Imagine if you had a partnership with industry where you had access to compounds never before available to you, which you could use to test ideas for new therapeutics and identify promising new treatments. That’s the unique program that the NIH National Center for Advancing Translational Sciences just announced, Discovering New Therapeutic Uses for Existing Molecules. This is an opportunity to establish new research relationships between NIH, the academic community, and the private sector. NCATS has partnered with Pfizer Inc., AstraZeneca, and Eli Lilly, who have agreed to make 20 compounds available. These compounds have already gone through extensive research and development, perhaps for one disease; passed initial safety testing in humans; but, in the end, were not effective for that particular disease. Much like azidothymidine (AZT), which proved unsuccessful as a cancer drug but revolutionized HIV treatment, we hope that some of these molecules will be put to new therapeutic uses.
Through this new program, researchers will have access to these molecules and related data to use for pre-clinical and feasibility studies. To support the program, NCATS will provide up to $20M in research grants in fiscal year 2013. We ask for your input on this program and encourage you to reply to this request for information by June 1, 2012.
There is also a notice of intent to publish a request for applications, so you can start planning your application. This notice announces a somewhat unusual process for NIH. We will use a pre-application process to select the most meritorious projects, which will then be invited to submit a subsequent application for a cooperative agreement. Those applicants will have established an agreement with the company prior to submitting their follow-on application. In another revolutionary step to facilitate the partnership, we developed template agreements to help streamline the legal and administrative process for partnering with industry and managing intellectual property.
We expect the RFA to be published in May 2012, with the first application due date in mid-July 2012. This venture represents a ground-breaking partnership between pharmaceutical companies and the biomedical research community, a new way of doing business at NIH, and, most importantly, significant potential benefits for patients. I encourage you to have a look and provide comments.