Imaging Biomarkers and the Future of Radiology

Two important observations made by both government and the pharmaceutical industry are that the pipeline for the development of new drugs for the treatment of a variety of diseases is shrinking and that the costs of such developments are escalating at an alarming pace [ 1 US Food and Drug Administration. Challenge and opportunity on the critical path to new medical products. Available at: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html. Google Scholar , 2 Smith J.J. Sorensen G. Thrall J.H. Biomarkers in imaging realizing radiology’s future. Radiology. 2003; 227: 633-638 Crossref PubMed Scopus (132) Google Scholar , 3 Kelloff G.J. Sigman C.C. New science-based endpoints to accelerate oncology drug development. Eur J Cancer. 2005; 41: 491-501 Abstract Full Text Full Text PDF PubMed Scopus (77) Google Scholar , 4 Seddon B.M. Workman P. The role of functional and molecular imaging in cancer drug discovery and development. Br J Radiol. 2003; 76: 128-138 Crossref Scopus (72) Google Scholar ]. The causes of the slowdown in drug development are perplexing in that there are multiple breakthroughs in basic science through the study of genomics, proteomics, and metabonomics, but these advances are not propagated or translated into new drugs for therapy. In other words, new technology discovery is advancing rapidly, but technology development is lagging. An example of this lag is in the effort to define the safety and efficacy of drugs. When adverse findings are found late in development, a drug is immediately eliminated from consideration, at a great loss of time and money. Tools are needed to define these issues earlier in the development cycle. Further along in the cycle, at the time of clinical trials, overall survival is a classical endpoint in determining clinical benefit. The difficulty is that this endpoint is not disease or patient specific and is very costly because of the large number of participants needed for study over long time periods to have a valid trial [ 3 Kelloff G.J. Sigman C.C. New science-based endpoints to accelerate oncology drug development. Eur J Cancer. 2005; 41: 491-501 Abstract Full Text Full Text PDF PubMed Scopus (77) Google Scholar , 4 Seddon B.M. Workman P. The role of functional and molecular imaging in cancer drug discovery and development. Br J Radiol. 2003; 76: 128-138 Crossref Scopus (72) Google Scholar ].