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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 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. Molecular structure of aminoflavone prodrug (NSC 710464). An IND application was filed with the FDA in early 2006 for this DTP-produced drug. D E V E L O P M E N T A L T H E R A P E U T I C S P R O G R A M ■ 103
C U R R E N T F U N D I N G O P P O R T U N I T I E S The Grants and Contracts Operations Branch at DTP uses a variety of support mechanisms to increase the rate of discovery of new compounds and new approaches to speed their development as cancer therapeutics and bring them to the clinic. 104 ■ P R O G R A M A C C O M P L I S H M E N T S 2 0 0 6 Open Program Announcement for Drug Development: Small Business Innovation Research/Small Business Technology Transfer Program Announcement: PA-06-120: http://grants.nih.gov/grants/guide/ pa-files/PA-06-120.html (expiration date 1/3/2007) Contact: Ted Williams 301-496-8785, tw133b@nih.gov By funding partnerships between small pharmaceutical companies and nonprofit research institutions, the Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) program gives drugs with potential their best commercial chance. This grant-making program supports research that has commercialization potential. Research funded by this mechanism must be a cooperative project between small business and a research institution. Review criteria for support emphasize innovation and the potential for commercialization.
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National Cancer Institute U.S. DEPA
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Clinical trials performed using an
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Dr. James H. Doroshow, Director Jam
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Cancer Diagnosis Program Dr. Sheila
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