Biomarker research for drug development

Yoshiya Oda

Eisai Co. Ltd.

Pharmaceutical industry is now facing very difficult situation to create new products. Therefore pharmaceutical industry has to enhance the efficiency and the productivity under limited resources. The highest success probability of drug development is probably infection disease area, because they have relatively easy diagnostics and very clear quantitative biomarkers (counting bacteria, amount of virus etc) during drug development. Neurology is located in opposite site because of lack of good models and less reliable diagnostics. Translation research may be able to change current drug development styles. When appropriate biomarkers are applied to drug development, all process may become smoother. Biomarkers play several roles in drug development to confirm target engagement of drug candidates, to determine right dose, to select right patients and to supply right medication. Pharmacodynamics (PD) is the study of the biochemical and physiological effects of drugs on the body by interacting drugs with the target molecules. PD is deeply related with mode-of-action of drug candidates, therefore PD biomarkers can achieve proof-of-mechanism (POM). Recent progress of disease etiology has provided sub-category of the disease. It is now highly important to identify right patient population among several disease sub-categories to increase response rate of the drug candidates and reduce number of subjects in clinical studies. Patient stratification is expected to increase the success rate and accelerate product creation, and leads patients toward personalized medicine era. Response/efficacy markers can be detected in early clinical study to increase confidence of projects, and can also encourage patients to continue taking right medicine. Biomarkers are also keys to diagnose disease and monitor disease situation. Several biomarker examples are discussed.

Address correspondence to Yoshiya Oda, Eisai Co. Ltd. (4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan)