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IGNITE FAQ


  1. What happened to the NINDS Exploratory/Developmental Projects in Translational R21 announcement (PAR-13-023)?
  2. Will the NINDS Exploratory/Developmental Projects in Translational Research (R21) PAR-13-023 program be re-issued or redesigned?
  3. What replaces the Translational R21 (PAR-13-023) announcement?
  4. What was the impetus for the new Innovation Grants to Nurture Initial Translational Efforts (IGNITE) initiative?
  5. What comprises the new IGNITE initiative?
  6. Can past applications submitted in response to the Translational R21 program (PAR-13-023) be submitted to either of the new PARs?
  7. To what announcements should small businesses apply?
  8. When are the next applications due?
  9. How can an investigator get guidance on how to write an application for these programs?
  10. Is contact with NINDS required prior to submitting an application?
  11. When will the first set of applications be reviewed?
  12. Where will my application be reviewed?
  13. When will the first set of applications be awarded?
  14. May foreign work be proposed in an application?
  15. Do I have to submit the structure/sequence for my therapeutic agent in my application?
  16. Who do we contact if we have questions?

 

1. What happened to the NINDS Exploratory/Developmental Projects in Translational R21 announcement (PAR-13-023)?

The Translational R21 announcement (PAR-13-023) will expire on January 8, 2015.

2. Will the NINDS Exploratory/Developmental Projects in Translational Research (R21) PAR-13-023 program be re-issued or redesigned?

This PAR will not be reissued, it has been redesigned into the new Innovation Grants to Nurture Initial Translational Efforts (IGNITE) program.

3. What replaces the Translational R21 (PAR-13-023) announcement?

The new Innovation Grants to Nurture Initial Translational Efforts (IGNITE) initiative replaces the Translational R21 (PAR-13-023) announcement with a suite of four funding opportunity announcements that are designed to provide a data package appropriate for entry into NINDS Cooperative Research to Enable and Advance Translational Enterprises (CREATE Bio) program for biologics/biotechnology products or the Blueprint Neurotherapeutics Network (BPN) program for small molecules.  This initiative is intended to provide short-term support for well-defined studies that are novel, have clear biological rationale, and relevance for therapy development to obtain missing requisite (or required) the data required for entry of promising therapeutics into the CREATE Bio or BPN programs.  

4. What was the impetus for the new Innovation Grants to Nurture Initial Translational Efforts (IGNITE) initiative?
 

The proposed initiative was intended to focus translational applications on the concise and end-goal driven early therapeutic discovery activities required for entry into our late-stage therapeutic discovery/development programs.  The initiative is clearly differentiated and delineated from the parent Translational R21 announcement for the following reasons:
1. The initiative is focused on funding proposals which specifically address the entry criteria for the cooperative agreement programs (CREATE Bio and BPN).
2. The initiative emphasizes specific deliverables designed to result in data packages relevant to the earliest phases of therapeutic discovery such as assay development and therapeutic agent identification and characterization.
3. The initiative emphasizes demonstration of rigorous planning and a detailed biological rationale that takes into account unmet medical need with supported relevance to the development of therapeutics to treat neurological disease.
4. The initiative allows more time compared to the existing program to deliver high quality and reliable results.
5. The initiative takes advantage of the R21/R33 mechanisms, when appropriate, which allow an internal review process along with implementing quality and RIGOR (NOT-NS-11-023) guidelines.  The R21/R33 mechanism also allows for an application organized upon successive dependent aims, which are a hallmark of goal-driven translational research.

5. What comprises the new IGNITE initiative?
 

The initiative consists of four Funding Opportunity Announcements (FOAs):

Current FOAs:

1. PAR-15-070: Assay Development and Therapeutic Agent Identification and Characterization to Support Therapeutic Discovery.  

This FOA uses the R21/R33 phased innovation mechanism to support development of  in vitro and ex vivo assays suitable for iterative screening efforts focused on the identification and characterization of  potential therapeutic agents for neurological disorders. The R21 phase will support the initial development and validation of in vitro and ex vivo assays.  The R33 phase will support: 1) iterative screening efforts of potential therapeutic agents, 2) characterization of promising therapeutic agents from the screen, and 3) efforts to design, prepare, and further characterize additional agents related to original hits. Transition from the R21 to the R33 phase is contingent upon the successful completion of proposed milestones.

The total project period for a combined R21/R33 application submitted in response to this FOA may not exceed three years, with no more than two years for the R21 phase and no more than two years for the R33 phase. Total direct costs may not exceed $750,000 for the entire 3-year project period, with no more than $250,000 for the R21 phase, and with no more than $500,000 in direct costs in any single year. Application budgets need to reflect the actual needs of the proposed project.

2.  PAR-15-071: Pharmacodynamics and/or In vivo Efficacy Studies for Small Molecules and Biologics/Biotechnology Products.  

This FOA uses the R21/R33 phased innovation mechanism to support characterization of potential therapeutic agents with reasonable potency and selectivity in pharmacodynamics and/or ex vivo or in vivo efficacy studies in order to advance the understanding of the agents. The goal is to adapt state-of-the-art pharmacological, pharmacokinetic and biological measures to probe the fundamental feasibility of selected therapeutic agents to serve as a starting point for therapy development. The R21 phase will support planning and preparation of therapeutic agent characterization in pharmacodynamics and/or in vivo efficacy animal studies.  The R33 phase will support execution of the pharmacodynamics and/or in vivo animal studies. Transition from the R21 to the R33 phase is contingent upon the successful completion of proposed milestones.  


The total project period for a combined R21/R33 application submitted in response to this FOA may not exceed three years, with no more than two years for the R21 phase and no more than two years for the R33 phase. Total direct costs may not exceed $750,000 for the entire 3-year project period, with no more than $250,000 for the R21 phase, and with no more than $500,000 in direct costs in any single year. Application budgets need to reflect the actual needs of the proposed project.

Upcoming FOAs:
3.  Neuroscience Translational Tools and Models

This FOA encourages identification and development of:  1) Novel animal models of neurological disease with clear phenotypic and/or genotypic similarities to the targeted human disorder, and 2) validated measures of a therapeutic test agent’s engagement with the intended molecular or cellular target (pharmacodynamics).

The goal is to promote the development and preliminary validation of translational animal models and pharmacodynamics measurements that will facilitate the evaluation of new therapeutic agents.

Research Project Grant Program (R01), awarded for 3 years, direct costs are limited to $500,000 for three years.
 

4. Neuroscience‐Focused Translational Platform Technology Development.

This FOA encourages neuroscience focused platform technology development to enable and accelerate drug discovery for therapeutics to treat neurological disorders.

The goal is to promote the development and optimization of transformative technologies that will significantly improve any phase of drug discovery and development.

This FOA uses the R01 Award mechanism. The total project period for an application submitted in response to this FOA may not exceed 3 years, total $500,000 direct cost.  


6. Can past applications submitted in response to the Translational R21 program (PAR-13-023) be submitted to either of the new PARs?

No, these are all new announcements and require a new application.

7. To what announcements should small businesses apply?


There are no criteria that exclude small business applications and there are no preferences given to academics vs. small business applicants.


8. When are the next applications due?
 

The due dates are as follows:

1. PAR-15-070: Assay Development and Therapeutic Agent Identification and Characterization to Support Therapeutic Discovery. Solicitation for this announcement was released on December 12, 2014 and the first application receipt date is on February 16, 2014.

2. PAR-15-071: Pharmacodynamics and/or In vivo Efficacy Studies for Small Molecules and Biologics/Biotechnology Products. Solicitation for this announcement was released on December 12, 2014 and the first application receipt date is on February 16, 2014.

3. Development and Validation of Translational Animal Models and Pharmacodynamic Measures Relevant to the Discovery of Therapeutics to Treat Neurological Disease. Solicitation for this announcement will be published in 2015. The first application receipt date will be announced later during the year.

4. Neuroscience Focused Platform Technology Development. Solicitation for this announcement will be published in 2015. The first application receipt date will be announced later during the year.


9. How can an investigator get guidance on how to write an application for these programs?
 

Applicants should contact NINDS program staff before a receipt date. The innovation grants R21/R33 will involve the participation of NINDS program staff in the planning and coordination of proposed milestones. Applicants are strongly encouraged to consult with NINDS program staff when planning an application. Consultations will include conference calls with NINDS program staff. Early contact provides an opportunity for NINDS program staff to provide further guidance on program scope, goals, and developing appropriate milestones. Other aspects of an application that are unique to this program will also be discussed.

10. Is contact with NINDS required prior to submitting an application?


It is strongly recommended that all potential applicants consult NINDS staff very early in the planning stage and before submission of an application is anticipated.

11. When will the first set of applications be reviewed?


The first set of applications will be reviewed in the spring/summer of 2015.

12. Where will my application be reviewed?


Competing applications for all of these new programs will be reviewed within the NINDS Scientific Review Branch and not at the Center for Scientific Review (CSR). 
 

13. When will the first set of applications be awarded?

The first set of applications will need approval from September 2015 Council and will be awarded soon after.

14. May foreign work be proposed in an application?
 

Yes. Applications from foreign institutions or containing foreign components may apply.  

15. Do I have to submit the structure/sequence for my therapeutic agent in my application?

Yes, disclosure of structure/sequences is required so that enough information is available to enable evaluation of the application. Applications that lack adequate information for reviewers to evaluate the scientific merit of the application are unlikely to score well. Applications are submitted for evaluation purposes only and are reviewed in closed private (non-public) sessions by reviewers who are under strict confidentiality agreements with the federal government. Therefore, information contained in applications would normally not be considered as a public disclosure and should not affect the applicant’s ability to apply for patents. However, filing patent applications prior to submission of a funding application is something an applicant should consider in conjunction with their legal counsel. Also, it should be noted that the submitted abstract would be published upon award of the grant, so the abstract should be drafted carefully so as not to be considered as an enabling disclosure. Please review NIH’s Guide Notice (NOT-OD-14-073) about maintaining confidentiality during review.

16. Who do we contact if we have questions?


A: Amir Tamiz, Ph.D. IGNITEinquiries@mail.nih.gov

Last updated December 15, 2014