Opportunity Information: Apply for PAR 14 292
Apply for PAR 14 292
- 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 Oral Diseases and Disorders Research 93.213 Research and Training in Complementary and Integrative Health 93.242 Mental Health Research Grants 93.273 Alcohol Research Programs 93.279 Drug Abuse and Addiction Research Programs 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Jul 22, 2014 and posted on Jul 22, 2014.
- Applicants must submit their applications by May 7, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture 3. (i) SBIR and STTR. Be a concern which is more than 50 percent directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 percent directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these OR (ii) SBIR only. Be a concern which is more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 percent of the concern OR (iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements. 4. Has, including its affiliates, not more than 500 employees.
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Opportunity Summary:
The Blueprint Neurotherapeutics Network (BPN) Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44) is a National Institutes of Health (NIH) funding opportunity designed to help move promising neuroscience small-molecule therapeutics from early discovery toward first-in-human testing. The core purpose of the program is translational: it supports investigators who already have a compelling biological rationale and credible starting chemistry and who need the specialized drug development capabilities, resources, and structured project management typically required to reach clinical entry. Rather than funding only academic-style research, the BPN model is built to de-risk and accelerate the steps that transform a hit compound into a development candidate and then into an Investigational New Drug (IND)-ready asset.
The award mechanism is a cooperative agreement (U44), meaning NIH is expected to have substantial involvement beyond simply providing funds. In practice, applicants are not just receiving money to spend independently; they are joining a networked development program with access to NIH-supported expertise and infrastructure. A major feature of BPN is the opportunity for awardees to work with NIH-funded consultants and contract research organizations (CROs) that provide professional drug discovery and development services. These external partners can cover key functions that are often bottlenecks for small companies, including medicinal chemistry optimization, pharmacokinetics and ADME work, toxicology planning and execution, formulation development, chemical synthesis under Good Manufacturing Practices (GMP), and Phase I clinical testing. The intent is to bring industry-standard rigor and execution to projects that are scientifically strong but may not have full in-house development capabilities.
Projects can enter the program at two main points, depending on maturity. The Discovery entry point is meant for teams with well-validated hit compounds that still need medicinal chemistry and related optimization to improve properties like potency, selectivity, brain exposure, metabolic stability, and safety margins. The Development entry point is meant for teams that already have a more advanced development candidate and are ready to progress through IND-enabling studies, including the toxicology and CMC (chemistry, manufacturing, and controls) work needed to support an IND submission, followed by Phase I clinical testing. Importantly, the program is structured so that projects beginning in Discovery can, if they meet predefined milestones, continue into the Development phase. This milestone-driven approach is a defining aspect of the opportunity: advancement is expected to be based on clear, objective go/no-go criteria aligned with real-world development decisions.
The scope is focused on small-molecule therapeutics for disorders of the nervous system, aligning with NIH neuroscience and related institute priorities. The listing of CFDA numbers (including neuroscience, mental health, addiction, alcohol research, child health, oral diseases and disorders, and complementary and integrative health research) signals that the opportunity can support a broad range of nervous system indications and translational neuroscience areas, as long as the project is fundamentally about developing a small-molecule intervention and moving it toward the clinic.
Eligibility is limited to United States small business concerns (SBCs). To qualify, an applicant must be a for-profit entity with a place of business in the U.S. and primarily operating in the U.S. (or contributing significantly to the U.S. economy), and it must meet standard small business size and ownership rules. The opportunity specifies that the small business must have no more than 500 employees including affiliates. It also describes permissible ownership structures under SBIR/STTR rules, including majority ownership by U.S. citizens or permanent residents and, for SBIR in particular, certain venture capital, hedge fund, or private equity ownership configurations as long as no single such entity owns more than 50 percent. Joint ventures can be eligible if they comply with the stated participation and registration requirements, including limits on foreign entity participation.
From an applicant-value standpoint, the program is designed to provide two complementary assets: direct funding for work performed in the awardee’s laboratory and access to an NIH-facilitated development ecosystem that can execute specialized studies through experienced CROs. This is especially relevant for small businesses trying to bridge the “valley of death†between early discovery and clinical proof-of-concept, where costs rise quickly and operational complexity increases. Another key point is that participants retain intellectual property rights to drug candidates developed through the program, which is an important incentive for commercialization and follow-on investment, and helps ensure that the small business can continue development beyond the supported milestones.
Administrative details in the source indicate this opportunity was posted July 22, 2014 (Funding Opportunity Number PAR 14-292) and has since closed and been archived (original and current closing date May 7, 2017; archive date June 7, 2017). The activity category is listed under Education, Health, Income Security and Social Services, and there is no cost sharing or matching requirement. The administering agency is NIH, and the funding instrument type is a cooperative agreement, consistent with the hands-on, milestone-based, team-oriented development model described in the announcement.
In summary, this BPN U44 opportunity was built for U.S. small businesses developing neuroscience small-molecule therapeutics that are ready to be pushed toward clinical testing. It offers milestone-driven support, integrates expert development partners and CRO resources across medicinal chemistry through Phase I, allows entry at either discovery optimization or IND-enabling development, and preserves IP rights for the participating company, with the overarching goal of advancing credible neurotherapeutic candidates into the clinic.
Frequently Asked Questions (FAQs)
What is the Blueprint Neurotherapeutics Network (BPN) U44 opportunity?
The Blueprint Neurotherapeutics Network (BPN) Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44) is an NIH funding opportunity designed to move promising neuroscience small-molecule therapeutics from early discovery toward first-in-human testing. It is a translational program focused on advancing credible drug candidates along a development path rather than supporting purely academic research.
What is the main goal of this program?
The program aims to de-risk and accelerate the work needed to turn a hit compound into a development candidate and then into an IND-ready asset, ultimately supporting progression toward clinical entry and Phase I testing.
What funding mechanism does this opportunity use?
This opportunity uses a cooperative agreement mechanism (U44), meaning NIH is expected to have substantial involvement beyond providing funding. Awardees participate in a networked development program with structured project management and access to NIH-supported expertise and infrastructure.
How is a cooperative agreement (U44) different from a typical grant?
Under a U44 cooperative agreement, NIH is substantially involved in the project. Applicants are not only receiving funds to use independently; they are joining a managed, milestone-driven development program that can include NIH-facilitated access to specialized drug development resources.
What types of projects does the program support?
The scope is focused on small-molecule therapeutics for disorders of the nervous system. Supported projects are expected to have a compelling biological rationale and credible starting chemistry, with the intent of advancing toward clinical testing.
Does the program support only neuroscience indications, or is the scope broader?
The program is focused on disorders of the nervous system, and the listing of CFDA numbers signals alignment with a broad range of nervous system-related areas (including mental health, addiction, alcohol research, child health, oral diseases and disorders, and complementary and integrative health research), as long as the project is fundamentally about developing a small-molecule intervention and moving it toward the clinic.
Who is eligible to apply?
Eligibility is limited to United States small business concerns (SBCs). The applicant must be a for-profit entity with a place of business in the U.S. and primarily operating in the U.S. (or contributing significantly to the U.S. economy), and must meet standard small business size and ownership rules.
Is there an employee limit for eligible small businesses?
Yes. The opportunity specifies that the small business must have no more than 500 employees, including affiliates.
Are specific ownership structures allowed under this opportunity?
Yes. The opportunity describes permissible ownership structures under SBIR/STTR rules, including majority ownership by U.S. citizens or permanent residents and, for SBIR in particular, certain venture capital, hedge fund, or private equity ownership configurations, as long as no single such entity owns more than 50 percent.
Can a joint venture apply?
Joint ventures can be eligible if they comply with the stated participation and registration requirements, including limits on foreign entity participation.
What are the two main entry points for projects?
Projects can enter through one of two tracks depending on maturity: the Discovery entry point or the Development entry point.
What is the Discovery entry point intended for?
The Discovery entry point is meant for teams with well-validated hit compounds that still need medicinal chemistry and related optimization to improve properties such as potency, selectivity, brain exposure, metabolic stability, and safety margins.
What is the Development entry point intended for?
The Development entry point is meant for teams that already have an advanced development candidate and are ready to progress through IND-enabling studies. This includes toxicology and CMC (chemistry, manufacturing, and controls) work needed to support an IND submission, followed by Phase I clinical testing.
Can a project that starts in Discovery continue into Development?
Yes. Projects beginning in Discovery can continue into the Development phase if they meet predefined milestones.
How does the milestone-driven approach work in this program?
The program is structured around clear, objective go/no-go criteria. Advancement is expected to be based on achieving predefined milestones that align with real-world drug development decision points.
What kinds of drug development capabilities can awardees access through the BPN network?
A key feature is access to NIH-funded consultants and contract research organizations (CROs) providing professional drug discovery and development services. These partners can support medicinal chemistry optimization, pharmacokinetics and ADME work, toxicology planning and execution, formulation development, GMP chemical synthesis, and Phase I clinical testing.
Does this opportunity fund work only at the awardee site, or can it also support outsourced studies?
The program is designed to provide both direct funding for work performed in the awardee's laboratory and access to an NIH-facilitated ecosystem that can execute specialized studies through experienced CROs.
What problem is the program trying to solve for small businesses?
The program is positioned to help small businesses bridge the "valley of death" between early discovery and clinical proof-of-concept, where costs increase and development becomes operationally complex.
Do awardees keep intellectual property (IP) rights to their drug candidates?
Yes. Participants retain intellectual property rights to drug candidates developed through the program, supporting commercialization and follow-on investment.
Is cost sharing or matching required?
No. The administrative details indicate there is no cost sharing or matching requirement.
Which agency administers this opportunity?
The administering agency is the National Institutes of Health (NIH).
What is the Funding Opportunity Number and when was it posted?
The opportunity was posted on July 22, 2014, and the Funding Opportunity Number is PAR 14-292.
Is this funding opportunity currently open?
No. The opportunity has closed and been archived. The original and current closing date was May 7, 2017, and the archive date was June 7, 2017.
What activity category is associated with this opportunity?
The activity category is listed under Education, Health, Income Security and Social Services.
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| Limited Competition Research Training for Career Development of Junior Faculty in Medical Education Partnership Initiative (MEPI) Institutions (D43) Apply for RFA TW 14 003 Funding Number: RFA TW 14 003 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $600,000 |
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| BRAIN Initiative New Technologies and Novel Approaches for Large Scale Recording and Modulation in the Nervous System (U01) Apply for RFA NS 15 003 Funding Number: RFA NS 15 003 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Optimization of Transformative Technologies for Large Scale Recording and Modulation in the Nervous System (U01) Apply for RFA NS 15 004 Funding Number: RFA NS 15 004 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Integrated Approaches to Understanding Circuit Function in the Nervous System (U01) Apply for RFA NS 15 005 Funding Number: RFA NS 15 005 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Planning for Next Generation Human Brain Imaging (R24) Apply for RFA MH 15 200 Funding Number: RFA MH 15 200 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $300,000 |
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| BRAIN Initiative Next Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH2/UH3) Apply for RFA NS 15 006 Funding Number: RFA NS 15 006 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Clinical Studies to Advance Next Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3) Apply for RFA NS 15 008 Funding Number: RFA NS 15 008 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $1,500,000 |
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