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AAMC Comments on NIH-Industry Program to Discover New Therapeutic Uses for Existing Molecules

June 8, 2012—AAMC June 1 submitted a letter to the National Institutes of Health (NIH)’s National Center for Advancing Translational Sciences (NCATS) in response to a May 11 request for information on the NIH-Industry Program to Discover New Therapeutic Uses for Existing Molecules.

NCATS sought input on a collaborative research program between pharmaceutical companies and the biomedical research community. The AAMC commended NIH leadership, NCATS, and the participating pharmaceutical companies on reaching this agreement and for implementing a pilot program that will share industry-tested compounds through collaboration with the research community.

The association also recommended that NCATS modify its current collaborative template agreements to ensure that academic and other research institutions are fully engaged as equal partners, and that NCATS determine in advance how the pilot program will be evaluated.

Under proposed template Collaborative Research Agreements (CRAs), the initiative will match drug candidates and related data from participating companies with the best ideas for new therapeutic uses put forward by the biomedical research community.

The goal is to discover new uses for drug compounds that have already cleared several steps in the development process, including testing for safety in humans, but which had been abandoned for further development by the pharmaceutical firms for business or related reasons [see Washington Highlights, May 4].

NCATS requested comment on many key issues, including  the proposed role and usefulness of the template CRAs and related confidentiality agreements and identifying the most significant challenges for public-private partnerships that foster drug rescue between biomedical researchers and the pharmaceutical industry. NCATS expects to release its initial request for applications to the new drug rescue and repurposing program this month.


Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926


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