Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)

The Blueprint Neurotherapeutics Network for Biologics (BPN Biologics) funding opportunity, offered by the National Institutes of Health (NIH) and supported by several participating NIH Institutes and Centers, aims to expedite the discovery and development of biologic-based therapeutics for nervous and neuromuscular system disorders. This initiative operates under a cooperative agreement (U44 mechanism) targeting small business concerns, providing both funding and access to specialized NIH-supported resources. Eligible therapeutic modalities include antibodies, peptides, proteins, oligonucleotides, gene and cell therapies, and other innovative biologic treatments, excluding small molecules. This phased funding mechanism is structured as a Fast-Track SBIR award, beginning with Phase I and advancing to Phase II upon meeting specific milestones. Phase I supports lead optimization and candidate selection within a two-year window, while Phase II focuses on IND-enabling studies and early-stage clinical trials over a three-year period. Projects must either enter at the discovery stage, with viable lead agents ready for optimization, or at the development stage, where a clinical candidate has already been selected. NIH collaborates closely with awardees through a Lead Development Team (LDT) comprising NIH staff, consultants, and the applicant’s research team. Applicants can choose to conduct all work through their own teams or leverage NIH-funded Contract Research Organizations (CROs) for specific development functions, including CMC activities, safety testing, and clinical coordination. Intellectual property generated through this collaboration remains with the awardee institution. To support regulatory readiness, awardees are expected to lead FDA engagements, including pre-IND and IND submissions, with NIH consultants providing assistance. To apply, organizations must be U.S.-based small business concerns and register with SAM.gov, eRA Commons, SBA Company Registry, and Grants.gov. Applications must include a detailed research strategy, Target Product Profile, Therapeutic Agent Profile, and Gantt chart. A letter of intent is requested 30 days prior to submission. The funding opportunity follows a biannual submission cycle with deadlines on January 15 and July 15 through 2027. The next cycle opens December 27, 2024, with a submission deadline of January 15, 2025. Applications are reviewed on scientific merit and strategic alignment, with awards announced approximately 11 months post-submission. The performance period may extend up to five years across both phases. The program is recurring, with anticipated next cycles mirrored semiannually. Funding is contingent on NIH appropriations and project merit. Interested parties are strongly encouraged to contact NIH staff well ahead of submission to ensure alignment with program goals.