The Annette Funicello Research Fund for Neurological Diseases (AFRFND) Request for Proposal

Program Announcement

 August 1, 2014

The purpose of this award is to support basic and translational research efforts to advance the diagnosis, understanding and therapy of neurovascular disease with particular focus upon the role of venous vasculature.  

Annette FunicelloISNVD Logo

I. FUNDING OPPORTUNITY DESCRIPTION

The Annette Funicello Research Fund for Neurological Diseases (AFRFND) is working in collaboration with the International Society for Neurovascular Disease (ISNVD) to administer this funding opportunity. There will be multiple grants awarded to support basic and translational research efforts to advance the diagnosis, understanding, and therapy of neurovascular disease with particular focus upon the role of venous vasculature.

The AFRFND has dedicated up to $250,000 to support proposals granted in this award cycle. Grants will be awarded in the amounts of $10,000 - $50,000 each to be used as “seed money” to provide preliminary information for larger research projects in the future. Applications with collaborations that partner with academic, industry and interdisciplinary investigator groups are highly encouraged. The AFRFND is interested in high payoff studies that will lead to subsequent study and peer-reviewed publication in respected journals. The funding will serve as seed money for larger-scale bench to bedside research that is yet to come.

II. FOUNDATION INFORMATION

The mission of the AFRFND is dedicated to funding research into the cause, treatment and cure of Multiple Sclerosis and other neurological diseases. AFRFND is a 501(c)3 non-profit with a specific interest in supporting clinical studies that seek to study the underlying cause of Multiple Sclerosis and therapies that show the promise of reversing the symptoms of this and other neurological diseases.

The foundation, AFRFND has no paid staff, which allows its organization to operate at little cost and per Annette's wishes, ensure nearly all donated funds are used for research purposes only. In addition to its own fundraising activities, it relies on direct donations and fund-raisers held by others on its behalf to continue its research funding efforts. All Fund assets and grant disbursements are overseen by the California Community Foundation, one of the top 50 largest foundations in the nation that manages funds created by individuals, families, corporations and non-profit organizations. If you wish to make a donation, simply click on the following link: http://annetteconnection.com/How-to-Help.php

All of our grant requests are reviewed by our Board and Committee Members http://annetteconnection.com/Meet-our-Board-Members.php. The ISNVD scientific expertise will be helping us with decision-making in terms of funding. Their Board members can be found here: http://www.isnvd.org.

III.AWARD INFORMATION

Recent research has indicated that many neurological diseases have contributing components of vascular insufficiency that may be related to venous abnormalities, including congestion, hypertension and vascular anomalies (either acquired or developmental). Equally, interventions have suggested interplay between cerebrospinal fluid, arterial and interstitial flow related to venous changes. Proposals are sought to assess a broad-range of related topics including:

  • Laboratory in-vitro or in vivo experiments in animal and human models focused upon elucidating or clarifying pathogenesis and disease modification with a focus upon vascular (venous) mechanisms

  • Understanding of central nervous system damage accumulation in relation to neurovascular disease

  • Comparative studies intended to clarify pathophysiologic mechanisms, define reproducible, applicable and relevant imaging and functional brain flow measures

  • Neurological diseases of interest include but are not limited to:

Multiple sclerosis, traumatic brain injury, Alzheimer’s disease, postural orthostatic hypotension, Parkinson’s disease and Aging

  • Comparative studies or development and validation of rehabilitative measures

  • Early phase single or multi-center clinical observational or neurovascular therapy trials

  • Neurovascular technologies that can increase effectiveness of medical treatment; for example improving brain outflow can help clear amyloid beta plaques in patients treated with certain drugs

Other Areas

Ideas outside of the advertised focus areas will be considered in scope if the proposers can demonstrate that they have the potential for improvement in the understanding or treatment of neurovascular disease. Proposals that integrate existing technologies or products into systems generally do not fall within the purview of the AFRFND and are likely to be rejected.

Multiple awards are anticipated

The amount of resources made available will depend on the quality of the proposals received and the availability of funds. Proposals identified for funding may result in a grant, cooperative agreement or other transaction depending upon the nature of the work proposed. Additionally, AFRFND reserves the right to accept proposals in their entirety or to select only portions of proposals for award. In the event that the AFRFND desires to award only portions of a proposal, negotiations may be opened with that proposer. If the proposed effort is inherently divisible and nothing is gained from the aggregation, proposers should consider submitting it as multiple independent efforts.

IV. ELIGIBILITY INFORMATION

All responsible sources capable of satisfying the AFRFND’s needs may submit a proposal that shall be considered by AFRFND. Foreign participants and/or individuals may participate to the extent that such participants comply with necessary research standards, protection of subject health and privacy, non-disclosure Agreements and any other governing statutes applicable under the circumstances.

Once the proposals have been received and prior to the start of proposal evaluations, the AFRFND will assess potential conflicts of interest and will promptly notify the proposer if any appear to exist. The Program Manager is required to review and evaluate all proposals received that are assigned to him/her and to manage all selected efforts.

If a prospective proposer believes that any conflict of interest exists or may exist (whether organizational or otherwise), the proposer should promptly raise the issue with AFRFND in their cover letter. If, in the sole opinion of the AFRFND after full consideration of the circumstances, any conflict situation cannot be effectively mitigated, the proposal may be returned without technical evaluation and withdrawn from further consideration for award.

Cost Sharing/Matching

Cost sharing is not required for any particular program; however, cost sharing will be carefully considered where there is an applicable condition relating to the selected funding. Cost sharing is encouraged where there is a reasonable probability of a potential larger scale and application related to the proposed research and development effort. For example, AFRFND's will not contribute to any indirect cost for applying Institutions.

Other Eligibility Criteria

Collaborative efforts/teaming are strongly encouraged.

V. APPLICATION AND SUBMISSION INFORMATION

Letter of Intent and Proposal Information

Proposers should submit a brief Letter of Intent. This procedure is intended to minimize unnecessary effort in proposal preparation and review. The time and due date for submission of the Letter of Intent is October 15st, 2014. The AFRFND will acknowledge receipt of the submission and confirm a control number assigned during the online submission process. This control number should be used in all further correspondence regarding the proposal.

When theLetter of Intent is submitted, The AFRFND will respond with either an invite to submit or rejection notice. The AFRFND will attempt to review Letters of Intent within sixty (60) calendar days after receipt and will allow proposers at least sixty (60) calendar days after review of their Letters of Intent in order to complete and submit their proposals. Early submissions of Letters of Intent and full proposals are strongly encouraged because selections may be made at any time during the evaluation process. All submitted proposals will be fully reviewed and a decision will be made as soon as possible. The Foundation will notify your office of either acceptance or denial in a timely manner. The absolute final date of proposal acceptance will be December 15st, 2014. Please do not submit any further correspondence after this date.

For All:

Any administrative questions or issues regarding this solicitation should be directed to the administrative address below; e-mail is preferred:

 

annettefund@annetteconnection.com

isnvdannettefund@isnvd.org

The Annette Funicello Research Fund

Fund-Raising Division

P.O. Box 599

Shafter, CA 93263

VI. PROPOSAL PREPARATION/SUBMISSION INSTRUCTIONS

Letter of Intent format

It is required that a Letter of Intent be submitted to determine the acceptability of the proposed concept to Board of Directors. This allows for comments to the proposer prior to full grant submission. Again, Letters of Intent are required and due to The Foundation by October 15th, 2014 and are to be e-mailed to: annettefund@annetteconnection.com

Letters of Intent should be concise and limited to less than four pages in length. All pages shall be printed, single-spaced on 8-1/2 by 11 inch paper with type not smaller than a 12-point font. The page limitation for Letters of Intent should not include figures, tables or charts. No formal transmittal letter is required. The Letter of Intent should contain the following sections:

  1. Project Title

  1. Applicant and Institution information

  1. Background and Rationale: This should clearly state the uniqueness of the idea presented in the context of existing state of the art in the technical area of interest.

  1. Specific Aims

  1. Preliminary Results

  1. Proposed approach: This section should describe the proposed approach and explain why it is unique.

  1. Methods:

  1. Research plan: Key milestones expected in the effort should be described. Team expertise and management plan: A brief discussion of the technical expertise of the proposed principal investigator and other key team members should be provided.

  1. Estimated time for project completion

  1. Estimated gross budget: An estimate of the program costs and duration (in months) should be included.

Full Proposal Format – Not to exceed 12 pages; (biosketches, references, supporting letters, and appendix of materials are separate and non-inclusive of the 12 page limit).

 

General Information

On page 1 of your proposal (cover page), please indicate the following:

  1. Proposed Title of Project
  2. Names of Authors
  3. Name of Institution
  4. Institutional Officers – President, CFO and Director of Sponsored Projects.
  5. Contact Information for all.
  6. Date Submitted

Project Information

This section includes basic information about the proposed project including a short project summary in layman’s terms to serve as an introduction to the proposal. This summary should also capture in condensed form, the rationale, methods and potential

significance of the proposed research. The Project Information Summary (page 2) should not be more than 500 words.

Project Staff

The Principal Investigator as well as other key professional personnel should be listed. This will assist the Society in more effectively tracking all of the researchers and clinicians who participate in Society-funded projects.

A biographical sketch template is provided for downloading in case you need one. If you already have a current biographical sketch, you can convert it to a PDF format and upload with your proposal. Biographical sketches are required for all professional personnel working on the project. All biographical sketches must be uploaded in PDF format and are considered exempt from the proposal 12-page limit; i.e.- they are in addition to the 12-page limit as are references, letters of support and appendices.

Proposal Narrative

The proposal narrative is the heart of the application. Details concerning the

preparation of the proposal narrative appear below. Specifications are 12 pages, single- spaced (not including references), 12 point or larger font and half-inch margins on all sides.

ORGANIZING YOUR NARRATIVE

To facilitate the review of your application, it is strongly recommended that you organize the discussion of your proposed research using the following guidelines:

Introduction

Give a short introductory paragraph to introduce your idea to The Board including a hypothesis.

Research plan

Include all text, figures and data tables related to the research plan in this section. The individual subsections below may be any length as long as the total for the entire research plan does not exceed the PAGE LIMIT of twelve pages (not including the list of literature references).

Background - Provide a brief summary of the background for this project, including existing knowledge in the area and long-term goals of your research.

Preliminary Results - Use this section to report the principal investigator's preliminary studies pertinent to the application. Include any information that will help establish the experience and competence of the investigator’s to pursue the proposed research.

Specific Aims - Provide a concise statement of each objective of the proposed research project.

Experimental Design and Methods - Describe the design of experiments and the procedures used to undertake the proposed studies. Where appropriate, include possible outcomes, pitfalls and alternative plans.

Relevance - Describe the relevance of your proposed studies to the human disease, multiple sclerosis. Indicate how your project will contribute to The AFRFND’s and Society's mission, which is to fund research focusing on the cause, treatment and cure of Multiple Sclerosis and other neurological diseases.

Facilities available - Describe the facilities available for the conduct of the proposed research, and list major items of equipment that are available for use in the project.

Other Support - The Society requires detailed information concerning current and pending support for personnel listed on the application. This information is useful in evaluating any potential overlap with the current application.

Budget - Please document in an excel spreadsheet, all related cost to the project. This may include personnel (salary and fringe), supplies, services, IRB approval and publication costs, etc.

Budget Justification - Please provide a brief paragraph stating why you will need the funding that you have requested.

Literature cited - To facilitate the review of your application, give the full title and bibliographic reference for all work cited in your application. Please note that the 12-page limit for the narrative does not include the references, i.e., the references can go beyond the 12-page limit.

Letters Submitted with Application

The Society also requires a few, select letters to be uploaded in a pdf format alongside your proposal to show evidence of collaborations with other researchers as well as IRB/IACUC approval. These are again, separate from the 12-page proposal limit and exempt from that rule.

  • Collaborative Arrangements - Letters of collaboration/support from all individuals whose cooperation is necessary for the proposed research should be included as part your PDF file and uploaded with your proposal.

  • Research involving Human Subjects - If your proposed research involves human subjects, you must provide a signed and dated approval letter from the Institutional Review Board or equivalent appropriate committee of your institution as part of the PDF file uploaded that contains all documents. If approval is pending, indicate that the project has been submitted to the committee for review in the Human Subjects section. Payment for a successful application will not begin until such signed and dated approval is received, reviewed and approved by the Society.

  • Research involving Vertebrate Animals - If you plan research with experimental animals, you must provide certification that the institution complies with all Federal, State and Local regulations and with the standards established by the Animal Welfare Acts and the documents entitled "Principles for Use of Animals" and "Guide for the Care and Use of Laboratory Animals", available from the Office of Protection from Research Risks, National Institutes of Health, Bethesda, MD 20205.

If approval has been granted, a copy of the signed and dated approval letter must be submitted as part of the PDF file uploaded to this site as your submission. If approval is pending, indicate that the project has been submitted to the committee for review in the Vertebrate Animals section. Payment for a successful application will not begin until such signed and dated approval is received, reviewed and approved by the Society.

Materials Submitted with Application

This is a listing of appendix materials uploaded in a subsequent section, along with the proposal. All appendix materials submitted with your application must be submitted electronically in PDF format as part of the application. Paper copies, CD’s, etc. will not be accepted and will be discarded if they are received by the Society. Materials submitted are not considered part of the 12-page limit.

  • Publications – Reprints, preprints, manuscripts, etc. that are relevant to the proposed project can be included as part of the appendix.

  • Clinical Trial Protocols - In some cases, a proposal submitted to the Society may involve a study that is an add-on to a clinical trial that has been funded by another agency. Although the clinical trial itself is not the focus of the proposal, it is essential for the peer-review panel to have detailed information about the trial. If the above scenario describes your proposal, you must include a copy of the clinical trial protocol as part of the appendix.

  • Other Materials - If your proposed study utilizes questionnaires or other types of printed assessment instruments, you may want to include these as part of the appendix. Many other types of materials could potentially be included in the appendix. However keep in mind that reviewers have a great deal of material to review and so you should choose your appended materials carefully.

VII. SUBMISSION OF YOUR PROPOSAL

Please combine all aspects of your submission into one large, final PDF file. This would include the proposal, biosketches, letters of support, materials submitted with application; i.e. – everything. Once you have combined your document into one PDF file, please e-mail your whole package to:annettefund@annetteconnection.com. PLEASE MAKE SURE THAT YOUR DOCUMENT IS MARKED WITH YOUR ASSIGNED CONTROL NUMBER FROM THE LETTER OF INTENT APPROVAL. 

VIII. APPLICATION REVIEW INFORMATION

Evaluation Criteria

Evaluation of proposals will be accomplished through a technical review of each proposal using the following criteria, which are listed in descending order of relative importance: (1) Ability to Meet Program Go/No-Go Metrics; (2) Scientific and Technical Merit; (3)Value to Defense; (4) Capabilities of the Personnel and Facilities to Perform the Proposed Effort; and (5) Cost Realism.

Ability to Meet Program Go/No-Go Metrics

The proposal establishes clear and well-defined research-specific “go/no-go” metrics to be used as exit and entry criteria for Government approval to progress through phases of the proposed effort. The metrics should be unambiguous, quantitative (to the extent possible), and pertinent to the critical-path items of the proposed effort, and should relate to how the technology will be utilized.

Scientific and Technical Merit

Proposers must demonstrate that their proposal is innovative and unique, that the technical approach is sound, that they have an understanding of critical technical issues and risk, and that they have a plan for mitigation of those risks. A significant improvement in capability or understanding above the state of the art must be demonstrated. All milestones must be clearly and quantitatively described.

Value to AFRFND’s and The Society’s Mission

Proposers must demonstrate the potential of successful research to advance the understanding or therapy of neurovascular diseases (with a focus upon venous disease), a clear statement of their program goals and a quantitative comparison with existing research. Equally important is the capability to transition the technology to the next phase research, industrial, and operational tools in such a way as to enhance the mission.

Capability of the Personnel and Facilities to Perform the Proposed Effort

Proposers must demonstrate that their team has the necessary background and experience to perform this project. The balance of the technical capabilities of the team must match that required in the program plan. The relevant experience of key personnel must be sufficient to provide confidence that the proposers can accomplish their objectives. Proposers must demonstrate that the combined facilities of the team are sufficient to accomplish the objectives of the proposal.

Cost Realism

Costs of the proposal must be realistic and provide a high value to the AFRFND.

IX. Reporting

The number and types of reports will be specified in the award document, but will include as a minimum quarterly scientific status reports. The reports shall be prepared and submitted in accordance with the procedures contained in the award document and mutually agreed on before award. Reports and briefing material will also be required as appropriate to document progress in accomplishing program metrics. A Final Report that summarizes the project and tasks will be required at the conclusion of the performance period for the award, notwithstanding the fact that the research may be continued under a follow-on vehicle.

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