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This Funding Opportunity Announcement (FOA) solicits Small Business Innovation Research (SBIR) Fast Track grant applications that propose to test and/or validate novel, state-of-the-art candidate biomarker platforms for predicting onset and progression of inflammatory diseases of interest to the NIAMS and for determining the pharmacodynamics, safety and/or efficacy of therapeutic agents targeting those diseases.
Improvements in high-throughput genomics, proteomics, and metabolomics have significantly facilitated the advancement of biomarker discovery, selection, and identification. Biomarker platforms, defined as a group of selected biomarkers, assays to detect them, and algorithms to interpret results, can integrate disease information from diverse pathways into quantitative data for simple interpretation. The technology is expected to be particularly useful in the evaluation of complex inflammatory or metabolic diseases in which multiple pathways are involved. However, these technological advances have not been translated into state-of-the-art, well-validated biomarker platforms for inflammatory diseases within NIAMS mission. The use of biomarker platforms in clinical studies of inflammatory diseases of interest to National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS) has been delayed by the lack of carefully conducted validation studies of new or existing platforms in well-characterized clinical cohorts.
For the purpose of this FOA, the NIAMS identifies four distinct stages in the process of bringing biomarkers platforms to study diseases and therapies: initial screening, feasibility, development and validation. Candidate biomarkers may be identified during the initial screening based, for example, on gene expression and protein array data, literature review and bio-informatics database searches. Feasibility studies can be used to determine which biomarker candidate(s) have the strongest association to disease activity and should include intensive qualification of biomarkers detection assays. Development studies generally include the final selection of top candidate biomarkers based on the optimization of detection assays and development and verification of algorithms in a well-characterized clinical cohort and/or specimen collection. In the validation stage, the final algorithm should be evaluated in a clinical cohort and/or specimen collection different from those used during feasibility or development studies. Validated biomarker platforms are expected to be accurate, stable, reliable, and sufficiently sensitive to measure inflammatory disease onset, progression, and/or therapy response.
The NIAMS seeks biomarker platform research projects for inflammatory diseases in the NIAMS mission focused on the following three stages: feasibility, development, and validation. New or existing biomarker platforms may be used on body fluids and/or tissue specimens to predict disease onset and progression, to study pharmacodynamics, or to determine therapeutic safety and/or efficacy. The SBIR Cooperative Agreement Fast-Track mechanism (U44) will be used. Phase I studies must address biomarker platform feasibility, and Phase II studies should be focused on further development and/or clinical validation. In cooperative agreements, the award recipient retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIAMS staff being involved as a partner with the awardees. The SBIR projects should evaluate putative biomarker platforms in already available, well-characterized clinical cohorts and/or specimen collections. Collaborative arrangements for use of specimen collections with repositories supported by voluntary organizations, NIH-funded research centers (such as the NIAMS Skin Disease Research Centers, Rheumatic Disease Research Centers, Centers of Research Translation, and Multidisciplinary Clinical Research Centers http://www.niams.nih.gov/Funding/Funding_Opportunities/activity_codes.asp#4&Research%20Programs%20and%20Centers%20(%20P%20 ) or other institutional resources are recommended and encouraged. This FOA will not support feasibility (identification) studies of biomarker candidates, the inception of new clinical cohorts or the collection of new specimens. Biomarker screening and discovery projects will not be considered responsive to this FOA. Applicants are highly encouraged to contact NIAMS staff to discuss project responsiveness.
Inflammatory diseases of interest to NIAMS include, but are not limited to, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, psoriatic arthritis, psoriasis, atopic dermatitis, alopecia areata, cicatricial and scaring alopecia, vitiligo, acne, rosacea, pemphigus, and MYOSITIS.
Examples of biomarker candidate platforms for feasibility, development and/or validation studies include, but are not limited to: