NIH has released new solicitations related to the reauthorized SBIR program. In years past the Omnibus solicitations were of four varieties: SBIR with or without clinical trials, and, STTR with or without clinical trials. Now these four Omnibus solicitations are simplified into two separate ‘parent’ solicitations: SBIR and STTR where the clinical trial is optional. They no longer have separate solicitations distinguishing between if a project requires a clinical trial or not.
Additionally, as part of the new reauthorization, NIH has released their Phase IIB Strategic Breakthrough award. This is congressionally mandated through the new legislation and allows significant follow-on funding for a company going beyond Phase II. The budgets allowed vary by institution but typically range from $3million to $4.5million with NCI allowing up to $15million in funding. Its important to note that this extra funding requires a 100% match from outside sources of funding. (Note that our SBIR Advance may qualify as part of the matching funds)
Finally, they have released the Commercial Readiness Pilot (CRP) solicitation. This program helps funded companies beyond their SBIR/STTR to move from late stage development into commercialization. Projects suitable for CRP are clinical studies, IND/IDE enabling studies, regulatory support, and manufacturing scaleup. Budgets for CRP studies typically range from $500k to $2million.
For all of these new solicitations, the next deadline is September 5 and will continue with the historic NIH deadlines of January 5, April 5, and September 5 of each year. Now is the time to work on your new NIH project. We, at the CTC, are always happy to assist and help you through the process.
