DoD Prostate Cancer Laboratory-Clinical Transition Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

DoD Prostate Cancer Laboratory-Clinical Transition Award

The PCRP Laboratory Clinical Transition Award mechanism was introduced in FY07. Since then, 36 applications have been received, and 6 have been recommended for funding. The Laboratory Clinical Transition Award supports g...

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Award $0 Deadline 5870 days ago Location Alabama Type grant Level Federal Closed posted Mar 2, 2010
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$2,400,000.
  • Next deadline: May 26, 2010.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
How was this generated?

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.

AI-generated. Always verify with the official source.

Award amount
$0
Deadline
5870 days ago
May 26, 2010
Total pool
$2.4M

About this opportunity

The PCRP Laboratory Clinical Transition Award mechanism was introduced in FY07. Since then, 36 applications have been received, and 6 have been recommended for funding. The Laboratory Clinical Transition Award supports goal- and product-driven preclinical studies of promising lead agents that have the potential to revolutionize prostate cancer clinical care. This award is intended to fund PIs who lack support to conduct the preclinical studies needed to advance lead agents to human testing. The goal of this award is the generation of pharmacology and toxicology data for inclusion in a Food and Drug Administration (FDA) Investigational New Drug (IND) application prior to current Good Manufacturing Practice (cGMP) production of the lead agent(s). Agents supported by this award mechanism are expected to have high potential for commercial licensing for continued development and clinical use. Applicants are expected to have a validated target, and to have identified either one lead agent or a limited number of lead agents for optimization before applying for this award. In addition, the PI should present data establishing the mechanism of action of the lead agent(s) on the target. Lead agents are defined as novel chemical therapeutics or imaging agents, that have potential clinical application to prostate cancer. Examples of lead agents include, but are not limited to: novel imaging contrast agents. Proposals must include preliminary data relevant to the lead agent(s) under development. Preliminary data must document target availability and distribution in relevant human tissues, and must provide substantive information from model systems that supports the potential efficacy of the lead agent(s) in humans. The National Cancer Institute (NCI) has constructed developmental pathways for translational research that may be useful for designing translational research studies for support under this mechanism. These pathways are comprehensive and span the entire translational research continuum from discovery of a target to clinical trials (http://www.cancer.gov/images/trwg/Developmental-Pathway-Agent-Drug_Biologics.pdf). Please note that the focus of this award is to support the development of the lead agent(s) up to but not including cGMP production of the agent. Studies proposed under this award may include, but are not limited to: • Comparative activity/efficacy testing to optimize a lead agent and/or define a single lead agent from a limited library of candidates. Such studies must be completed within 12 months of the start date of the award. If the studies are not completed within 12 months of award initiation, the government reserves the right to terminate the award. • Toxicology screening • Pharmacokinetics ( excretion) studies • Pharmacodynamic studies • Radiation dosimetry DOD FY10 Prostate Cancer Laboratory-Clinical Transition Award 4 • Development and validation of assays and reagents required to measure biological responses and molecular endpoints of the lead agent; such studies may only be proposed in conjunction with lead agent development • Combination of the lead agent with agents already in clinical testing or practice Studies proposed under this award should not include: • Target discovery • Drug screening • Development of devices • New modifications of agents already in clinical testing or practice (other than in combination with the lead agent) • Mechanism of action studies • Prevention agents Projects involving human subjects or specimens will be supported only if they are exempt under Title 32 of the Code of Federal Regulations Section 219.101(b) (4) (32 CFR 219.101(b) (4)) or qualify for expedited review under 32 CFR 219.110 or 21 CFR 56.1102. Clinical trials are not allowed. In general, a clinical trial is defined as a prospective study where an intervention ( procedure, or other) is tested on human subjects for a measurable outcome.

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Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
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  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
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  • New Hampshire
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  • Oregon
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  • Rhode Island
  • South Carolina
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  • District of Columbia

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Citation details

Source systemgrants.gov
Source ID52284
PostedMar 2, 2010

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