PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])

Research tools: Imaging, reagents, assays including microassays, microfluidics, bioinformatics and nanotechnology for investigations of blood diseases, transfusion and cellular therapies 

Diagnostics: devices, biomarkers, imaging, and assays for non-malignant blood disorders  

Therapeutics: drugs, blood product and cellular therapies, and gene therapy for non-malignant blood disorders  

Development of molecular imaging reagents/techniques and nanotechnology-based drug delivery systems that detect and allow for specific targeting of lung diseases, such as plexiform lesions in PAH (pulmonary arterial hypertension), microvascular loci susceptible to rarefaction/pruning in obstructive airway diseases like emphysema, or fibrotic triggers in IPF (idiopathic pulmonary fibrosis).

Development of reagents and methods to identify and isolate stem/progenitor cells, and direct differentiation to specific functional organ units. These reagents may include antibodies for stem/progenitor cell detection and sorting, biomaterials for optimizing the microniches of stem/progenitor cells, as well as methods for 3-D regeneration of tissue.

Development and validation of techniques(or algorithms) to study the microbiome in situ, including, but not limited to:

• Sampling the microbiome of different lung or gut segments while minimizing contamination from other locations.
• Development of an analytical system to study the metabolic products of the lung and gut microbiome from breath condensate.

Characterization and in vivo or in vitro applications of miRNA panels that target lung-resident mesenchymal or fibroblast cells and directly or indirectly promote lung repair or regeneration.

Development of high throughput methods to apply microfluidics technology in discovery of molecular profiles (DNAs, RNAs, proteins, or metabolites) in a large number of sputum or exhaled breath condensate samples collected from lung disease patients.  

High-definition, conformal, biocompatible mesh technologies made from nanoscale materials are revolutionizing electronic-tissue interfaces. Applications that leverage this technology should expand or enhance the ability of present systems to monitor and treat cardiovascular and pulmonary disorders such as arrhythmias, sleep apnea, asthma, and COPD.

Develop new and improved methods to assess, monitor, or predict cardiovascular toxicity of therapeutic agents. Methods or assay platforms that utilize in vitro (e.g., re-programmed cells and engineered 3D-tissue constructs) and in silico approaches are encouraged.

For citizens returning to an urban environment after release from prison or jail, develop and validate mobile app solutions they can use to improve their health outcomes related to cardiovascular diseases including but not limited to hypertension. For example, these solutions should use evidence-based guidelines for the management of cardiovascular disease such as care planning, medication management, assessment or monitoring of cardiovascular disease and decision support that includes multi-level (health systems, provider, and patient) facets. Solutions should also include user support documentation for all potential users of the technology, including but not limited to patients, family/caregivers, and providers.

New animal models for the study of chronic venous insufficiency (CVI) and post-thrombotic syndrome, and innovative approaches for their prevention and treatment.

Development of mechanical circulatory support devices for individuals with congenital heart disease and single ventricle physiology after Fontan surgical palliation.

Novel non-invasive strategies that detect early subclinical changes in cardiac structure, function, and /or tissue are needed to improve detection and monitoring of chemotherapy-induced cardiac injury in order to improve cardioprotection and effectiveness of cancer therapeutics. Strategies that increase sensitivity and precision of existing or enhance imaging technologies with respect to normal and altered cardiac structure, function, energetics, and metabolism are sought. Pre-clinical or patient studies using molecular changes or biomarkers to enhance early detection of cardiac derangements are also responsive.

Develop innovative technology and/or service delivery models or designs to increase the adoption, uptake, and sustainability of evidence-based guideline recommendations for the management of heart, lung, blood, and sleep disorders. These should include multi-level (health systems, provider, and patient) facets and benefit ethnic/racial minority groups, rural populations, and low socioeconomic status groups.

Adaptation of microfluidic technology platform to address needs in the following areas:

• Small volume blood sampling and testing in pediatric/neonatal setting. Monitoring of blood values in pediatric intensive care units is dependent on obtaining sufficient blood volumes for testing. Since neonates may provide only small volume samples, there is a pressing clinical need for the development of devices capable of performing blood tests on samples sizes of <100 uL.
• Vascular hemostasis assays – development of devices capable of simultaneously performing multiple blood coagulation testing on sample sizes <100 uL. Devices should be automated with little user training required.
• Complete blood cell count performed on blood sample sizes <100 uL. Devices should be automated with little user training required.
• Evaluation of the peripheral blood for biomarkers linked to the microbiome and their predictive value in identifying disease risk factors. The microbiome may significantly impact human health, both in health and disease. Interactions of the body with these microbial organisms may yield biomarkers with predictive value in determining risk of disease and subsequent prognosis.

Studies confirm that iron deficiency occurs in blood donors and that frequent donors and premenopausal women are at increased risk. Scientific evidence supports the need for routine monitoring of iron stores by testing ferritin, preferably prior to blood donation. Reliable point of care ferritin testing would expedite the process of identifying iron deficiency and would in turn, protect individuals from potentially damaging further donations and/or indicate the need for iron supplementation. Applicants are encouraged to develop an innovative, inexpensive,point of care device that would accurately and reproducibly measure ferritin levels in humans.

Development and validation of high-throughput genomic assays that enable reliable profiling of circulating cell free RNA for noninvasive detection of tissue damage associated with Heart, Lung, Blood, or Sleep diseases.