Manufacture of Bulk Chemical and Bulk Pharmaceutical Ingredients

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The Developmental Therapeutic Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) conducts development of agents with anticancer activity. The agents arise from a variety of peer-reviewed sources via many mechanisms such as NCI Experimental Therapeutics (NExT), Drug Development Group (DDG), and Rapid Access to NCI Discovery Resources (RAND). In addition, development projects could arise from Development of Clinical Imaging Agents and Enhancers (DCIDE) program, Division of Chemoprevention (DCP) program, Type-1 Diabetes RAID program (T1D-RAID), and NIH Rapid Access to Intervention Development (NIH-RAID) program. The NCI intramural program has also been a source of compounds for development. The contractor provides services to manufacture a variety of the selected bulk compounds in multi-gram and/or kilogram scale. The prepared bulk material is to be used for preclinical toxicity studies, preformulation and clinical trials for the various cancer indications. Technical reports submitted by the contractors may be used to support Investigational New Drug Applications (IND) submitted to the US Food and Drug Administration (FDA). Contracts have been chosen as instruments to accomplish the goals of cancer drug development at the NCI.