This grant is offered by the Department of Defense ALS Research Program to support the development of therapeutic leads for Amyotrophic Lateral Sclerosis (ALS). Activities include lead compound validation, optimization, formulation, stability studies, and preparation for FDA Investigational New Drug (IND) submission. Applicants must have preliminary data and support for their proposed therapeutic approach. Collaboration with other institutions or industry partners is encouraged, especially for those with limited ALS experience. The closing date for applications is July 21, 2016.
Opportunity ID: 281906
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-16-ALSRP-TDA |
| Funding Opportunity Title: | Amyotrophic Lateral Sclerosis Research Program 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 01, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jul 21, 2016 |
| Current Closing Date for Applications: | Jul 21, 2016 |
| Archive Date: | Aug 20, 2016 |
| 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 a wide range of development activities ranging from validation of therapeutic leads to U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) submission. The proposed studies are expected to be empirical in nature and product-driven. Applications supported by this award must begin with lead compounds in hand. Examples of activities that will be supported by this award include: • Secondary validation of lead compounds obtained from screening or by other means to demonstrate target selectivity and mechanism of action, • Optimization of potency and pharmacological properties, development of structure-activity maps via synthesis, and testing of derivatives and sister compounds, • Studies on formulation and stability, • Development of GMP production methods, • Collection of data for FDA IND applications, to include compound characterization, absorption, distribution, metabolism, and excretion (ADME) studies, and dose/response and toxicology studies. In parallel with lead compound validation and development, applicants are strongly encouraged to assess in vivo efficacy or target engagement (measurement of target binding or proximal downstream effects) in a relevant preclinical ALS model(s). Applications must include preliminary data and other supporting information relevant to the phase(s) of the preclinical development, such as the following: • Background data supporting the putative mechanism of action as a viable therapeutic approach An identified bioactive compound or limited group of identified lead molecules with: ○ Proof of identity and purity ○ Selectivity for the intended target over closely related targets (when the target is known) • Availability of primary and secondary in vitro bioactivity assays for optimization or structure-activity relationship studies • Availability of appropriate preclinical animal models of ALS to assess in vivo efficacy or desirable mechanism-specific drug activity at the intended target (target engagement) Investigators interested in basic research focused on ALS drug discovery are encouraged to apply for the FY16 ALSRP Therapeutic Idea Award (Funding Opportunity Number: W81XWH-16-ALSRP-TIA), which does not require preliminary data (http://cdmrp.army.mil/funding/alsrp.shtml). Collaborations: The preclinical drug development process may require resources beyond those available at single institutions. Collaborations with other research institutions and partnerships with biotechnology/pharmaceutical industry partnerships are encouraged. Biotechnology or pharmaceutical companies intending to apply for the Therapeutic Development Award are encouraged to leverage their own resources to complement the funding provided by this award. 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. Applicants with limited ALS experience are strongly encouraged to collaborate with those having substantial expertise in ALS research and/or ALS model systems. Letters confirming/supporting the collaboration are required. |
| 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 |
|---|---|---|
Related Documents
Folder 281906 Full Announcement-FY16 ASLRP TDA PA -> ALSRP_FY16_TDA_PA_GG.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 | PKG00221259 | Mar 01, 2016 | Jul 21, 2016 | View |
Package 1
Mandatory forms
281906 RR_SF424_2_0-2.0.pdf
281906 RR_Budget_1_3-1.3.pdf
281906 RR_KeyPersonExpanded_2_0-2.0.pdf
281906 PerformanceSite_2_0-2.0.pdf
Optional forms
281906 RR_SubawardBudget30_1_3-1.3.pdf
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