Repurposing News
Partnership for Cures leads the way in funding "patient impact" research that will get treatment to patients faster, but we are not alone in recognizing the power of finding new uses for existing drugs and therapies.
NIH Offers Funding - Fall 2008
Title: Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)
Request for Applications (RFA) Number: RFA-FD-09-001
Application Due Date(s): February 4, 2009; February 3, 2010
Resubmission Due Date(s): October 15, 2009 and October 15, 2010
Earliest Anticipated Start Date(s): November 2009 and November 2010
Purpose
The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's “Background and Significance” section documentation to support the estimated prevalence of the orphan disease or condition and an explanation of how the proposed study will either help gain product approval or provide essential data needed for product development.
Number of Awards. Funds Available and Anticipated
Of the estimated FY 2010 funding ($14.1 million), approximately $10 million will fund non-competing continuation awards, and approximately $4.1 million will fund 10 to 12 new awards, subject to availability of funds. It is anticipated that funding for the number of non-competing continuation awards and new awards in FY 2011 will be similar to FY 2010.
Budget and Project Period
Grants will be awarded up to $200,000 or up to $400,000 in total (direct plus indirect) costs per year for up to 4 years. Please note that, the dollar limitation will apply to total costs, not direct costs, as in previous years. A fourth year of funding is available only for Phase 2 or 3 clinical studies. Applications for the smaller grants ($200,000) may be for Phase 1, 2, or 3 studies. Study proposals for the larger grants ($400,000) must be for studies continuing in Phase 2 or 3 of investigation.
