Department of Defense(DOD) Prostate Cancer Research Program Laboratory-Clinical Transition Award: Stage 1

The summary for the Department of Defense(DOD) Prostate Cancer Research Program Laboratory-Clinical Transition Award: Stage 1 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.

Department of Defense(DOD) Prostate Cancer Research Program Laboratory-Clinical Transition Award: Stage 1: The Prostate Cancer Research Program (PCRP) Laboratory-Clinical Transition Award: Stage I supports goal- and product-driven preclinical studies of promising lead agents that have the potential to revolutionize prostate cancer clinical care. The Laboratory-Clinical Transition Award: Stage II, to be offered in Fiscal Year 2010 (FY10) pending availability of funds, will be described briefly at the end of this section. The Stage I 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 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 Stage I Award, 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 have identified either one lead agent or a limited number of lead agents for optimization before applying for this award. All Stage I Award proposals must include preliminary data relevant to the lead agent(s) under development. Preliminary data must provide information regarding target availability and distribution in relevant human tissues and must support the efficacy of each agent in model systems. 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 will 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 (see Appendix 3). Participating institutions must be willing to resolve potential intellectual and material property issues and to remove institutional barriers that might interfere with achieving high levels of cooperation to ensure that the intent of the mechanism is met. In addition, a clear and appropriately powered statistical plan for lead agent development must be included in the proposal. 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 Stage I Award is to support the optimization of an identified lead agent up to but not including current Good Manufacturing Practice (cGMP) production of the agent. Laboratory-Clinical Transition Award: Stage II The Stage II Award will facilitate and expedite 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. All PIs funded by the Stage I Award who have viable lead agents are encouraged to compete for the Stage II Award, which is anticipated to be offered in FY10 pending receipt of appropriations. The Stage II Award will also be open to PIs who have not submitted to or been funded by the FY07 Stage I Award. Full guidance regarding the format and content of the Stage II Award proposal will be provided in the Program Announcement for the Stage II Award. Please note that there is no guarantee that funds will be available for the Laboratory-Clinical Transition Award: Stage II.