NINDS Cooperative Program in Translational Research Small Business Awards (U44)

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The goal of this funding opportunity announcement (FOA) is to support preclinical development and testing of new therapies for neurological disorders. The program will facilitate encouragementation, development, and review of therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. Phase II and Fast-Track SBIR cooperative agreements are supported under the program. Phase I, as part of a Fast-Track, supports preliminary steps in the process for the preclinical development of therapeutics. To be eligible for Phase II support, either based on a previously successful Phase I or as part of a Fast-Track, projects must include therapeutic leads and in vivo proof of concept on efficacy. Phase II supports preclinical optimization and testing of the leads, and projects must be sufficiently advanced that an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) can be submitted by the end of the project period. Phase II cannot support early-stage therapeutic discovery activities such as screening. The program scope excludes clinical research, basic research, and studies of disease mechanism. The scope includes only therapy development activities, so development of diagnostics, biomarkers, or rehabilitation strategies cannot be supported. This is a milestone-driven SBIR cooperative agreement program involving participation of NINDS staff in the development of the project plan and monitoring of research progress.

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