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A significant number of promising diagnostic imaging agents are not available
for use in clinical trials. Many of these agents could enhance clinical
medicine, either by providing a measure of response to chemopreventive
interventions or therapy or by serving as surrogate endpoints to preventive
measures or therapy. Multiple barriers inhibit successful development, but two
of the most important are (1) uncertain economic potential that prohibits
access to necessary resources and (2) lack of knowledge of clinical and
regulatory requirements. These barriers have become more obvious as
interdisciplinary boundaries have expanded to include technical researchers
such as combinatorial chemists and bioengineers.
Although researchers in an academic medical environment may have access to
necessary resources for product development, others may have little or no
access to such resources. Even among those with academic medical affiliation,
competing needs for increasingly limited resources may prohibit development of
a promising new agent. At the same time, advances in genomics and molecular
biology have changed the nature of new diagnostic enhancers and molecular
imaging probes. The emphasis on highly specific molecular targets and processes
has led to products with increased complexity and higher costs of development
but smaller market potential.
This trend has effectively created a large class of "orphan-like" agents, which
investors consider too risky for further development yet may have the potential
to impact diagnosis and treatment significantly. This particular barrier
applies not only to academia and small business but also to large businesses,
where there may be significant numbers of potential diagnostic agents that do
undergo further development for the commercial market.
The DCIDE program is intended to supply or enable missing steps so that
promising discoveries may be translated to the clinical research environment
despite the absence of development capacity, clinical connections, or industry
interest. The DCIDE program will focus on promising diagnostic agents that are
not otherwise likely to undergo adequate pre-clinical testing to warrant an IND
application.
The DCIDE program is not intended to provide full-scale clinical development
but will facilitate the performance of pre-clinical evaluation to establish
proof of principle of a compelling hypothesis. Once this is accomplished for
specific products, it is anticipated that clinical development will continue
along established mechanisms under the sponsorship of either private companies
or the National Cancer Institute.
The DCIDE program is not intended as competition for private industry;
investigators intending to license discoveries to companies should not be
deterred from doing so by the existence of a successful DCIDE program. Also it
does not seem likely that companies interested in licensing an academic
discovery will wish to risk loss of the opportunity by allowing the compound to
go through the DCIDE program process first. It does, however, seem likely that
the DCIDE program will add value to discoveries that are initially regarded by
companies as problematic and will make these discoveries more attractive
licensing candidates for industries.
To optimize the return from resources devoted to the program, developed probes
will be maintained in a Translational Probe Library. This library will
facilitate accessibility of housed probes for clinical trials groups or
investigators as well as for pre-clinical researchers interested in in vivo
imaging studies, including proof-of-principle animal model studies.
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