Expanding Applications of Personalized Medicine: Use of biomarkers in prognostic, predictive and pharmacogenetic tests in a targeted approach

Over the past decade, several significant advances in targeted therapies have improved the ability to treat certain cancers, the most notable early successes been trastuzumab in breast cancer and imatinib in chronic myelogenous leukemia. Recently, several important breakthroughs have occurred, including the identification of a mechanism of resistance to EGFR monoclonal antibodies in colorectal cancer, which may be followed by further predictive tests leading to a reduction in the use of ineffective therapies.

‘Expanding Applications of Personalized Medicine’ is a report published by Business Insights that provides an in-depth analysis of current applications in personalized medicine, and highlights future opportunities and clinical advances. Ongoing research into predictive biomarkers of resistance/efficacy and how they will optimize treatment and improve patient outcomes are explored. This report provides a unique summary of ongoing clinical trials incorporating personalized medicine approaches, based on an analysis of over 6,000 clinical studies. Although investment in personalized medicine is beginning to show valuable results, its integration into routine clinical practice has been slow and it currently does not impact the care of the vast majority of patients. To widen the benefits of personalized medicine over the next ten years, several obstacles need to be overcome, including increased regulatory burden, lack of reimbursement, demonstration of clinical utility and integration into drug development.


Key findings

• Clinical trials using predictive biomarkers are on the rise. 2009 has seen a ten-fold increase in the number of clinical trial using predictive biomarkers since 2005.

• There are approximately 5,000 industry-sponsored active clinical trials. These include Phase I, II or III, and around two million participants

• Pharma companies may be selecting targets that are least sensitive to genetic variation. only those compounds that are likely to be effective in the general population will progress into late-stage development, sustaining the "blockbuster" business model.

• The major barrier to the wider implementation of personalized medicine is increasingly related to economic, rather than scientific issues, with diagnostic companies facing development times and costs comparable to pharmaceuticals
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• Oncotype DX is the most commercially successful genomic based prognostic test to date. Genomic Health has invested around $84 million in R&D and just over $130 million on sales and marketing since 2004.


Use this report to

• Understand the driving forces shaping personalized medicine and how this will impact the current "blockbuster" business model


• Identify novel prognostic tests in development that may result in more accurate and objective prognosis, improving risk assessment in the treatment planning

• Recognize the major barriers to personalized medicine, including economic challenges and levels of evidence required to gain insurance coverage

• Understand how companies are integrating novel predictive markers of resistance/efficacy into the drug development process

• Develop strategies to optimize your portfolio and identify new areas for market entry