The Role of Pharmacogenomics in Personalized Medicine
Decision Resources, Inc, June 2006, Pages: 28
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.
Business Implications·
Pharmacogenomics is used to determine how genomic variations modify the behavior of drugs. It is increasingly included in regulatory submissions for drug approvals. In 2005, all of the major regulatory authorities published guidelines to formally address the use of such data in new drug submissions. Although the guidelines are now voluntary, they will likely become mandatory in the near future. Patient stratification based on genomics data should lead to smaller late-stage trials that will fail less often and cost less, thereby reducing the overall cost of late-stage clinical development. However, preclinical and early-stage development costs may increase as a result of the cost of designing gene-based assays and then using these assays to screen and select patients for inclusion in later clinical trials. Pharmacogenomics will therefore shift costs to earlier stages of drug development, a move that should not be a burden on big pharma but could put a burden on smaller companies. The public has reservations about the use of pharmacogenomics, especially as it relates to privacy, health insurance coverage, and access to genetic data. On the other hand, health care payers could benefit significantly if expensive procedures are prescribed only for patients who can benefit from them. From an industry perspective, the application of pharmacogenomics is expected to have a negative impact on potential revenues of new products as a result of market segmentation. Many more new chemical entities will need to be developed, a requirement that will strain available resources. However, as products such as the breast cancer therapy trastuzumab (Genentech/Roche’s Herceptin) demonstrate, some pharmacogenomics-based products may still become blockbuster drugs. As pharmacogenomics testing and personalized medicine become more prevalent, the revenue growth rate of major pharmaceutical companies may initially slow. The ability of these companies to produce products using pharmacogenomics will depend, in large part, on their strategies for codeveloping diagnostic tests with therapeutic drugs, with or without a diagnostics partner.
- 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
List of Figures & Tables
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%
Companies Mentioned Include:
- Genome Express
- Icoria
- Electa Lab
- Pfizer
- Roche
- Millennium
- NIAID
- Merck
- Bayer Healthcare
- Genaissance Pharmaceuticals
Customers who bought this item also bought
All rights reserved. © Copyright 2013 Research and Markets WWW4
Terms and Conditions Privacy Policy Publishers Employment Opportunities Site Map Link to us Webmaster Affiliate Network
