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The Role of Pharmacogenomics in Personalized Medicine

Published by: Decision Resources

Published: Jun. 30, 2006 - 28 Pages

The price of this report has been reduced due to its age. The original price was $2,025 for PDF.

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

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.

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