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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,Clinical Biostatistics,Graduate School of Medical and Dental Sciences
Tokyo Medical and Dental University, 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
Akiko Okamoto, DrSc
Janssen R&D, Johnson & Johnson, United States
Senior Director, Global Head of Clinical Biostatistics for Neuroscience
MASTER KEY Project – a Basket/Umbrella Trial and a Registry Study for Rare Cancers in Japan
Hitomi Okuma, MD, PhD
National Cancer Center Hospital, Japan
Head, International Research and Development Section
Regulatory perspectives: Current state of Development of Oncology Drugs on Precision Medicine in Japan
Takahiro Nonaka, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Head of Epidemiology, Medical information Division
Global Regulatory & Industry Situation about Platform Trials
Michael Krams, MD
Janssen R&D, Johnson & Johnson, United States
Vice President, Global Head of Quantitative Sciences