DOD Prostate Cancer Laboratory-Clinical Transition Award: Stage I

The summary for the DOD Prostate Cancer Laboratory-Clinical Transition Award: Stage I grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Dept of the Army USAMRAA, which is the U.S. government agency offering this grant.
DOD Prostate Cancer Laboratory-Clinical Transition Award: Stage I: 1. Overview The PCRP Laboratory-Clinical Transition Award: Stage I mechanism was introduced in FY07. Since then, 17 proposals have been received and 3 have been recommended for funding. The Laboratory-Clinical Transition Award: Stage I represents the first step of a three-step sequence to foster the bench-to-bedside transition of promising agents into the clinic to benefit prostate cancer patients. The Laboratory-Clinical Transition Award: Stage I supports goal- and product-driven preclinical studies of lead agents that have the potential to revolutionize the prevention, detection, or treatment of prostate cancer. The second step, the Laboratory-Clinical Transition Award: Stage II, will fund production and testing of current Good Manufacturing Practices (cGMP) agents before clinical trials. The Laboratory-Clinical Transition Award: Stage II, described briefly at the end of this section, will be offered in FY10 pending availability of funds. The third step, conduct of Phase I and Phase II clinical trials of the cGMP-produced agent, may be sponsored through the PCRP Clinical Trial Award, which is anticipated to be offered yearly pending availability of funds, or similar award mechanisms from other funding sources. 2. Laboratory-Clinical Transition Award: Stage I The Laboratory-Clinical Transition Award: Stage I 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 sufficient data to justify inclusion of lead agents into future clinical trials for the prevention, detection, or treatment of prostate cancer. For the purposes of the Laboratory-Clinical Transition Award: Stage I, lead agents are defined as biological or chemical therapeutics, imaging agents, or preventive agents that have potential clinical application to prostate cancer. Examples of lead agents include but are not limited to: novel chemotherapeutics, antibodies, viral particles, and contrast agents. PIs are expected to identify and have access to either one lead agent or a limited number of lead agents for optimization at the time of proposal submission. All Laboratory-Clinical Transition Award: Stage I proposals must include preliminary data relevant to the lead agent(s) under development. Preliminary data must provide information regarding target availability and distribution in human prostate cancer tissues and must support the relevance of the target for the prevention, detection, or treatment of human prostate cancer. Preliminary data must also support the efficacy of each agent in model systems. The National Cancer Institute has constructed developmental pathways for translational research (http://www.cancer.gov/images/trwg/Developmental-Pathway-Agent-Drug_Biologics.pdf) 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. Please be aware that the Laboratory-Clinical Transition Award: Stage I only supports research from the identification of a lead agent up to but not including cGMP production of the agent. This award may not be used to conduct clinical trials. Studies that may be funded under this award include, but are not limited to: . Comparative activity/efficacy testing to 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, funding for the award may be terminated. . Toxicology screening . Drug metabolism, biodistribution, and pharmacokinetic assays . Pharmacodynamic studies . Radiation dosimetry . Development and validation of assays and reagents required to measure biological responses and molecular endpoints Studies that may NOT be funded under this award include, but are not limited to: . Target discovery . Drug screening . Development of devices . Development of serum- or tissue-based biomarkers for the primary diagnosis of disease . New combinations or formulations of conventional therapeutics Preclinical studies 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. Studies that do not qualify for exempt status or expedited review will be administratively withdrawn and will not be funded. The preclinical drug development process may require resources beyond those available at a single laboratory or institution. As such, the PI must disclose any patents, issued or pending, and/or licenses, granted and/or pending, with respect to the lead agent(s) as well as any known patents that block the development of the lead agent(s). In the event that the project requires the use of a non-commercially available technology/material that is patented by a third party, the PI must provide documentation that the third party patent holder does not object to the PIs use of the patented technology/material. Since the ultimate goal of translational research is to obtain Investigational New Drug (IND) approvals on lead agents, PIs are expected to abide by US Food and Drug Administration (FDA) proposed and existing regulations governing the conduct of preliminary studies and the collection of data in support of an IND application (refer to http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm). Please note that the focus of the Laboratory-Clinical Transition Award: Stage I is to support the optimization of an identified lead agent up to but not including cGMP production of the agent. Clinical trials are not acceptable under this mechanism. PIs wishing to apply for funding for a clinical trial should utilize the Clinical Trial Award mechanism. 3. Laboratory-Clinical Transition Award: Stage II The Laboratory-Clinical Transition Award: Stage II will facilitate and expedite the next stage of the bench-to-bedside transition of promising lead agents by funding: . Full-scale cGMP production of the agent for clinical trials. . Studies with the cGMP-produced agent (e.g., toxicology and pharmacology) to support an IND application (or equivalent) to the FDA or other regulatory agency. . Development of a clinical protocol for submission to the PCRP Clinical Trial Award or a clinical trial award mechanism from another funding source. Collaboration with the existing PCRP Clinical Consortium for protocol development will be encouraged but not required. All PIs funded by the Laboratory-Clinical Transition Award: Stage I who have viable lead agents are encouraged to compete for the Laboratory-Clinical Transition Award: Stage II, which is anticipated to be offered in FY10 pending receipt of appropriations. The Laboratory-Clinical Transition Award: Stage II will also be open to PIs who have not submitted to or been funded by the Laboratory-Clinical Transition Award: Stage I. Full guidance regarding the format and content of the Laboratory-Clinical Transition Award: Stage II proposal will be provided in the Program Announcement for the Laboratory-Clinical Transition Award: Stage II. Please note that there is no guarantee that funds will be available for the Laboratory-Clinical Transition Award: Stage II.
Federal Grant Title: DOD Prostate Cancer Laboratory-Clinical Transition Award: Stage I
Federal Agency Name: Dept of the Army USAMRAA
Grant Categories: Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: W81XWH-08-PCRP-LCTAI
Type of Funding: Grant Cooperative Agreement
CFDA Numbers: 12.420
CFDA Descriptions: Military Medical Research and Development
Current Application Deadline: No deadline provided
Original Application Deadline: Jul 02, 2008
Posted Date: Feb 15, 2008
Creation Date: Feb 15, 2008
Archive Date: Aug 01, 2008
Total Program Funding: $5,400,000
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards: 5
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
Grant Announcement Contact
PA HELP: 301-619-7079; [email protected]
eReceipt HELP: 301-682-5507; [email protected] [email protected] CDMRP Helpdesk
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