of tissue chips to help predict drug safety

NIH - Tissue Chip for Drug Screening

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