Alzheimer' Drug Discovery Foundation Biomarker Discovery
Due Date: 3/2/22
Funding $300,000/year for 2 years
Requires collaboration between 2-4 PIs with one being located at a pharmaceutical or biotech company. They have specific interest in biomarkers that are not imaging or CSF based.
DIAGNOSTICS ACCELERATOR AND TARGET ALS FOUNDATION BIOMARKER DISCOVERY RFP
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.
LETTER OF INTENT DETAILS
THE DIAGNOSTICS ACCELERATOR AND TARGET ALS CONSORTIUM
Review the Application Instructions for steps on applying.
For program-related inquiries, please contact:
Sarah Giardina, PhD, MBA, Associate Director, Biomarker Development, ADDF
Manish Raisinghani, M.B.B.S, PhD, CEO, Target ALS
For application submission inquiries, please contact:
Mission Related Investments Team
This foundation has the Core Funding Program which funds Drug Development for Alzheimer's which may be more relevant to the work in Warren. They accept LOIs on a rolling basis, with the next due date of 2/4/22 (followed by another on 5/20/22). The Drug Development RFP seeks to support in vivo preclinical studies that advance lead molecules developed for Alzheimer’s disease and related dementias to IND-enabling studies. This award is up to $600,000 for one year.
DRUG DEVELOPMENT PROGRAM
FUNDING OPPORTUNITY DESCRIPTION
The Drug Development RFP seeks to support in vivo preclinical studies that advance lead molecules developed for Alzheimer’s disease and related dementias to IND-enabling studies. The proposed studies should be structured to deliver a compound with strong potential for clinical and commercial application.
This funding opportunity prioritizes novel drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia. For this reason, amyloid targeted approaches and cholinesterase inhibitor proposals will not be considered for this RFP.
Stage of discovery:
- Preclinical pharmacokinetics (PK) and pharmacodynamics (PD) (primarily to inform dose selection for in vivo efficacy studies), as well as preliminary rodent tolerability studies
- In vivo efficacy or proof-of-concept studies in animal models of disease or aging, with a focus on direct and indirect markers of target engagement and downstream pharmacologic effects
- Please note: Applications that focus on basic research (including target discovery), assay development, and screening to identify hit compounds are not a priority for this RFP and will be withdrawn
- Please note: IND-enabling work and clinical trials are supported through the Program to Accelerate Clinical Trials (PACT) RFP
Therapeutic modalities: Includes small molecules, biologics, gene therapies, antisense oligonucleotides, and stem cells. Development of novel devices or delivery systems will not be considered for this RFP.
Drug mechanisms or modes of action: Novel drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia are considered high priority. These include, but are not limited to:
- Mitochondrial & metabolic function
- Synaptic activity and neurotransmitters
- Vascular function
- Other mechanisms and modes of action related to the biology of aging (e.g. senescent cells)
- Other novel mechanisms or modes of action that are supported by compelling evidence demonstrating a rational biological connection to the disease process
- Please note: Anti-amyloid approaches (e.g. anti-amyloid aggregation, beta-amyloid vaccines, beta- or gamma-secretase inhibitors) and cholinesterase inhibitor proposals will not be considered
EXPECTATIONS AND EVALUATION
Review the Application Instructions for steps on applying.
We encourage you to contact us if you would like to discuss your proposed project and receive initial feedback.
For scientific inquiries, please contact:
Jonathan Sabbagh, PhD, Associate Director, Scientific Affairs
For inquiries related to contracting and the online funding portal, please contact:
Mission Related Investments Team