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U.S. National Institutes of Health
Cancer Diagnosis Program Cancer Imaging Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Radiation Research Program Translational Research Program Biometric Research Branch Office of Cancer Complementary and Alternative Medicine
Last Updated: 04/25/2012

MAJOR ONGOING INITIATIVES

Drug Development Initiatives

Rapid Access to Intervention Development — for Academics

http://dtp.nci.nih.gov/docs/raid/raid_index.html

Contact:

Coordinator, RAID Program
301-496-8720, raid@dtpax2.ncifcrf.gov

Translating promising target-directed compounds into drugs for human use is an exacting task that requires very specific, interrelated activities. NCI supports this critical arm of drug development through a variety of initiatives, including DTP’s Rapid Access to Intervention Development (RAID) program.

RAID provides preclinical drug and biologic development resources to academic investigators who want to conduct their own clinical trials. Once an optimal compound is selected via R·A·N·Dor another discovery path, RAID facilitates further preclinical development.

Since its inception in 1998, the RAID program has approved 126 projects, through which 15 small molecules and 17 biologic agents later entered clinical trials.

The goal of RAID is to provide clinical proof-of-principle that a new molecule or approach is a viable candidate for expanded clinical evaluation. Tasks supported by RAID include:

  • Large-scale synthesis and formulation
  • Pharmacology and toxicology
  • In vivo screening
  • Developmental tasks necessary to translate discoveries to the clinic
  • Regulatory affairs, so that FDA requirements are likely to be satisfied by participating investigators seeking to test new molecular entities in the clinic

RAID is not a mechanism for obtaining grants. To access the services of the RAID program, academic researchers may submit applications twice yearly—February 1 and August 1. Submissions are reviewed by a panel of extramural experts who assess the strength of hypothesis, scientific novelty, and cost-benefit ratio of the project. Once a project is accepted, DTP provides drug development resources free of charge. The output of RAID activities will be both products and information made fully available to the originating investigator for support of an IND application and clinical trials.

Drug Development Group — for Academics and Industry

http://dtp.nci.nih.gov/docs/ddg/ddg_descript.html

Contact:

Office of the DTP Associate Director
301-496-8720, ddg@dtpax2.ncifcrf.gov

The Drug Development Group (DDG) meets monthly to consider developing drugs from discoveries in the NCI intramural and extramural academic communities, as well as with the pharmaceutical industry, where successful development leads to an NCI-sponsored clinical trial. By contrast, the products of the RAID program will, in general, be returned directly to the originating investigator for clinical trials.

Compounds at all stages of development are considered on an individual basis. The DDG is responsible for oversight and for preclinical and clinical decision-making at the key “go–no go” decision points. The DDG prioritizes use of DCTD resources supporting preclinical development by DTP and clinical development by CTEP, (one exception is that the Biological Resources Branch Oversight Committee governs acquisition and production of biologics approved by DDG).

Initial presentation of an agent to the DDG requires an identified CTEP or DTP staff member to act as liaison. The NCI liaison coordinates with the originator, who supplies an application summarizing the tasks and support specifically being requested.

In 2005, aminoflavone prodrug (NSC 710464), produced by DTP, was one of the drugs that successfully made it through development under the auspices of the DDG, with an IND application filed with the FDA in early 2006. This drug may kill tumor cells without destroying bone marrow or having other toxic effects.