Technology Development Research for Establishing Feasibility and Proof of Concept (R21 - Clinical Trial Not Allowed)
Funding Agency:
- National Institutes of Health
Support for Early-Stage Technology Development Is Critical to Advancing Biomedical Research
Technological advances are crucial for accelerating biomedical research. Technology enables science by providing new ways to address questions, and more importantly, by allowing researchers to pose new questions that could not be anticipated in the absence of the enabling technology. New knowledge drives the imperative for new tools, and those tools stimulate new questions, in a mutually reinforcing feedback loop that drives science forward. Early technology development can be described in two stages: (I) exploratory proof-of-concept research to determine the feasibility and best approach(es) for a technology development project, and (II) the subsequent research and development that focus on creating and validating a working prototype technology before application to untested biomedical problems is possible. This NOFO invites projects in Stage I - evaluation of an untested concept. A companion NOFO, PAR-25-203 Focused Technology Research and Development (R01- Clinical Trial Not Allowed) supports Stage II projects - i.e., research and development of a working prototype. Applications that address specific biological questions in addition to developing specific technologies are not responsive to the goals of these NOFOs but may be submitted to the Parent R01 funding announcement or other NOFOs (e.g., NIGMS Maximizing Investigators' Research Awards).
Applications to this NOFO should propose technology development at a conceptual stage, not yet supported by any proof-of-concept data, in order to demonstrate feasibility of the proposed technology and/or establish the most likely path to successful development. When compared to current state-of-the-art technology, the proposed concept should lead to a technological breakthrough or a significant tool to advance current biomedical research. The project’s starting point should be the current state of knowledge, and concepts of the new technology must not have been already tested for feasibility. Project aims should focus on either(a) exploratory research to identify, among several possibilities, the approach with the highest likelihood of success, or (b) demonstrating feasibility of a specific novel approach.
For this NOFO, technology refers to tools, methods, and techniques that enable a broad spectrum of biomedical research that falls within the NIGMS mission including, but not limited to:
- laboratory instruments and other devices,
- algorithms and software,
- chemical reagents and processes,
- biological molecules or systems that have been modified by human intervention for use as research tools.
Further, this NOFO calls for innovative exploratory technology development predicated on an explicitly described broad need or challenge in biomedical research. This need should exceed current technological capability, with the state-of-the-art technological performance defining the starting point. Comparison of the proposed technical performance improvement to the state of the art will provide the rationale for developing a fundamentally different technology. While specific well-characterized test systems may be used for validation, applications should highlight the broad utility of the technology for biomedical research.
Responsiveness Criteria
Proof of Concept: This NOFO supports proof-of-concept studies to develop prototypes and exploratory technologies that do not have demonstrated feasibility in the literature, are not based on preliminary data, and are not obvious extensions of the current state of the art. The expected project outcome must be a clear test of concept, either positive or negative. The proposed concept must be innovative, represent a significant advance over the state of the art, and address current obstacles to advancing biomedical research.
Validation: Application to synthetic models or well-characterized biological systems to assess performance can be included at this stage. To be considered for funding, applications of the technology must be limited to well-characterized models or systems chosen to facilitate technology development rather than to immediately address biological questions. The project aims must be focused entirely on the technology development.
Application budgets are limited to a total of $275,000 Direct Costs over the two-year project period. No more than $200,000 Direct Costs may be requested in any single year. Direct cost limits exclude consortium F&A costs. The budget must be well justified and reflect the actual needs of the proposed project.
February 16, 2025; June 16, 2025; October 16, 2025
Alvin T. Yeh
Division of Biophysics, Biomedical Technology, and Computational Biosciences
National Institute of General Medical Sciences (NIGMS)
Email: NIGMS_techdev@nigms.nih.gov
Kadir Aslan, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences (NIGMS)
Email: NIGMS_techdev@nigms.nih.gov