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Through the DCIDE program, the developer of a promising diagnostic agent or
probe will be given access to the pre-clinical development resources of the
National Cancer Institute in a manner that is intended to remove the most
common barriers between laboratory discoveries and IND status.
Through a competitive selection process, the DCIDE program may supply
assistance in any or all of the following activities:
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Steps in pre-clinical development that are necessary to convert a potential new
agent into a diagnostic drug candidate suitable for early clinical testing (IND
status) and that are generally not otherwise available to the investigators.
These steps may include pharmacokinetics, dosimetry, imaging feasibility,
IND-directed toxicology, etc.
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Regulatory affairs, so that requirements of the Food and Drug Administration
may be satisfied by any investigator who seeks Investigational New Drug status.
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Access to probes for approved pre-clinical protocols (including animal models).
The DCIDE program process will consist of two stages of evaluation. Stage 1
will be a competitive evaluation performed by a specially constituted DCIDE
Evaluation Panel, consisting of non-NCI experts from academia and industry.
This evaluation panel will provide individual opinions on the requests for
resources. This evaluation panel will include imagers with molecular imaging
expertise, molecular biologists, combinatorial chemists, radiochemists,
pharmacists, and oncologists. Criteria for the initial evaluation are stated
below. Requests for resources with sufficiently high merit scores will then
move to Stage II, where a committee of NCI staff members will evaluate the
scored requests for resources. NCI staff will select the requests for resources
that are most consistent with resources available for expedited development.
Agents that undergo successful development and testing will be maintained in a
probe library. The DCIDE library will be a source of probes that researchers
may find beneficial in basic research, including in vivo animal model imaging
studies. This resource may expand the clinical applications of the probes by
providing better understanding of mechanisms and imaging criteria. Requests for
probes for this purpose will undergo internal review at NCI to ensure study
design appropriate to the proposed objectives. The DCIDE program will either
provide agents directly or facilitate their availability. Radiotracer-labeled
probes represent a special case that will require direct source / investigator
affiliation, with NCI fulfilling mainly an informational role.
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