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Clinical Genomics: The Impact of Genomic Technology on Clinical Trials and Medical Practice assesses the challenges and future prospects for incorporating genomics technologies into standard clinical practice. The report examines some of the ways in which genomics could directly contribute to clinical practice, evaluates the scientific, technological, legal, and regulatory issues that will have a significant impact on the future adoption of genomics in clinical settings, and discusses the emerging business opportunities that will arise as the widespread application of genomics to clinical drug development, diagnostics, and medical practice comes to fruition. Recent events suggest that genomics may finally be poised to make a significant contribution to clinical practice in the near future. In 2003, the Human Genome Project completed the sequence of all human genetic material, providing an essentially complete catalogue of all human genes. Since the practice of genomics relies on large-scale, comprehensive analyses of genes, this information will prove very valuable in speeding the implementation of genomics in clinical settings. Furthermore, the U.S. federal government is emerging as a driving force for the adoption of genomics in clinical settings. In 2003, two major U.S. federal agencies issued reports indicating that implementation of genomics in the clinic is of high priority. The National Institutes of Health (NIH) issued a vision statement summarizing how genomics can contribute to the future of the practice of medicine. The U.S. Food and Drug Administration (FDA) issued draft guidelines for the submission of genomic data in drug applications, signifying a potentially pivotal change in the use of genomics in drug development. The clinical genomics environment is ripe with opportunities for all players in the field, pharmaceutical companies, biotech firms, diagnostics manufacturers, tool suppliers, and researchers, as the NIH and FDA make it clear that increased use of genomics in the practice of medicine and drug development is both anticipated and encouraged. However, clinical genomics is far from widespread and still faces significant hurdles. Clinical Genomics: The Impact of Genomic Technology on Clinical Trials and Medical Practice examine the most important factors that will impact the transition towards more extensive adoption of genomics technologies in clinical trials and medical practice. This report offers critical strategic guidance to all companies participating in the application of genomics to the prediction, detection, and diagnosis, and treatment of disease. Critical Issues in Clinical Genomics Are Presented in This New Study: > Clinical genomics applications for predicting a patient's response to drugs, improving clinical trials, and better drug design. > The impact of new FDA guidelines on pharmacogenomics and the submission of genomic data. > Biological, technological, economic, and sociological hurdles to incorporating genomics in the clinical setting. > The expanding business and market opportunities in the field in areas such as toxicogenomics, oncology, infectious disease, and identity screening. About the Author Gwen Acton, Ph.D., is president of Vivo Group, a consulting firm specializing in evaluation and management of genomics and life science technology. Prior to this, Dr. Acton served as Director of Scientific Development at the Whitehead Institute for Biomedical Research, and ran the operations of the Functional Genomics Program at the Whitehead Institute/M.I.T. Center for Genome Research. Dr. Acton received a doctorate in molecular biology and genetics from M.I.T. and served as a faculty member at Harvard University in the Department of Molecular and Cellular Biology. Report #37 Publishing in April 2004 by Cambridge Healthtech, est. 100 pages. Publisher: Cambridge Healthtech Advisors To order go to this URL: http://www.bioportfolio.com/cgi-bin/acatalog/Cambridge_Healthtech_Advisors.html#a497
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