INTRODUCTION

The Diagnostics Accelerator (DxA) at the Alzheimer’s Drug Discovery Foundation (ADDF) – a partnership of funders including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, and The Association for Frontotemporal Degeneration among others – and Target ALS have a shared goal of advancing biomarkers for neurodegeneration. Alzheimer’s disease, frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS) are all heterogeneous at the clinical, neuropathological and genetic levels, and increasing evidence indicates that the three disorders share common features. As such, biomarker research targeting mechanisms or pathways common across the three diseases holds promise to advance and facilitate biomarker discovery and validation.

Biomarkers for neurodegenerative diseases have seen significant advances in recent years with substantial improvements in imaging and CSF-based assays. However, given the cost associated with imaging and the invasiveness of CSF-based approaches, there is limited feasibility in widespread screening and use. In addition to diagnosis, biomarkers are essential for guiding drug development in clinical trials, monitoring treatment efficacy and side effects, along with providing individualized information on disease progression.

The Diagnostics Accelerator & Target ALS Foundation

The Diagnostics Accelerator is a research initiative dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program challenges, assists and funds the research community in both academia and industry to develop novel peripheral and digital biomarkers.

Target ALS Foundation is an independent non-profit 501(c)(3) foundation working to accelerate ALS drug development and break down barriers to ALS research. Target ALS has revolutionized ALS research through their landmark Innovation Ecosystem model, fostering unprecedented scientific collaboration between academia and the pharmaceutical/biotech industry.

The Diagnostics Accelerator and Target ALS are joining forces to fund biomarker research targeting biomarkers that might be common to disease pathways or pathophysiologies in Alzheimer’s disease, FTD and ALS to facilitate biomarker discovery and validation. In doing so, the Diagnostics Accelerator and Target ALS aim to drive towards an improved understanding of the heterogeneity of these neurodegenerative diseases and offer potential solutions for differential diagnosis.

Projects will be funded via two mechanisms:

Option 1: As a grant through Target ALS Foundation

Only collaborative projects will be funded. Each collaborative project must include two to four investigators with at least one based at a pharmaceutical/biotechnology company working around a common biomarker (please refer to “FUNDING PRIORITIES”). It is expected that each funded collaborative project will receive up to $300,000 USD per year, according to a justified budget as described below. Each collaborative project will receive the grant for a maximum two-year period.

The maximum budget for a lab that is part of the collaborative project – including direct funding to the pharma/biotech partner – cannot exceed a maximum of $100,000 per lab/year and cannot exceed $300,000 in total per collaborative project/year. Confidentiality of each collaborator’s data, research and intellectual property will be strictly honored. Target ALS Foundation does not seek ownership of any intellectual property or financial gains that result, directly or indirectly, from its funding.

All proposals will be evaluated on scientific and technical merit, potential future applicability in the clinic, level of innovation, investigator and organizational capabilities, context of use, methodological considerations, and proposed samples or subjects, as described below (see “Project Proposal Details”).

The collaborative projects will support two broad categories:

Exploratory pilot studies that aim to test the utility of an existing fluid biomarker approach for the first time in an Alzheimer's disease or related dementia and ALS population. These projects should already have preliminary human data from another neurodegenerative disease indication. Support will also be considered for transferring methods to measure biomarkers of interest currently in CSF to blood, saliva or urine.

Proof-of-principle 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 in Alzheimer’s disease or FTD and ALS. For peripheral biomarkers, preliminary assay performance data for the proposed studies should be included.

Option 2: As a mission-related investment from the Diagnostics Accelerator at the ADDF

Projects that succeed in the exploratory or proof-of-principle stage funded by Target ALS may be eligible for follow-on funding provided the biomarker is involved in Alzheimer’s disease or related dementia disease pathophysiology. Direct applications are also welcome, providing the appropriate technical and business data packages can be assembled. It is the aim of the Diagnostics Accelerator to advance biomarkers to the clinic. With that in mind, collaborative projects, as well as individual labs that are part of the collaborative projects funded through Target ALS Foundation, may be eligible for follow on funding through a one-time award of up to $500,000 via a mission-related investment from the Diagnostics Accelerator, provided the biomarker is involved in Alzheimer’s disease or related dementia disease pathophysiology. Funding will be provided to enable progress through the regulatory path with the aim of making the biomarker related tools and assays available to the worldwide community.

APPLICATION SUBMISSIONS

Review the Project Details above for what to include in the Body of the Application. Proposals, references, biosketches, biofluid repository agreement (where appropriate), and the collaborative project agreement should be compiled into a single PDF and uploaded where indicated in the full proposal section of the ADDF Funding Portal.

In addition, the Budget and Justification should be uploaded as a separate document in the ADDF Funding Portal.

For program-related inquiries, please contact:
Sarah Giardina, PhD, MBA, Associate Director, Biomarker Development, ADDF
sgiardina@alzdiscovery.org

Manish Raisinghani, M.B.B.S, PhD, CEO, Target ALS
manish.raisinghani@targetals.org

For application submission inquiries, please contact:
Mission Related Investments Team
grants@alzdiscovery.org