Opportunity Information: Apply for PAR 14 289
Apply for PAR 14 289
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS CREATE Bio Development Track Preclinical and Early phase Clinical Development for Biotechnology Products and Biologics (U44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Jul 18, 2014 and posted on Jul 18, 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 NINDS CREATE Bio Development Track (U44) grant opportunity, Funding Opportunity Number PAR 14-289, was a National Institutes of Health program designed to help move promising biotechnology-based therapeutics for neurological disorders from late preclinical development into IND-enabling work and, when appropriate, into early clinical testing. It specifically targeted products that fall under the mission of the National Institute of Neurological Disorders and Stroke (NINDS), and it focused on therapeutics that are considered biotechnology products or biologics rather than small-molecule drugs. Examples named in the announcement include peptides, proteins, oligonucleotides, gene therapies, and cell therapies, which reflects an emphasis on modern therapeutic modalities often requiring specialized manufacturing, analytics, and regulatory planning.
A core expectation of this FOA was that applicants could not be at the concept stage. To enter the CREATE Bio Development Track, a project needed to already have an identified therapeutic candidate with a credible foundation of supporting data. In practical terms, NINDS was looking for a lead candidate that had already demonstrated key “drug-like†properties aligned with its intended clinical use, such as adequate bioactivity, stability, manufacturability, and bioavailability, along with convincing in vivo efficacy and/or evidence of target engagement. The program was meant to fund the expensive and operationally complex work that comes after a candidate is chosen, when developers need to confirm readiness for human testing through rigorous safety, pharmacology, chemistry/manufacturing/controls (CMC), and other regulatory-aligned studies.
The supported scope centered on IND-enabling activities and early-phase clinical development. IND-enabling studies typically include the package of nonclinical safety assessments, dose-ranging toxicology, biodistribution or immunogenicity work when relevant, and the CMC development needed to consistently produce the therapeutic under appropriate quality standards, as well as the development of assays and release criteria. The FOA also allowed support for early phase clinical trials, but it made clear that running a clinical trial was not mandatory for a successful application. The key endpoint NINDS wanted to see by the end of the award was, at minimum, submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). That emphasis signals that the program’s purpose was translational: reducing the gap between academic-style proof-of-concept results and the regulatory-grade evidence required to begin testing in humans.
Structurally, the award mechanism was a U44 cooperative agreement, which generally indicates more substantial NIH programmatic involvement than a typical grant. The cooperative agreement format is often used for milestone-driven development programs where the agency expects active coordination, progress tracking, and alignment with product development and regulatory expectations. The funding instrument sat in the “Health†activity category and was tied to CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The opportunity did not require cost sharing or matching funds, lowering the barrier for small companies that may not yet have significant revenue.
Eligibility was limited to U.S. small business concerns (SBCs), consistent with SBIR/STTR-style requirements for company size and U.S. economic presence. To qualify, an applicant had to be a for-profit entity with a place of business in the United States and generally operating primarily in the U.S. (or otherwise making a significant contribution to the U.S. economy through taxes or use of American labor/materials). It also needed to fit an allowable legal structure (such as an LLC or corporation), meet ownership and control rules that account for individual U.S. citizen/permanent resident ownership or certain venture-backed ownership structures (with specific limits on any single investment entity’s ownership), and have no more than 500 employees including affiliates. In other words, this FOA was not open to universities applying directly as the prime applicant, nor to large pharmaceutical companies; it was aimed at small businesses positioned to function like product developers and to take responsibility for manufacturing and regulatory deliverables.
Administratively, the FOA was posted and created on July 18, 2014, with an original and final closing date of May 7, 2017, and it was archived on June 7, 2017. The sponsoring agency was NIH, and the public listing pointed applicants to the full announcement on the NIH Grants Guide website. Contact details included the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues, which is typical for archived FOAs.
In summary, PAR 14-289 represented a targeted, milestone-oriented pathway for U.S. small biotech companies developing neurologically focused biologics to complete the practical work needed for FDA readiness. The program’s defining features were (1) a requirement for a well-characterized therapeutic candidate at entry, (2) support for IND-enabling development with optional early clinical studies, and (3) an expectation that the project would culminate in an IND submission, positioning the product for first-in-human evaluation and further clinical advancement.
FAQs: NINDS CREATE Bio Development Track (U44) - PAR 14-289
What is the NINDS CREATE Bio Development Track (U44) program?
It was a National Institutes of Health (NIH) program run by the National Institute of Neurological Disorders and Stroke (NINDS) to help advance promising biotechnology-based therapeutics for neurological disorders from late preclinical development into IND-enabling work and, when appropriate, into early clinical testing.
What is the Funding Opportunity Number for this grant?
The Funding Opportunity Number (FOA) was PAR 14-289.
What types of therapeutics did this FOA focus on?
The FOA focused on biotechnology products/biologics rather than small-molecule drugs. Examples cited included peptides, proteins, oligonucleotides, gene therapies, and cell therapies.
What disease area or scientific mission did projects need to align with?
Projects needed to fall under the mission of NINDS, meaning they had to target neurological disorders within NINDS program priorities.
Was this program intended for concept-stage ideas?
No. Applicants were expected to be beyond the concept stage and to enter the program with an identified therapeutic candidate supported by credible data.
What did NINDS expect applicants to already have at the time of application?
NINDS expected an identified lead therapeutic candidate with a solid foundation of supporting data and key drug-like properties relevant to the intended clinical use. Examples mentioned included adequate bioactivity, stability, manufacturability, and bioavailability, plus convincing in vivo efficacy and/or evidence of target engagement.
What development stage did this FOA support?
It supported the expensive and operationally complex development work that typically occurs after a candidate is selected, focused on preparing a product for regulatory submission and potential first-in-human testing.
What are "IND-enabling" activities in the context of this opportunity?
IND-enabling activities generally referred to the nonclinical and CMC (chemistry, manufacturing, and controls) work needed to support an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The description included nonclinical safety assessments, dose-ranging toxicology, and studies such as biodistribution or immunogenicity when relevant, along with CMC development, assays, and release criteria.
Did the FOA allow clinical trials?
Yes. The FOA allowed support for early phase clinical trials, but it also made clear that conducting a clinical trial was not required for a successful application.
Was submitting an IND required as an endpoint?
Yes. The key endpoint NINDS wanted to see by the end of the award was, at minimum, submission of an IND application to FDA.
What does the U44 mechanism mean for applicants?
The award used a U44 cooperative agreement mechanism, which generally implies substantial NIH programmatic involvement compared to a standard grant. It is commonly used for milestone-driven development programs with active coordination, progress tracking, and alignment to product development and regulatory expectations.
Which NIH institute sponsored this opportunity?
The sponsoring agency was NIH, with the program specifically tied to NINDS.
What activity category was this funding listed under?
The activity category was listed as Health.
What CFDA number was associated with this opportunity?
The FOA was tied to CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
Was cost sharing or matching funding required?
No. The opportunity did not require cost sharing or matching funds.
Who was eligible to apply as the prime applicant?
Eligibility was limited to U.S. small business concerns (SBCs). Applicants needed to be for-profit entities with a place of business in the United States and generally operating primarily in the U.S. (or otherwise making a significant contribution to the U.S. economy through taxes or use of American labor/materials).
Were universities eligible to apply directly as the prime applicant?
No. The description indicates this FOA was not open to universities applying directly as the prime applicant.
Were large pharmaceutical companies eligible to apply?
No. The FOA was aimed at small businesses and not large pharmaceutical companies.
What company size limits applied?
To qualify as an eligible small business concern under this FOA, the company needed to have no more than 500 employees, including affiliates.
Did the FOA include ownership and control requirements?
Yes. Eligibility included meeting ownership and control rules, including individual U.S. citizen/permanent resident ownership or certain venture-backed ownership structures, with specific limits on any single investment entity's ownership.
When was PAR 14-289 posted and when did it close?
The FOA was posted/created on July 18, 2014. The original and final closing date was May 7, 2017. It was archived on June 7, 2017.
Where was the full announcement hosted?
The public listing pointed applicants to the full announcement on the NIH Grants Guide website.
Who was listed as a contact for technical access or linking issues?
The contact details included the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues, which is typical for archived FOAs.
What was the overall purpose of PAR 14-289?
The purpose was to provide a milestone-oriented pathway for U.S. small biotech companies developing neurologically focused biologics to complete the work needed for FDA readiness, emphasizing an identified candidate at entry, IND-enabling development (with optional early clinical studies), and culminating in an IND submission.
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