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Session 6 / Venue 1: Current Situation of Early and Exploratory Clinical Studies as one of the Leading Countries with Drug Development
Session Chair(s)
Atsushi Ohtsu, MD, PhD
Director, Exploratory Oncology Research & Clinical Trial Center
National Cancer Center, Japan
In recent years, high-quality and speedy clinical trials in Japan have started recognized overseas, starting a trend for Japan to conduct FIH and POC studies, which used to be preceded by foreign countries. In order to spread the growing strength of Japan, collaboration among academia, industry, and regulatory agencies is particularly essential. In this session, we will discuss the current status and future prospects of early and exploratory clinical trials from the points of view of academia, industry, and regulatory agencies.
Speaker(s)
Efforts by National Cancer Center EPOC
Toshihiko Doi, MD, PhD
National Cancer Center Hospital East, Japan
Deputy Director / Chief, Experimental Therapeutics
Positioning and Future Prospects of Early and Exploratory Clinical Trials in Japan in Terms of Development Strategies by Pharmaceutical Companies
Koichi Katsura
Nippon Boehringer Ingelheim Co., Ltd., Japan
Head of Medical Division
Japan’s Strategic Cooperation with Academia to take the Initiative in Early and Exploratory Clinical Studies
Hideki Maeda, PhD
Meiji Pharmaceutical University, Japan
Professor, Department of Regulatory Science
Japan’s Strategic Cooperation with Academia to take the Initiative in Early and Exploratory Clinical Studies
Yuta Ogawa
Ministry of Health, Labour and Welfare, Japan
Office of Clinical Trial Promotion, Research and Development Division
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