The Department of Defense’s Amyotrophic Lateral Sclerosis Therapeutic Development Award aims to support the preclinical development of therapeutic leads for ALS. The grant focuses on activities such as lead validation, optimization, formulation studies, and GMP production methods. Applicants are required to identify lead molecules with demonstrated biological activity relevant to ALS disease. The grant does not fund model or screening system development. The maximum period of performance is 2 years, and supported activities range from post-discovery validation to IND submission. Validation of biomarkers for drug activity and clinical progression is also encouraged alongside therapeutic lead development.
Opportunity ID: 275281
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-15-ALSRP-TDA |
| Funding Opportunity Title: | DoD Amyotrophic Lateral Sclerosis Therapeutic Development 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: | 2 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Mar 18, 2015 |
| Last Updated Date: | Mar 30, 2015 |
| Original Closing Date for Applications: | Aug 20, 2015 |
| Current Closing Date for Applications: | Aug 20, 2015 |
| Archive Date: | Sep 19, 2015 |
| Estimated Total Program Funding: | $3,200,000 |
| 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 Therapeutic Development Award supports the preclinical development of therapeutic leads for ALS. The proposed studies are expected to be empirical in nature and product-driven.New for FY15: The maximum period of performance is 2 years. The Therapeutic Development Award no longer supports development of model or screening systems or the conduct of screening. Those activities are now supported under the ALSRP FY15 Therapeutic Idea Award mechanism.Applications must clearly identify a lead molecule, or limited group of lead molecules, possessing demonstrated biological activity on a pathway relevant to ALS disease onset and/or progression.The FY15 Therapeutic Development Award supports a wide range of post-discovery development activities ranging from post-discovery validation right up to IND submission. Supported activities must begin with lead compounds in hand and can include (1) secondary validation of leads obtained from screening or by other means to demonstrate target selectivity and mechanism of action, (2) optimization of potency and pharmacological properties and development of structure-activity maps via synthesis and testing of derivatives and sister compounds, (3) studies of formulation and stability, and/or (4) development of GMP production methods, (5) collection of data needed for Food and Drug Administration (FDA) Investigational New Drug (IND) applications to include compound characterization, absorption, distribution, metabolism, excretion (ADME) studies, and dose/response and toxicology studies.Validation of existing biomarkers and development of them as markers for mechanism-specific drug activity and/or clinical progression, in parallel with therapeutic lead validation and development, is also of interest. |
| 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:Email: help@eBRAP.org |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Section IV ADMINISTRATIVE ACTIONS, A. Rejection has been amended to include: “Project Narrative exceeds page limit. “ |
Mar 30, 2015 | |
| Section IV ADMINISTRATIVE ACTIONS, A. Rejection has been amended to include: “Project Narrative exceeds page limit. “ |
Mar 30, 2015 | |
| Mar 30, 2015 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-15-ALSRP-TDA |
| Funding Opportunity Title: | DoD Amyotrophic Lateral Sclerosis Therapeutic Development 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: | 2 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Mar 18, 2015 |
| Last Updated Date: | Mar 30, 2015 |
| Original Closing Date for Applications: | Aug 20, 2015 |
| Current Closing Date for Applications: | Aug 20, 2015 |
| Archive Date: | Sep 19, 2015 |
| Estimated Total Program Funding: | $3,200,000 |
| 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 Therapeutic Development Award supports the preclinical development of therapeutic leads for ALS. The proposed studies are expected to be empirical in nature and product-driven.New for FY15: The maximum period of performance is 2 years. The Therapeutic Development Award no longer supports development of model or screening systems or the conduct of screening. Those activities are now supported under the ALSRP FY15 Therapeutic Idea Award mechanism.Applications must clearly identify a lead molecule, or limited group of lead molecules, possessing demonstrated biological activity on a pathway relevant to ALS disease onset and/or progression.The FY15 Therapeutic Development Award supports a wide range of post-discovery development activities ranging from post-discovery validation right up to IND submission. Supported activities must begin with lead compounds in hand and can include (1) secondary validation of leads obtained from screening or by other means to demonstrate target selectivity and mechanism of action, (2) optimization of potency and pharmacological properties and development of structure-activity maps via synthesis and testing of derivatives and sister compounds, (3) studies of formulation and stability, and/or (4) development of GMP production methods, (5) collection of data needed for Food and Drug Administration (FDA) Investigational New Drug (IND) applications to include compound characterization, absorption, distribution, metabolism, excretion (ADME) studies, and dose/response and toxicology studies.Validation of existing biomarkers and development of them as markers for mechanism-specific drug activity and/or clinical progression, in parallel with therapeutic lead validation and development, is also of interest. |
| 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:Email: help@eBRAP.org |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-15-ALSRP-TDA |
| Funding Opportunity Title: | DoD Amyotrophic Lateral Sclerosis Therapeutic Development 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: | 2 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Mar 30, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Aug 20, 2015 |
| Archive Date: | Sep 19, 2015 |
| Estimated Total Program Funding: | $3,200,000 |
| 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 Therapeutic Development Award supports the preclinical development of therapeutic leads for ALS. The proposed studies are expected to be empirical in nature and product-driven. New for FY15: The maximum period of performance is 2 years. The Therapeutic Development Award no longer supports development of model or screening systems or the conduct of screening. Those activities are now supported under the ALSRP FY15 Therapeutic Idea Award mechanism. Applications must clearly identify a lead molecule, or limited group of lead molecules, possessing demonstrated biological activity on a pathway relevant to ALS disease onset and/or progression. The FY15 Therapeutic Development Award supports a wide range of post-discovery development activities ranging from post-discovery validation right up to IND submission. Supported activities must begin with lead compounds in hand and can include (1) secondary validation of leads obtained from screening or by other means to demonstrate target selectivity and mechanism of action, (2) optimization of potency and pharmacological properties and development of structure-activity maps via synthesis and testing of derivatives and sister compounds, (3) studies of formulation and stability, and/or (4) development of GMP production methods, (5) collection of data needed for Food and Drug Administration (FDA) Investigational New Drug (IND) applications to include compound characterization, absorption, distribution, metabolism, excretion (ADME) studies, and dose/response and toxicology studies. Validation of existing biomarkers and development of them as markers for mechanism-specific drug activity and/or clinical progression, in parallel with therapeutic lead validation and development, is also of interest. |
| 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:Email: help@eBRAP.org |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-15-ALSRP-TDA |
| Funding Opportunity Title: | DoD Amyotrophic Lateral Sclerosis Therapeutic Development 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: | 2 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Mar 30, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Aug 20, 2015 |
| Archive Date: | Sep 19, 2015 |
| Estimated Total Program Funding: | $3,200,000 |
| 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 Therapeutic Development Award supports the preclinical development of therapeutic leads for ALS. The proposed studies are expected to be empirical in nature and product-driven. New for FY15: The maximum period of performance is 2 years. The Therapeutic Development Award no longer supports development of model or screening systems or the conduct of screening. Those activities are now supported under the ALSRP FY15 Therapeutic Idea Award mechanism. Applications must clearly identify a lead molecule, or limited group of lead molecules, possessing demonstrated biological activity on a pathway relevant to ALS disease onset and/or progression. The FY15 Therapeutic Development Award supports a wide range of post-discovery development activities ranging from post-discovery validation right up to IND submission. Supported activities must begin with lead compounds in hand and can include (1) secondary validation of leads obtained from screening or by other means to demonstrate target selectivity and mechanism of action, (2) optimization of potency and pharmacological properties and development of structure-activity maps via synthesis and testing of derivatives and sister compounds, (3) studies of formulation and stability, and/or (4) development of GMP production methods, (5) collection of data needed for Food and Drug Administration (FDA) Investigational New Drug (IND) applications to include compound characterization, absorption, distribution, metabolism, excretion (ADME) studies, and dose/response and toxicology studies. Validation of existing biomarkers and development of them as markers for mechanism-specific drug activity and/or clinical progression, in parallel with therapeutic lead validation and development, is also of interest. |
| 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:Email: help@eBRAP.org |
Related Documents
Folder 275281 Full Announcement-1 -> alsrp_fy15 tda pa.3_gg.pdf
Packages
| Agency Contact Information: | CDMRP Help Desk Phone: 301-682-5507 Email: 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 | PKG00215657 | Mar 18, 2015 | Aug 20, 2015 | View |
Package 1
Mandatory forms
275281 RR_SF424_2_0-2.0.pdf
275281 RR_Budget_1_3-1.3.pdf
275281 RR_KeyPersonExpanded_2_0-2.0.pdf
275281 PerformanceSite_2_0-2.0.pdf
Optional forms
275281 RR_SubawardBudget30_1_3-1.3.pdf
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