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DIAGNOSTICS ACCELERATOR: PERIPHERAL BIOMARKERS PROGRAM
One of the key barriers to the development of a disease-modifying treatment for Alzheimer's disease is an insufficient toolbox of biomarkers to easily and more specifically screen and diagnose patients, stage disease progression, monitor response to treatment, and improve the rigor and efficiency of clinical trials. Across diseases, clinical trials are twice as likely to succeed when patients are selected using validated biomarkers. In cancer, validated biomarkers have transformed drug development and clinical practice over the last decade. Now is the time to develop this strategy for Alzheimer's disease.
Notable advances have been made in developing biomarkers for Alzheimer's disease in recent years. Currently available imaging and CSF-based assays for beta-amyloid and tau are already used in clinical practice and clinical trials with high diagnostic accuracy. Efforts are underway in CSF to expand beyond this core set of biomarkers that correlate with disease-related proteinopathy in the brain to biomarkers that may reflect other correlates and key mediators of the disease, including inflammation, vascular injury, synaptic dysfunction, oxidative stress, among others.
However, there remains a clear and pressing need for inexpensive and minimally invasive biomarker tests to more easily and accurately screen and identify patients at the earliest stages of disease before the onset of irreversible injury and associated symptoms. Clinical biomarkers also are needed to monitor progression of the disease and assess response to treatments as they become available. Recently, ultrasensitive assays that detect beta-amyloid peptide ratios and peptide secondary structure in blood have been developed that correlate with brain and CSF amyloid load. Substantial work is still required to bring these and additional, validated, and minimally invasive biomarkers into the clinic.
Given the pathological heterogeneity of Alzheimer's disease and related dementias, this next generation of peripheral biomarkers must be able to characterize the individual's underlying pathophysiology. This will require an expansion of the biomarker panel beyond what is currently available. Developing these biomarkers will be critical for a broader characterization of pathology in patients with Alzheimer’s disease by identifying different patient sub-types based on biological phenomenon.
Diagnostics Accelerator is a partnership of funders dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias, and to advance the development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge the research community to develop novel biomarkers from peripheral modalities. Peripherally-sourced biomarkers will enable greater patient tolerability, integration with existing sample testing infrastructure, and the scalability and affordability necessary for population-level screening.
- Letter of Intent: Sep. 14, 2018
- Invited Full Proposals: Nov. 16, 2018
Areas of Interest
In its first request for proposals, Diagnostics Accelerator is soliciting projects to develop biomarkers for Alzheimer's disease and related dementias accessible from the periphery. Proposals addressing a range of potential clinical uses are of interest, especially tests for early screening and diagnosis, clinical trial enrichment, quantification of patient responses to therapeutics, or prediction of conversion from mild cognitive impairment to Alzheimer’s disease. Applicants are encouraged to demonstrate both the technical rigor that underlies recent successes in peripheral biomarkers as well as bold and creative approaches to this longstanding challenge.
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.