National Cancer Institute - NCI Division of Cancer Treatment and ...

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