Diagnostics Accelerator: Peripheral Biomarkers Program

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:

• Context of Use concise description of the biomarker's specified use in in drug development
• 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

The following types of projects will be supported through this RFP:

1. Exploratory awards will support 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 population. These projects should already have preliminary human data from another disease indication. A limited number of awards will be considered in this category.
   
   Generally, projects at this stage will be awarded up to approximately $250,000 based on stage and scope of research. However, this is not a cap and higher funding levels will be considered if the proposed budget is well justified.
2. 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 justify this in your full proposal if invited.
3. 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 pathophysiology. 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 analytes 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 exploratory or proof-of-principle stage may be eligible for follow-on funding.

Funding is open to researchers and clinicians worldwide at:

• Academic medical centers and universities or nonprofits
  Industry partnerships are strongly encouraged.
• For profit companies
  Funding is provided through mission-related investments that require return on investment. Existing companies and new spinouts are both eligible.

In addition to funding, the initiative will provide support from a network of consultants with industry and regulatory expertise. Consultants will be made available to both academic and biotech programs receiving funding from this award. Consultants will help awardees refine study designs and meet critical milestones. Consultants will also help to identify follow-on funding opportunities and partners that will advance biomarkers towards commercialization.

It is expected that data will be shared as appropriate; however, if data sharing would interfere with obtaining intellectual property protection, it can be deferred as required. Letters of support from the groups providing samples that agree to this policy should be included since many cohorts have strict data sharing requirements.