Opportunity Information: Apply for PAR 14 287
Apply for PAR 14 287
- 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 (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.)
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- 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 Discovery Track Optimization in Preparation for Development of Biotechnology Products and Biologics (U44) opportunity (Funding Opportunity Number PAR-14-287) was a National Institutes of Health program run through the National Institute of Neurological Disorders and Stroke (NINDS) to help small businesses move promising biologic-style therapies from early proof of concept into a much more development-ready state. It focuses specifically on therapeutic biotechnology products and biologics aimed at neurological disorders within the NINDS mission, including modalities such as peptides, proteins, oligonucleotides, gene therapies, and cell therapies. The core purpose of the FOA is not basic discovery for its own sake, but practical lead optimization: taking a lead or set of leads that already show convincing proof of concept and systematically improving them so that one optimized candidate emerges with properties that align with the intended clinical use.
This FOA used the U44 cooperative agreement mechanism, which generally indicates substantial programmatic involvement from NIH staff compared with a standard grant. In practice, that means awardees should expect active coordination with the NIH program team around milestones, go/no-go decisions, and development planning, with an emphasis on creating a credible package of data that supports the next stage of translational development. The overall arc of the Discovery Track described here is to produce an optimized candidate that is ready to enter the separate CREATE Bio Development track, where the work would continue toward IND-enabling studies and ultimately an Investigational New Drug (IND) application.
The work supported under this announcement centers on demonstrating that the optimized candidate has the kinds of attributes that typically determine whether a biologic therapy can realistically progress toward human testing. The FOA highlights characteristics such as sufficient bioactivity, stability, manufacturability, and bioavailability, as well as in vivo efficacy and/or target engagement. In other words, it is aimed at the engineering and validation steps that turn an interesting biological idea into something that looks and behaves like a viable therapeutic product: potent enough to matter, stable enough to store and deliver, manufacturable with a feasible process, and supported by animal or other in vivo data that show it hits the intended target and produces the desired therapeutic effect (or a convincing surrogate of effect). The endpoint is not an IND filing during this award, but a candidate positioned to enter the next CREATE Bio stage that is designed to enable IND submission.
Eligibility was limited to United States small business concerns (SBCs), reflecting the SBIR/STTR-oriented nature of the program. To qualify, an applicant needed to be a for-profit entity with a U.S. place of business and primary U.S. operations (or otherwise make a significant contribution to the U.S. economy), organized under common business forms such as an LLC or corporation. It also had to meet ownership and control requirements that accommodate traditional small businesses as well as certain venture-capital-backed structures permitted under SBIR rules, and it could not exceed 500 employees including affiliates. There was no cost sharing or matching requirement, which reduces barriers for early-stage companies that are still building capital.
From an administrative perspective, this was a discretionary funding opportunity in the health category, under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The FOA was posted July 18, 2014, and it ultimately closed May 7, 2017, with an archive date of June 7, 2017. The listed award ceiling was $500,000, indicating the program’s intent to fund focused, milestone-driven optimization efforts rather than large, open-ended development programs. The sponsoring agency was NIH, specifically NINDS, and the public listing provided a link to the full announcement on the NIH grants site along with NIH Office of Extramural Research (OER) webmaster contact information for access and technical issues.
In plain terms, this program was designed for small biotech companies that already have a biologic therapeutic concept with strong early proof of concept for a neurological indication, and now need targeted funding and NIH guidance to do the disciplined optimization work required to nominate a development candidate. The deliverable at the end is a well-characterized, optimized biologic candidate with credible evidence of activity and practical drug-like properties, positioned to move into the CREATE Bio Development track where the emphasis shifts to IND-enabling development and regulatory readiness.
FAQs: NINDS CREATE Bio Discovery Track Optimization (U44) - PAR-14-287
What is the NINDS CREATE Bio Discovery Track Optimization (U44) opportunity?
It was a National Institutes of Health (NIH) program run through the National Institute of Neurological Disorders and Stroke (NINDS) designed to help U.S. small businesses advance promising biologic-style therapies from early proof of concept into a more development-ready state through disciplined, milestone-driven optimization work.
What is the Funding Opportunity Number (FOA number) for this program?
The Funding Opportunity Number listed for this opportunity was PAR-14-287.
Which NIH institute sponsored the program?
The sponsoring institute was the National Institute of Neurological Disorders and Stroke (NINDS), within NIH.
What mechanism did this funding use, and what does it imply?
This opportunity used the U44 cooperative agreement mechanism. A cooperative agreement generally means NIH staff have substantial programmatic involvement compared with a standard grant, including active coordination on milestones, go/no-go decisions, and development planning.
What types of projects were a fit for this FOA?
This FOA was intended for projects that already had convincing proof of concept for a therapeutic biotechnology product or biologic aimed at a neurological disorder within the NINDS mission, and now needed practical lead optimization to produce a single optimized candidate aligned with the intended clinical use.
Is this program meant for basic discovery research?
No. The core purpose was not basic discovery for its own sake, but practical lead optimization: systematically improving a lead or set of leads that already demonstrate proof of concept so one optimized candidate emerges.
What kinds of therapeutic modalities were included?
The FOA focused on therapeutic biotechnology products and biologics, including modalities such as peptides, proteins, oligonucleotides, gene therapies, and cell therapies.
What disease area focus did the program target?
The focus was on neurological disorders within the NINDS mission.
What was the main goal or deliverable by the end of the Discovery Track?
The intended endpoint was an optimized biologic candidate that is well-characterized and positioned to enter the separate CREATE Bio Development track. The emphasis was on nominating an optimized candidate with properties aligned to the intended clinical use, supported by credible data.
Does the Discovery Track award support filing an IND by the end of the project?
No. The FOA description indicates the endpoint was not an IND filing during this award. Instead, the goal was to produce a candidate positioned to enter the next CREATE Bio stage designed to enable IND submission.
How does this Discovery Track relate to the CREATE Bio Development track?
The Discovery Track was described as the stage that optimizes and validates a candidate so it is ready to enter the CREATE Bio Development track, where work continues toward IND-enabling studies and ultimately an Investigational New Drug (IND) application.
What kinds of attributes was the FOA trying to optimize and demonstrate?
The FOA highlighted development-relevant characteristics such as sufficient bioactivity, stability, manufacturability, and bioavailability, along with in vivo efficacy and/or target engagement. The intent was to generate a credible package of data showing the candidate behaves like a viable therapeutic product.
What does "lead optimization" mean in the context of this FOA?
In this program, lead optimization meant taking a lead or set of leads with convincing proof of concept and systematically improving them so that one optimized candidate emerges with properties that support its intended clinical use (for example, potency and stability, feasibility of manufacturing, and supportive in vivo data).
What types of evidence did the FOA emphasize for showing a candidate is development-ready?
The announcement emphasized evidence that the optimized candidate has adequate bioactivity and practical, drug-like properties (including stability, manufacturability, and bioavailability), plus in vivo efficacy and/or in vivo target engagement to support progression toward human testing in the next stage.
Who was eligible to apply?
Eligibility was limited to United States small business concerns (SBCs), consistent with the SBIR/STTR-oriented nature of the program.
What business characteristics were required for eligibility as a small business concern (SBC)?
Based on the provided description, an eligible applicant needed to be a for-profit entity with a U.S. place of business and primary U.S. operations (or otherwise make a significant contribution to the U.S. economy), organized as a common business form such as an LLC or corporation, meeting applicable ownership and control requirements (including certain venture-capital-backed structures permitted under SBIR rules), and not exceeding 500 employees including affiliates.
Was cost sharing or matching required?
No. The opportunity did not require cost sharing or matching.
What was the maximum award amount mentioned?
The listing included an award ceiling of $500,000, reflecting an intent to support focused, milestone-driven optimization rather than large, open-ended development programs.
What CFDA number was associated with this program?
The opportunity was listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
What category was this discretionary funding opportunity listed under?
It was described as a discretionary funding opportunity in the health category.
When was the FOA posted, and when did it close?
The FOA was posted on July 18, 2014, and it ultimately closed on May 7, 2017. The archive date listed was June 7, 2017.
What kind of involvement should an awardee expect from NIH during the project?
Because it used a U44 cooperative agreement, awardees should expect active coordination with the NIH program team, including alignment on milestones, go/no-go decisions, and development planning, with an emphasis on building a credible data package for the next stage of translational development.
Who was the sponsoring agency, and where could applicants find the full announcement?
The sponsoring agency was NIH (specifically NINDS). The public listing referenced a link to the full announcement on the NIH grants site.
Who was listed as a contact for access or technical issues?
The public listing referenced NIH Office of Extramural Research (OER) webmaster contact information for access and technical issues.
What kind of company was this program designed to help, in plain terms?
It was designed for small biotech companies that already have a biologic therapeutic concept with strong early proof of concept for a neurological indication and now need targeted funding and NIH guidance to perform the optimization work required to nominate a development candidate.
What would success look like at the end of this award?
Success would look like an optimized biologic candidate with credible evidence of activity and practical development properties (such as stability and manufacturability), supported by in vivo efficacy and/or target engagement, and positioned to move into the CREATE Bio Development track for IND-enabling development and regulatory readiness.
Browse more opportunities from the same agency: National Institutes of Health
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Next opportunity: NINDS CREATE Bio Development Track Preclinical and Early phase Clinical Development for Biotechnology Products and Biologics (U44)
Previous opportunity: NINDS CREATE Bio Discovery Track Optimization in Preparation for Development of Biotechnology Products and Biologics (U01)
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