Opportunity Information: Apply for PAR 14 286
Apply for PAR 14 286
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS CREATE Bio Discovery Track Optimization in Preparation for Development of Biotechnology Products and Biologics (U01)" 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) Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) County governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Public and State controlled institutions of higher education Private institutions of higher education State governments Native American tribal governments (Federally recognized) Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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 Discovery Track Optimization in Preparation for Development of Biotechnology Products and Biologics (U01) grant opportunity (Funding Opportunity Number PAR-14-286) was a National Institutes of Health (NIH) cooperative agreement designed to move promising biologic-style therapeutics from an early proof-of-concept stage into a more development-ready state. Its central purpose was to support projects focused on neurological disorders within the mission of the National Institute of Neurological Disorders and Stroke (NINDS), specifically targeting the "optimization" phase where an initial therapeutic lead has already shown convincing activity and now needs to be engineered and refined into a candidate that is realistically suitable for downstream development.
This FOA was aimed at therapeutic modalities broadly categorized as biotechnology products and biologics, including (but not limited to) peptides, proteins, oligonucleotides, gene therapies, and cell therapies. Rather than funding basic discovery work or exploratory biology alone, it focused on the practical, translational steps required to improve a lead into an optimized candidate. That optimization emphasis typically includes improving bioactivity and functional potency, enhancing stability (for example, resistance to degradation or improved shelf-life), and ensuring the therapy has properties that fit the intended clinical use. It also highlights manufacturability, which points to real-world feasibility such as scalable production, reproducible quality, and compatibility with standard manufacturing approaches for biologics. In addition, the FOA called out bioavailability and in vivo efficacy and/or target engagement, signaling that applicants were expected to generate data showing the therapy reaches the relevant tissue, interacts with the intended biological target in an organism, and produces measurable therapeutic effects in appropriate models.
A key feature of the program was its role as an entry point into a larger development pipeline: the expectation was that, by the end of the award, successful projects would be positioned to transition into the CREATE Bio Development track. In practical terms, that means the Discovery Track was intended to deliver an optimized candidate with a convincing package of properties aligned with clinical translation, so that subsequent work could focus on the remaining development steps needed to support an Investigational New Drug (IND) application. The FOA was explicit that the end state should be a candidate "ready for entry" into the Development track, which implies that projects needed to plan their milestones around generating decision-quality evidence of readiness rather than stopping at incremental improvements.
Administratively, this opportunity was offered as a discretionary funding program using the U01 mechanism, which is a cooperative agreement. Compared with a standard research project grant, a cooperative agreement generally implies substantial scientific and/or programmatic involvement from the funding agency during the project, often through milestone-driven management, regular progress interactions, and coordination with NINDS program staff. The activity category fell under health, and the CFDA listing associated with it was 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The announcement was posted on July 18, 2014, with an original and final closing date of May 7, 2017, and it was archived on June 7, 2017.
Eligibility was broad and included a wide range of U.S.-based entities such as public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) organizations), small businesses, for-profit organizations other than small businesses, and multiple levels of government (state, county, city/township, special district). It also explicitly included various institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), and other minority-serving institutions. Importantly, the FOA allowed participation by non-U.S. entities as well: foreign organizations and foreign institutions were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components as defined by NIH policy were allowed. There was no cost sharing or matching requirement listed for applicants.
For those seeking the official announcement text and details that typically include application instructions, review criteria, and any milestone or program-specific requirements, the FOA directed applicants to the NIH Grants Guide page at http://grants.nih.gov/grants/guide/pa-files/PAR-14-286.html. For access issues or linking problems, the contact listed was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
FAQs: NINDS CREATE Bio Discovery Track Optimization (U01) - PAR-14-286
What is the NINDS CREATE Bio Discovery Track Optimization in Preparation for Development of Biotechnology Products and Biologics (U01) opportunity?
It was a National Institutes of Health (NIH) cooperative agreement funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) intended to move promising biologic-style therapeutics from early proof-of-concept into a more development-ready state by focusing on optimization work.
What is the Funding Opportunity Number (FOA number) for this program?
The Funding Opportunity Number was PAR-14-286.
What stage of research and development was this FOA designed to support?
This FOA focused on the optimization phase, where an initial therapeutic lead has already shown convincing activity and needs to be engineered and refined into a candidate that is realistically suitable for downstream development.
Was this program intended to fund basic discovery research?
No. Based on the description provided, it was not aimed at basic discovery work or exploratory biology alone. It emphasized practical, translational optimization steps to improve a lead into an optimized candidate.
What types of therapeutics or modalities were in scope?
The FOA targeted biotechnology products and biologics, including (but not limited to) peptides, proteins, oligonucleotides, gene therapies, and cell therapies.
What disease or scientific area did projects need to address?
Projects were expected to focus on neurological disorders within the mission of NINDS.
What does "optimization" mean in the context of this FOA?
Optimization referred to engineering and refining an existing therapeutic lead to improve properties relevant to development and eventual clinical use. Examples called out include improving bioactivity and functional potency, enhancing stability (such as resistance to degradation or improved shelf-life), and ensuring the therapy has properties that fit the intended clinical use.
Did the FOA emphasize manufacturability?
Yes. It highlighted manufacturability and real-world feasibility considerations such as scalable production, reproducible quality, and compatibility with standard manufacturing approaches for biologics.
Were applicants expected to generate in vivo data?
Yes. The FOA called out bioavailability and in vivo efficacy and/or target engagement, indicating an expectation for data showing the therapy reaches relevant tissue, interacts with the intended biological target in an organism, and produces measurable therapeutic effects in appropriate models.
What was the intended end result by the end of the award?
The stated goal was to deliver an optimized candidate ready for entry into the CREATE Bio Development track, implying a package of decision-quality evidence of readiness rather than only incremental improvements.
How does this FOA relate to the CREATE Bio Development track?
The Discovery Track served as an entry point into a larger development pipeline, with the expectation that successful projects would transition into the CREATE Bio Development track after producing an optimized candidate aligned with clinical translation.
What grant mechanism was used?
It used the U01 mechanism, which is a cooperative agreement.
What does it mean that this was a cooperative agreement (U01)?
A cooperative agreement generally implies substantial scientific and/or programmatic involvement from the funding agency during the project, often including milestone-driven management, regular progress interactions, and coordination with NINDS program staff.
What is the CFDA number associated with this opportunity?
The CFDA listing associated with it was 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
What was the activity category?
The activity category fell under health.
When was the announcement posted?
The announcement was posted on July 18, 2014.
What were the closing dates for applications?
The original and final closing date was May 7, 2017.
Is this funding opportunity still active?
No. It was archived on June 7, 2017.
Who was eligible to apply within the United States?
Eligibility was broad and included public and private institutions of higher education; nonprofits (including 501(c)(3) and non-501(c)(3) organizations); small businesses; for-profit organizations other than small businesses; and multiple levels of government (state, county, city/township, and special district).
Were minority-serving institutions specifically included?
Yes. The FOA explicitly included Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), and other minority-serving institutions.
Could foreign organizations apply?
Yes. Foreign organizations and foreign institutions were eligible to apply. In addition, non-U.S. components of U.S. organizations were eligible, and foreign components as defined by NIH policy were allowed.
Was cost sharing or matching required?
No cost sharing or matching requirement was listed.
Where could applicants find the official FOA text and detailed instructions?
The FOA directed applicants to the NIH Grants Guide page: http://grants.nih.gov/grants/guide/pa-files/PAR-14-286.html
Who could be contacted for access issues or linking problems with the FOA page?
The contact listed was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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