NINDS Cooperative Program in Translational Research for Resistant Epilepsy and Epileptogenesis (U01) | Apply Online

Frequently Asked Questions (FAQs)

What is the NINDS Cooperative Program in Translational Research for Resistant Epilepsy and Epileptogenesis (U01)?

It is a National Institute of Neurological Disorders and Stroke (NINDS) funding opportunity that supports translational, preclinical development of promising epilepsy therapies. The goal is to move therapy-directed projects from the lab toward readiness for clinical testing.

What is the main purpose of this funding opportunity?

The central aim is to support preclinical development of treatments that could: (1) cure epilepsy, (2) prevent epilepsy from developing after a brain injury or other high-risk condition (epileptogenesis), or (3) improve treatment for people with intractable (drug-resistant) epilepsy.

What kinds of projects are a good fit for this FOA?

Projects that are already in the translational development stage and are focused on advancing a therapeutic lead through practical preclinical work. The program is designed to help teams optimize and validate an existing candidate so it can be positioned for regulatory submission and clinical testing.

Does an applicant need to already have a therapeutic lead?

Yes. Applicants must already have a therapeutic lead with demonstrated activity against the intended disease target. This FOA is not intended for idea-stage concepts or early discovery where the therapeutic lead has not yet been established.

What does "therapeutic lead with demonstrated activity" mean in this context?

Based on the FOA description, it means the project should begin with a candidate (such as a drug, biologic, or device concept) that has already shown activity relevant to the disease target. The award supports further development work rather than initial target identification or exploratory screening.

What types of therapeutic approaches can be supported?

The FOA references development of a drug candidate, a biologic, or a device concept, with the expectation that the work will progress toward the appropriate FDA regulatory package for that technology (IND for drugs/biologics or IDE for devices).

What stage of development is the U01 track intended for?

The U01 cooperative agreement track is intended for projects that are further along in translational development and can credibly reach an FDA regulatory submission (IND or IDE, depending on the technology) within the project period.

What is the expected outcome by the end of the award?

Projects are expected to be advanced enough that, by the end of the award period, the team can submit an FDA regulatory package appropriate to the technology: an IND (Investigational New Drug) for drugs/biologics or an IDE (Investigational Device Exemption) for devices.

What activities does this FOA specifically not support?

It explicitly excludes early-stage therapeutic discovery activities such as high-throughput screening, as well as clinical research. It also does not support basic research or studies aimed primarily at understanding disease mechanisms.

Is clinical research allowed under this opportunity?

No. The FOA states it does not support clinical research. The emphasis is on preclinical development work that prepares a therapeutic lead for regulatory transition into clinical testing.

Is basic research on epilepsy mechanisms supported?

No. The FOA emphasizes that it does not support basic research or studies aimed primarily at understanding disease mechanisms. The focus is on development and de-risking of a therapeutic lead rather than generating new biological insights for their own sake.

Does this program fund high-throughput screening to find new candidates?

No. High-throughput screening and other early discovery efforts are explicitly excluded. The program assumes the applicant already has a lead and needs support for preclinical development steps.

What does it mean that this is a U01 cooperative agreement?

A U01 is a cooperative agreement, meaning NIH has a more active partnership role than in a standard grant. NIH staff participate in shaping the project plan and monitor progress over time, with the work organized around concrete milestones.

How are projects managed under this cooperative agreement structure?

The FOA describes the projects as milestone-driven, with NIH involvement in planning and ongoing progress monitoring. This is meant to keep projects focused on development benchmarks and go/no-go decisions typical of translational programs.

What is meant by "milestone-driven" and "go/no-go" benchmarks?

The FOA indicates that the program uses concrete development milestones to track progress, and decisions about continuing or redirecting work are guided by whether those milestones are met. The intent is to efficiently move projects through common translational hurdles.

How does this U01 opportunity relate to the R21 announcement?

This U01 runs in parallel with a separate announcement that has identical scientific scope but uses the R21 exploratory/developmental mechanism (PAR-10-143). The R21 is positioned as an exploratory track, while the U01 is positioned for more advanced translational development.

Which announcement number is associated with this U01 opportunity?

The full announcement is referenced via the NIH Grants Guide page for PAR-10-144.

How much funding is planned under this program?

NINDS planned up to $3.6 million in total costs to support at least one new award per year over three years, though the actual number and size of awards may vary based on application quality, project duration, and proposed budgets.

How many awards are expected?

The announcement lists an expected award count of one, while also noting that awards depend on the application pool and proposed scope (so the final number could vary).

Is cost sharing or matching required?

No. The opportunity states there is no cost sharing or matching requirement.

Who is eligible to apply?

Eligibility is broad and includes nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), public and private institutions of higher education, and multiple levels of government (including state, county, city/township, and special districts), among others.

Are specific institution types and communities included in eligibility?

Yes. The FOA includes eligibility for institution types and communities such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based/community-based organizations, U.S. territories or possessions, and non-U.S. (foreign) entities and regional organizations.

Which federal agency administers this opportunity?

The administering agency is the National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS).

What is the CFDA number associated with this program?

The associated CFDA number is 93.853, listed as Extramural Research Programs in the Neurosciences and Neurological Disorders.

When was this opportunity posted and what are the key dates mentioned?

The source information indicates the opportunity was posted on March 19, 2010. It also lists key dates including an original closing date of May 7, 2013, an archived status with an archive date of April 15, 2011, and a current closing date listed as March 15, 2011 in the provided record.

Is this opportunity currently active or archived?

The provided record indicates an archived status, with an archive date of April 15, 2011. The record also includes closing date information (including a current closing date listed as March 15, 2011).