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.