The scope of the Phase I portion of a Fast-Track in the program includes all activities in the pre-clinical therapy development pipeline, and the Phase I can be structured in any way necessary to support subsequent pre-clinical development tasks during the Phase II project.
However, the Phase II awards in the program support milestone-driven projects that begin with identified candidate therapeutics and proceed through Investigational New Drug (IND) or Investigational Device Exemptions (IDE). Therefore, the primary purpose of the Phase I awards is, when appropriate, to support preliminary steps in therapy development that are outside the scope of the Phase II projects.
Phase I awards include, but are not limited to:
• Creation and validation of screening assays for therapy development. The assays may be intended for primary or secondary screening efforts at any level of throughput.
• Creation of animal models of neurological disorders for therapy development. Animal models that will be used for basic research are outside the scope of the program.
• Identification of candidate therapeutics, including primary or secondary screening efforts at any level of throughput. Primary screening efforts are not supported by the U01 and U54 cooperative agreement mechanisms in the NINDS Translational Research Program.
• Development of preliminary proof-of-principle data on the efficacy of candidate therapeutics.