This Funding Opportunity Announcement (FOA) invites applications for support of pre-clinical studies to repurpose existing experimental or FDA approved drugs or biologics (existing therapeutics) that have already begun or completed at least a Phase l trial.
The hypothesis for proposed studies
must be developed using innovative processes to identify the therapeutic/indication pair.
Examples include independent crowdsourcing strategies (e.g., http://www.ncats.nih.gov/ntu/assets/current, http://openinnovation.astrazeneca.com/, or any website that lists experimental therapies), or use of computational algorithms.
The initial UG3 award will support the development of milestone-driven rigorous, pre-clinical target engagement and/or efficacy studies.
Once UG3 pre-clinical milestones have been met, the UH3 award may be made to support clinical trial planning:
this includes complete planning, design, and preparation of the documentation necessary for implementation of Phase I and/or Phase II clinical trials for a new therapeutic use.