展開医療用バイオマーカーが業界に及ぼす影響

Abstract

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