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14th DIA Japan Annual Meeting 2017


[V8-S4] Clinical Development of Biosimilar Products

    Session Chair(s)
      Teruyo  Arato, PhD

      Teruyo Arato, PhD

      • Professor, Clinical Research and Medical Innovation Center
      • Hokkaido University Hospital, Japan
    Biosimilar products have been actively developed globally, and it has been widely discussed how to evaluate the biosimilarity with reference product. This session will focus mainly on scientific considerations of clinical development and clinical trial for biosimilar products. Speakers will introduce key features of clinical data package and study design in the development of biosimilar products. In addition, some statistical issues will be discussed. We would also like to discuss the differences of approaches among countries/regions, which could be the challenges in global development.
    Speaker(s)
      Yuko  Kawakita, RPh

      Biosimilar Challenges from the Point of View of Project Management

      Yuko Kawakita, RPh

      • Global Project Management Department
      • Daiichi Sankyo Co., Ltd., Japan
      Duu-Gong  Wu, DrSc, PhD

      Regulatory and Scientific Issues on Biosimilar Development in the U.S: Lessons Learned from Recent Approvals

      Duu-Gong Wu, DrSc, PhD

      • PPD, United States
      Nan  Zhang, PhD

      Statistical Considerations for the Development of Biosimilar Products

      Nan Zhang, PhD

      • Biostatistics Manager
      • Amgen Inc., United States
      Kota  Tokushige, MS

      Comparative Clinical Study Designs for Biosimilar Development Program

      Kota Tokushige, MS

      • Oncology Development & Medical Affairs Department
      • Novartis Pharma K.K., 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