SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)

The Commercialization Readiness Pilot (CRP) program is designed to help small business concerns (SBCs) move their NIH-funded SBIR or STTR projects from late-stage development to commercialization. The program supports later-stage research and development (R&D) and/or technical assistance that is not typically supported through Phase II or Phase IIB grants or contracts. This includes independent replication or confirmation of key studies, IND- or IDE-enabling studies, clinical studies, manufacturing scale-up and related quality activities, and regulatory and other specialized technical support. Key aspects of the program include: • The CRP program is open to SBCs that have had an active NIH SBIR or STTR Phase II or Phase IIB contract, grant, or cooperative agreement from NIH within the last 36 months. • Only one CRP award is allowed per project. • SBCs with currently active and newly awarded Phase II or Phase IIB awards from one of the participating ICs are also eligible. • The program aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage. • A significant amount of the work in a CRP award may be subcontracted to other institutions, but the SBC is expected to maintain oversight and management of the R&D throughout the award.