- 001: Funding Opportunity Description
The purpose of this Funding Opportunity Announcement (FOA) is to solicit Small Business Innovation Research (SBIR) applications to undertake the development of biomarker panels for point-of-care assessment. For the purpose of this FOA, biomarkers include measureable biochemical characteristics associated with the severity of acute sleep deprivation, chronic sleep deficiency, or sleep disorders. The goal of biomarker panel development in this FOA is the assessment of sleep-related risks to health (pathophysiology) or safety. Development strategies that leverage existing data on the chemistry of sleep and circadian biology would be highly desirable. For instance, insufficient sleep or irregular sleep may be reflected in existing data from immunological, metabolic, and hormonal markers of pathophysiology. Systematic modeling of the physiological pathways regulated by sleep and circadian biology may lead to the discovery of novel biomarker candidates. Recent advances in circadian biology suggest that measurable characteristics of the daily rhythm in genomic chemistry may lead to the identification of biomarker candidates in downstream physiological functions such as the regulation of glucose.
Applications should include a strategy to evaluate the specificity and sensitivity of candidate biomarkers and panels for selected applications such as aiding in the stratification of risks to safety or disease, estimating the impact of sleep problems on quality of life, or evaluating efficacy of sleep disorder interventions. Biomarker-based indices developed under this FOA must be designed to outperform widely-used single variable assessments such as self-reported sleep duration and psychomotor vigilance performance. Combinations of biomarkers selected from a larger pool of candidates need to be validated with respect to accuracy and reliability of estimating the severity of the sleep problem and its prognostic value for assessment of associated risks to health or safety. Examples of biosamples considered practical for population-based studies and point-of-care testing include, but are not limited to, easily accessible body fluids and tissues such as saliva, buccal mucosa, urine, and blood. Proposed biomarkers may include, but are not limited to, molecules (protein/lipid state, genes, gene products, metabolites of external substances, etc.), cells, and measures of biological function/state that correlate with normative or pathophysiological sleep health and symptoms of excessive “sleepiness.” Biomarkers derived from monitoring brain electrical activity may be employed as part of the development strategy leading to biomarker panels based on easily accessible body fluids and tissues. Development strategies are encouraged to employ existing datasets and new analyses of existing biosamples. Prospective data and sample collection may be proposed within the budgetary limitations of this grant mechanism.
Phase II Applications: Phase II applications are required to include an Advisory Committee consisting of appropriate experts to provide oversight and critical evaluation of the clinical development plan and its components.
Fast-Track Applications: Note that Fast-Track applications are not accepted in response to this FOA.