V6-S4

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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