National Cancer Institute Cbc Program

Purpose: The NCI Chemical Biology Consortium (CBC) is a developing biotech-like venture designed to assist investigators in the development of novel cancer therapeutics. The program goal is to increase the number of early-stage drug candidates entering the NCI development pipeline by establishing a drug discovery consortium on the scale of a small biotech company. The focus of the group will be on high-risk, underrepresented areas, and in significantly advancing the discovery of novel agents against specific molecular and genetic cancer targets. The program will provide access to cutting-edge tools for iterative drug discovery, optimization, and development, including, when necessary, Phase 0 clinical trials. Project tasks are generally to be completed in collaboration with CBC investigators, NCI's Division of Cancer Treatment and Diagnosis (DCTD), the Center for Cancer Research (CCR) staff, and NCI/DTP staff and contractors, rather than through directed investigator grants. The program differs significantly from other NCI drug development programs in that eligibility for resources requires information sharing by members in a collaborative consortium (as noted under Intellectual Property below).

Website: http://dctd.cancer.gov/CurrentResearch/ChemicalBioCon-sortium.htm

Eligibility: Government, academia, and industry

Intellectual Property: All consortium members will be required to sign a good-faith Intellectual Property Agreement. This agreement details the management structure of the CBC, and provides a mechanism for cooperation and information sharing among the participants. The agreement outlines confidentiality requirements, resource and data sharing, and describes intellectual property protections under the existing statutory Bayh-Dole statutory framework. NCI will have the option to clinically develop successful compounds (new molecular entities (NMEs)) created by the CBC.

Background: The NCI has historically supported a vigorous and successful pre-clinical drug development program for identified drug candidates. The effort has focused on late-stage development leading to first-in-man studies. Within this effort, the NCI has supported, among other tasks, animal toxicology and the manufacture of both bulk drug and clinical dosage form. These specific tasks have traditionally presented a formidable monetary roadblock to many investigators and NCI's role has been to provide a bridge for academic investigators to move their agents from the lab into clinical trials. Lesser emphasis has been placed on the early discovery tasks, such as target identification and validation, lead identification, and optimization. A major goal of the CBC will be to re-invigorate NCI's early discovery effort, and establish the framework for state-of-the-art iterative drug discovery. Resource allocation for projects within the CBC will be managed as part of the integrated NExT pipeline.

Logistics: Applications to the CBC will be managed through the NExT program application (https://dctd.cancer.gov/nextapp/setUp.do), and are to be submitted electronically and will be reviewed by a panel of experts. Questions should be directed to individuals listed on the website.

Program Capabilities: The CBC program has the capability of performing a full range of standard drug discovery and development tasks, in addition to the more specialized tasks listed below.

  • HTS of compound libraries, including natural products
  • Access to a network of highly experienced medicinal chemists
  • Molecular and small-animal imaging
  • Animal modeling of targeted therapies, including pre-clinical PK and PD
  • Development and validation of PD assays to confirm drug effect on molecular target in pre-clinical studies and clinical trials conducted under an exploratory INDA, or in a traditional Phase I/II setting
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