Diagnostics Accelerator: Biobank Sharing RFP

SAMPLE SHARING PRIORITIES

For applications requesting funding and samples, please submit proposals through the Peripheral Biomarkers Program.

Modalities: A range of samples, including plasma, serum, whole blood, and CSF are available together with a large number of clinical and other biomarker variables. Please note that some blood samples may have matched CSF. Associated patient data will only be made available to successful applicants at the discretion of the organization providing the samples.

Biomarker targets: Proposed approaches will be evaluated on biological plausibility linking the biomarker to Alzheimer’s pathophysiology and the strength of assay performance and validation data.

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:

  • Context of Use: Concise description of the biomarker's specified use in in drug development, as defined by the FDA.
  • Methodological considerations: Including the analyte and assay platform, the type and number of samples needed, the performance of the assay, and the strategy for maximizing reproducibility and robustness. Power calculations and relevant statistical methodologies for data analysis should be included.

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

  1. Proof-of-principle studies should be supported by prior human data justifying that the candidate markers might function as biomarkers that could be used to support clinical trials for Alzheimer’s disease or related dementias.
  2. Validation awards will support the further development of previously identified biomarkers for use in Alzheimer’s disease research.

Proposals must include specific aims and must employ an established analytical methodology, including a clear biological rationale for the biomarker and a plan for how the samples will be used, power analysis, and any statistical details.

Applicants should address how proposed studies would move the biomarker towards the clinic including strategies for regulatory approval and scale-up together with commercialization where appropriate. Proposals should consider compatibility with existing sampling infrastructure, scalability, and intellectual property position. Where available, target biomarkers in peripheral fluids should be compared to quantitative measurements using PET and/or CSF, and outcomes beyond cognition alone.

ELIGIBILITY

Funding is open to researchers and clinicians worldwide at:

  • Academic medical centers and universities or nonprofits
    Industry partnerships are strongly encouraged.
  • For profit companies
    Existing companies and new spinouts are both eligible.

Review Process

Applications are reviewed in a three-step process:

  1. Letters of Intent (LOI): The ADDF’s DxA team will evaluate LOIs to determine whether the proposed use of samples is consistent with the ADDF's mission and the priorities of the Biobank Sharing partners.

    Timeline: Generally, applicants can expect to be notified within 2-3 weeks of their LOI submission.
     
  2. Full proposal: Invited full proposals are reviewed by members of our external scientific and regulatory review boards. Our 150+ reviewers represent some of the world’s most recognized experts from academia, biotech, and pharma. Proposals will then undergo further due diligence by the ADDF science team and advisory boards to arrive at a final funding decision.
  3. Final Decision: The ADDF will work to connect strong proposals with the relevant Biobank Sharing partners. The final decision will rest with the Biobank Sharing partner.

    Timeline: Generally, applicants can expect to be notified within 3-4 months of their full proposal submission.
     

LETTER OF INTENT

Applicants should submit a Letter of Intent (LOI) through the ADDF Funding Portal.

1. Fill in contact and project information (e.g. title, duration, samples requested).

2. For applicants who want to be considering in the sample sharing program please check the appropriate box.

3. The LOI includes brief descriptions of the following:

  • Scientific Rationale and Background: Describe how the proposed biomarker relates to the disease process, and how your approach compares with others in development for the same or similar target/mode of action or biomarker modality (300 words maximum).
  • Specific Aims: List specific aims and/or milestones.
  • Summary of Key Supporting Data: Provide a brief summary of key analytical and clinical data that justify the proposed study (300 words maximum).

Full Proposal

The Body of the Application should include the following: (a) Project Description, (b) Sample Use Justification and Statistical Analysis, and (c) Biographical Information. These sections should be compiled into a single PDF and uploaded where indicated in the full proposal section of the ADDF Funding Portal.

PROJECT DESCRIPTION

The project description is the central part of the proposal and should contain the eight sub-sections listed below (indicate each sub-section by number in the proposal). Sub-sections 1-6 should not exceed 5 pages of written text. Embed figures in the text if possible. Use at least 11pt. font and 1" margins.

BACKGROUND AND RATIONALE

  • Provide the biological rationale that links the candidate biomarker to disease pathophysiology.
  • Describe the candidate biomarker's relevance to diagnosis or drug development for Alzheimer's disease. Discuss related programs in the field, if any are known, and please explain the advantages of your program.
  • Discuss the novelty of the proposed approach and its leading context of use (CoU).

Supporting Data

  • Provide relevant supporting data.
  • Provide data for the analytical method, such as sensitivity, specificity, accuracy, parallelism, precision, sample stability, and other characteristics.
  • The analytical method should incorporate the recommendations from C-PATH Points to consider document. An additional reference could be the FDA Bioanalytical Method Validation Guidance (PDF)
  • For your request to be considered, the ADDF may need to share your full proposal with the industry partners providing access to samples. However, if you require certain aspects to be redacted or excluded to protect IP / proprietary information, please discuss with the ADDF team.
  • Please provide information on your funding sources that will enable you to complete the proposed work.

Project Plan and Objectives

  • Objectives: List specific aims and milestones with clearly defined go/no-go decision points for advancement of the project.
  • Timeline: Use the DxA Project Plan Template (.xlsx) to provide a schedule for the completion of the proposed milestones/deliverables.
  • Outline strategies for commercial scale-up, manufacturing, possible cross-platform compatibility, and regulatory approval, including the timeline for FDA submissions and milestones.

Experimental Design and Methods

  • Provide details for each analytical method proposed and the measurement methodology. Include possible strategies if issues arise and any plans for the development of combined measures that may provide greater validity than an individual measure. Include the sourcing of all components of the analytical methods proposed.
  • Provide a statistical analysis plan. Include a power analysis to justify the number of samples per group.
  • Describe the strategies for maximizing reproducibility, including standard operating procedures for pre-analytical, analytical, and post-analytical stages.
  • Regulatory plan (including regulatory pathway and regulatory strategy details) and key milestones / checkpoints along with the estimated timeline. Download regulatory plan.

Description of Investigative Team and Resources

  • Describe the investigative team and explain how specific expertise of each member will contribute to completing the study objectives.
  • Where internal expertise is not available, include a description of external partners (e.g. consultants, contract research organizations / CROs) that will help to execute the experimental work.
  • Discuss the inclusion of any consultants with assay development expertise that were involved in the design of preclinical or clinical studies or the development of the commercialization plan.
  • Discuss relationships with commercial diagnostics platform companies or plans to partner. Summarize the materials, technologies, and/or expertise provided by these collaborators.

OTHER SUPPORT

List financial support awarded and pending, and include grant title, principal investigator, percent effort of investigator, granting agency, amount, and projected funding period.

Biographical Information

Include a biosketch for each of the key personnel involved in the project. Existing NIH biosketch forms or other formats are accepted.

SUPPLEMENTAL MATERIALS

The following materials are optional. If not submitting Supplemental Materials, upload a PDF stating "N/A." Otherwise, compile all the materials into a single PDF and upload as "Supplemental Materials." These materials can include:

  • Letters of support/collaboration
  • Figures that cannot be embedded into the body of the application but are directly relevant to the application and may be helpful to the review committee.

Limit the number of additional attachments included. You may also include unpublished manuscripts. Publications that are publicly available online should be linked to in lieu of attaching the full files. Do not include presentation decks or full patents.

 

APPLICATION SUBMISSIONS

For program-related inquiries, please contact:
Patricia Saletti, PhD, Program Officer, Diagnostics Accelerator
psaletti@alzdiscovery.org

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