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.
Deadlines:
PAR-17-465 Expiration Date New Date October 31, 2020 per issuance of NOT-TR-20-025. (Original Expiration Date: September 8, 2020 )
Application budgets need to reflect the actual needs of the proposed project but may not be greater than:
UG3: up to $200,000 direct costs/year
UH3: up to $100,000 direct costs.
UG3: Up to 24 months (adult indications) or 36 months (pediatric indications) may be requested
UH3: Up to 12 months may be requested
