Diagnostics Accelerator: Body of the Application Instructions

Before Getting Started

  1. Review our funding opportunities and carefully read the RFP for which you're applying.
  2. Read the Application and Funding Policies.
  3. Log in or create an account using the ADDF Funding Portal  to begin the application process. Please note, new applicants should allow 1-2 business days for registration.

 

Review Process

Applications are reviewed in a two-step process:

  1. Letters of Intent (LOI): The DxA team will evaluate LOIs to determine whether the proposed project is consistent with our mission and funding priorities.

    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 business review boards. Our 150+ scientific and business reviewers represent some of the world’s most recognized experts from academia, biotech, and pharma. Proposals deemed fundable by reviewers will then undergo further due diligence by the DxA team and advisors to arrive at a final funding decision.

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, amount 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: Focus this section on 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 clinical data that justify the proposed study (300 words maximum)
  • For resubmissions only: A written point-by-point response to each of the reviewers' comments is required. Upload as "Applicant Response to Reviewers".

Full Proposal

The Body of the Application should include the following: (a) Project Description, (b) Budget and Justification, (c) Biographical Information, and (d) Study Population Worksheet. These four sections 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.

PROJECT DESCRIPTION

The project description is the central part of the proposal should contain the eight sub-sections listed below (indicate each sub-section by number in the proposal). Sub-sections 1-6 should not exceed 15 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(s) to disease pathophysiology. Refer to the Diagnostics Accelerator Peripheral Biomarker program or the Diagnostics Accelerator Digital Biomarker program for project details.
  • Describe the candidate biomarker's relevance to diagnosis or drug development for Alzheimer's disease and/or related dementias. Discuss related programs in the field; if any are known, please explain the advantages of your program.
  • Discuss the novelty of the proposed approach and its leading context of use (CoU). It is recommended to focus on one CoU, however, if multiple CoU are proposed, please describe additional biomarker categories here and ensure study design will support these additional categories.

Supporting Data

Provide relevant supporting data.

  • Include data that demonstrates how the candidate biomarker(s) is connected to the disease process.
  • For peripheral biomarkers, provide data for the analytical method such as sensitivity, specificity, accuracy, parallelism, precision, sample stability, and other characteristics.
  • For peripheral biomarker Validation projects, 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 peripheral biomarker Sample Sharing Program requests: Provide a description of the population characteristics (e.g. SCD, MCI etc.), other biomarker data (e.g. amyloid status, CSF biomarkers if available etc.), sample type needed (e.g. plasma, CSF), approximate volume and numbers of samples needed along with a statistical validation plan and how these samples will add value to your proposed biomarker study. 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.
    • If requesting samples only, please provide information on your funding sources that will enable you to complete the proposed work
    • In some instances, sample sharing requests will only be considered with a well-developed, robust and reliable analytical method

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 for each quarter of the year for each year of funding.
  • Discuss potential pitfalls of the program with sufficient risk assessment and criteria to substantiate continuation of the program at each milestone.
  • Discuss critical next experiments in order to advance the program to attract additional funding/licensing.
  • For all projects, but in particular validation projects, outline strategies for commercial scale-up, manufacturing, possible cross-platform compatibility, and regulatory approval, including the timeline for FDA submissions and milestones (please note that LOI submission within two years of project start date is expected for all validation studies).

Experimental Design and Methods

  • Complete the Study Population Worksheet (doc). If using specimens from an existing cohort, a letter of support from the PI of the study is required.
  • Describe sample collection methods, storage, stability, and extraction procedures.
  • 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 subjects or samples per group.
  • For validation studies, describe the strategies for maximizing reproducibility, including standard operating procedures for pre-analytical, analytical, and post-analytical stages. Please describe your regulatory and commercialization strategies.

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. Please provide competitive quotes from more than one vendor where possible. Quotes should be uploaded in the Appendix Materials.
  • 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.
  • For validation projects, discuss relationships with commercial diagnostics platform companies or plans to partner. Summarize the materials, technologies, and/or expertise provided by these collaborators.

Intellectual Property (IP)

  • Provide information on existing IP and stage of prosecution. If no IP currently exists, describe the projected plan to generate IP; note if you expect the project to generate new IP.
  • Indicate any freedom to operate issues.

Other Support

List other financial support, awarded and pending, and include grant title, principal investigator, percent effort of investigator, granting agency, amount, and projected funding period. Indicate any overlap between the aims or investigator effort from other funding with the proposed work.

References

 

Budget and Justification

The budget form (excel) can be downloaded here. Complete the budget template and provide a brief justification for each line item. Please review permissible costs here.

Biographical Information

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

BUSINESS PACKET (For For-Profit Applicants)

CONFIDENTIALITY STATEMENT

The ADDF Diagnostics Accelerator initiative has adopted a venture model of confidentiality which does not seek or require or sign Confidential Disclosure Agreements (CDAs). Since the ADDF Diagnostics Accelerator initiative is working in a narrowly defined medical field, we see many business plans and clinical research proposals that can be overlapping. CDA's could disable the initiative from reviewing fairly and fully each of the large number of proposals that have been submitted. So, specifically for this initiative, the ADDF and Gates Ventures cannot sign CDAs.

Nevertheless, confidentiality is a critical component of what we do as an organization. The ADDF strictly abides by the rules of fair play and respect for confidentiality. In addition, all independent reviewers engaged by the ADDF have written confidentiality agreements with the ADDF.

Business applicants should provide access to a data room. All of the following are required. In the event that these materials are not available, please provide justification. Compile into a single PDF and upload as "Business Packet." or ensure that all documents are contained in your data room and provide a single PDF with the information required for data room access. Please note, the ADDF provides example templates hyperlinked below to assist you in compiling the relevant information, however we welcome you to use your own formats/templates if available.

  • Data room access – provide relevant details for accessing your data room, or reach out the ADDF team to request the names & email addresses of all those who will require access.
  • Statement of Need
  • Business Plan or Corporate Strategy: include summary of the envisioned product concept (e.g. target product profile, value proposition), competitive analysis, company description and history, mission statement, market analysis with unmet need, market size and revenue forecast (including total available market (TAM), serviceable available market (SAM), serviceable obtainable market (SOM) projections), competitive landscape, risk analysis, milestones, scientific and financial goals, and future plans Download example market analysis template
  • Description of Management Structure: include a list of board members, scientific advisors and key FTE (current and projected) Download example template
  • Full breakdown of the current Capitalization Table and description of investors to date. Please note, unless prohibited by confidentiality, the ADDF requires each investor to be named. Download example capitalization table
  • Company Valuation Download example company valuation template
  • Financial Statements for the current and prior two years (if available): balance sheet, income statement, cash flow statement, forward looking P&L projection for the next 2-5 years (if not captured in the above documents)
  • Company's Current Annual Budget and planned fundraising / financing plans
  • Resolution of pending or known legal proceedings
  • Intellectual Property Summary: note all IP linked to the project, including pending or granted IP, and if you expect to generate new IP; if the patent(s) are openly available online, please include the link(s) in lieu of attaching full files. Download example IP summary template
  • High level regulatory plan (including regulatory pathway and regulatory strategy details) and key milestones / checkpoints along with the estimated timeline. Download regulatory plan

SUPPLEMENTAL MATERIALS

All of the following 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
  • Quotes from vendors or contract research organizations (CROs). Please include competitive quotes from more than one vendor where possible.
  • 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.
  • IRB-ready clinical protocols

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.