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FAQs for PAR-16-065

1. What is the purpose of this FOA?

The overall goal is to identify, optimize, and evaluate measures of neurophysiological processes that are disrupted within or across mental disorders and which can be assessed in animals and humans. The primary purpose is to improve the efficiency of the therapeutic development process by addressing inconsistencies between the preclinical screening pipeline and clinical evaluation of new treatment candidates and thereby hasten the development of more effective treatments for mental disorders. Expected outcomes:

  • To identify measures as translational assays for testing potential new drug and device therapies and their targets across preclinical development and in early human studies.
  • To identify measures where performance between the preclinical species and humans is dissimilar, thus establishing a firm basis for limiting predictions of clinical effects based on preclinical findings.

2. Do all applications require both the UG3 and UH3 phases?

Yes, the UG3 phase is required to optimize the assay for cross species performance evaluation in the UH3 phase. Any assays where there is already sufficient data collected in both species to evaluate an assay would likely not be considered sufficiently innovative.

3. Are there any special considerations in selecting the preclinical species?

The FOA supports assay development around those measures that assess the highest level of shared function across species (i.e., the highest common denominator). In most cases, this will limit the selection of the non-human species to mammals.

For a pharmacological manipulations (as might be used in the UH3 phase), doses ranges selected for cross species evaluation of the performance of the assay should be based on pharmacokinetic data for the drug in both species and with the same route of administration.

4. How is the evaluation of applications from foreign investigators different from U.S. investigators?

Non-U.S. institutions are eligible to apply, and collaborations with non-U.S. investigators are allowed. For applications submitted by foreign organizations, reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources. See the Grants and Funding webpage for additional information for foreign applicants and grantees.

5. I would like to test a novel treatment candidate in humans and in animals. Is this research goal aligned with the intent of the FOA?

No. The main purpose of this FOA is to develop and evaluate novel brain-based measures as assays for translational purposes, not to develop or test therapeutic candidates or targets. Applicants seeking support for therapeutics development or the clinical evaluation of new potential therapeutics are directed to the FOAs listed on the NIH/NIMH Therapeutics Discovery Research webpage.

6. Are cell culture studies allowed?

No. Assay measures must be in intact humans and animals.

7. Can studies in patients be included?

No, only healthy humans and animals are included. Patient populations and preclinical disease models are excluded.

8. Do projects need to include more than one non-human species in addition to healthy humans?

No, one non-human species is sufficient. It is allowable to include more than one non-human species in an assay, with a clear rationale. The goal is to compare assay performance between humans and the other species, and not to evaluate across non-human species.

9. Can the proposal include multiple tasks using different non-human species (e.g., looking at one task across rodent and human and a second task across monkeys and humans)?

Yes, the inclusion of different species for different assays is allowable.

10. The UG3 allows/encourages exploration of multiple assays – do all proposed assays/tasks have to target the same circuit/domain?

No, projects can focus on one circuit function/domain or multiple, based on capability and potential.

11. Should the UG3 and UH3 include all of the same assays?

Not necessarily. Go/no-go criteria outlined in the UG3 phase should be sufficiently clear to guide the selection and prioritization of measures and manipulations for full evaluation in both species in the UH3.

12. Can tasks be proposed that are already validated in one species and only require translation to the other species?

Yes, that would be allowable.

13. Are high-risk, high-reward assays allowed/encouraged?

Yes, high risk assays with limited validation data are allowed. It is anticipated that the UG3 phase will be used to conduct initial feasibility and validation work and that many assays will fail at this stage.

14. Is it necessary to have an identified circuit or physiological readout in both species or is a physiological readout in humans and a behavioral readout in animals sufficient?

A physiological readout is required for both species. A solely behavioral measure would not be sufficient to address the goals of the announcement.

15. I am interested in developing and testing a physiological measure. Is it necessary to have the behavioral output as well?

No, a behavioral measure is not required.

16. Is it allowable to propose mechanistic studies for the UH3 phase?

No, mechanistic studies are outside the scope of this announcement.

17. Are industry partners allowed?

Collaborations between academic and industry partners are encouraged as long as the data and protocol sharing plan goals can be achieved.

18. Are new collaborations allowed or do the groups need to have already established working relationships?

Yes, new collaborations are allowed. It is anticipated that new collaborations between groups may need to be developed to address the goals of this RFA.