○ Preproposal Narrative (three-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs (uniform resource locators) that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application. The Preproposal Narrative should include the following: – Innovation: Describe how the project may introduce a new paradigm, challenge current paradigms, introduce novel concepts or agents, or exhibit other uniquely creative qualities that may lead to potential therapeutics for ALS. Innovative uses or investigations of previously developed resources are acceptable. – Impact: State explicitly how the proposed work will have an impact on the development of therapeutics for ALS and on patient populations. Outline, in general terms, the next steps to transition the study outcomes to therapeutic application(s). – Research Strategy and Feasibility: Explain the rationale for selecting the specific target(s) for investigation. Concisely state the project’s objectives and specific aims. Describe how the proposed experiments demonstrate the testability of the hypothesis. Describe the “high-risk/high-reward” nature of the DOD FY23Amyotrophic Lateral Sclerosis Therapeutic Idea Award 12 testable hypothesis to be investigated. If animal models are to be used, describe the selected model and its relevance to the hypothesis. Explain the feasibility of the study leading to a therapy for ALS. – For Pre-Applications Submitted Under the Biomarker Option: Describe the biomarker category and intended use in ALS therapeutic development, including regulatory considerations for use in ALS clinical trials. ○ Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following: – References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers, and publisher, as appropriate). – List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations, acronyms, and symbols used in the Preproposal Narrative. – Key Personnel Biographical Sketches (five-page limit per individual): All biographical sketches should be uploaded as a single combined file. Biographical sketches should be used to demonstrate background and expertise through education, positions, publications, and previous work accomplished. • Tab 6 – Submit Pre-Application This tab must be completed for the pre-application to be accepted and processed.
