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[V1-S1] The Experience of Global Phase 1 Study (Japan/US) –Oncology Area-
Session Chair(s)
Hironobu Saito, PHD
Corporate Advisor, Daiichi Sankyo Co., Ltd., 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)
Carol Woodward, MSC
Vice President, Development, Innovations and European Operations, Sarah Cannon, United Kingdom
How is Global Phase 1 Managed?
Yutaka Noguchi, MSC
Manager, Oncology Clinical Development Department, Daiichi Sankyo Co., Ltd., Japan
The Experience of “Japan-US” First-In-Human Study in Oncology
Toshihiko Doi, MD, PHD
Deputy Director / Chief, Experimental Therapeutics, National Cancer Center Hospital East, Japan
Johanna Bendell, MD
Chief Development Officer, Director, Drug Development Unit Nashville, Sarah Cannon, United States
Toshio Shimizu, MD, PHD
Professor, Department of New Experimental Therapeutics and Early Phase 1 Drug De, Kansai Medical University Hospital, Japan