Applications of pharmacogenomics in drug development

Reportlinker.com announces that a new market research report is available in its catalogue: Reportlinker Adds Pharmacogenomics: Delivering on the Promise

Pharmacogenomics (PGx) is often considered "the great new wave" in medicine, promising better, safer, and more affordable healthcare. Yet its adoption and widespread use in the clinic is up against some tremendous challenges. This report considers:

• Drivers of PGx
• Applications of PGx in drug development
• Industry experiences with PGx and lessons learned
• Type of evidence needed to establish clinical utility
• Challenges to moving PGx forward
• Survey results and expert views on utilization of PGx

Pharmacogenomics: Delivering on the Promise explores the pharmacogenomic (PGx) realm of personalized medicine, analyzing current R&D and market trends related to the use of genetic information to predict how well patients will respond to certain drugs. Pharmacogenomics is an extremely difficult business, one for which there are no easy answers. Even companies manufacturing and marketing already successful pharmacogenomic drug-test combinations continue to face difficulties. This report examines how these and other companies have (or are) navigating through the scientific, statistical/experimental design, and "clinical utility" landscape of PGx.

Not the least of the challenges facing pharmacogenomics is scientific. Separating a consistent, predictive association between a SNP or other genetic marker and a drug response phenotype from all the other variables that play into drug response can be next to impossible. Once candidate associations are identified, knowing how to design clinical trials capable of teasing out these associations in the clinic and aligning those trials in preparation for regulatory review create another set of challenges. Pharmacogenomics: Delivering on the Promise considers prospective versus retrospective clinical trial design and when, if ever, the FDA might allow the latter for regulatory decision-making purposes.