For those Phase I SBIR awardees developing therapeutics targeted toward neurological disorders, and planning on submitting for a Phase II SBIR award to fund pre-clinical trials, check out the NINDS Cooperative Program in Translational Research (U44). This special funding opportunity is directed at translating basic science research into new drug candidates for neurological disorders. These awards are not intended for early stage discoveries such as high throughput screening, but will fund later stage projects. Even those sufficiently advanced that an IND or IDE application would be filed at the end of the project period.
These awards are larger than traditional Phase II awards, with allowable budgets up to $1M per year and a 3 year max. Phase I applications are not allowed, however, a FastTrack application may be submitted as long as the Phase I portion is in preparation for a Phase II to fund pre-clinical trials. If you have already received a Phase II, this mechanism can also be used to fund a competing renewal application with the same allowable budget as above.
Cooperative Agreements are an NIH funding mechanism that allows NIH programming staff to be more involved with the evolution and progress of a project. Specifically, go/no-go assessments can be made and funding halted if sufficient progress is not made. This is attractive to the NIH as it allows them to be more closely involved with large grant awards and use their funding more wisely.
For more information contact the NINDS SBIR/STTR Program Director, Dr. Randall Stewart, to discuss your project and it’s applicability to this program. Regular receipt dates (Apr 5, Aug 5, Dec 5) apply, and program staff should be contacted 10 weeks prior to submission.