A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals

Active
No
Status
Closed
Release Date
August 25th, 2023
Open Date
August 25th, 2023
Due Date(s)
November 14th, 2023
Close Date
November 14th, 2023
Topic No.
NIH/NIA 010

Topic

Technology to facilitate characterization of the exposome in under-resourced populations for AD/ADRD Studies

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2023

Summary

The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking proposals for a Small Business Innovation Research (SBIR) contract related to the technology to facilitate characterization of the exposome in under-resourced populations for AD/ADRD studies. The goal of this research is to develop technologies that enable remote or self-sampling, allowing greater participation of under-resourced populations in research on age-related diseases such as Alzheimer's and related dementias. The research aims to address the difficulties in collecting environmental and biological samples from these populations, which often carry a high burden of these diseases. The solicitation emphasizes the need for remote sampling tools that enable self- or caregiver-collected specimens for longitudinal population-based studies, linking environmental exposures to molecular changes associated with adverse aging and the development of Alzheimer's and related dementias. Additionally, there is a need for portable air sampling devices that capture physical and bioaerosols in liquid media to maintain their viability. The technologies should be user-friendly and enable sample capture at the point of exposure, with the samples shipped back to a central lab facility for analysis. The solicitation encourages proposals that adhere to the specified budget amounts and project periods. The anticipated awards include 1 to 2 projects, with a budget of $500,000 for Phase I (12 months) and $2,500,000 for Phase II (2 years). Fast-Track and Direct-to-Phase II proposals will also be accepted.

Description

Number of anticipated awards: 1 to 2 Budget (total costs, per award): Phase I: $500,000 for 12 months; Phase II: $2,500,000 for 2 years Fast- Track proposals will be accepted. Direct-to-Phase II proposals will be accepted for companies that have already demonstrated feasibility and rigorously achieved the deliverables as described for Phase I. It is strongly suggested that proposals adhere to the above budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded. Summary: Characterizing the exposome requires collection of both environmental and biological samples. However, under resourced populations, who often carry the highest burden of age-related diseases, are often precluded from participating in epidemiologic studies due to difficulties in collecting these environmental and/or biological samples. By lowering the barriers to these data collection efforts, NIA will be better able to study the etiology of complex diseases such as Alzheimer’s and related dementias in more representative populations.

The development of technologies that will enable remote or self-sampling will enable greater participation of under resourced populations in research. However, there are several unmet needs for remote sampling tools that enable self- or caregiver-collected specimens that will allow longitudinal population-based studies to link environmental exposures to molecular changes associated with adverse aging and development of Alzheimer’s and related dementias over a period of time. Short term changes (weeks/months) are useful for following disease progression, while longer term changes (years/decades) are useful for developing predictive biomarkers and understanding the etiology of disease.

Furthermore, there is a need for portable air sampling devices that capture both physical and bioaerosols in liquid media to maintain their viability, as well as a need for need for technologies that are user friendly and enable sample capture at the point of exposure (e.g., homes, workplaces, public spaces) with the samples shipped back to a central lab facility for high content biological and chemical analysis.

The ability to combine remote/point-of-exposure collection devices with technology that samples human specimens will provide a powerful lens into a person's exposure and their physiological response to those exposures. For large population-based cohort studies, environmental and physiological samples can be collected prospectively and analyzed at a later point once it is known which study participants will experience outcomes later in life (e.g., onset of dementia, etc.).