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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1

第15回DIA日本年会

未曾有の変革の時代、イノベーション創出とグローバルヘルスへの貢献を、どのような連携の下で進めていくか

[V6-S4] New Drug Development Approaches to Realize Precision Medicine (Registry Study, Platform Trial)

Session Chair(s)

Akihiro  Hirakawa, PHD

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)

Akiko  Okamoto, DRSC

Akiko Okamoto, DRSC

Senior Director, Global Head of Clinical Biostatistics for Neuroscience, Janssen R&D, Johnson & Johnson, United States

Hitomi  Okuma, MD, PHD

Hitomi Okuma, MD, PHD

Head, International Research and Development Section, National Cancer Center Hospital, Japan

Takahiro  Nonaka, PHD

Takahiro Nonaka, PHD

Head of Epidemiology, Medical information Division, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Michael  Krams, MD

Michael Krams, MD

Vice President, Global Head of Quantitative Sciences, Janssen R&D, Johnson & Johnson, United States

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