Abstract
Introduction
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
- .
- 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
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