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Tokyo Big Sight

Nov 12, 2017 9:30 AM - Nov 14, 2017 5:30 PM

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

Specially Appointed Professor

Tottori University, Chromosome Egineering Research Center, 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

The Experience of Global Phase l Study in Japanese Site

Noboru Yamamoto, MD, PhD

National Cancer Center Hospital, Japan

Deputy Director, Department of Experimental Therapeutics

Chia-Chi (Josh) Lin

The Experience of Global Phase l Study in Asian Site

Chia-Chi (Josh) Lin

Department of Oncology, National Taiwan University Hospital, Taiwan

Director of Phase I Center

Kaku Saito, MSc, PMP

Global Phase l Study : The Experience and the Outcome

Kaku Saito, MSc, PMP

Daiichi Sankyo, Inc., United States

Manager

Experiences in Joining Oncology Global First-in-Human Studies

Hideyasu Ishibashi, PhD

Novartis Pharma K.K., Japan

Head, Translational Clinical Oncology

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