U.S. National Institutes of Health

Drug Development Group— for Academics and Industry

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

Contact:
Office of the 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 the pharmaceutical industry, where the originators are certain at the outset that NCI should hold any resulting IND and manage any subsequent clinical trials. 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 will be 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, except that the Biological Resources Branch Oversight Committee (BRB-OC) 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.