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SUMMARY
In This Issue...
Failure rates for the development of new drugs will continue to rise if basic
research findings cannot be quickly turned into valuable medicines. The result
of increasing drug failures will be a pharmaceutical industry that is
unsustainable, an industry that will not be able to refresh lean drug
development pipelines merely by pushing more preclinical projects into
development. As a result, translational medicine is one of the fastest growing
areas of drug discovery and development today. Biomarkers are at the heart of
this effort. This report looks at the modernization of the drug development
process through widespread adoption of translational studies using biomarkers.
We discuss different types of biomarkers, including the potential use of new
imaging technologies, and assess whether these changes are sufficient to
reverse the industry's productivity decline. We review two case studies on
drugs that could have benefited from having clinic-ready biomarkers and
examine what lessons can be learned. Lastly, some companies are engaged in
developing biomarkers in combination with drugs. We discuss some of these
companies, their products, and the role of the FDA in promoting such
co-development activities.
TABLE OF CONTENTS
- The Dawn of Translational Medicine
- Recent FDA Initiatives
- Uses of Biomarkers
- The FDA's Support and Direct Involvement in Improving the Development of
Medical Products
- Research Biomarkers
- Cancer Research
- Alzheimer's Disease Research
- Toxicity Biomarkers
- Pharmacogenetic Biomarkers
- The Value of Clinic-Ready Biomarkers
- Lessons to Be Learned from the COX-2 Inhibitor Rofecoxib (Vioxx)
- Lessons to Be Learned from Gefitinib (AstraZeneca's Iressa)
- Unique Challenges of Genomic Data
- The FDA's Position on Pharmacogenomic Data
- Genomic Biomarkers in the Clinic
- High Hopes for New Imaging Techniques
- Theranostics/Companion Diagnostics
- Roche Diagnostics and Lilly Cancer Drugs
- Clinical Data's Depression Drug Test
- Bristol-Myers Squibb's Commitment
- Potential Impact of Biomarker Use
- Addendum: Critical Path Opportunities List of 76 Priority Projects-March
2006
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