HHS SBIR RFA-AG-12-009

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 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 RFA on T2 research (RFA-AG-12 010).  Additional information on NIA funding considerations for RFA-AG-12-009 and RFA-AG-12-010 is available at: http://www.nia.nih.gov/GrantsAndTraining/FundingOpportunities/TranslationalResearch.htm .

RESEARCH OBJECTIVES:

Eligible small businesses are invited to submit grant applications (including Phase I, Phase II and Fast Track SBIR applications) proposing to develop and deliver technologies or products appropriate to the needs of midlife or older adults and to clinicians responsible for their care.  Responsive applications will include a description of the specific healthcare requirement or need of the older population being addressed.

Applicants should also include a timeline and milestones for projects submitted in response to this FOA. All types of applications whether they are Phase I, Phase II or Fast Track should include a timeline with project stages, milestones, etc., but the nature of the timeline should be appropriate to the work proposed.  The timeline should delineate a series of project stages, identify criteria for completion of work stages and provide contingency plans for each work stage.  It is important that the applicant includes the criteria and contingency plans that will be used to determine milestone completion before proceeding to the next  stage of the project.

T1 translational topics include but are not limited to:

Creation and validation of screening assays for therapy development. The assays may be intended for primary or secondary screening efforts at any level of throughput.

Creation of animal models of MCI, AD and normal cognitive aging for therapy development. Animal models that will be used for basic research are outside the scope of the program.

Validation of putative therapeutic targets that are mechanistically linked to cognitive aging, MCI and AD.

Identification of candidate therapeutics, including primary or secondary screening efforts at any level of throughput.

Development of preliminary proof-of-principle data on the efficacy of candidate therapeutics.

Development and/or testing of novel methods to identify phenotypes with different AD risk profiles (imaging, biochemical and cognitive biomarkers, individually or in combination).

Non-invasive or minimally obtrusive technology for monitoring specific physiologic outcomes (e.g., pulmonary function, metabolism) in a free-living setting.

Portable diagnostic or therapeutic systems  (e.g., devices for point-of-care  diagnosis, adaptation of existing interactive video games to train older individuals for mobility problems).

Development of assistive technologies for age-related mobility problems.

Development and testing of new vaccine formulations to improve vaccine response in older adults.

Development of stem cell-or progenitor cell- based interventions to repair or rejuvenate aged tissues.

Development of technologies or products to relieve skin conditions associated with prolonged immobilization (e.g., sores or wounds resulting from long-term confinement to a bed).

New sampling and data collection methodologies for use in large population-based household surveys and behavioral interventions of relevance to aging.  These include:

Experience sampling and new devices for real-time collection of data.

Performance based measures for cognitive or physical functioning as well as new instruments for cognitive testing, sleep quality, assessment of basic decision-making domains, or assessments of social behaviors.

Improvements to blood spot technology for biological data collection (this includes the development of multiple and reliable assays for limited blood spot specimens).

Development of Survey/Archiving/Database support, including:

Development of new databases and database support to satisfy data and research needs in aging as well as the development of innovative data archives to make current statistical and epidemiological data more accessible and policy relevant.

Development of data extraction web tools for public use databases.

Development of innovative methods and software to provide improved access to complex longitudinal studies or surveys that cannot be placed in open data archives because of confidentiality issues.

Development of innovative methods and software to facilitate analysis of personal data linked to geocoded data, biological, cognitive or genetic measures, with improved protection for confidentiality.

Development of data infrastructure and tools for assessing the economic impact of federally-funded research.