OpportunityTitle: DoD FY11 Prostate Cancer Research Program Laboratory-Clinical Transition Award
Description: The PCRP Laboratory-Clinical Transition Award mechanism was introduced in FY07. Since then, 49 applications have been received, and 9 have been recommended for funding. The Laboratory-Clinical Transition Award supports product-driven preclinical studies of promising lead agents that have the potential to revolutionize prostate cancer clinical care. This award is intended to fund Principal Investigators (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 U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application and/or (new for FY11) 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. The PI must provide a transition plan (including potential funding and resources) showing how the product will progress to clinical trials and/or delivery to market after the completion of the PCRP award. 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 biological, molecular, or chemical therapeutics or imaging agents, that have potential clinical application to prostate cancer. Examples of lead agents include, but are not limited to: novel chemotherapeutics, antibodies, nanoparticles, and imaging contrast agents. Applications must include preliminary data relevant to the lead agent(s) under development. Any preliminary data provided should be from the laboratory of the PI or member(s) of the collaborating team. 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. In addition, applications must describe a statistical/analytical plan(s) to support the proposed studies. These analyses must be consistent with current FDA guidance. 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). All applications for the Laboratory-Clinical Transition Award are highly recommended to address one of the FY11 PCRP overarching challenges. The PCRP seeks to fund projects from the wide spectrum of basic to clinical research; however, if the proposed project does not address one of the overarching challenges, the application should provide a description to justify how the project will nevertheless address a critical need in the field of prostate cancer research and/or patient care. Studies proposed under this award may include, but are not limited to: &#239;&#191;&#189; 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. &#239;&#191;&#189; Toxicology screening &#239;&#191;&#189; Pharmacokinetics (e.g., absorption, distribution, metabolism, and excretion) studies &#239;&#191;&#189; Pharmacodynamic studies &#239;&#191;&#189; Radiation dosimetry &#239;&#191;&#189; 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 &#239;&#191;&#189; Combination of the lead agent with agents already in clinical testing or practice &#239;&#191;&#189; cGMP production of the lead agent Studies proposed under this award should not include: &#239;&#191;&#189; Target discovery &#239;&#191;&#189; Drug screening &#239;&#191;&#189; Development of devices &#239;&#191;&#189; New combinations, formulations, or modifications of agents already in clinical testing or practice (other than in combination with the lead agent) &#239;&#191;&#189; Mechanism of action studies &#239;&#191;&#189; Prevention agents The preclinical drug development process may require resources beyond those available at a single laboratory or organization. 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 may block the development of the lead agent(s). The PI must provide documentation, such as a Material Transfer Agreement, of access to and permission to use all intellectual and material property. Participating organizations must be willing to resolve potential intellectual and material property issues, and to remove organizational barriers that might interfere with the cooperation necessary to ensure that the proposed studies can be completed. PIs are expected to abide by the FDA existing and proposed guidance 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). Projects involving human subjects or anatomical substances 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. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. For more information on clinical research, a Human Subject Resource Document is provided at https://cdmrp.org/Program_Announcements_and_Forms/. Additional information on the protection of human subjects and exempt or expedited review status may be found at https://www.bids.tswg.gov/. Applications proposing studies that do not qualify for exempt or expedited review status will be administratively withdrawn. PIs seeking funding for a clinical trial should consider submitting an application for the FY11 PCRP Clinical Trial Award.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: Phone:  301-682-5507