BRAIN Initiative: Reagent Resources for Brain Cell Type-Specific Access to Broaden Distribution of Enabling Technologies for Neuroscience (U24 Clinical Trial Not Allowed)
Funding Agency:
- National Institutes of Health
Resource Objectives
Reagent resources supported under this NOFO must include three main functions. First, the resources will interface with Armamentarium reagent design and development projects (award recipients from RFA-MH-25-100 or other Armamentarium NOFOs), who will design, validate, and catalogue brain cell type-selective reagents. Second, the resources will conduct scaled-up production of the designed and validated reagents. Third, the resources will disseminate reagents to neuroscience research users. Facilities are sought to enable access to brain cell types in vertebrate species that are of significant interest to neuroscience researchers. Such resources are envisioned to support especially investigation of brain cell types and/or species with previously limited access.
Research Scope
1. Interfacing with Armamentarium Reagent Design and Validation Projects
Applicants must propose plans to partner with at least one Armamentarium reagent design and development project (recipients of awards from RFA-MH-25-100 or other Armamentarium NOFOs). Plans must be described to receive validated reagent designs, reagent templates, and/or seed reagents from the partner(s). A significant proportion of the reagent designs, templates, and/or seed reagents from the partner(s) must be received. Plans must also be described for interfacing with the partner(s), for example, to improve the reagents, further validate reagents, optimize the scaling up of reagent production, and/or augment cataloguing of the reagents. The reagent types for production will depend on the nature and progress of the Armamentarium reagent design and development projects. The types of reagents to be produced could include but are not limited to viral vectors, nucleic acid constructs, and nanoparticles designed for selective access to and manipulation of brain cell types. NIH will facilitate additional collaborations with the Armamentarium reagent design and development project as appropriate through a research consortium (see further below).
2. Scaled-up Reagent Production
Applicants must propose plans to scale up production of a significant proportion of the reagents from the partner(s). The plans must detail strategies for scaled-up reagent production at an RLI or IDeA-eligible institution. Institutional commitment must be assured for the planned reagent production facilities and can include provision of adequate staff, facilities, and training resources that can contribute to the planned reagent production. Quality control metrics for reagents must be described, and quality assurance for the production processes must be delineated. Applicants must describe plans for the characterization, formulation, evaluation, and validation of the efficacy, reproducibility, stability, activity, and unique characteristics of produced reagents. Reagents for in vivo use must be proposed to be highly purified and produced in a manner safe and appropriate for use in animals and/or human ex vivo tissue and cells. Storage, inventory management, and domestic and international distribution approaches must be outlined.
3. Disseminating Reagents to Neuroscience Research Users
Applicants must propose plans to catalogue scaled-up product inventory for dissemination to users in the neuroscience community generally, including those at RLIs, institutions in IDeA-elgible states, and elsewhere. Such catalogues must be made widely accessible and kept updated. Plans to manage reagent delivery to users must be described. Efforts to assess the ongoing user demand for various reagents as well as to receive and incorporate constructive user feedback must be outlined. Applicants are required to propose creation of a website to achieve the above user interface objectives.
Successful applicants will be responsible for management and oversight of large-scale production and distribution activities including, but not limited to, material transfer and licensing agreements, webhosting, and recovery of production and distribution costs. Applicants are expected to include project management effort and personnel for proposed facilities for the production and dissemination of reagents.
Applications may propose to incorporate technology development and optimization, but these efforts should be integrated into a larger reagent production and distribution project. For example, technology development and optimization could be incorporated to augment or improve existing methods for scaled-up reagent production based on feedback from reagent users.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
February 14, 2025
Douglas S. Kim, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-6463
Email: douglas.kim@nih.gov