Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Cerebroprotection- Interventions from Small Businesses (U44 Clinical Trial Not Allowed) | RFA NS 22 033

Frequently Asked Questions (FAQs)

What is the Stroke Preclinical Assessment Network (SPAN) funding opportunity?

It is a National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS) funding opportunity titled "The Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Cerebroprotection - Interventions from Small Businesses (RFA-NS-22-033)." It supports preclinical stroke therapy development through a coordinated testing network.

What funding mechanism does SPAN use?

This opportunity uses a cooperative agreement mechanism, specifically U44, to support Phase II SBIR projects.

Is this a Phase I or Phase II SBIR opportunity?

It is focused on Phase II SBIR projects.

What is the central goal of this FOA?

The central goal is to move the most promising acute cerebroprotective interventions closer to human testing by evaluating them through rigorous, standardized, and parallel preclinical studies in well-established experimental models of ischemic stroke.

Does this funding opportunity support clinical trials?

No. The FOA is explicitly not for clinical trials. Its purpose is to strengthen and de-risk the preclinical evidence base so that only the strongest candidates advance toward later-stage clinical development.

What kinds of interventions are intended to be supported and evaluated?

The interventions of interest include cerebroprotective drugs, biologics, devices, or other strategies intended to protect brain tissue during an ischemic stroke, especially when administered before reperfusion or around the time blood flow is restored.

What does "acute cerebroprotection" mean in the context of this program?

In this context, acute cerebroprotection refers to interventions designed to reduce brain injury during an ischemic stroke and/or around the time reperfusion occurs, when blood flow is restored and additional injury can occur.

Why does the FOA emphasize timing around reperfusion?

Because modern stroke care increasingly relies on reperfusion therapies (such as thrombectomy and thrombolysis), and there is a major clinical need for add-on treatments that can limit injury during and after restoration of blood flow. The FOA therefore highlights interventions given before or near reperfusion.

What preclinical stroke models are highlighted?

The FOA highlights experimental ischemic stroke paradigms such as transient middle cerebral artery occlusion (tMCAo), a model that mimics arterial blockage followed by reperfusion and allows study of both ischemic damage and reperfusion-related injury.

How is SPAN structured as a program?

SPAN is designed as a coordinated, multi-site preclinical testing network that can evaluate up to eight interventions, using shared protocols, harmonized outcome measures, and coordinated project management to enable parallel evaluation across sites.

How many interventions can the SPAN network evaluate?

The network is designed to evaluate up to eight interventions.

Do awardees work independently, or as part of a consortium?

Awardees are expected to become part of the SPAN consortium and collaborate closely with other SPAN components rather than operating in isolation.

Who are the main SPAN partner components that awardees are expected to collaborate with?

Successful applicants are expected to collaborate with (1) the SPAN Coordinating Center (supported under RFA-NS-22-004), (2) the network testing laboratories (supported under RFA-NS-22-003), and (3) other intervention contributors (RFA-NS-22-032).

What is the purpose of having a Coordinating Center and multiple testing laboratories?

The stated intent is to make evaluation more efficient and more credible by using shared protocols, coordinated project management, and harmonized outcome measures across sites, while testing multiple candidate therapies in parallel.

What does it mean that this is a "cooperative agreement" (U44)?

Because it is a cooperative agreement, NIH and network leadership typically have substantial involvement in shaping milestones, coordinating work across the network, and ensuring the studies meet agreed-upon rigor and transparency expectations.

What stage of development should an applicant's intervention be at?

Applicants are expected to bring a promising cerebroprotective intervention supported by rigorous and extensive preliminary data. The project should not be speculative or early-concept; it should already have convincing preclinical evidence suggesting readiness for more definitive network-based assessment.

What is the role of preliminary data for this FOA?

The FOA emphasizes that the intervention should be supported by rigorous and extensive preliminary data to justify why it should be tested in the SPAN network.

How should SPAN be viewed in the translational pipeline?

The program is described as a translational "stress test" intended to validate (or rule out) candidates using a level of rigor and standardized evaluation that can be difficult for a single small business to achieve alone.

Why does SPAN focus on standardized and parallel evaluation across sites?

The network approach is meant to reduce the historical risk of failed translation in stroke neuroprotection by improving reproducibility, standardizing testing, and enabling parallel or head-to-head style evaluations across established laboratories.

What is the expected deliverable or outcome of participating in SPAN?

The deliverable is not a clinical study. The intended outcome is a stronger, more decision-ready preclinical package that helps determine whether the intervention is ready to move toward human trials.

Who is eligible to apply?

Eligibility is limited to small businesses applying under the SBIR framework, consistent with the Phase II SBIR focus.

Are foreign (non-U.S.) entities eligible to apply?

No. Foreign (non-U.S.) entities are not eligible to apply.

Are non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations are also not eligible.

Are any foreign components allowed under this opportunity?

Yes, foreign components (as defined under NIH Grants Policy) may be allowed in some circumstances. This generally means discrete elements of the project could potentially be performed abroad if they meet NIH policy requirements and are well-justified.

Which agency administers this opportunity?

The administering agency is NIH, and the specific institute noted is NINDS.

What is the activity category of this funding opportunity?

The activity category listed is health.

What CFDA number is associated with this opportunity?

The CFDA number listed is 93.853.

What was the closing date listed for this opportunity?

The original closing date in the provided listing was March 14, 2022.

What is the listed award ceiling?

The listed award ceiling is $300,000, reflecting the scale of support indicated in the source data.

What problem in stroke therapy development is SPAN trying to address?

The FOA notes that stroke neuroprotection has historically seen many candidates that looked promising early but failed to translate later. SPAN aims to reduce that risk by improving rigor, standardization, and reproducibility in preclinical testing.

How can participation benefit a small business?

The program can serve as a structured bridge between internal R&D and the broader translational pipeline by connecting companies with experienced preclinical stroke labs and an NIH-supported framework that may strengthen the evidence package for future clinical-stage investment and regulatory planning.