Opportunity ID: 353158

General Information

Document Type: Grants Notice
Funding Opportunity Number: HT942524ALSRPCOBA
Funding Opportunity Title: DOD Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 5
Assistance Listings: 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Version: Synopsis 3
Posted Date: Mar 25, 2024
Last Updated Date: Apr 23, 2024
Original Closing Date for Applications: Jul 10, 2024
Current Closing Date for Applications: Jul 10, 2024
Archive Date: Aug 09, 2024
Estimated Total Program Funding: $6,100,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:

Additional Information

Agency Name: Dept. of the Army — USAMRAA
Description:

The FY24 ALSRP Clinical Outcomes and Biomarkers Award (COBA) supports the development and/or validation of clinical outcomes and biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). Projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients.

Research may include, but is not limited to:

  • Target engagement biomarkers.

  • Objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic.

  • Predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup.

  • Diagnostic, prognostic, or disease progression

  • Validate clinician-, observer-, patient-reported and/or performance outcomes to better support clinical trial success metrics.

  • Define ALS subtypes using patient-based resources to link biosamples and/or digital data elements to rigorous molecular and clinical data.

  • Realize improved strategies that better measure disease progression for people living with ALS.

  • Augment biospecimens, outcome, or digital health data to an on-going clinical trial.

  • Correlate clinical-trial related data (e.g., biosample, imaging, digital health data) with clinical outcomes or responses to therapies.

Use of existing well-characterized and highly curated clinical resources is encouraged. Examples of patient-based ALS resources include ongoing or completed clinical trial datasets, biorepositories of clinical specimens, registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://www.cdc.gov/als/Default.html), large omics datasets, patient-report outcomes, digital biomarker datasets, and databases of clinical data and/or metadata. 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.health.mil/alsrp/resources/ALSRPresources). Other resources may be used, provided they have an adequate description of repository parameters and mechanisms for broad access.

Link to Additional Information:
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

CDMRP Help Desk

Phone: 301-682-5507

Email: help@eBRAP.org
Email:help@eBRAP.org

Version History

Version Modification Description Updated Date
Funding Instrument Type change to Grant and the PA has been updated to reflect the LOI Apr 23, 2024
Modified Opportunity Title Mar 25, 2024
Mar 25, 2024

DISPLAYING: Synopsis 3

General Information

Document Type: Grants Notice
Funding Opportunity Number: HT942524ALSRPCOBA
Funding Opportunity Title: DOD Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 5
Assistance Listings: 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Version: Synopsis 3
Posted Date: Mar 25, 2024
Last Updated Date: Apr 23, 2024
Original Closing Date for Applications: Jul 10, 2024
Current Closing Date for Applications: Jul 10, 2024
Archive Date: Aug 09, 2024
Estimated Total Program Funding: $6,100,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:

Additional Information

Agency Name: Dept. of the Army — USAMRAA
Description:

The FY24 ALSRP Clinical Outcomes and Biomarkers Award (COBA) supports the development and/or validation of clinical outcomes and biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). Projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients.

Research may include, but is not limited to:

  • Target engagement biomarkers.

  • Objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic.

  • Predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup.

  • Diagnostic, prognostic, or disease progression

  • Validate clinician-, observer-, patient-reported and/or performance outcomes to better support clinical trial success metrics.

  • Define ALS subtypes using patient-based resources to link biosamples and/or digital data elements to rigorous molecular and clinical data.

  • Realize improved strategies that better measure disease progression for people living with ALS.

  • Augment biospecimens, outcome, or digital health data to an on-going clinical trial.

  • Correlate clinical-trial related data (e.g., biosample, imaging, digital health data) with clinical outcomes or responses to therapies.

Use of existing well-characterized and highly curated clinical resources is encouraged. Examples of patient-based ALS resources include ongoing or completed clinical trial datasets, biorepositories of clinical specimens, registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://www.cdc.gov/als/Default.html), large omics datasets, patient-report outcomes, digital biomarker datasets, and databases of clinical data and/or metadata. 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.health.mil/alsrp/resources/ALSRPresources). Other resources may be used, provided they have an adequate description of repository parameters and mechanisms for broad access.

Link to Additional Information:
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

CDMRP Help Desk

Phone: 301-682-5507

Email: help@eBRAP.org
Email:help@eBRAP.org

DISPLAYING: Synopsis 2

General Information

Document Type: Grants Notice
Funding Opportunity Number: HT942524ALSRPCOBA
Funding Opportunity Title: DOD Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 5
Assistance Listings: 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Version: Synopsis 2
Posted Date: Mar 25, 2024
Last Updated Date: Mar 25, 2024
Original Closing Date for Applications:
Current Closing Date for Applications: Jul 10, 2024
Archive Date: Aug 09, 2024
Estimated Total Program Funding: $6,100,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:

Additional Information

Agency Name: Dept. of the Army — USAMRAA
Description:

The FY24 ALSRP Clinical Outcomes and Biomarkers Award (COBA) supports the development and/or validation of clinical outcomes and biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). Projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients.

Research may include, but is not limited to:

  • Target engagement biomarkers.

  • Objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic.

  • Predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup.

  • Diagnostic, prognostic, or disease progression

  • Validate clinician-, observer-, patient-reported and/or performance outcomes to better support clinical trial success metrics.

  • Define ALS subtypes using patient-based resources to link biosamples and/or digital data elements to rigorous molecular and clinical data.

  • Realize improved strategies that better measure disease progression for people living with ALS.

  • Augment biospecimens, outcome, or digital health data to an on-going clinical trial.

  • Correlate clinical-trial related data (e.g., biosample, imaging, digital health data) with clinical outcomes or responses to therapies.

Use of existing well-characterized and highly curated clinical resources is encouraged. Examples of patient-based ALS resources include ongoing or completed clinical trial datasets, biorepositories of clinical specimens, registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://www.cdc.gov/als/Default.html), large omics datasets, patient-report outcomes, digital biomarker datasets, and databases of clinical data and/or metadata. 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.health.mil/alsrp/resources/ALSRPresources). Other resources may be used, provided they have an adequate description of repository parameters and mechanisms for broad access.

Link to Additional Information:
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

CDMRP Help Desk

Phone: 301-682-5507

Email: help@eBRAP.org
Email:help@eBRAP.org

DISPLAYING: Synopsis 1

General Information

Document Type: Grants Notice
Funding Opportunity Number: HT942524ALSRPCOBA
Funding Opportunity Title: Amyotrophic Lateral Sclerosis, Clinical Outcomes and Biomarkers Award
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 5
Assistance Listings: 12.420 — Military Medical Research and Development
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Mar 25, 2024
Last Updated Date: Mar 25, 2024
Original Closing Date for Applications:
Current Closing Date for Applications: Jul 10, 2024
Archive Date: Aug 09, 2024
Estimated Total Program Funding: $6,100,000
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:

Additional Information

Agency Name: Dept. of the Army — USAMRAA
Description:

The FY24 ALSRP Clinical Outcomes and Biomarkers Award (COBA) supports the development and/or validation of clinical outcomes and biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). Projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients.

Research may include, but is not limited to:

  • Target engagement biomarkers.

  • Objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic.

  • Predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup.

  • Diagnostic, prognostic, or disease progression

  • Validate clinician-, observer-, patient-reported and/or performance outcomes to better support clinical trial success metrics.

  • Define ALS subtypes using patient-based resources to link biosamples and/or digital data elements to rigorous molecular and clinical data.

  • Realize improved strategies that better measure disease progression for people living with ALS.

  • Augment biospecimens, outcome, or digital health data to an on-going clinical trial.

  • Correlate clinical-trial related data (e.g., biosample, imaging, digital health data) with clinical outcomes or responses to therapies.

Use of existing well-characterized and highly curated clinical resources is encouraged. Examples of patient-based ALS resources include ongoing or completed clinical trial datasets, biorepositories of clinical specimens, registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://www.cdc.gov/als/Default.html), large omics datasets, patient-report outcomes, digital biomarker datasets, and databases of clinical data and/or metadata. 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.health.mil/alsrp/resources/ALSRPresources). Other resources may be used, provided they have an adequate description of repository parameters and mechanisms for broad access.

Link to Additional Information:
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

CDMRP Help Desk

Phone: 301-682-5507

Email: help@eBRAP.org
Email:help@eBRAP.org

Folder 353158 Full Announcement-FY24 ALSRP COBA -> HT942524ALSRPCOBA_GG2.pdf

Packages

Agency Contact Information: CDMRP Help Desk
Phone: 301-682-5507
Email: help@eBRAP.org
Email: help@eBRAP.org
Who Can Apply: Organization Applicants

Assistance Listing Number Competition ID Competition Title Opportunity Package ID Opening Date Closing Date Actions
12.420 PKG00285539 Mar 25, 2024 Jul 10, 2024 View

Package 1

Mandatory forms

353158 RR_SF424_5_0-5.0.pdf

353158 AttachmentForm_1_2-1.2.pdf

353158 RR_PersonalData_1_2-1.2.pdf

353158 RR_KeyPersonExpanded_4_0-4.0.pdf

353158 RR_Budget_3_0-3.0.pdf

353158 PerformanceSite_4_0-4.0.pdf

Optional forms

353158 RR_SubawardBudget30_3_0-3.0.pdf

2025-07-12T09:40:49-05:00

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