On February 20-21, 2017, the Critical Path Institute's Predictive Safety Testing Consortium (PSTC), the RIKEN Institute, National Institute of Health Sciences, Japan Pharmaceutical Manufacturers' Association, and the Japan Society of Toxicology will collaboratively hold the Japan Safety Biomarker Workshop at the RIKEN Institute, in Yokohama, Japan.
This two-day conference assembles leading scientists and researchers from industry and academia, and government regulatory authorities, and provides a unique opportunity to gain perspective on biomarker development and application of biomarkers in preclinical and clinical research. Topics to be covered include an overview of biomarkers in drug development, application of biomarkers in clinical use, and biomarker qualification.
The objective of the conference is to engage scientific and regulatory scientists in Japan for the qualification of biomarkers. The conference format is designed to elicit participant feedback on biomarker qualification and identify areas for synergy across the pharmaceutical industry and academia.
PSTC is a unique, public-private partnership that brings pharmaceutical companies together to share, validate, and qualify safety testing methods under the advisement of worldwide regulatory agencies, including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the PMDA.
PSTC's primary goal is the qualification of novel translational safety biomarkers for use in early clinical drug development trials.