The Laboratory - Clinical Transition Award supports product-driven preclinical studies of promising lead agents or medical devices that have the potential to revolutionize prostate cancer clinical care.
Lead Agents: It is anticipated that lead agent development projects supported by this award will focus on 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 establishing agent production according to current Good Manufacturing Practice (cGMP). Applicants are expected to have a validated target and to have identified 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 lead agent's mechanism of action and demonstrating reliability, reproducibility, effectiveness (including sensitivity and specificity), and target availability and distribution in relevant human tissues. In addition, the inclusion of substantive information from model systems that supports the potential efficacy of the lead agent in humans is highly recommended. 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: Medical device projects to be supported by this award will test medical devices in preclinical studies with the intent of achieving an 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, as well as target availability and distribution in relevant human tissues. In addition, the inclusion of substantive information from model systems that supports the potential efficacy of medical device in humans is highly recommended. 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.
The mission of the FY14 PCRP is to find and fund research that will lead to the elimination of death from prostate cancer and enhance the well-being of men experiencing the impact of the disease. Specifically, the PCRP seeks to promote highly innovative, groundbreaking research; high-impact research with near-term clinical relevance; multidisciplinary, synergistic research; translational studies to support the fluid transfer of knowledge between bedside and bench; research on patient survivorship and quality of life; the next generation of prostate cancer investigators through mentored research; and research on disparities in the incidence and mortality of prostate cancer.
Consistent with the program's mission to eliminate death from prostate cancer and enhance the well-being of men experiencing the impact of the disease, including those from disproportionately affected populations, each PCRP funding opportunity either requires or encourages applications to address one of the following four PCRP overarching challenges:
- Develop better tools for early detection of clinically relevant disease
- Distinguish aggressive from indolent disease in men newly diagnosed with prostate cancer
- Develop effective treatments and address mechanisms of resistance for men with high risk or metastatic prostate cancer
- Develop strategies to optimize the physical and mental health of men with prostate cancer
All applications for the FY14 PCRP funding opportunities are also expected to address at least one of the following PCRP focus areas:
- Biomarker Development: Validation and qualification of biomarkers for early detection of clinically relevant disease or for prognosis or prediction and assessment of response to therapies
- Genetics: Understanding host or tumor genetics and epigenetics responsible for susceptibility, disease progression, and treatment outcomes for clinically relevant prostate cancer
- Imaging: Development of new anatomic, functional, and molecular imaging approaches for the detection and management of clinically relevant prostate cancer
- Mechanisms of Resistance: Understanding primary and acquired resistance to therapy
- Survivorship and Palliative Care: Improving the quality of life and well-being of prostate cancer patients and their families
- Therapy: Identification of new targets, pathways, and therapeutic modalities
- Tumor and Microenvironment Biology: Understanding the intrinsic and extrinsic mechanisms contributing to tumor development and the progression of prostate cancer
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