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14th DIA Japan Annual Meeting 2017


[V3-S5] Changing Landscape of Phase I Trials in Oncology

    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
    The role of phase I trial is changing to streamline cancer clinical development. It is common to carry out a dose escalation trial using 3 + 3 design, but in recent years various novel designs including global phase 1 trials are drawing attention. By knowing various options related to phase 1 trials, development strategies can be optimized. In this session, we will discuss on the novel designs, multiregional phase 1 trial, and phase 1 trials based on the characteristic of investigational drug.
    Speaker(s)
      Akihiro  Hirakawa, PhD

      Changing Landscape of Phase I Trials in Oncology: Overview

      Akihiro Hirakawa, PhD

      • Project Associate Professor, Department of Biostatistics and Bioinformatics
      • Graduate School of Medicine, The University of Tokyo, Japan
      Tomoyuki  Kakizume, PhD

      Points to be Consider when Joining Multi-Regional First-In-Human Studies in Oncology

      Tomoyuki Kakizume, PhD

      • Clinical Development Japan, Integrated Biostatistics Japan Department
      • Novartis Pharma K.K., Japan
      Tomohiro  Tanaka, MS

      Strategic Phase I Trials based on the Characteristic of Investigational Drug

      Tomohiro Tanaka, MS

      • Group Manager, Clinical Science & Strategy Department
      • Chugai Pharmaceutical Co., Ltd., Japan
      Hiroyuki  Sato, PhD

      PMDA Perspective

      Hiroyuki Sato, PhD

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

Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313
Japan@DIAglobal.org
www.diajapan.org