Contact:
Mary K. Wolpert, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Telephone: (301) -496-8783
E-mail: wolpertm@exchange.nih.gov

Objective:

The goal is to establish National Cooperative Drug Discovery Groups, which are defined as partnerships between NCI, academia, nonprofit organizations and industry for the discovery of new and more effective anticancer treatments. The participation of industry is encouraged (but not required) through cost-sharing arrangements since early interactions with industry can shorten the time for subsequent development and marketing of new agents. The role of NCI is to facilitate but not direct studies. NCDDGs are funded as cooperative agreements (U19s) and support a multidisciplinary team approach to the discovery of new, rationally based or natural-source derived anticancer treatments or strategies. The term "treatment" is used broadly to cover small, synthetic molecules, complex natural products, or biologicals, such as gene therapy, vaccines and monoclonal antibodies. "Strategies" may include novel drug delivery techniques to increase specificity and reduce toxicity of proposed treatments.

Description:

This solicitation represents a reissuance of RFA CA-99-010 that was published in the NIH Guide on April 14, 1999. The NCDDG program, which was created in 1982, has a track record of success in bringing new agents and strategies to clinical trial and eventual marketing. Multidisciplinary and usually multi-institutional Groups are formed under the direction of a Principal Investigator who provides conceptual leadership and ensures Group cohesiveness. Both new and incumbent Groups are encouraged to apply. Each Group may have three to five non-overlapping, complementary projects that work together synergistically in the creation of new treatment entities or strategies. Cores that provide support functions to projects may also be included and must serve at least two projects. Each Group is free to define their own approach to drug discovery and each project within a Group must contribute to the overall goal of drug discovery. Intensive research in cancer biology has yielded a wealth of information on the nature of cancer cells and potential new targets and points of vulnerability in numerous processes, including signal transduction, cell cycle control, and metastasis. New research tools and technologies have also emerged which lead to greater insights and provide enhanced speed and efficiency in the drug discovery process. Timely clinical evaluation of products discovered on NCDDGs is encouraged; however, advanced development activities such as large-scale production for clinical trials, toxicology in support of Investigational New Drug Applications, or pilot clinical trials are beyond the scope of the initiative. These latter activities may be supported by industry, other government programs, or private venture capital.