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

Clinical trials performed using an exploratory
investigational new drug (IND) will
facilitate targeted therapies entering
early phase evaluation where the target
can be carefully monitored. The goal of
this new guidance is to safely shorten the
timeline for drug development. As part of
the DCTD-CCR collaboration, novel agents
for high-priority targets originating from
academic and other extramural researchers
will be eligible to take advantage of
intramural resources.
Exploratory IND studies are ideal, as
well, for imaging and other advanced
technology applications aimed at developing
clinically relevant assays of biomarkers
that could help predict whether
later-stage trials are likely to be successful.
Biomarker assays can also assess the efficacy,
mechanism of action, and toxicity
of promising treatments. DCTD is also
improving its capabilities to develop
and validate pharmacodynamic markers.
The division is developing standardized
operating procedures for handling human
tissue specimens and for pharmacodynamic
assays. One major goal of this
program is to incorporate molecular
imaging techniques routinely into early
therapeutics development; in particular,
there will be a special emphasis on the
development of novel imaging probes
for monitoring new drug targeting to
tumors and for determining the therapeutic
benefit of the targeted therapy.
The goal is to produce a diverse portfolio
of pharmacodynamic assays and imaging
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The implementation of CTWG initiatives, modernization and
integration of cancer therapeutics development, and expansion of
the pipeline of potential cancer therapies underscore NCI’s position
as a premier developer of novel cancer therapeutics and diagnostics.
tools that are in the public domain. These
complex tasks are time-consuming and
expensive, and NCI is well suited to take
on this enterprise. It is anticipated that
this investment will reap many benefits
by making a library of new molecular tools
available to all researchers in the cancer
research community to assess new
targeted drugs and diagnostics.
These efforts also support an NCI-wide
priority to better integrate preclinical
and clinical research. In addition to partnering
with intramural researchers in CCR,
DCTD is working to link preclinical and
clinical resources seamlessly within the
division. This will support extramural trials
of targeted therapies and foster better
assimilation of molecular imaging and
radiation techniques into therapeutics
development. Teams of experts across
NCI will unite to form integrated drug
development teams. A joint CCR-DCTD
drug development committee will oversee
these teams, determine resource
priorities, assess agent progress, identify
gaps in the portfolio particularly suited
to NCI drug development efforts, and
evaluate new compounds for inclusion
in the pipeline.
The steps being taken to implement the
CTWG initiatives, modernize and integrate
cancer therapeutics development using
the exploratory IND and other approaches,
and expand the pipeline of potential cancer
therapies underscore NCI’s position as
a premier developer of novel cancer therapeutics
and diagnostics.