ADDF-Harrington Scholar Program: 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 listed in the RFP.

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 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 or related dementias. Discuss related programs around the same target, including any with conflicting data; if any are known, please explain the advantages of your program.
• Discuss potential mechanism-related side effects and off-target activities linked to modulating the target.

2. Supporting Data

Please refer to the RFP for expectations and provide relevant supporting data. Target validation data is a critical component of the application and an important part of the evaluation process.

• Provide data that demonstrate a rational biological connection of the drug target to Alzheimer’s disease or a related dementia.
• Describe how the lead or clinical molecule was selected (i.e. types of screening assays, optimization).

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.
• HDI provides drug development advisors and project management throughout the term of the grant. In what areas do you anticipate needing support?

4. Experimental Design and Methods

Provide details on the study design and methods, including types of assays, sample sizes, statistical methods, etc. When proposing a lead optimization campaign, please include a testing funnel with clear cut-off criteria for each step.

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
• Please also list the following contacts:
  • Official to be Notified if Awarded: Name/Title, Phone, Email
  • Technology Transfer Office Contact: Name/Title, Phone, Email
  • Media/PR Contact: Name/Title, Phone, Email

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. Please include links to relevant issued patents or published patent applications and mention if the IP is owned by you/your institution, co-owned with other institution(s) or a for-profit third-party.
• 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

• Compound Report Card  complete the form for the most promising single lead compound or candidate molecule.
• Animal Studies Questionnaire  (required for any project proposing efficacy or proof-of-concept studies in animal models)
• Budget and Justification 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 (click here for blank NIH biosketch forms) or other formats are accepted.

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:

• 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.