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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.
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