Opportunity Information: Apply for PAR 08 235
Apply for PAR 08 235
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Cooperative Program in Translational Research Small Business Awards (SBIR 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 Jan 26, 2009 and posted on Aug 12, 2008.
- Applicants must submit their applications by Sep 7, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The NINDS Cooperative Program in Translational Research Small Business Awards (SBIR U44), Funding Opportunity Number PAR 08-235, is a National Institutes of Health grant opportunity designed specifically for small businesses that are ready to move a neuroscience therapeutic concept through the late preclinical stage and toward entry into human testing. The core aim is translational: it supports projects that identify and carry out preclinical testing of new therapeutics for neurological disorders, with the explicit intent of accelerating the path from promising research findings to therapeutic candidates that are mature enough to be considered for clinical evaluation.
A key feature of this program is that it is not meant for very early discovery work. Applicants are expected to come in with a therapeutic lead that already has demonstrated activity against the intended disease target, meaning there should be credible evidence the candidate does something relevant to the biology of the disorder. The funding is then focused on what usually sits between an initial hit/lead and a clinical trial-ready product: preclinical optimization and rigorous preclinical testing. In practical terms, this can include activities such as refining the therapeutic candidate, establishing or improving formulation, completing pharmacology and toxicology packages, running proof-of-concept studies in appropriate models, and generating the kinds of data required to support regulatory interactions.
The program is structured around a clear endpoint: the work must be sufficiently advanced by the end of the award period that the company could submit an IND (Investigational New Drug) or IDE (Investigational Device Exemption) application to the U.S. Food and Drug Administration. That expectation signals that NINDS is looking for projects with a realistic and well-mapped regulatory path, including defined development steps and the ability to produce the documentation and study results that regulators typically require before first-in-human studies can begin.
Several categories of work are explicitly out of scope. The announcement emphasizes that it does not support early-stage therapeutic discovery activities such as high-throughput screening. It also excludes clinical research, basic research, and studies primarily aimed at understanding disease mechanisms. In other words, the program is not intended to fund exploratory biology or hypothesis-generating studies; it is meant to fund development work that is directly tied to advancing a therapeutic candidate toward clinical readiness.
In terms of funding mechanism, this opportunity uses the SBIR Cooperative Agreement (U44) for Phase II and Fast Track applications. The cooperative agreement aspect matters because it implies active involvement from NINDS staff beyond what is typical for a standard grant. The program is milestone-driven, and NINDS staff participate in shaping the project plan and monitoring progress. This generally means applicants should expect to propose measurable, go/no-go milestones, agree to regular progress tracking, and be prepared for substantive programmatic engagement aimed at keeping the development effort aligned with translational goals and timelines.
Awards are contingent on the availability of funds and on receiving a sufficient number of strong applications. The total dollars awarded and the number of awards are not fixed in advance and will vary depending on the quality of the proposals, the length of the proposed project periods, and the budgets requested. The opportunity was posted August 12, 2008, with an original and final closing date of September 7, 2011, and it is now archived (archive date October 8, 2011). The Catalog of Federal Domestic Assistance listing associated with the program is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), and the eligible applicant pool is limited to small businesses, consistent with SBIR requirements.
FAQs: NINDS Cooperative Program in Translational Research Small Business Awards (SBIR U44)
What is this funding opportunity?
This is a National Institutes of Health (NIH) grant opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) called the Cooperative Program in Translational Research Small Business Awards (SBIR U44). The Funding Opportunity Number is PAR 08-235.
What is the main purpose of the program?
The program is designed to help small businesses move a neuroscience therapeutic concept through late preclinical development and toward entry into human testing. Its central goal is translational: supporting preclinical testing and development work that accelerates promising therapeutic leads toward clinical evaluation readiness.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with SBIR requirements.
What stages of development does this program support?
The program supports late preclinical development work, specifically the stage between having a therapeutic lead and being ready to begin human testing. It is intended for projects that already have a credible therapeutic lead and now need the optimization and preclinical package needed for regulatory consideration.
Does the program support very early discovery research?
No. The program is explicitly not meant for very early discovery activities. Applicants are expected to begin with a therapeutic lead that has already demonstrated activity against the intended disease target.
What does NINDS expect applicants to have before applying?
Applicants are expected to have a therapeutic lead with demonstrated activity relevant to the intended disease target. In other words, there should be credible evidence that the candidate has an effect tied to the biology of the neurological disorder being addressed.
What types of activities can be supported under this program?
Supported work is focused on preclinical optimization and rigorous preclinical testing needed to advance a therapeutic candidate toward clinical readiness. Examples described in the opportunity include refining the therapeutic candidate, establishing or improving formulation, completing pharmacology and toxicology packages, conducting proof-of-concept studies in appropriate models, and generating data typically required to support regulatory interactions.
What is the expected endpoint by the end of the award period?
By the end of the award period, the project is expected to be sufficiently advanced that the company could submit an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA).
Why is IND/IDE readiness emphasized?
The IND/IDE expectation signals that NINDS is looking for projects with a realistic and well-mapped regulatory path, including defined development steps and the ability to produce the documentation and study outcomes that regulators generally require before first-in-human studies can begin.
What work is explicitly out of scope?
The opportunity states that it does not support early-stage therapeutic discovery activities such as high-throughput screening. It also excludes clinical research, basic research, and studies primarily aimed at understanding disease mechanisms.
Does this program fund clinical trials or other clinical research?
No. Clinical research is explicitly excluded. The program is focused on preclinical development activities that prepare a therapeutic candidate for potential entry into human testing, not on conducting human studies.
Is basic research or disease mechanism research allowed?
No. The announcement excludes basic research and studies primarily aimed at understanding disease mechanisms. The intent is not exploratory biology or hypothesis-generating work, but development work directly tied to advancing a therapeutic candidate toward clinical readiness.
What funding mechanism is used?
This opportunity uses the SBIR Cooperative Agreement (U44) mechanism for Phase II and Fast Track applications.
What does it mean that this is a cooperative agreement (U44)?
A cooperative agreement implies active involvement from NINDS staff beyond what is typical for a standard grant. NINDS staff participate in shaping the project plan and monitoring progress, with an emphasis on keeping the development effort aligned with translational goals and timelines.
Are projects milestone-driven?
Yes. The program is milestone-driven. Applicants should expect to propose measurable, go/no-go milestones, agree to regular progress tracking, and be prepared for substantive programmatic engagement from NINDS.
How are awards and funding amounts determined?
Awards are contingent on the availability of funds and the receipt of a sufficient number of strong applications. The total dollars awarded and the number of awards are not fixed in advance and may vary based on application quality, proposed project period length, and requested budgets.
Is this funding opportunity still open?
No. The opportunity is archived. It was posted on August 12, 2008, had an original and final closing date of September 7, 2011, and an archive date of October 8, 2011.
What is the associated CFDA number?
The associated Catalog of Federal Domestic Assistance (CFDA) listing is 93.853, titled Extramural Research Programs in the Neurosciences and Neurological Disorders.
What kinds of projects fit best with this program?
Projects that fit best are those where a small business has a therapeutic lead with demonstrated target-relevant activity and needs support for the late preclinical work required to reach a point where an IND or IDE submission could be made. The focus is on development, optimization, and preclinical evidence generation that directly supports clinical entry readiness.
What kinds of projects are unlikely to be a good fit?
Projects focused on early discovery (such as high-throughput screening), clinical research, basic research, or primarily on understanding disease mechanisms are described as out of scope for this program.
Does NINDS involvement affect how a project should be planned?
Yes. Because this is a cooperative agreement with active NINDS participation, project plans should be structured around clear, measurable milestones and a practical translational path, with the expectation of ongoing monitoring and programmatic engagement.
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