The Role of Pharmacogenomics in Personalized Medicine

Table of Contents

• Contents The Personalization of Medicine
• Pharmacogenomics
  • Defined
  • Drug Efficacy
  • Bronchodilators
  • Gefitinib and Erlotinib
  • Trastuzumab
  • Drug Metabolism
• The Economics of Personalized
  • Medicine
  • Pharmacogenomics' Impact on Clinical Trial Costs
  • Case History: deCODE Genetics' Use of Pharmacogenomics in Heart Attack Trials
  • Pharmacogenomics' Impact on Drug Revenues and Markets
  • Pharmacogenomics' Impact on the Blockbuster Model of Drug Development
  • Pharmacogenomics' Impact on Other Commercial Strategies
• Case Study: Treatment of Ten Hypothetical Patients With and Without Pharmacogenomic
  • Testing
  • Recent Pharmacogenomic Deals and Alliances
  • Regulatory Initiatives to Support the Use of Pharmacogenomics in Drug Development
  • United States
• Americans' Attitudes Toward Pharmacogenomics and Personalized Medicine
  • Europe
  • Japan
  • Outlook
  • The Public's Perspective
  • Pricing and Reimbursement
  • Development of Diagnostic Tests

• Figure 1 Application of Pharmacogenomics and Effects on Drug Responses
• Figure 2 Potential Impact of Pharmacogenomics on Drug Revenues, Gains, and Losses Figure 3 Maintaining Revenues in a Pharmacogenomic Era
• Figure 4 Pharmacogenomics: Potential Effect on Drug Development Costs
• Figure 5 Rapidly Increasing Use of Pharmacogenomics Information in New Drug Labels, 1945-2005
• Figure 6 Worldwide Projected Sales of Trastuzumab (Herceptin), 2005-2010 (millions of U.S. dollars)
• Table 1 Lowering Clinical Development Costs Using Pharmacogenomics: Potential to Reduce Costs by 25-45%
• Table 2 Diagnosis and Treatment Revenues for Ten Patients With and Without Genomic Testing
• Table 3 Clinical Data's Acquisitions in the Fields of Pharmacogenomics and Molecular Diagnostics, 2005-2006
• Table 4 Gene Logic: Select Pharmacogenomics Collaborations
• Table 5 deCODE Genetics: Select Pharmacogenomic Collaborations
• Table 6 FDA Guidance for Pharmacogenomic Data Submissions, March 2005