Competition's Moi Loi

  



Before Getting Started

Start studying French 3 Level 3. Learn vocabulary, terms, and more with flashcards, games, and other study tools. A letter of intent (LOI) is a document declaring the preliminary commitment of one party to do business with another. The letter outlines the chief terms of a prospective deal.

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  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.

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Competition's Moi Loi Thoi

Review Process and Timeline

Applications are reviewed in a two-step process:

  1. Letters of Intent (LOI): ADDF’s science team will evaluate LOIs to determine whether the proposed project is consistent with the ADDF's 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 ADDF’s science team and advisors to arrive at a final funding decision.
    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, amount requested).
2. The LOI includes brief descriptions of the following:

Competition's Moi Loi Dieu

  • Scientific Rationale and Background: Focus this section on how the proposed drug target or 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. For clinical trials, briefly describe trial design, including population and endpoints. (300 words maximum)
  • Summary of Key Supporting Data: Provide a brief summary of key preclinical (in vitro and in vivo) or 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

An approved LOI is required prior to submission of a full proposal. If invited, submit a full proposal through the ADDF Funding Portal.

Applicants unable to submit the full proposal by the deadline may submit their proposal during the next cycle without submitting a new LOI, unless the proposed work has changed. After two missed deadlines, applicants must submit a new LOI.

In addition to the auto-filled sections from the LOI (that will carry over to the full proposal, and can be edited or expanded upon at this stage), you will be asked to write the following:

  • Executive Lay Summary: A succinct, non-confidential description of the proposed work that communicates the public health relevance of the project to the public (300 words maximum). If the application is funded, the lay summary will be posted on our online portfolio.
  • Biographical Summary: This should be written in the third person and should contain information such current position, highest degree held, and current area of research (300 words maximum).

The remainder of the full proposal includes the following information, to be uploaded as PDFs.

  • Body of the application
  • Business packet (only for biotech companies)
  • Supplemental material (optional)

Review the instructions below for the required sections and forms for the Body of the Application, Business packet and Supplemental material.

Body of the Application

This body of the application should include the (A) Project Narrative and (B) Relevant Forms. Please compile these into a single PDF in the order shown below and upload as “Body of the Application”. Expectations and evaluation criteria are listed in the appropriate RFPs.

Competition

A. Project Narrative

The project narrative is the central part of the proposal and should contain the sub-sections 1-8 listed below (indicate each sub-section by number in the proposal). Sub-sections 1-6 should not exceed 20 pages of written text. Legible figures should be embedded in the text. Use at least 11pt. font and 1' margins.

1. Background and Rationale (this section should not exceed 2 pages)

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  • Discuss how the proposed mechanism or mode of action or biomarker relates to the disease process. The strongest proposals will include target validation evidence in human samples (if available) or in transgenic or aged animal models.
  • Discuss the novelty of the proposed approach for Alzheimer's disease, related dementias, and/or cognitive aging. Discuss related programs around the same target or biomarker modality, including any with conflicting data; if any are known, please explain the advantages of your program.
  • For drug development/clinical programs, discuss potential mechanism-related side effects and off-target activities linked to modulating the target.

2. Supporting Data

Please refer to the appropriate RFP for expectations and provide relevant supporting data.

3. Project Plan and Objectives

  • List specific aims and/or scientific milestones with clearly defined go/no-go decision points for advancement of the project.
  • Timeline: Provide a schedule for the completion of the proposed milestones/deliverables for each quarter of the year for each year of funding (this can be in table or Gantt chart format).
  • 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.

Competition's Moi Loi Hoa

4. Experimental Design and Methods

Provide details on the study design and methods, including types of assays, sample sizes, statistical methods, etc.

5. Description of Drug Discovery Team and Resources

  • Describe the investigative team, showing that the required expertise and resources are in place to complete 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 packet).
  • Discuss the inclusion of any consultants with drug development expertise that were involved in the design of preclinical or clinical studies or the development of the commercialization plan.
  • Where applicable, identify any potential commercial partners, and indicate whether you have initiated conversations with these companies

6. Intellectual Property (IP)

  • Provide information on existing IP and stage of prosecution (e.g. use, composition of matter). 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.
  • Include a brief discussion on future directions and eventual path towards commercialization.

7. Other Research Support

List other research grants, awarded and pending. 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.

8. References

There is no preferred citation style. Please limit to 100 references.

B. Relevant Project Detail Forms

Complete and submit the form(s) that are relevant for your project. Budgets and biosketches are required for all proposals. The project narrative and the relevant forms should be uploaded as a single PDF and in the order listed below:

  • Compound Report Card (required for drug discovery/clinical programs and PET ligand development programs)
  • Fluid Biomarker Report Card (required for fluid biomarkers). Refer to the FDA Bioanalytical Method Validation Guidance for appropriate parameters to include for the proposed assay.
  • Animal Studies Questionnaire (required for any project proposing efficacy or proof-of-concept studies in animal models)
  • Human Subjects Questionnaire (required for any clinical trial or biomarker study that will recruit human subjects)
  • Budget and Justification(required for all programs). Complete the budget template and provide a brief justification for each line item. Please review permissible costs here.
  • Biographical Information (required for all programs). Include a biosketch for each of the key personnel involved in the project. Existing NIH biosketch forms (click here for blank NIH biosketch forms) or other formats are accepted.

Business Packet: (Only for biotech companies)

The Business packet is required for all biotech companies and should include the information below. Please compile a single PDF and upload as “Business Packet”.

Competition
  1. Statement of Need
  2. Business Plan or Corporate Strategy – include company description and history, mission statement, market analysis, risk analysis, milestones, scientific and financial goals, and future plans
  3. Description of Management Structure – include a list of board members
  4. Capitalization Table
  5. Financial Statements – balance sheet, income statement, cash flow statement
  6. Company's Current Annual Budget
  7. Description of Investors to Date
  8. 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

Supplemental Materials (optional):

If you are submitting supplemental materials, please compile into a single PDF and upload as “Supplemental Materials.” This can include additional information that may be helpful to the review committee, such as:

  • IRB-ready clinical protocols
  • Quotes from vendors or contract research organizations (CROs). Please include competitive quotes from more than one vendor where possible.
  • Letters of support/collaboration
  • Unpublished manuscripts (Up to 3 unpublished papers will be accepted)

Competition's Moi Loi Mot

Publications and patents that are openly available online should be linked in lieu of attaching the full files. Please do not include presentation decks or full patents.

ADDF Funding Portal

If you have any questions about the online application system or process, please contact the Grants and Mission-Related Investments Team at grants@alzdiscovery.org.