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Tokyo Big Sight

2018 年 11 月 11 日 9:30 上午 - 2018 年 11 月 13 日 5:40 下午

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

15th DIA Japan Annual Meeting 2018

Innovative technologies such as AI, big data/genomics, and cell/gene therapies are poised to transform healthcare product development across the globe – join us to discuss these topics.

[DIAmond Session 2] Innovative Clinical Trials: A Painting of the Future

Session Chair(s)

Takuko  Sawada

Takuko Sawada

Director and Vice Chairperson of the Board

Shionogi & Co., Ltd., Japan

Technological innovation surrounding clinical trials such as introduction of IoT, AI, secondary use of clinical data, applying simulation etc. is progressing at an unprecedented speed. There is also a growing need for clinical trials in a new framework, such as precision medicine or development of regenerative medicinal products and/or gene therapy. On the other hand, the development cost and productivity improvement challenges are still large, and Japan specific regulations could be a hurdle to implement innovative way. Under such an environment, the real value of Japan in global development is being sought after. In this session, following the overview of the whole session, the current state of remote trial model and new evidence building by secondary data use will be shared. With such background information, the direction Japan should go and what is necessary will be discussed.

Speaker(s)

Hiromichi  Shirasawa, MD

Paradigm Shift of Clinical Developments

Hiromichi Shirasawa, MD

MSD K.K., Japan

Vice President and Executive Officer, Head of Japan Development

Bryan  McDowell, MBA, MSc

Embracing Technologies to Enable Smarter, Patient-Focused, Drug Development

Bryan McDowell, MBA, MSc

Clario, Switzerland

Vice President, eCOA Clinical Science and Consulting

Dalvir  Gill, PhD

Dalvir Gill, PhD

TransCelerate BioPharma Inc., United States

Chief Executive Officer

Jackie  Kent

Jackie Kent

Society for Clinical Research Sites (SCRS), United States

Vice President, Diversity and Special Projects

Kazuhiko  Mori, PhD, MSc

Kazuhiko Mori, PhD, MSc

Japan Pharmaceutical Manufacturers Association (JPMA), Japan

Senior Managing Director

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