メニュー 戻るV6-S4

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

  • Project Associate Professor, Department of Biostatistics and Bioinformatics
  • Graduate School of Medicine, The University of 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

Platform Trial in Neuroscience

Akiko Okamoto, DrSc

  • Senior Director, Global Head of Clinical Biostatistics for Neuroscience
  • Janssen R&D, Johnson & Johnson, United States
Hitomi  Okuma, MD, PhD

MASTER KEY Project – a Basket/Umbrella Trial and a Registry Study for Rare Cancers in Japan

Hitomi Okuma, MD, PhD

  • Clinical Trial Management Section, Research Management Division
  • National Cancer Center Hospital, Japan
Takahiro  Nonaka, PhD

Regulatory perspectives: Current state of Development of Oncology Drugs on Precision Medicine in Japan

Takahiro Nonaka, PhD

  • Office of New Drug V
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Michael  Krams, MD

Global Regulatory & Industry Situation about Platform Trials

Michael Krams, MD

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

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