Opportunity Information: Apply for PAR 14 288
Apply for PAR 14 288
- 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 (UH2/UH3)" 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: Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Small businesses Native American tribal governments (Federally recognized) City or township governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NINDS CREATE Bio Development Track (UH2/UH3) grant opportunity (PAR-14-288) is a National Institutes of Health cooperative agreement designed to move promising biotechnology-based therapeutics and biologics toward the clinic for diseases and conditions within the mission of the National Institute of Neurological Disorders and Stroke (NINDS). The program is centered on translational development rather than basic discovery, meaning it is meant for teams that already have a defined therapeutic candidate in hand and are ready to perform the kinds of rigorous studies needed to support an FDA filing and, potentially, first-in-human testing. It specifically targets biotechnology products and biologics such as peptides and proteins, oligonucleotides, gene therapies, and cell therapies, reflecting an emphasis on modalities that often require specialized manufacturing, analytics, and regulatory planning to reach clinical readiness.
A key entry requirement is that applicants must have an identified candidate that already demonstrates properties consistent with the intended clinical use. In practical terms, NINDS is looking for a lead therapeutic that has convincing evidence of bioactivity and a feasible path to development, including acceptable stability, manufacturability, and bioavailability, plus supportive in vivo efficacy data and/or clear target engagement. The intent is to avoid funding projects that are still selecting a lead or are too early to credibly plan IND-enabling work. This also signals that the program expects a development plan that looks like a real preclinical-to-clinic roadmap, including product characterization, dose and route rationale, and a realistic understanding of development risks and how they will be managed.
The scope of work supported by the FOA includes IND-enabling preclinical studies for the candidate and can extend into early phase clinical trials. IND-enabling activities typically include the package of pharmacology, toxicology, safety, and chemistry/manufacturing/controls (CMC) work required for an Investigational New Drug application to the U.S. Food and Drug Administration. While the announcement does not enumerate each study type in the summary text provided, the overall purpose is clear: generate the data and documentation needed to justify human testing and to meet regulatory expectations for initiating clinical studies. Importantly, the FOA allows support for early phase clinical trials, but it does not make a clinical trial mandatory; the minimum endpoint for a successful project is submission of an IND application to FDA by the end of the award period.
This opportunity uses the UH2/UH3 mechanism, which is commonly structured as a phased cooperative agreement. In this format, the early phase (UH2) is typically used to complete specific, time-sensitive, and milestone-driven development activities, and the later phase (UH3) supports advancement into the next stage once predefined milestones are met. Because it is a cooperative agreement rather than a standard grant, applicants should expect substantial NIH program involvement during the life of the project, often including milestone oversight, regular progress reviews, and coordination around development decisions that affect the likelihood of reaching an IND and initiating clinical evaluation.
Eligibility is broad and includes academic institutions, nonprofit organizations, for-profit organizations (including small businesses and other for-profits), and multiple levels of government entities. The FOA also permits applications from non-U.S. entities and foreign institutions, as well as non-U.S. components of U.S. organizations, and allows foreign components as defined by the NIH Grants Policy Statement. Additional eligible applicant categories listed include HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and other minority-serving institutions, along with faith-based and community-based organizations and eligible federal agencies. There is no cost sharing or matching requirement stated for this opportunity.
Administratively, the opportunity is categorized as discretionary funding and falls under the health funding activity area, with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The FOA was posted and created on July 18, 2014, had an original and current closing date of May 7, 2017, and was archived on June 7, 2017. Although it is archived and therefore not currently open under those dates, it remains a useful reference point for understanding how NINDS structured its CREATE Bio Development Track program and what it expected of applicants pursuing biologics development toward IND submission and early clinical testing. The full announcement was hosted at grants.nih.gov under the provided link, and the NIH Office of Extramural Research webmaster contacts were provided for access or technical issues.
FAQs: NINDS CREATE Bio Development Track (UH2/UH3) - PAR-14-288
What is the NINDS CREATE Bio Development Track (UH2/UH3) opportunity?
It is a National Institutes of Health (NIH) cooperative agreement run by the National Institute of Neurological Disorders and Stroke (NINDS) to advance biotechnology-based therapeutics and biologics toward the clinic for diseases and conditions within the NINDS mission. The focus is translational development (preclinical-to-clinical readiness), not basic discovery.
What is the main goal of the program?
The program is designed to support the rigorous development work needed to enable an FDA filing (specifically an Investigational New Drug, or IND, application) and, potentially, to move into early phase clinical testing. A stated minimum endpoint for a successful project is submission of an IND application to the U.S. Food and Drug Administration (FDA) by the end of the award period.
Is this program intended for basic research or discovery of new targets?
No. The program is centered on translational development rather than basic discovery. It is intended for teams that already have a defined therapeutic candidate and are prepared to conduct IND-enabling development studies.
What kinds of products does this FOA target?
It specifically targets biotechnology products and biologics, including modalities such as peptides and proteins, oligonucleotides, gene therapies, and cell therapies. The emphasis reflects that these modalities often require specialized manufacturing, analytics, and regulatory planning to reach clinical readiness.
Do applicants need to have a therapeutic candidate already identified?
Yes. A key entry requirement is an identified candidate that already demonstrates properties consistent with the intended clinical use. The program is not meant for projects that are still selecting a lead candidate or are too early to credibly plan IND-enabling work.
What does NINDS expect to see about the candidate's readiness?
NINDS is looking for a lead therapeutic with convincing evidence of bioactivity and a feasible path to development. The summary information describes expectations such as acceptable stability, manufacturability, and bioavailability, plus supportive in vivo efficacy data and/or clear target engagement.
What types of activities can be supported under this opportunity?
The scope includes IND-enabling preclinical studies and may extend into early phase clinical trials. IND-enabling activities generally include the pharmacology, toxicology, safety, and chemistry/manufacturing/controls (CMC) work needed for an IND submission to FDA.
Are clinical trials required under this FOA?
No. Early phase clinical trials are allowed, but a clinical trial is not mandatory. The minimum endpoint described is submission of an IND application to FDA by the end of the award period.
What is an IND-enabling package in the context of this program?
Based on the summary provided, IND-enabling work refers to the set of preclinical and CMC activities used to support an Investigational New Drug application to FDA. The summary does not enumerate every study type, but it indicates the overall purpose is to generate the data and documentation needed to justify initiating human testing and meet regulatory expectations.
What does the UH2/UH3 mechanism mean for applicants?
The opportunity uses a phased cooperative agreement mechanism. The early phase (UH2) is typically used for specific, time-sensitive, milestone-driven development activities, and the later phase (UH3) supports advancement to the next stage once predefined milestones are achieved.
How is a cooperative agreement different from a standard NIH grant for this program?
Because it is a cooperative agreement, applicants should expect substantial NIH program involvement during the project. The summary describes involvement such as milestone oversight, regular progress reviews, and coordination around development decisions tied to reaching an IND and potentially initiating clinical evaluation.
What kinds of plans should an application include to fit this program?
The summary indicates the program expects a realistic preclinical-to-clinic roadmap, including product characterization, dose and route rationale, and a clear understanding of development risks and how those risks will be managed.
Who is eligible to apply?
Eligibility is broad and includes academic institutions, nonprofit organizations, for-profit organizations (including small businesses and other for-profits), and government entities at multiple levels. Additional eligible categories listed include HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, other minority-serving institutions, faith-based and community-based organizations, and eligible federal agencies.
Are non-U.S. (foreign) organizations eligible?
Yes. The FOA permits applications from non-U.S. entities and foreign institutions, as well as non-U.S. components of U.S. organizations. It also allows foreign components as defined by the NIH Grants Policy Statement.
Is cost sharing or matching required?
No cost sharing or matching requirement is stated in the information provided.
What is the funding type and activity area for this opportunity?
The opportunity is categorized as discretionary funding and falls under the health funding activity area.
What is the CFDA number associated with this program?
The CFDA number listed is 93.853, titled Extramural Research Programs in the Neurosciences and Neurological Disorders.
Is this funding opportunity currently open?
No. The information provided states the FOA was posted/created on July 18, 2014, had an original and current closing date of May 7, 2017, and was archived on June 7, 2017. As archived, it is not currently open under those dates.
Why might this archived FOA still be useful?
Even though it is archived, it can serve as a reference for how NINDS structured its CREATE Bio Development Track and what it expected from applicants developing biologics toward IND submission and early clinical testing.
Where was the full announcement hosted?
The full announcement was hosted at grants.nih.gov under the provided link in the original listing.
Who was listed for help with access or technical issues?
The NIH Office of Extramural Research webmaster contacts were provided for access or technical issues.
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