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DIAGNOSTICS ACCELERATOR: DIGITAL BIOMARKERS
Recent innovations in technology now provide novel ways to collect, track, and analyze patient data. These digital tools can provide quantifiable indicators or biomarkers of a patient's physiological and/or behavioral state.
Digital biomarkers have the potential to add significant value to clinical trials, reach broader swaths of the population, empower patients and caregivers, and greatly improve treatment outcomes.
Decades of research have identified a variety of symptom domains that correlate with the different stages of Alzheimer's disease and related dementias. These symptoms include changes in speech, cognitive impairment such as loss of memory and executive function, sensory/motor function, as well as impairment in higher order and daily functions. By leveraging advances in computational capabilities, coupled with readily available sensors in consumer electronics, we can begin to identify and monitor subtle, yet pertinent changes caused by neurodegenerative disease with digital biomarkers. Importantly, these tests can provide objective, passive, continuous, longitudinal, and/or quantifiable physiological and behavioral data with the potential increase in the statistical power of clinical trials, thus reducing cost, improving the ability to detect outcomes, and facilitating personalized therapeutic approaches.
In addition to improving clinical trials, digital biomarkers will revolutionize patient treatment and care. Primary care physicians and caregivers could soon have the technological capability to capture essential information around a patient's prognosis, reaction to treatment, and general quality of life, all of which are currently hard to accurately evaluate with sporadic in-clinic assessments. Given the ubiquitous nature of consumer electronics such as wearables and mobile devices along with powerful computational platforms, digital biomarkers have the potential to serve as patient engagement, compliance, and monitoring tools.
Various technological platforms (mobile phones, wearables, tablets, and cloud-based tools) provide monitoring capabilities with limited additional cost and operational burden on the healthcare system, clinical researcher, caregiver, or patient. While promising, these approaches require extensive technical and clinical validation to be fully accepted into traditional clinical practice. The development of digital biomarkers will depend on leveraging the data garnered from these different technologies. The Diagnostics Accelerator initiative will fast-track the development of these new technologies and the digital biomarkers using the data generated from these technologies.
The Diagnostics Accelerator is a partnership of funders dedicated to accelerating the development of affordable and accessible biomarkers for Alzheimer's disease, frontotemporal degeneration, and other related dementias. The Diagnostics Accelerator supports research and development through translational research awards and access to consulting support from industry experts. The current RFP is soliciting projects to develop and validate digital biomarkers for Alzheimer's disease and related dementias. Digital biomarkers are defined as objective, quantifiable physiological and behavioral data that are collected, measured and analyzed by means of digital devices such as portables, wearables, or ambient sensors. Digital biomarkers range from computerized or app-based versions of traditional neurocognitive tests to novel technology platforms that combine multiple complex data sources into a phenotypic signature.
Proposals addressing a range of potential clinical uses are of interest, especially technologies for early assessment and those aiding in diagnosis and monitoring treatment response or rate of disease progression. Creative approaches to leverage new and existing software and hardware are encouraged. Importantly, the use of the digital technology should be driven by 1) an unmet patient or scientific need for a better assessment and/or 2) providing a more cost-effective, efficient, and less burdensome approach to diagnosis and monitoring in clinical practice and clinical trials.
- Letter of Intent: June 7, 2019
- Invited Full Proposals: August 16, 2019
Funding is open to researchers and clinicians worldwide at:
- Academic medical centers and universities or nonprofits
Industry partnerships are strongly encouraged.
- Biotechnology companies
Funding is provided through mission-related investments that require return on investment. Existing companies and new spinouts are both eligible.