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[V1-S1] The Experience of Global Phase 1 Study (Japan/US) –Oncology Area-
Session Chair(s)
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.
Speaker(s)
How is Global Phase 1 Managed?
Carol Woodward, MSc
Sarah Cannon, United Kingdom
Vice President, Development, Innovations and European Operations
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
National Cancer Center Hospital East, Japan
Deputy Director / Chief, Experimental Therapeutics
Johanna Bendell, MD
Sarah Cannon, United States
Chief Development Officer, Director, Drug Development Unit Nashville
Toshio Shimizu, MD, PhD
National Cancer Center Hospital, Japan
Head of Physician (Oncology Phase 1 Unit), Dept of Experimental Therapeutics