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Virtual Event

2021年5月18日 (火) 午後 4:00 - 2021年5月18日 (火) 午後 11:00


DIA Master Protocol Workshop 2021 in Japan


This event will be conducted online via Zoom.

Simultaneous Japanese/English interpretation available.

Click Here to View the Flyer

In recent years, various innovations have been applied in the development of medical technologies which have had significant impact. New technologies have helped boost productivity and reduce development time and costs.

Such trends have also been seen in the healthcare industry, and, together with the additional impact of the COVID-19 pandemic, we are witnessing growing use of new technologies and new methods in drug development.

DIA Japan has established workshops focused on the latest technologies supporting innovation in this environment under its recent hot-topic “Cutting Edge Series.” The Master Protocol was selected as the latest method to improve clinical trial efficiency as Part 2 of this “Cutting Edge Series.”

In this environment, addressing critical clinical issues while reducing costs remains challenging. In recent years, complex clinical studies (using basket, umbrella, and platform designs) have been conducted with mainly great results in Europe and the US; for example, I-SPY 2, EPAD, DIAN-TU, GBM AGILE, etc. The MASTER KEY Project, adopting a method of simultaneously conducting multiple clinical trials with accumulating rare cancer registry data, has been conducted in Japan. These studies have been useful in exploring and validating common disease characteristics.

This “Master Protocol Workshop” was designed to not only help prepare Master Protocols but to share knowledge and discuss issues essential to conducting basket, umbrella and other complex clinical trials. Through case studies, we will introduce and explain differences in regulations between Japan, the US and Europe; issues and considerations when conducting complex clinical trials; and how to evaluate the results of multiple clinical trials. We will also discuss the challenges and expectations for promoting complex clinical trials among industry, regulators, and other experts in Japan.

We sincerely await your participation.  


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  • Akihiro  Hirakawa, PhD
    Akihiro Hirakawa, PhD Professor,Clinical Biostatistics,Graduate School of Medical and Dental Sciences
    Tokyo Medical and Dental University, Japan
  • Morihiko  Hayashi, DVM
    Morihiko Hayashi, DVM Clinical Development, Clinical Science & Strategy
    Chugai Pharmaceutical Co., Ltd., Japan
  • Toshinori  Higashi, PhD
    Toshinori Higashi, PhD Vice President, Regulatory Science
  • Masakazu  Hirata, MD, PhD
    Masakazu Hirata, MD, PhD Clinical Reviewer, Division of RS Consultation, Kansai Branch
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 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
  • Akiko  Ikeda, RPh
    Akiko Ikeda, RPh Associate Director, Regulatory Development Dept.
    Janssen Pharmaceutical K.K., Japan
  • Atsushi  Tsukamoto, PhD, MSc
    Atsushi Tsukamoto, PhD, MSc Head is Therapeutic Area Strategies
    Daiichi Sankyo, United States

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