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ALS Biomarker Collaboration

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Request for Proposals: ALS ACT: Biomarker Discovery for ALS
Release Date: 1 December 2017: Letter of intent due: 8 January 2018
Upload LOI and email it to: researchgrants@alsa-national.org
Link to online LOI submission: ALS ACT Biomarker RFP December 2017
http://alsa.spectrumportal.net/IndividualApplicants/Application/0/26
LOI Form: Download from the ALS Association website

Questions about the RFP:
Lucie Bruijn, PhD, MBA, Chief Scientist, The ALS Association
lucie@alsa-national.org 1 727 412 0234

ALS Finding a Cure (ALS FAC), the ALS Association (ALSA) are pleased to announce a call for biomarker discovery projects. The call for proposals is open to academia and industry world-wide and is part of a broader initiative, the “ALS Biomarker Collaboration,“ encouraging the development of new biomarkers in a pre-competitive space. Proposed projects should be completed over 12-18 months.

Budget should not exceed $100,000. Up to 10% indirect costs can be included in this total amount. Should applicants require more than the allowed budget for the study, match funds should already be secured at the time of the application and a letter of collaboration included.

Applicants are encouraged to make use of existing biospecimens. A comprehensive list of resources and contacts is available here.

Please contact the repositories directly to discuss availability of samples and provide a letter of support with your LOI describing the samples that will be provided. Biomarker discovery efforts are not limited to biofluids.

Deadlines
Release Date: December 1, 2017
Letter of Intent: January 8, 2018
Notification to submit full application: January 27, 2018
Full Application: February 26, 2018
Recipients Announced: April, 2018
Award starts once all necessary paperwork and administrative forms have been signed off by the institution(s) and the funding agencies.

Background
There is an urgent need for improved ALS biomarkers - for diagnosis, target engagement and disease progression. In the United States, ALS affects one in approximately 40,000 people, with 5,000 new diagnoses each year. There are currently three FDA-approved treatments for ALS, riluzole (Rilutek), Neudexta and edaravone (Radicava). Unfortunately, most clinical development programs for ALS therapeutics have failed to show efficacy. The discovery of ALS biomarkers would aid drug discovery and demonstrate biological effect of promising therapeutics.

The goal of this Request for Proposal is to help discover ALS biomarkers that could 1) be used in ALS trials to expedite the development of new therapeutic approaches for ALS and/or 2) reduce delays in diagnosis and hasten the chance for people with ALS to initiate approved ALS therapies.

About ALS Biomarker Consortium
A pre-competitive biomarker initiative encouraging public and private partnerships to develop biomarkers to advance drug development and treatment options for people living with ALS.

About ALS ACT
ALS ACT is a novel academic-foundation-industry partnership to accelerate treatments for people living with ALS. In partnership with The ALS Association and The ALS Finding a Cure Team, composed of researchers from General Electric (GE) Healthcare and four academic sites, ALS ACT will enact a multi-pronged approach to expediting clinical trials in ALS.

About The ALS Association
The ALS Association is the only national non-profit organization fighting Lou Gehrig’s Disease on every front. By leading the way in global research, providing assistance for people with ALS through a nationwide network of chapters, coordinating multidisciplinary care through certified clinical care centers, and fostering government partnerships, The Association builds hope and enhances quality of life while aggressively searching for new treatments and a cure. For more information about The ALS Association, visit our website at www.alsa.org

About ALSFAC
The sole purpose of the ALS Finding A Cure®, a program of The Leandro P. Rizzuto Foundation, is funding research to find a cure. For more information about ALSFAC, visit our website at www.alsfindingacure.org . ALS Finding A Cure® is a program of The Leandro P. Rizzuto Foundation.

Selection Criteria
The review committee will evaluate letter of intent based on the following criteria:

  1. Significance: Does the study aim to develop a biomarker that is relevant to therapy development for ALS or earlier diagnosis of the disease.
  2. Approach: Are the scientific methods sound? Is the study design appropriate for the intended purpose/application of the proposed biomarker?
  3. Innovation: Are new approaches being explored?
  4. Investigator/Sponsor: Is the investigator or sponsor appropriately trained/qualified to carry out the study?
  5. Environment/Collaborative Potential: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed study take advantage of useful collaborative arrangements? Will the study utilize resources available through available repositories? Partnerships with Industry for partial support are encouraged.

Should you be invited to submit a full application, application forms will be provided and applications must include the following. Applications will be treated as confidential documents.

  1. Research Plan
    Abstract
    Specific Aims
    Background and Significance
    Preliminary Studies
    Research Design and Methods (study design; participant description; data to be collected; plan of analysis)
    Supportive Documentation including a proposed timeline
    References
    Appendix materials are allowed. For studies requiring an IND, please indicate the status of the IND application in the Request for Proposal application.
  2. Budget and Ancillary Documents
    Budget and budget justification – direct and indirect costs
  3. Biographical Sketch of key personnel

Conditions of the Grant

  1. Proprietary Rights
    The Principal Investigator/Sponsor will maintain full control of scientific work and all corresponding responsibilities. A scope of work will be agreed upon by all parties prior to initiation of funding. If necessary, confidentiality agreements will be incorporated. We do encourage sharing of data and publication as part of the ALS Biomarker Collaboration to encourage development of biomarkers in a pre-competitive space, recognizing the significant benefit for the broader community to expedite therapy development.
  2. Reporting
    For all projects, a six monthly and final report are required.
  3. Publications
    All publications, as well as abstracts of presentations at scientific meetings, posters, or any other form of publication that results from a study supported by this award must carry the following acknowledgement: ‘This research was in part supported by a grant from the ALS Association, and ALS Finding a Cure® Foundation’.
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