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[V6-S4] New Drug Development Approaches to Realize Precision Medicine (Registry Study, Platform Trial)
Session Chair(s)
Akihiro Hirakawa, PHD
Professor, Department of Clinical Biostatistics, Institute of Science Tokyo, Japan
Precision Medicine, which provides optimal treatment for each disease subtype, has been proposed from the viewpoint of providing appropriate treatment individually tailored and patients first. In a conventional clinical trial, basically, a single study treatment / group / disease is a subject, and a more efficient approach is required to evaluate multiple treatment candidates for each more detailed subtype. In this session, new approaches in Japan and overseas in therapeutic areas such as oncology, neuroscience, etc, will be introduced about implementation of disease registry including Master Key Project in Japan, new designs using the Bayesian statistics such as Platform design, consortium building, etc. and will be discussed future directions and challenges.
Speaker(s)
Platform Trial in Neuroscience
Senior Director, Global Head of Clinical Biostatistics for Neuroscience, Janssen R&D, Johnson & Johnson, United States
MASTER KEY Project – a Basket/Umbrella Trial and a Registry Study for Rare Cancers in Japan
Head, International Research and Development Section, National Cancer Center Hospital, Japan
Regulatory perspectives: Current state of Development of Oncology Drugs on Precision Medicine in Japan
Head of Epidemiology, Medical information Division, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Global Regulatory & Industry Situation about Platform Trials
Vice President, Global Head of Quantitative Sciences, Janssen R&D, Johnson & Johnson, United States
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