Biomarkers are utilized in all stages of drug development
Imaging techniques enable highly sensitive and quantitative analysis of morphology and function in the living tissues, such as brain, heart and kidneys. As imaging can also provide useful insights for translational research from non-clinical to clinical study, it is noticed as an innovative technology that increases the success rate of drug development. To determine the optimal dosage of new drugs and assess drug efficacy, we are studying on the measurement of receptor occupancy by Positron Emission Tomography (PET, upper right figure) and evaluation of brain neural network by Magnetic Resonance Imaging (MRI, lower right figure). In addition, imaging technique is useful tools to evaluate the validity of drug discovery targets and identify the right patients, because it can be performed on living humans.
Molecular biomarkers are extremely useful in facilitating development and research of new pharmaceutical drugs. Molecular biomarkers, such as proteins, genes, and metabolites, help in understanding the changes in a living body caused by pharmaceutical drug administration and pathological conditions. Therefore, molecular biomarkers can promote the appropriate use of pharmaceutical drugs. We are conducting research to explore new biomarker molecules and validate known molecules. We aim to (1) select patients appropriately to maximize the value of pharmaceutical drugs and (2) improve the efficiency and success probability of clinical development (clinical trials). For example, we are conducting research on biomarkers for efficacy prediction based on the mechanism of action as a life cycle management (LCM: Initiatives for long-term effective use of launched drugs) study of Pirespa® (generic name: pirfenidone), a therapeutic drug for idiopathic pulmonary fibrosis (IPF).