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  5. Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (UH2/UH3)

Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (UH2/UH3)

Submission Date: January 16, 2015

Award Ceiling: TBD

The National Center for Advancing Translational Sciences (NCATS) seeks to expand the therapeutics discovery program piloted in 2012 to explore new therapeutic uses for proprietary drug candidates (Agents) across a broad range of human diseases. This innovative program allows investigators to propose new therapeutic uses for Agents from pharmaceutical company partners. A strong application will be supported by scientific evidence that modulation of the Agents target will have a positive impact on the disease/condition. PAR-14-213 encourages X02 pre-applications for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules. The X02 pre-application is the first step in the application process for PAR-14-212, PAR-14-210, and PAR-14-211; applicants must read the entire companion FOAs. The X02 pre-applications will be evaluated by outside experts. Investigators whose X02 pre-applications are judged to be the most meritorious will be notified of the opportunity to submit a UH2/UH3 application under this FOA or a UH3 under PAR-14-211 or a UH2/UH3 application under PAR-14-210 in the case of a pediatric indication. The UH2/UH3 is a two stage application. 1. The UH2 (Stage 1) may be used to support milestone-driven preclinical studies to verify target engagement in a disease model and/or Phase 1b clinical trials using the selected Agent in its existing formulation/route of administration to identify the dose or exposure of the Agent in the proposed patient group, and inform patient selection. Support for the UH2 may be requested for a period that may vary from six months up to one year.UH2 projects that have met the scientific milestones and feasibility requirements will be eligible for rapid transition to the second UH3 stage after NIH administrative review. 2. The UH3 (Stage 2) will support milestone-driven Phase 2a trials to demonstrate that the Agent, made available for this program by the pharmaceutical partners, modulates the target and has the potential to yield the desired clinical outcome in the proposed disease population. The project period for the UH3 stage is up to two years.

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