DIAGNOSTICS ACCELERATOR: PERIPHERAL BIOMARKERS PROGRAM

DEADLINES:

Must be received by 5:00pm ET on the deadline date.

Letter of intent: September 14, 2018

This is the final deadline for applicants to submit letters of intent. Letters of intent will be accepted and reviewed on a rolling basis up until this deadline.

Invited full proposal: November 16, 2018

REQUISITES

Open to researchers and clinicians worldwide at:

-          Academic medical centers and universities or nonprofits. Industry partnerships are strongly encouraged.

-          Biotechnology companies. Funding provided through mission-related investments that require return on investment. Existing companies and new spinouts are both eligible.

AMOUNT

- Proof-of-principle awards: up to $500,000

- Validation awards: Award amounts will be based on stage and scope of research.

Advancing Peripheral Biomarkers for Alzheimer’s and Related Dementias

Bill Gates and ADDF co-founder Leonard Lauder are partnering and adopting a new approach that brings together philanthropic capital with a venture mindset to advance bold new ideas for easier and more accurate diagnosis of Alzheimer's disease and related dementias.

Main characteristics

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.

Two types of projects will be supported through this RFP:

Proof-of-principle awards will support exploratory analyses of biomarkers at a small scale (e.g., 50-100 human samples)

Validation awards will support biomarkers that need to be tested at a larger scale (e.g., 500-1000 samples)

Projects that succeed in the proof-of-principle stage may be eligible for follow-on funding in the form of a validation award.

FUNDING PRIORITIES

Modalities: Blood and other peripheral markers, including saliva, urine, and ocular biomarkers are encouraged. The development of CSF and neuroimaging biomarkers will not be considered for this RFF; however, we encourage the use of these modalities to validate proposed biomarkers.

Biomarker targets: Proposed approaches will be evaluated on biological plausibility linking the biomarker to disease pathophysiology. Examples of target areas of interest include, but are not limited to:

-          Neuroprotection

-          Neurodegeneration

-          Protein misfolding

-          Synaptic integrity and/or activity

-          Vascular injury and blood-brain barrier integrity

-          Mitochondria and metabolic function

-          Oxidative stress

-          White matter changes

Other novel approaches that are supported by compelling evidence that demonstrate a rational biological connection to the disease process are encouraged.

Context of use: This RFP is open to all biomarker categories that will advance drug development for Alzheimer’s and related dementias. These categories, as defined by the FDA, include diagnostic, monitoring, predictive, prognostic, pharmacodynamic/response, safety, and susceptibility/risk biomarkers. The expected context of use, which defines a biomarker’s intended use clinically as a diagnostic or in drug development, should be described in the application. Additionally, the applicant should articulate where in the path to commercialization the study falls and what is the proposed plan forward.

PROJECT DETAILS

All proposals will be evaluated on scientific and technical merit, level of innovation, and investigator and organizational capabilities. Additionally, proposals will be evaluated on the following criteria:

-          Biomarker context of use and how the biomarker will be incorporated into clinical use

-          Methodological considerations including sample collection and storage, quality and reliability of the assay used, and strategy for maximizing reproducibility.

-          Samples should be obtained from well-characterized cohorts and when possible, should include individuals from minority and disparity populations

Two types of projects will be supported through this RFP:

1.- Proof-of-principle awards will support exploratory analyses of biomarkers at a small scale (e.g., 50-100 human samples) that are supported by human data demonstrating that the candidate markers correspond with disease pathophysiology. Preliminary assay validation data for the proposed studies should be included.

Generally, projects at this stage will be awarded up to $500,000 based on stage and scope of research. However, if there is a compelling reason to go above this level, please contact us before submitting.

2.- Validation awards will support biomarkers that need to be tested at a larger scale (e.g., 500-1000 samples) and are supported by a significant body of human data demonstrating that the biomarker(s) correspond with disease patophysiology. Applicants should be able to address how validation studies would move the biomarker towards the clinic and should define their strategies for regulatory approval and commercial scale-up. Assays should be well developed. Proposals should consider compatibility with existing sampling infrastructure, scalability, and intellectual property position, and standard operating procedures should be in place. Validation studies should compare peripheral analysis to quantitative measurements using PET and/or CSF, going beyond comparisons to cognition alone.

Award amounts will be based on stage and scope of research.

Projects that succeed in the proof-of-principle stage may be eligible for follow-on funding in the form of a validation award.

APPLICATION SUBMISSIONS

For program-related inquiries: Lauren Friedman, PhD, Director, Scientific Affairs
212.901.8017
lfriedman(ELIMINAR)@alzdiscovery.org

For application submission inquiries: Grants and Mission-Related Investments Team
212.901.7998
grants(ELIMINAR)@alzdiscovery.org