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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V1-S1] The Experience of Global Phase 1 Study (Japan/US) –Oncology Area-

Session Chair(s)

Hironobu  Saito, PhD

Hironobu Saito, PhD

Specially Appointed Professor

Tottori University, Chromosome Egineering Research Center, Japan

Now a days, First in Human (FIH) study is implemented in US, and the development in Japan is conducted based on the data of US FIH study. To have the leadership in global development, Japan sites should attend global phase 1 with US sites. In this session, the US expert will show her experiences about global phase 1 studies in US, and the Japanese expert will show his experience about global phase 1 study from management points of view. Finally, Japanese academia experts and US expert of Phase 1 will join the panel and discuss the future global phase 1 including Japanese sites.


Carol  Woodward, MSc

How is Global Phase 1 Managed?

Carol Woodward, MSc

Sarah Cannon, United Kingdom

Vice President, Development, Innovations and European Operations

Yutaka  Noguchi, MSc

The Experience of “Japan-US” First-In-Human Study in Oncology

Yutaka Noguchi, MSc

Daiichi Sankyo Co., Ltd., Japan

Manager, Oncology Clinical Development Department

Toshihiko  Doi, MD, PhD

Toshihiko Doi, MD, PhD

National Cancer Center Hospital East, Japan

Deputy Director / Chief, Experimental Therapeutics

Johanna  Bendell, MD

Johanna Bendell, MD

Sarah Cannon, United States

Chief Development Officer, Director, Drug Development Unit Nashville

Toshio  Shimizu, MD, PhD

Toshio Shimizu, MD, PhD

National Cancer Center Hospital, Japan

Head of Physician (Oncology Phase 1 Unit), Dept of Experimental Therapeutics