Academia-industry partnership will undertake preclinical development and feasibility studies in humans.
NIH’s new National Center for Advancing Translational Sciences (NCATS) has launched an initiative through which pharma companies’ sidelined drug candidates will be developed for new potential indications in partnership with academic researchers. The Discovering New Therapeutic Uses for Existing Molecules Initiative will focus on compounds that have already negotiated key steps in development, including safety testing in humans. Pfizer, AstraZeneca, and Eli Lilly have already signed up as NCATS partners, and have agreed to make dozens of compounds available for the pilot phase of the initiative.
The pilot phase of the initiative will have at its disposal about $20 million in fiscal 2013 to support preclinical and clinical feasibility studies on about 20 compounds from industry collaborators. The funding will be awarded to support two- to three-year staged, cooperative agreement research grants. Under the awards researchers will conduct preclinical validation and clinical feasibility studies in the first stage, and proof-of-concept clinical trials in the second stage, to evaluate whether a compound is effective against a previously unexplored disease target.
“Clearly, we need to speed the pace at which we are turning discoveries into better health outcomes,” comments NIH director Francis S. Collins, M.D. “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.”
NCATS was established at the end of 2011 to promote and catalyze the development of new therapeutics and diagnostics across a range of disease areas. In addition to the newly launched drug repositioning initiative, NCAT also coordinates the Clinical and Translational Science Awards program, which promotes the development of translational medicine infrastructure, skills, and networking capabilities.