T1 Translational Research on Aging: Small Business Innovation Awards (R43/R44 Clinical Trial Optional)

Background

The involvement of small businesses in translational aging research could hasten the pace at which scientific advances are transformed into commercial products to improve or maintain the health and functional independence of older adults.  Therefore, this funding opportunity announcement (FOA) is intended to support innovative research conducted by small businesses to advance the availability of novel devices, products, health care practices and programs with the potential for commercial success and the likelihood to benefit the lives of older adults. 

For the purposes of this FOA, T1 translational research on aging is defined as the application of basic and clinical biomedical or basic behavioral and social research findings towards the development of new strategies for prevention and treatment of age-related pathologies. T1 translational research approaches could include the development of novel research tools, as well as new or existing technologies to diagnose, prevent or treat age-related conditions, functional decline and disability or for the promotion of health and well-being in mid- and later life.  For example, SBIR grant applications may be submitted for the development of novel diagnostic assays, diagnostic or assistive devices, point- of-care technologies, as well as the pre-clinical development of therapeutics involving small molecules, biologics and devices, for normal cognitive aging, Mild Cognitive Impairment (MCI) and Alzheimer’s disease (AD).

Applicants interested in proposing translational research projects relating to the development, evaluation or dissemination of scientific findings into new health care practices and community programs for older adults, and development of new technologies to enhance productivity in aging research should refer to the companion FOA on T2 research (PAR-18-184).

Research Objectives

Eligible small businesses are encouraged to submit grant applications (Phase I, Phase II and Fast Track SBIR applications) proposing to develop and deliver technologies or products appropriate to the needs of older adults and to clinicians responsible for their care. 

T1 translational topics of interest include:

• Development and validation of human in vitro testing systems (e.g., for high throughput screening, toxicity studies, proof-of-concept studies) derived from older individuals.  For example, current efforts related to tissues-on-a chip do not adequately address potential differences in biological effects or toxicities of new compounds (or repurposed agents) as a function of age. The availability of these types of tests would provide insight into potential species differences in the biological effects or toxicities of new compounds much earlier in the translational process than is currently possible. 
• Interventions targeting putative aging mechanisms that influence the risk or progression of multiple age-related conditions.
• Development of new vaccine formulations to improve vaccine responses in older adults.     Current efforts to develop vaccine formulations using newly developed adjuvants or altered delivery protocols are not commonly being tested for use in vaccine formulations for older individuals. The testing of adverse effects of these protocols with aged animal models would provide much needed information with regard to the applicability of these vaccine formulations for use in older populations. 
• Development of stem cell or progenitor cell based interventions to repair or rejuvenate aged tissues.  Development of interventions for dysfunctional cellular responses related to tissue remodeling or wound healing. Some of the technologies or products being developed could be applied to wound healing in the elderly, including venous leg ulcers or pressure ulcers, for example.
• Development of sensitive, specific and standardized tests for diagnostic screening of MCI and dementia; for example, the development of novel neuropsychological, biochemical and neuroimaging methods for the early detection of cognitive impairment and MCI and the early diagnosis of AD, and development of new tests for detection of pre-clinical AD.
• Discovery, development, and/or evaluation of drugs, biological or natural products, including central nervous-system delivery systems to remediate age-related cognitive decline, and to treat the cognitive impairment and/or behavioral symptoms associated with MCI, AD, and other dementias of aging as well as to slow and/or reverse the course of the disease or to prevent it entirely.
• AD target discovery and validation through the application of systems biology and systems pharmacology approaches

See Section VIII. Other Information for award authorities and regulations.