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

Developmental Therapeutics
Project Management Office
Compounds entering the joint early therapeutics
development program will be managed
by project teams with members from
both DCTD and CCR. A new Developmental
Therapeutics Project Management Office
will employ a business-focused approach
for tracking the advancement of agents
from discovery through completion.
The office will track compounds in exploratory
IND studies as well as those targeted
therapies being supported by collaborations
between DTP and the DCTD Cancer
Therapy Evaluation Program (CTEP).
Establishment of a National Clinical
Target Validation Laboratory
To address the mechanistic gap that
occurs because of difficulties in determining
the effect of a therapeutic intervention
on its putative site of action in patients,
in 2005, the DTP Toxicology and Pharmacology
Branch was expanded to include
NCTVL. This laboratory will elucidate novel
methodologies in target tissues specifically
applicable to human cancer clinical
trials. These methodologies will demonstrate
the therapeutic effects of small molecule
anticancer agents on specific cellular
pathways of interest. The advantages of
this crucial endeavor, which will utilize the
unparalleled resources of NCI to provide
an essential support mechanism for the
Institute’s national therapeutics development
effort, are:
■ Provision directly to the intramural and
extramural cancer therapeutics and
■ ■ ■
The expansion of the DTP Toxicology and Pharmacology Branch
to include a National Clinical Target Validation Laboratory
will provide an essential support mechanism for the Institute’s
national therapeutics development effort.
cancer prevention communities of
a resource to develop and perform
validated procedures on tumor or
surrogate tissues for the evaluation
of molecularly targeted therapies.
These procedures will be exported to
the extramural cancer clinical research
community as part of NCI’s current early
therapeutics development program, as
well as to the NCI’s intramural program,
speeding the completion of translational
clinical investigations nationwide.
NCTVL will utilize small and difficult-toobtain
patient specimens, in advance
of patient entry into clinical trials, to
develop quality-controlled methodologies
for correlative clinical investigations
essential to the evaluation of therapeutics
efficacy. The laboratory will serve a
central core function, performing target
validation assays for patients treated
within CCR as well as for patient samples
from NCI-funded extramural investigators
lacking the expertise or facilities to
perform such assays.
■ Development of procedures allowing
extramural investigators with ongoing
clinical trials that are part of the current
NCI-funded phase I and II program,
Cancer Centers, Specialized Programs
of Research Excellence (SPOREs), or the
cooperative groups to utilize NCI laboratory
or clinical resources for the evaluation
of molecular targets critical to the
completion of their studies. Investigators
will access resources through direct
patient referral to CCR or by obtaining
DCTD support for the development of
correlative laboratory procedures for
their own investigations.
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 ■ 99