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14th DIA Japan Annual Meeting 2017

[V3-S6] Drug Developments for Rare Cancer and Fraction Areas

    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
    In rare cancer and fraction areas, phase 2 trials are conducted as pivotal trials, but their regulatory requirements differ depending on the target disease, standard treatment, and so on. It is important to organize the basic ideas of clinical development in rare cancer and fraction areas and make it easier to establish a path for drug approval. In this session, we will focus on the industry-academia cooperation to make development more efficient along with the clarification of regulatory requirements. The basic idea of clinical development in these area are organized.
      Kan  Yonemori, MD, PhD

      Collaborative Challenge for Drug Development in Rare Cancer Field

      Kan Yonemori, MD, PhD

      • Department of Breast and Medical Oncology
      • National Cancer Center Hospital, National Cancer Center, Japan
      Miki  Harumiya, MPharm

      The Current Status and the Issue of Drug Development for Rare Cancer and Rare Fraction Area from the Pharmaceutical Industry Perspective

      Miki Harumiya, MPharm

      • Japan Development, Solid Tumor Clinical Development Dept.
      • Novartis Pharma K.K., Japan
      Noriyuki  Komiyama, MSc

      PMDA Perspective: Rare Cancer Review - Now and Future

      Noriyuki Komiyama, MSc

      • Deputy Review Director, 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