Notice of Intent to Publish a Funding Opportunity Announcement for the NINDS Epilepsy Centers without Walls Program on Disease Modification or Prevention (U54)

Notice Number: NOT-NS-14-028

Key Dates
Release Date: May 12, 2014
Estimated Publication Date of Announcement:  June 2014
First Estimated Application Due Date:  Nov 2014
Earliest Estimated Award Date:  May 2015 
Earliest Estimated Start Date:  July 2015

Related Announcements
None

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for multidisciplinary, collaborative research conducted by a team of investigators in an Epilepsy Center Without Walls (CWOW) focused on developing disease modifying or prevention therapies for epilepsy. Current treatments for epilepsy control seizures but do not appear to alter the course of the disease, and do not prevent epilepsy from developing in those individuals at risk. The ultimate goal of this CWOW is to support the development of rigorous evidence-based justification for further translational activities for a first-in-class disease modifying or prevention therapy in a defined population of individuals with, or at high risk of developing, epilepsy.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The FOA is expected to be published in June 2014 with an expected application due date in November 2014. The NINDS will consider funding for up to two Epilepsy CWOWs for development of disease-modifying or prevention therapies, depending on the scientific merit of the applications submitted and availability of funds.

This FOA will utilize the Cooperative Specialized Research Center Grant (U54) activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into this area of neurology and neuroscience to begin to develop collaborative teams to apply for this new FOA. Such teams should include individuals with expertise in translational therapeutics development. Applications from all qualified teams are encouraged, including but not limited to teams supported by a prior Center Without Walls P20 planning grant.

Applications for a Center without Walls should come from a multidisciplinary, collaborative team proposing synergistic research projects and appropriate scientific and administrative cores. The goal of a Center without Walls on Disease Modification or Prevention is to develop the rigorous evidence base needed to justify investment in further translational activities for a first-in-class disease modifying or prevention therapy for a defined population of individuals with, or at risk of developing, epilepsy. The proposed administrative core should include detailed policies regarding publication and assignment of intellectual property rights, as well as plans for sharing pre-competitive data, reagents and methods with the broader epilepsy research community. Each Center without Walls should have at least one core facility that shares its services or resources with the national or international epilepsy research community and another core that promotes education and outreach activities with the patient community. The Center without Walls application must include three or more related, integrated, and high-quality research projects that provide a multi-disciplinary, yet unified, approach to the problem to be investigated.

A Center without Walls application may include preclinical studies and/or non-interventional clinical studies, as necessary given the state of the field for a particular indication. During review, CWOW applications will be considered in three different tracks:

  • Preclinical studies track: This track includes CWOW applications that consist entirely of projects that involve studies in preclinical model systems. These studies may include, but are not limited to, those that seek to develop in vitro assays, establish rigorous preclinical proof of efficacy, preliminary pharmacokinetics and pharmacodynamics, effect of repeated exposures, or definition of appropriate treatment windows, duration, or dosing and route of administration paradigms.

  • Clinical studies track: This track includes CWOW applications that consist entirely of projects that involve studies in clinical populations or healthy volunteers. These studies may include, but are not limited to, those that seek to establish or validate 1) biomarkers of risk, disease progression, or treatment response, 2) tools to determine target engagement of therapeutic candidates, or 3) clinical outcome measures and study designs appropriate for evaluating disease-modifying or prevention treatments.

  • Dual studies track: This track includes CWOW applications that consist of projects that involve studies in both preclinical model systems and clinical populations.

All CWOW applications should include a description of the key limitations in our current knowledge that prevent the proposed interventions from immediately entering translational development. The projects and cores included in the CWOW application should be designed to directly address and overcome these limitations. Ideally, at the completion of the CWOW activities, a rigorous evidence base will be available to enable further translational development of the chosen therapeutic approach. Through the cores, new CWOW resources and collaborations will also be made available to the larger epilepsy research community and should help facilitate translational research for other disease modifying or prevention approaches.

The NINDS has highlighted the importance of well-designed and transparently reported studies as the foundation for translating basic research discoveries into treatments. Investigators should be aware of the considerations described in NOT-NS-11-023 as these issues will be considered in the review of applications.

Interested prospective applicants are strongly encouraged to consult with the NINDS Scientific/Research Staff identified in the FOA prior to preparing an application.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Brandy Fureman, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917
Email: furemanb@ninds.nih.gov

 

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