Daiichi-Sankyo Pharma Development, USA
The role of biomarkers has been increasing in guiding decisions in every phase of drug development; from drug discovery to post-marketing. In addition to using of biomarkers to assess patients safety, as an efficacy indicator and in POC & POM, biomarkers can predict patients response to a compound by identifying certain patient populations that are more likely to respond to the drug therapy or to avoid specific adverse events. This shift toward personalized medicine can help the drug industry achieve the goal of cost-effective and faster research, especially in poorly served areas such as neurodegenerative disorders and cancer. Although biomarkers can be an effective tool to enhance probability of success in drug development, without good understating of its limitations, it can be just hype. There are a lot of analytical and pre-analytical limitations need to be addressed. This talk will highlight the following topics: 1.Biomarkers and their potential utility in drug development. 2. Limitations. 3. Possible mitigation of some issues.