オーダーメイド医療（個別化医療）におけるファーマコゲノミクスの役割

Abstract

The pharmaceutical industry is very gradually moving away from the blockbuster model of drug development to a model whereby medicines are designed to treat the specific patient, not the population as a whole. This trend is known as personalized medicine. Pharmacogenomics, which determines how genomic variations in people modify the behavior of drugs, will facilitate the development of personalized medicine. In this report, we examine how the use of pharmacogenomics will affect today's drug development strategies. We discuss many of the economic considerations now facing the industry in deciding whether or not to embrace pharmacogenomics in personalized medicine. Our Spectrum Expert Commentary addresses the attitudes of Americans on these issues.

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