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DoD Amyotrophic Lateral Sclerosis Therapeutic Idea Award
The FY20 ALSRP Therapeutic Idea Award supports hypothesis-driven therapeutic development and is designed to promote new ideas aimed at drug or treatment discovery that are still in the early stages of development.
Development and/or modification of preclinical model systems or the application
of high-throughput screens to define or assess lead compounds for ALS treatment may also be proposed.
All research projects should include a well-formulated, testable hypothesis based on strong scientific rationale that holds translational potential to improve ALS treatment and/or advance a novel treatment modality.
Preliminary data are not required.
While the inclusion of preliminary data is not prohibited, the strength of the application should not rely on preliminary data, but on the innovative approach.Projects that focus primarily on investigating the pathophysiology of ALS, without consideration of therapeutic development, are not within the scope of this Funding Opportunity.Innovation and impact are important aspects of the Therapeutic Idea Award.
Research deemed innovative may introduce a new paradigm, challenge current paradigms, introduce novel concepts or technologies, or exhibit other uniquely creative qualities that may lead to potential therapeutics for ALS.
Impact may be near-term or long-term, but must be significant and move beyond an incremental advancement.The Therapeutic Idea Award encourages applications submitted by early career investigators as well as applications that include meaningful and productive collaborations between investigators.
Applicants from outside the ALS research field are encouraged to include collaborators with the necessary relevant expertise, such as experience with ALS model systems, endpoints, and pathogenic findings.Identification of treatment approaches using biological correlates of disease activity and progression in pre-existing, de-identified human specimens from well-characterized, adequately controlled, and sufficiently powered patient cohorts is encouraged.
Examples of acceptable sources for pre-existing biosamples or datasets include controlled clinical trials, observational studies, publicly available biorepositories, and registries (e.g., Centers for Disease Control and Prevention [CDC] National ALS Registry and/or Biorepository; https://www.cdc.gov/als/Default.html).
Active duty military and/or Veteran patient populations or resources should be considered.
A list of suitable resources can be found on the ALSRP web page (https://cdmrp.army.mil/alsrp/resources/ALSRPresources).
Other resources may be used, provided a letter of support adequately describes the relevant repository parameters and mechanisms for broad access to data and samples.
All specimens must exist at the time of application submission; collection of new specimens will not be supported.
Therapeutically Relevant Biomarker Option:
The FY20 ALSRP Therapeutic Idea Award Therapeutically Relevant Biomarker Option encourages applicants to include the development of biomarker(s) in parallel with the main proposed Therapeutic Idea Award research effort.
Additional funding, as described in Section II.D.5, Funding Restrictions, is being offered for the co-development of biomarkers that will enhance the drug development process.
Efforts may include development of target engagement biomarkers, objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic, or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup.
Development of markers for the purposes of diagnosis, prognosis, or measurement of disease progression without consideration of the therapeutic development process will not be supported.
Development and/or modification of preclinical model systems or the application
of high-throughput screens to define or assess lead compounds for ALS treatment may also be proposed.
All research projects should include a well-formulated, testable hypothesis based on strong scientific rationale that holds translational potential to improve ALS treatment and/or advance a novel treatment modality.
Preliminary data are not required.
While the inclusion of preliminary data is not prohibited, the strength of the application should not rely on preliminary data, but on the innovative approach.Projects that focus primarily on investigating the pathophysiology of ALS, without consideration of therapeutic development, are not within the scope of this Funding Opportunity.Innovation and impact are important aspects of the Therapeutic Idea Award.
Research deemed innovative may introduce a new paradigm, challenge current paradigms, introduce novel concepts or technologies, or exhibit other uniquely creative qualities that may lead to potential therapeutics for ALS.
Impact may be near-term or long-term, but must be significant and move beyond an incremental advancement.The Therapeutic Idea Award encourages applications submitted by early career investigators as well as applications that include meaningful and productive collaborations between investigators.
Applicants from outside the ALS research field are encouraged to include collaborators with the necessary relevant expertise, such as experience with ALS model systems, endpoints, and pathogenic findings.Identification of treatment approaches using biological correlates of disease activity and progression in pre-existing, de-identified human specimens from well-characterized, adequately controlled, and sufficiently powered patient cohorts is encouraged.
Examples of acceptable sources for pre-existing biosamples or datasets include controlled clinical trials, observational studies, publicly available biorepositories, and registries (e.g., Centers for Disease Control and Prevention [CDC] National ALS Registry and/or Biorepository; https://www.cdc.gov/als/Default.html).
Active duty military and/or Veteran patient populations or resources should be considered.
A list of suitable resources can be found on the ALSRP web page (https://cdmrp.army.mil/alsrp/resources/ALSRPresources).
Other resources may be used, provided a letter of support adequately describes the relevant repository parameters and mechanisms for broad access to data and samples.
All specimens must exist at the time of application submission; collection of new specimens will not be supported.
Therapeutically Relevant Biomarker Option:
The FY20 ALSRP Therapeutic Idea Award Therapeutically Relevant Biomarker Option encourages applicants to include the development of biomarker(s) in parallel with the main proposed Therapeutic Idea Award research effort.
Additional funding, as described in Section II.D.5, Funding Restrictions, is being offered for the co-development of biomarkers that will enhance the drug development process.
Efforts may include development of target engagement biomarkers, objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic, or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup.
Development of markers for the purposes of diagnosis, prognosis, or measurement of disease progression without consideration of the therapeutic development process will not be supported.
Who's Eligible
Relevant Nonprofit Program Categories
Obtain Full Opportunity Text:
http://www.grants.gov
Additional Information of Eligibility:
There is not an application process for this project.
This is a notice of intent to award a single source grant to The Conservation Fund under justification 505 DM 2.14(B1)
Full Opportunity Web Address:
http://www.grants.gov
Contact:
Agency Email Description:
CDMRP Help Desk
Agency Email:
Date Posted:
2020-01-17
Application Due Date:
Archive Date:
2020-08-22
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