Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44) | PAR 17 201

Opportunity Information: Apply for PAR 17 201

The Blueprint Neurotherapeutics Network (BPN) U44 opportunity is an NIH cooperative agreement designed to help small businesses push promising small molecule programs for nervous system disorders further down the drug development pipeline, with a clear emphasis on getting viable candidates into clinical testing. The program is structured to support real translational work rather than early exploratory science, meaning applicants are expected to bring forward projects with a reasonable path toward a drug candidate and to execute a milestone-driven plan that advances compounds toward an Investigational New Drug (IND) submission and first-in-human studies.

A central feature of the BPN model is the division of labor between the awardee and NIH-supported resources. The small business awardee remains responsible for the disease- and target-specific parts of the project, including creating or running specialized assays, employing proprietary disease models, using target validation tools, and generating the biology and pharmacology data that depends on the applicant's unique expertise. Importantly, the grant covers the work performed in the awardee's own labs for these project-specific activities. At the same time, the awardee gains access to a broader development infrastructure through collaboration with NIH-funded consultants and optional use of NIH contract research organizations (CROs). These CROs can supply capabilities that many small companies lack in-house, such as medicinal chemistry support, pharmacokinetics and ADME studies, safety and toxicology testing, formulation development, scale-up and chemical synthesis, Good Manufacturing Practices (GMP) manufacturing, and Phase I clinical testing. In practice, this setup is meant to reduce bottlenecks that often stall small molecule programs, especially when they move from academic-style discovery into regulated preclinical and clinical workflows.

Projects can enter the program at two different points depending on their maturity. At the Discovery stage, the goal is to take promising "hit" compounds and optimize them through medicinal chemistry and iterative testing, typically focusing on potency, selectivity, physicochemical properties, metabolic stability, brain penetration when relevant, and early safety liabilities. If a Discovery-stage project meets agreed milestones, it can transition forward into Development activities under the same overall program pathway. At the Development stage, the expectation is that the applicant already has a credible development candidate (or is close) and needs support to complete IND-enabling work. That usually includes formal toxicology studies performed under appropriate standards, required pharmacology packages, formulation and manufacturing plans suitable for human dosing, and then execution of Phase I clinical testing to establish initial safety, tolerability, and pharmacokinetics in people. The throughline is practical readiness for clinical entry rather than open-ended research.

Because this is a cooperative agreement (U44), NIH involvement is typically more hands-on than a standard grant. While the applicant drives the scientific strategy and execution of their specialized work, the program is built around coordinated project management, the use of external experts, and milestone-based decision points. This kind of structure is meant to keep projects moving, prioritize resources toward candidates that continue to meet performance and safety criteria, and provide the kind of development discipline that is often necessary to reach the clinic.

The opportunity is specifically aimed at small businesses as eligible applicants. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply under the stated terms. However, foreign components may be allowed in some cases as defined by the NIH Grants Policy Statement, so applicants with any international collaborations would need to pay close attention to the eligibility and component rules in the full funding opportunity announcement.

The intellectual property arrangement is another major incentive. Awardee institutions retain their own IP rights and, notably, receive assignment of IP rights from BPN contractors for drug candidates developed within the program. That means the small business is positioned to control downstream patent prosecution and licensing negotiations for candidates advanced through BPN-supported contractor work, which can be critical for attracting partners or investors later. This feature is meant to ensure that participating companies do not lose control of their assets simply because key development steps were executed with NIH-associated contractors.

Administrative details in the source information identify the funding opportunity as PAR 17-201, offered by the National Institutes of Health, categorized as discretionary funding, and using the U44 cooperative agreement mechanism. The activity category is listed broadly under education, health, income security, and social services, and the program aligns with multiple CFDA numbers (93.121, 93.213, 93.242, 93.273, 93.279, 93.853, 93.865, 93.866, 93.867), reflecting the multi-institute nature of NIH neuroscience and translational therapeutic development efforts. The original closing date shown is 2017-12-21, and the record creation date is 2017-03-09, indicating this specific listing refers to that historical solicitation cycle.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.213, 93.242, 93.273, 93.279, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2017-03-09.
• Applicants must submit their applications by 2017-12-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 17 201

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