The Impact of Genomics on Clinical Trials - Biologics Market Research

The Impact of Genomics on Clinical Trials
CHA Advances Reports
Feb 2006
Pages: 125
Price: EUR? 3,745.00
The Impact of Genomics on Clinical Trials and Medical Practice evaluates the potential of clinical genomics to transform drug development and the practice of medicine. The report projects significant growth opportunities in this field, balanced with a realistic assessment of the challenges and hurdles to bringing clinical genomics to mainstream medicine.
Clinical genomics is the application of large-scale, high-throughput genomics technologies in clinical settings, such as clinical trials or primary care of patients. Clinical genomics promises to allow a molecular understanding of disease and drug response, with benefits in all areas of medicine.
Contributing to the growth of genomics, in 2005 the FDA issued guidelines for applications of genomics in drug development, with the stated hope that genomics will improve the safety and effectiveness of medicines. Given this mandate, clinical genomics applications appear to have crossed a threshold with the recent approval of several clinical genomics products. These approvals are expected to provide important precedents for other product approvals in the near future.
Examples reviewed in the report include the following:
- Affymetrix's AmpliChip Cytochrome P450 Genotyping Test: In 2004 this test, a DNA chip that identifies variations in two genes affecting response to a wide variety of drugs, became the first microarray approved for treatment decisions by the FDA.
- Third Wave Technologies' Invader UGT1A1 Test: This test for detecting heightened risk of adverse reaction to the chemotherapy drug irinotecan was FDA-approved in 2005 as the first pharmacogenetic companion diagnostic paired with a specific drug therapy.
Genomics applications in clinical trials are also dramatically rising. It is now estimated that about 20% of U.S. clinical trials use some sort of genomics approach, with the highest percentage in oncology trials. While this trend is expected to accelerate during the next few years, the field still faces considerable regulatory, technical, economic, and sociological hurdles. The full promise of clinical genomics applications may not be fully realized for at least another ten to fifteen years. However, as genomics transitions away from primarily research to more clinical applications, the field will be ripe with business opportunities and the report examines some of the business and strategic factors relevant to the further adoption of genomics technologies in clinical trials and medical practice.
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.