How Are Translational Medicine Biomarkers Impacting Industry?

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