TECHNICAL INFORMATION RESEARCH RESOURCES FOR CANCER PREVENTIVE AGENT DEVELOPMENT

Ccs Associates, Inc., San Jose CA

Investigators

Abstract

The National Cancer Institute, Division of Cancer Prevention (DCP) requires the continuation of technical information support resources for cancer preventive agent identification, development, and qualification for clinical trials. The projects required to satisfy the RFP workscope shall provide the diverse technical support services needed for DCP?s preclinical and clinical development of the most promising cancer chemopreventive agents. Technical support includes agent background, rationale, chemistry, and testing documents for use in decision making and in planning clinical development strategies by the DCP Agent Development Committee; by the Chemopreventive Agent Development Research Group and other DCP Research Groups; by the PREVENT Cancer Program; by regulatory support, clinical trial monitoring, and repository acquisition, formulation, and distribution personnel under contract to the DCP. This support would extend as appropriate, by investigators conducting the preclinical studies and clinical trials; by DCP program staff for analysis and planning; by NCI program review committees established following recommendations of the NCI Board of Scientific Advisors; and by other NCI staff, officials of other government agencies, and other scientists (e.g., at universities, research institutes, medical centers, pharmaceutical and other private sector collaborator sites, etc.). Sophisticated, comprehensive and multidisciplinary technical resources are required because currently the DCP senior scientists scrutinize and prioritize many candidate agents yearly for initial preclinical evaluation, continually evaluate dozens of agents in clinical development tracks at milestone decision points for further development with the objective of qualifying agents for INDs and early clinical trials, and oversee a portfolio of advanced clinical trials of potential cancer preventive agents. Additionally, advances in ?-omic? technologies, molecular modeling, and bio-informatics related to agent identification, optimization, development, and qualification for clinical testing are increasing information management requirements in order to make informed decisions and strategic planning. This contract supports DCP?s clearly defined and integrated plan for developing chemopreventive agents from discovery to the clinic.