The Department of Defense’s Amyotrophic Lateral Sclerosis Research Program (ALSRP) offers the Therapeutic Development Award to support the preclinical assessment and development of therapeutics for ALS. This grant funds empirical, product-driven studies, including the development of high-throughput screens, validation of preclinical models, ADME/toxicology testing, and cGMP production. It aims to advance novel ALS therapies, supporting activities up to Investigational New Drug (IND) submission. Applicants must provide relevant preliminary data and a clear statistical plan, demonstrating the project’s impact on therapeutic development. Clinical trials are not supported. Collaborations, including those with biotechnology and pharmaceutical companies, are encouraged to leverage diverse resources for preclinical drug development.
Opportunity ID: 233014
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-13-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: | May 03, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Sep 18, 2013 |
| Current Closing Date for Applications: | Sep 18, 2013 |
| Archive Date: | Oct 18, 2013 |
| Estimated Total Program Funding: | $4,800,000 |
| Award Ceiling: | $0 |
| Award Floor: | $0 |
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 ALSRP Therapeutic Development Award (TDA) mechanism was first offered in FY07. Since then, 128 Therapeutic Development Award applications have been received, and 12 have been recommended for funding. The TDA supports the preclinical assessment of therapeutics for ALS. The proposed studies are expected to be empirical in nature and product-driven but may have a hypothesis-driven approach, provided the focus is on therapeutics. It is anticipated that the agents and/or data generated from these awards will lead to the advancement of new therapies for ALS. The TDA mechanism is designed to support preclinical testing and development of therapeutics for ALS. Applications must include preliminary data relevant to the phase(s) of the preclinical development process covered by the proposed research. The application should include a clear statistical plan of analysis, if appropriate. Applicants must clearly and explicitly articulate what impact the project may have on therapeutic development for ALS. Clinical trials will not be supported with this Program Announcement/Funding Opportunity. Therapeutic Development Award applications are limited to the areas of programmatic interest listed below. Applications must focus on one or more of these areas to be considered for funding. Applications that do not focus on at least one of the following areas will be administratively withdrawn. Development and/or validation of high-throughput screens to define targets with therapeutic potential or to identify lead agent candidates for ALS treatment and be an asset for the ALS research community; Development, modification, and/or validation of preclinical model systems in order to assess lead compounds and potential therapeutics by pharmacological and/or pharmacokinetic testing. Such models would also serve as improved tools for the ALS research community; Development and optimization of pharmacologic agents through Adsorption, Distribution, Metabolism, Excretion (ADME) studies, and toxicology testing, including Investigational New Drug (IND)-enabling pharmacology/toxicology testing; Formulation and stability studies, design and implementation of full-scale, pilot current Good Manufacturing Practice (cGMP) production of therapeutics and/or delivery systems for use in advanced preclinical and initial clinical trials; Development of pharmacologic agents up to IND submission to initiate Phase I clinical trials after the awards completion. In contrast, investigators interested in more basic research focused on ALS therapeutics should consider the FY13 ALSRP Therapeutic Idea Award, which does not require preliminary data (http://cdmrp.army.mil/funding/alsrp.shtml). If a therapeutic agent(s) that is the subject of a Therapeutic Development Award application was initially developed under an ALSRP Therapeutic Idea Award (TIA), the applicant should describe the role of the TIA in that development. The preclinical drug development process may require resources beyond those available at a single organization. Therefore, Therapeutic Development Awards are open to investigators participating in collaborations focused on identifying and/or testing lead agents for the treatment of ALS. Collaborations should be dedicated to a single, preclinical development project rather than an additive set of subprojects. If a collaboration is proposed, letters confirming/supporting the collaboration are required. If the collaboration is multi-organizational, participating organizations should ensure the success of the collaboration by resolving potential intellectual and material property issues and by removing organizational barriers that might interfere with achieving high levels of cooperation. A proposed means to resolve these issues must be delineated in an Intellectual and Material Property Plan to be included with the application. Due to the nature of the work involved in the development process, biotechnology and pharmaceutical companies are invited to apply. Whether a biotechnology or pharmaceutical company applies for this mechanism as an individual applicant or as part of a collaboration, the company is expected to leverage its own resources to complement the funding provided by this award. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
CDMRP Help Desk
301-682-5507 Email:help@cdmrp.org |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 233014 Full Announcement-1 -> alsrp fy13 tda pa_gg.pdf
Folder 233014 Full Announcement-1 -> fy13 cdmrp gai_2may2013.pdf
Packages
| Agency Contact Information: | CDMRP Help Desk 301-682-5507 Email: help@cdmrp.org |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| PKG00176271 | May 03, 2013 | Sep 18, 2013 | View |
Package 1
Mandatory forms
233014 RR_SF424_1_2-1.2.pdf
233014 PerformanceSite_1_4-1.4.pdf
233014 RR_Budget-1.1.pdf
233014 RR_KeyPersonExpanded_1_2-1.2.pdf
Optional forms
233014 RR_SubawardBudget30-1.2.pdf
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