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

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Description

The Blueprint Neurotherapeutics Network (BPN) is a funding initiative by the NIH Blueprint for Neuroscience Research designed to support small U.S. businesses in advancing small molecule drug discovery and development projects targeting disorders of the nervous system. The program facilitates the translation of promising compounds into clinical candidates by providing funding and access to NIH-funded consultants and contract research organizations (CROs) specializing in medicinal chemistry, pharmacokinetics, toxicology, formulation development, GMP chemical synthesis, and Phase I clinical testing.

Applicants are responsible for conducting all disease- or target-specific assays, models, and research tools in their own laboratories. They may collaborate with NIH consultants and augment their projects with CRO services. Projects can enter the program at two stages:

• Discovery Stage: Optimization of hit compounds through medicinal chemistry and preclinical studies.
• Development Stage: Advancement of a development candidate through IND-enabling toxicology studies and Phase I clinical trials.

Projects entering at the Discovery stage that meet milestones may continue into Development. The program emphasizes milestone-driven progress with administrative reviews to determine advancement. Intellectual property rights for drug candidates developed remain with the awardee institutions, including rights assigned from BPN contractors, allowing control over patent prosecution and licensing.

The BPN does not support biologics, diagnostics, devices, or studies beyond Phase I clinical testing. It is focused exclusively on small molecule therapeutics for nervous system conditions aligned with the missions of participating NIH Institutes and Centers.

Due Dates

• Application Due Dates: August 9, 2023 (final listed date)
• AIDS Application Due Dates: September 7, 2023 (final listed date)
• Letter of Intent: 30 days prior to application due date

Note: This specific FOA has expired, but it has been reissued as PAR-24-063. Researchers should consult the NIH Guide for current opportunities.

Funding Amount

• Phase I: Up to $500,000 total costs per year, for up to 2 years.
• Phase II: Up to $1,500,000 total costs per year, for up to 3 years.
• Budgets must reflect actual project needs; NIH pays contractors and consultants directly.
• Equipment requests are allowed but discouraged unless essential.
• Travel funds may be included for meetings related to the program.

Eligibility

• Only U.S.-based small business concerns (SBCs) are eligible.
• SBCs must be for-profit, have a place of business in the U.S., and meet SBA size standards (≤500 employees).
• Ownership and control requirements apply, including restrictions on foreign ownership and venture capital ownership.
• Foreign institutions and non-domestic components of U.S. organizations are not eligible.
• PD/PI must have the skills and resources to conduct the research; primary employment requirements apply depending on SBIR or STTR status.
• Multiple applications allowed if scientifically distinct.
• Compliance with SBA performance benchmarks for Phase I to Phase II transition and commercialization is required.

Application Process

• Applications must be submitted electronically via Grants.gov and tracked in eRA Commons.
• Applicants must complete all required registrations (DUNS, SAM, SBA Company Registry, eRA Commons).
• Follow SBIR/STTR (B) instructions in the SF424 (R&R) Application Guide, with program-specific instructions.
• Letter of Intent is encouraged but not required.
• Applications must include detailed Specific Aims and Research Strategy sections addressing clinical impact, biological rationale, testing strategy, innovation, and commercialization plans.
• Applicants must specify entry stage (Discovery or Development) and provide milestone plans.
• Data Management and Sharing Plan required.
• Intellectual property strategy and commercialization history must be described.
• Human subjects and clinical trial information must be included if applicable.
• Budget should cover only work performed by PD/PI and staff; contractor costs are paid separately by NIH.
• Milestones and go/no-go criteria are critical for progression.

Additional Information

• The program is a cooperative agreement with substantial NIH involvement, including assignment of a Lead Development Team (LDT) co-chaired by the PD/PI and NIH consultants.
• The LDT guides project strategy, milestones, and coordination.
• Clinical Development Team (CDT) replaces LDT during clinical trial phases.
• Projects must adhere to Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and current Good Manufacturing Practices (cGMP) for clinical trial materials.
• Intellectual property rights remain with the awardee; awardees are responsible for patent filings and commercialization efforts.
• Projects not appropriate for this FOA include biologics, diagnostics, devices, animal model development, and studies beyond Phase I clinical trials.
• NIH Institutes and Centers participating include NINDS, NEI, NIA, NIAAA, NICHD, NIDCR, NIMH, NCCIH, and NIDA, each with specific research interests and priorities.
• Applicants are encouraged to contact NIH program staff to discuss alignment and project suitability.

External Links

• NIH Blueprint Neurotherapeutics Network (BPN) FOA (Expired)
• NIH Blueprint for Neuroscience Research
• NIH Grants Policy Statement
• NIH SBIR/STTR Application Guide
• NIH Guide for Grants and Contracts
• NIH Data Management and Sharing Policy

Contact Information