Application Instructions

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 detailed in the relevant RFPs, so please review the instructions carefully. If helpful, you can use the attached template as a guide.

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)

• 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 relevant 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, and contrast with the advantages of your program.
• For 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.

• Drug Development RFP
• Neuroimaging and CSF Biomarker RFP
• Prevention RFP
• Accelerating Drug Discovery for FTD RFP (AFTD)

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 and/or attract additional funding/licensing.

4. Experimental Design and Methods

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

5. Description of 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 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 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 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.
  • Budget up to 3 years
  • Budget up to 5 years
• 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.

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”. If helpful, you can use the attached template as a guide.

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

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)

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.