Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems and/or Pharmacodynamic Markers to Facilitate the Discovery of Neurotherapeutics (R21/R33) | Apply Online

FAQs: NIH IGNITE R21/R33 (RFA-NS-16-013) Neurotherapeutics Tools and Translational Platforms

What is the purpose of the NIH IGNITE R21/R33 funding opportunity (RFA-NS-16-013)?

This NIH (HHS-NIH) IGNITE FOA is intended to accelerate early neurotherapeutics discovery by improving the tools researchers use to test and translate potential treatments. It focuses on building practical, fit-for-purpose translational platforms and readouts that make preclinical results more predictive of what will happen in humans.

What kinds of projects does this FOA support?

The FOA invites two primary categories of work: (1) developing and validating translationally relevant animal models and human tissue ex vivo systems that better reproduce the phenotypic and physiological features of a specific, defined neurological disorder, and (2) developing and validating clinically feasible pharmacodynamic (PD) markers for therapies aimed at neurological diseases.

What is meant by “translational relevance” in this opportunity?

Translational relevance refers to how well a model system or PD marker helps bridge preclinical testing and human biology. For models, this means better reflecting disease biology and progression. For PD markers, this means being able to show whether a therapy is engaging its intended biology and producing a meaningful response in a way that could credibly carry into clinical studies.

What are “pharmacodynamic (PD) markers” in the context of this FOA?

Within this FOA, PD markers are measurements intended to indicate whether a therapy is affecting its intended biological pathway and producing a measurable response. The FOA emphasizes PD markers that are clinically feasible for neurological disease therapies and that can support continuity between preclinical studies and later clinical work.

What model systems are encouraged?

The FOA encourages development and validation of animal models and human tissue ex vivo systems that more faithfully reproduce phenotypic and physiological features of a particular, defined neurological disorder, with demonstrated improvement in how well the system reflects disease features relevant to translation.

Does the FOA support endpoint development?

Yes. A key theme is endpoint development, including assays, testing paradigms, and measurable outcomes used to evaluate efficacy. Strong applications propose endpoints that are feasible and informative in animal or ex vivo settings and also have a credible path for use in clinical studies.

What is the emphasis on “fit-for-purpose” platforms and readouts?

The FOA emphasizes practical platforms and measurements designed to answer translational questions in neurotherapeutics discovery. The goal is not novelty in principle alone, but tools and readouts that meaningfully measure therapeutic effects and help de-risk the path from lab studies to later-stage development.

Is this FOA intended to fund basic research on disease mechanisms?

No. This opportunity is explicitly not meant for basic disease-mechanism research. It does not support building models primarily to interrogate disease etiology.

Does this FOA fund projects aimed at identifying new drug targets?

No. The FOA does not support projects aimed at identifying new drug targets.

Does this FOA fund human clinical validation of the proposed models or PD markers?

No. The FOA does not fund human clinical validation of the proposed model systems or PD markers. The intent is to support translational methods that enable drug discovery and early development, without moving into full clinical confirmation.

Where does this program fit within NIH’s broader efforts?

This FOA is positioned within the broader IGNITE suite, which focuses on enabling exploratory and early-stage drug discovery by strengthening foundational tools and measurements needed to evaluate candidate neurotherapeutics.

What grant mechanism is used for this funding opportunity?

This is a discretionary NIH grant using the R21/R33 mechanism. It generally aligns with a phased approach: an exploratory development and initial validation phase followed by a subsequent phase for more advanced validation and refinement once predefined milestones are met.

How does the phased R21/R33 structure relate to project expectations?

Based on the description provided, the R21/R33 structure supports moving from early development and initial validation to more advanced validation and refinement, contingent on meeting predefined milestones.

What is the award ceiling for this opportunity?

The listed award ceiling is $250,000.

How many awards are expected?

The opportunity indicates an expected three awards.

When was this opportunity posted and when did it close?

The opportunity was posted on November 3, 2015 (and created the same day). The closing date was January 7, 2018, and the record indicates the original and current closing date are the same.

What CFDA numbers are associated with this opportunity?

The FOA is listed under CFDA numbers 93.279 and 93.853.

How is this opportunity categorized?

It is categorized under Education and Health.

What types of organizations are eligible to apply?

Eligibility is broad and includes state, county, city/township, and special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (outside of higher education); for-profit organizations other than small businesses; and small businesses. The record notes that additional eligibility details are referenced in the full announcement.

Are small businesses eligible under this FOA?

Yes. Small businesses are included in the list of eligible organization types, with additional eligibility details referenced in the full announcement.

Are for-profit organizations eligible under this FOA?

Yes. The eligibility list includes for-profit organizations other than small businesses, and also separately includes small businesses.

Are tribal governments or tribal organizations eligible?

Yes. Federally recognized tribal governments and other tribal organizations are included among eligible applicants.

Are institutions of higher education eligible?

Yes. Public and private institutions of higher education are included among eligible applicants.

Are government entities eligible to apply?

Yes. State, county, city/township, and special district governments are listed as eligible applicants, as well as independent school districts.

What is the main “success criterion” implied by the FOA?

The emphasis is on demonstrating improved translational relevance. For model systems, this means showing they better reflect disease biology and progression. For PD markers, this means showing they can feasibly indicate target biology engagement and meaningful response with a credible path toward clinical use, while staying within the translational methods scope (not clinical validation).

What types of outcomes are this FOA trying to improve in neurotherapeutics discovery?

The FOA aims to improve decision-making by increasing confidence that preclinical findings will better predict human outcomes, using better disease-relevant models, ex vivo human tissue systems, and clinically realistic PD markers.