DoD Amyotrophic Lateral Sclerosis, Therapeutic Development Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

DoD Amyotrophic Lateral Sclerosis, Therapeutic Development Award

The Therapeutic Development Award supports research ranging from validation of therapeutic leads to Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to...

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Deadline 2809 days ago Location Alabama Type grant Level Federal Closed posted Apr 10, 2018
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$4,800,000.
  • Next deadline: October 11, 2018.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
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The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

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Deadline
2809 days ago
Oct 11, 2018
Total pool
$4.8M

About this opportunity

The Therapeutic Development Award supports research ranging from validation of therapeutic leads to Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited ALS experience are strongly encouraged to collaborate with those having substantial expertise in ALS research and/or ALS model systems. Examples of activities that will be supported by this award include: • Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds • Validation of early pilot studies, including the use of multiple ALS model systems and/or replicating preliminary data with more time points or additional doses • Studies on formulation and stability leading to Good Manufacturing Practice (GMP) production methods • IND-enabling studies, to include compound excretion (ADME) studies, and dose/response and toxicology studies in relevant model systems Validation of treatment approaches in appropriately powered and controlled studies using biological correlates of disease activity and progression in pre-existing, de-identified human specimens from well-characterized patient cohorts is encouraged. Examples of acceptable cohorts for study include controlled clinical trials, observational studies, and registries ( Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://wwwn.cdc.gov/als/). Active duty military and/or Veteran patient populations or resources should be considered. All specimens must exist at the time of application submission; collection of new specimens will not be supported. Applications supported by this award must begin with lead compounds in hand and must include preliminary data relevant to the phase of development, such as: • Proof of identity and purity • Selectivity for the intended target over closely related targets • Availability of primary and secondary in-vitro bioactivity assays for optimization or structure-activity relationship studies • Availability of proof-of-concept efficacy data in appropriate preclinical model systems of ALS, including whole animal and cellular model systems, or informative clinical data from a related human disease Investigators interested in basic research focused on ALS drug discovery are encouraged to apply for the FY18 ALSRP Therapeutic Idea Award (Funding Opportunity Number: W81XWH- 18-ALSRP-TIA), which does not require preliminary data (http://cdmrp.army.mil/funding/alsrp). Therapeutically Relevant Marker Option (New for FY18!): The FY18 ALSRP Therapeutic Development Award Therapeutically Relevant Marker Option encourages applicants to develop a specific marker(s) in parallel with the advanced therapeutic development effort. Additional funding, as described in Section II.D.5, Funding Restrictions, is being offered for the co- development of markers that will enhance the drug development process. Efforts may include development of 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 measurement of disease progression without consideration of the therapeutic development process will not be supported. To apply for this option, applicants must submit a Therapeutically Relevant Marker Statement (see Attachment 11) that clearly describes the marker and its potential to improve the efficacy of the therapeutic development process. For further description, see Section II.D.2.b.ii, Full Application Submission Components.

Funding agency

Defense Health Agency Contracting Activity - DHACA
Federal agency

Tags

Healthcare & Biotech Manufacturing Arts & Culture Education & Research Veterans Science, Tech & Engineering (STEM)
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Who can apply

Eligibility details aren't on file yet — check the agency source link in the Documents tab for the latest rules.

Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming
  • District of Columbia

How to apply

We don't have application instructions on file yet — head straight to the official source.

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Source documents

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Canonical NOFO, application packet, and forms
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Direct downloads (NOFO PDFs, application forms, FAQs) will appear here once our team attaches them. For now, the agency site has the canonical packet.

Citation details

Source systemgrants.gov
Source ID302955
PostedApr 10, 2018

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