SBIR and STTR Grants

The NIH acknowledges that there is the possibility of a significant gap between Phase I and Phase II funding. The following strategies are recommended to reduce the duration and impact of this gap:

• Instead of applying for Phase I and Phase II grants sequentially, an investigator may elect to apply for a "fast-track" combined Phase I and Phase II application. In essence, this requires the submission of a Phase II application while planning for receiving both a Phase I and a Phase II award with a single application. This, however, is only suitable if the company can demonstrate a high likelihood of having a successful Phase I. For this reason, only 5.8% of funded SBIR applications were on the fast track.
• Another option is to apply directly for a Phase II grant. This can be done if a company already has sufficient preliminary data to support a Phase II application and would rather skip to the more substantial funding and time allocation of Phase II.
• A bridge award (of $1 million) is also available for up to three years from some NIH institutes, like the NCI, to bridge the gap between Phase II and Phase III.
• Apply for Phase II during Phase I. In this scenario, the Phase II application is prepared while the Phase I study is being conducted, and once the Phase I tasks are accomplished (which may occur before the formal end date of the Phase I grant if the team is efficient and successful), the Phase II application is immediately submitted. However, this can still lead to delays for the review process, or if a resubmission is required. Submitting a Phase II grant before the stated tasks of the Phase I are completed is not recommended, though, since successful completion of the Phase I tasks are a criteria for awarding a Phase II grant in many cases.