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Washington Highlights

NIH Launches Collaborative Program with Industry to Spur Therapeutic Development

May 4, 2012—Secretary of Health and Human Services (HHS) Kathleen Sebelius and National Institutes of Health (NIH) Director Francis Collins, M.D., Ph.D., May 3 announced a collaborative pilot program to provide researchers with pharmaceutical industry compounds to explore new treatments for patients.

The Discovering New Therapeutic Uses for Existing Molecules is the first signature initiative of NIH's National Center for Advancing Translational Sciences (NCATS).  NCATS is partnering initially with Pfizer, AstraZeneca, and Eli Lilly and Company, which have agreed to make dozens of their compounds available for the initiative's pilot phase.  Additional companies may join and contribute their compounds for further investigation.

Dr. Collins noted that, in recent years, researchers have succeeded in identifying the causes of more than 4,500 diseases. But it has proven difficult to turn such knowledge into new therapies; effective treatments exist for only about 250 of these conditions.   “NIH looks forward to working with our partners in industry and academia to tackle an urgent need that is beyond the scope of any one organization or sector,” said Dr. Collins.

The initiative will provide researchers with access to compounds that already have cleared several key steps in the development process, including safety testing in humans.  NIH expects to award approximately $20 million total in FY 2013 to support research grants of up to three years duration for pre-clinical and clinical feasibility studies. These studies will test more than 20 compounds from industry partners for their effectiveness against a variety of diseases and conditions. The companies will provide the researchers with access to the compounds and related data.

The pilot program incorporates innovative template agreements designed to streamline the legal and administrative process for participation by multiple organizations. These template agreements reduce time, cost, and effort, as well as allow greater participation than traditional partnerships.

The templates also provide a roadmap for handling intellectual property used in or developed through the program. Participating industry partners will retain the ownership of their compounds, while academic research partners will own any intellectual property they discover through the research project with the right to publish the results of their work.

Additional details and an opportunity to comment on the new NCATS program are available in a Request for Information (RFI): Input on the NIH-Industry Program to Discover Therapeutic Uses for Existing Molecules, NOT-TR-12-002. NIH will accept responses to the RFI until June 1. 

NIH also published a Notice of Intent to Publish a Request for Pre-Applications NOT-TR-12-001.  The request for applications and information on the compounds is expected to be released later this month.

Contact:

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559
Email: dbmoore@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org