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Tokyo Big Sight

2017 年 11 月 12 日 9:30 上午 - 2017 年 11 月 14 日 5:30 下午

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

14th DIA Japan Annual Meeting 2017

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[V1-S1] To Manage Global Phase l Study - Oncology Development -

Session Chair(s)

Hironobu Saito, PHD

Hironobu Saito, PHD

Corporate Advisor, Daiichi Sankyo Co., Ltd., Japan

Even in the case that a new seed has been found in Japan, US/ Europe is leading the clinical development, in which global phase l study is started in US/Europe and the first approval is planned in US/EU. To lead global development, Japan need the skill to manage global Phase l and develop global human resource. In the oncology area, the transformation from Step by step (Phase l,ll,lll) to patients oriented development (Expanded Phase l, Confirmed Phase ll, Conditional Approval) is discussed and challenged. The most important action is to develop global human resource in Japan. For example the person who is able to find the dose in the case of limited data and limited time. In the first session, the presenters will share how the sponsor prepares non-clinical data, CMC data to set up global phase l study. In the second session, the global site (US/EU/Asia/Japan) will share the efforts and the experiences to deal with global Phase l study.

Speaker(s)

Noboru Yamamoto, MD, PHD

Noboru Yamamoto, MD, PHD

Deputy Director, Department of Experimental Therapeutics, National Cancer Center Hospital, Japan

The Experience of Global Phase l Study in Japanese Site

Chia-Chi (Josh) Lin

Chia-Chi (Josh) Lin

Director of Phase I Center, Department of Oncology, National Taiwan University Hospital, Taiwan

The Experience of Global Phase l Study in Asian Site

Kaku Saito, MSC, PMP

Kaku Saito, MSC, PMP

Manager, Daiichi Sankyo, Inc., United States

Global Phase l Study : The Experience and the Outcome

Hideyasu Ishibashi, PHD

Head, Translational Clinical Oncology, Novartis Pharma K.K., Japan

Experiences in Joining Oncology Global First-in-Human Studies