DoD FY13 Prostate Cancer Laboratory-Clinical Transition Award
The PCRP Laboratory - Clinical Transition Award (LCTA) mechanism was introduced in FY07. Since then, 95 applications have been received, and 12 have been recommended for funding. The LCTA supports product-driven preclinical studies of promising lead agents or medical devices 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 or medical devices to human testing, as follows: Lead Agents: It is anticipated that lead agent development projects supported by this award will be generating pharmacology and toxicology data in preclinical studies for inclusion in a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application and/or current Good Manufacturing Practice (cGMP) production. 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 on the target or preliminary data demonstrating reliability, reproducibility, and effectiveness (including sensitivity and specificity). Lead agents are defined as novel biological and molecular or chemical therapeutic or imaging agents having potential clinical application to prostate cancer. Examples of lead agents include, but are not limited to, novel chemotherapeutics, antibodies, nanoparticles, imaging contrast agents, and others. Medical Devices: Projects to be supported by this award will test medical devices in preclinical studies with the intent for FDA Investigational Device Exemption (IDE) application and/or cGMP production of the medical device. As appropriate, the PI should present preliminary data demonstrating reliability, reproducibility, and effectiveness (including sensitivity and specificity) for the medical device. Examples of medical devices include, but are not limited to, diagnostic or prognostic tests (e.g., microfluidic device, genomic and genetic microarray devices), imaging devices, and other medical technology. Lead agents or medical devices supported by this award 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) to describe how the product will progress to clinical trials and/or delivery to market after the completion of the PCRP award. The PCRP strongly encourages investigators to leverage existing resources with commercial partners to increase potential gains in translating preclinical research outcomes for continued development and clinical application. Applications that demonstrate cost-sharing with commercial partners are particularly encouraged. Applications must include strong scientific rationale and preliminary data relevant to the lead agent or medical device 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 or medical device in humans. In addition, applications must describe a statistical/analytical plan to support the proposed studies, if applicable. These analyses must be consistent with current FDA guidance. The National Cancer Institute has constructed developmental pathways for translational research that may be useful for designing translational research studies for support under the LCTA 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). PIs applying to the LCTA are expected to address at least one of the PCRP focus areas and are highly encouraged to address one of the PCRP overarching challenges. If the proposed project does not address any of the overarching challenges, the application should include 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: • Comparative activity 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 lead agent has not been finalized within 12 months of award initiation, the Government reserves the right to terminate the award. • Toxicology screening • Pharmacokinetics (e.g., absorption, distribution, metabolism, and excretion) studies • Pharmacodynamic studies • Radiation dosimetry • Testing medical devices for safety or effectiveness in preclinical systems • 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 • cGMP production of the lead agent or medical device Studies proposed under this award should not include: • Target discovery • Drug screening • Early development of medical devices • New combinations, formulations, or modifications of agents already in clinical testing or practice (other than in combination with the lead agent) • Mechanism of action studies • Prevention agents
Office: U.S. Army Medical Research Acquisition Activity
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