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Exciting New Program

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.

8 thoughts on “Exciting New Program

  1. Pingback: New program pairs NIH with industry to find novel uses for old drugs « OHSU Research News

  2. 20 compounds? This sounds ridiculous. Screening is easily done on hundreds and thousands of compounds, and there are rather complex libraries of “known” compounds available for such a use. Perhaps, adding these twenty to such a library would make more sense. Giving out grants to screen twenty compounds would be a huge waste of funds that are desperately needed elsewhere. It is, of course, a government gift to several big pharma companies, who have failed in developing these drugs, still want to make money our of them, but do not know how. At the very least, a company could have announced a grant to study possible uses of “inhibitor of X”, and not use public funds for it.

    • The request for applications has not been released yet, but it should be out soon and will provide more information about the compounds.

  3. I have an existing patent and a patent pending on new uses for an old drug that is no longer on patent for its original use. I have identified a new molecular target for the drug and clinical evidence of its efficacy for new applications. Will there be any mechanism in the Therapeutics Discovery agenda to facilitate my partnering with a pharmaceutical company in furthering this drug for new clinical applications?

  4. NCATS’ Therapeutics Discovery program funding and collaboration information is available now at http://ncats.nih.gov/therapeutics.html. Answers to frequently asked questions about program details are available at http://www.ncats.nih.gov/research/reengineering/rescue-repurpose/therapeutic-uses/therapeutics-faq.html. Following is an FAQ relative to your question:

    Q. Is this funding opportunity limited to the molecules provided through the Therapeutics Discovery pilot program or can investigators propose other molecules? If investigators have a molecule they believe may have a new use but is not listed in the molecule directory for this program, can they apply?

    A. This funding opportunity is limited to those molecules provided by pharmaceutical company collaborators for the Therapeutics Discovery pilot program through a Memorandum of Understanding with the NIH. The program will not provide support for molecules not listed in the molecule directory. We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Institute or Center contacts can assist in addressing questions related to proposed new therapeutic uses of other potential molecules that might be of interest in specific disease areas.

  5. NCATs seems to be entirely focused on drug development. Are there any plans in the works for device development?

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