3B-O2-1445 PDF
Pharmacodynamics biomarkers: application and considerations in clinical development
The premise of the implementation of eligible pharmacodynamics (PD) biomarkers in clinical development of drugs is based on their qualification and understanding of human disease networks on a molecular level, which may be relevant to risk factors, pathogenesis, prognosis, and relapse/remission. Especially, information on PD biomarkers characterized with drug exposure in target tissues, drug binding to target molecules, drug effect on the downstream pathway, and linkage to clinical endpoints in early drug development stage can be critical for demonstration of mode of action (MOA) and GO/NO GO decision for the next late clinical stages.
In implementation of PD biomarkers in clinical studies, we face various challenges such as biomarker qualification and method validation for biomarker analysis. Biomarkers can be classified by validity based on their clinical evidence. In contrast, for critical decision making, rigorous validation should be conducted. I would like to introduce our processes on selection of PD biomarkers in Phase II study in subjects with an immunological disease.