This RFA will be a two-stage process with an initial LOI submissions and review, followed for an invitation only full grant application process.
All LOIs must be submitted through our online portal at: Biomarker RFA online submission portal. We strongly encourage applicants to view the screens in the online portal system before beginning a LOI. All communications and correspondence will be sent to the identified PI.
All submissions undergo an administrative and scientific review by individuals under a confidentiality agreement. All submitted materials may be shared with our funding partners.
Applicants should ensure that submitted proposals fit the goals of the funding program, are clearly and logically written, with sufficient details to ensure that reviewers understand all critical aspects of the proposed project methods and plan. Given the length of the LOI (approximately two pages) it is not possible to provide the full scope of the methodological details but sufficient detail to assess strategy should be provided.
For questions about the letter of intent application process and the online system please contact Maria Fonseca, Grants Associate at [email protected]. For questions about the scope of the application, please contact Linda Jones, PT, PhD, Senior Scientific Director, Reeve Research (Consultant), at [email protected]. Please note questions must be sent no later than 48 hours prior to the submission deadline.
The following sections are included in the online LOI:
Administrative Section: Applicant details, high level information on project team, NIH biosketches for key personnel, and budget summary. See online for details.
Check Boxes to Indicate: Type and class of biomarkers, preclinical/clinical/both.
Letter of Intent Summary:
Please label each section in the LOI summary section (10,000-character limit) per headings below and address the requested information under each heading.
Biomarker and Intended Use
Clearly identify the biomarker(s) or biomarker signature/panel to be studied and its proposed context of use in spinal cord injury. Describe the biological process, injury characteristic, or therapeutic response the biomarker is intended to measure or reflect.
Significance and Unmet Need
Describe the scientific or clinical need the biomarker is intended to address, limitations of currently available measures, and the added value of the proposed biomarker. Explain how successful development or validation would advance SCI research or therapeutic development.
Supporting Evidence and Stage of Development
Summarize preliminary data and/or published findings supporting the biomarker and indicate its current stage of development. Identify the key evidence needed to advance the biomarker to its next stage. If relevant, indicate whether the biomarker may ultimately be a candidate for an FDA or other regulatory Biomarker Qualification Program. Biomarkers at all stages of development are eligible.
Proposed Study, Rigor and Feasibility
Briefly describe the proposed research, including the study population or experimental model, key methods, analyses and major milestones or decision points. Address reliability, reproducibility, sensitivity, specificity, and/or validity as appropriate to the biomarker and its stage of development. Describe access to the samples, datasets, models, populations, technologies, or other resources necessary to complete the proposed work.
Relevance SCI and Future Utility
Describe how the proposed work will improve the design, interpretation, or informativeness of preclinical and/or clinical SCI research and how successful completion will advance the biomarker toward broader research, therapeutic development, regulatory and/or clinical utility. Proposals may focus on preclinical research, clinical research, or both; cross-species applicability is not required unless relevant to the proposed biomarker and its intended use.
Review criteria for Letters of Intent include the following:
Biomarker Rational and Intended Use: Is the biomarker clearly defined with a compelling scientific rationale and a clear, relevant context of use in SCI?
Significance, Unmet Need, Potential Impact: Would successful development or validation of this biomarker address an important need and meaningfully improve SCI research or therapeutic development?
Supporting Evidence and Developmental Readiness: Is there sufficient evidence to justify the proposed next stage of biomarker development? Is the proposed work appropriate for the biomarker’s current stage and does it address an important next step or evidence gap?
Proposed Study, Rigor and Feasibility: Is the proposed study scientifically sound, rigorous, and feasible? Are the methods, analyses, milestones, and relevant validation measures appropriate to the biomarker’s intended use and stage of development? Are necessary resources available?
Relevance to SCI and Future Utility: Would successful completion improve preclinical and/or clinical SCI research and meaningfully advance the biomarker toward further development, validation, or use?
Team: Does the proposed team have the knowledge and ability to execute the proposed studies for biomarker development?
