3rd Japan Taiwan Oncology Phase I Trial Conference Agenda 時間：2014 年 4 月 19-20 日 地點：台大國際會議中心 301 講堂（100 台北市徐州路 2 號） 19 April 2014 01:00-01:10PM Topic Opening remark Ann-Lii Cheng, National Taiwan University Hospital, Taipei, Taiwan Kazuhiko Nakagawa, Kinki University Faculty of Medicine, Osaka, Japan 01:10-01:50PM Keynote Speech: Early Phase Trials in the Future - Basic Researcher's Perspective Kazuto Nishio, Kinki University Faculty of Medicine, Osaka, Japan 01:50-02:20PM Development of novel agents in Asian cancers: PD-1/PD-L1 inhibitors Kazuhiko Nakagawa, Kinki University Faculty of Medicine, Osaka, Japan 02:20-02:50PM Oncology phase I trials in Merck KGaA Kazuto Nishio, Kinki University Faculty of Medicine, Osaka, Japan 02:50-03:10PM Coffee break 03:10-03:30PM Completed phase I trial of alectinib: Presenter James Chih-Hsin Yang, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan 03:30-03:50PM Completed phase I trial of alectinib: Discussant Chia-Chi (Josh) Lin, National Taiwan University Hospital, Taipei, Taiwan 03:50-04:10PM Japan / Taiwan phase I trial models: Japanese investigator’s perspectives Kazuto Nishio, Kinki University Faculty of Medicine, Osaka, Japan 04:10-04:30PM Japan / Taiwan phase I trial models: Taiwanese investigator’s perspectives Chia-Chi (Josh) Lin, National Taiwan University Hospital, Taipei, Taiwan 04:30-04:50PM Japan / Taiwan phase I trial models: Statistician’s perspectives Kazuhiko Nakagawa, Kinki University Faculty of Medicine, Osaka, Japan 04:50-05:00PM Wrap up on day one James Chih-Hsin Yang, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan 20 April 2014 08:00-08:10AM Topic Highlight on day one James Chih-Hsin Yang, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan 08:10-08:40AM Development of novel agents in Asian cancers: IGF1R inhibitors Kazuhiko Nakagawa, Kinki University Faculty of Medicine, Osaka, Japan 08:40-09:10AM Development of novel agents in Asian cancers: MET inhibitors James Chih-Hsin Yang, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan 09:10-09:40AM Oncology phase I trials in Boehringer Ingelheim Chia-Chi (Josh) Lin, National Taiwan University Hospital, Taipei, Taiwan 09:40-10:00AM Coffee break 10:00-10:20AM Completed phase I trial of TLC388: Presenter Jih-Hsiang Lee, National Taiwan University Hospital, Taipei, Taiwan 10:20-10:40AM Completed phase I trial of TLC388: Discussant Chia-Chi (Josh) Lin, National Taiwan University Hospital, Taipei, Taiwan 10:40-11:10AM Development of novel agents in Asian cancers: CDK inhibitors James Chih-Hsin Yang, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan 11:10-11:40AM Development of novel agents in Asian cancers: PI3K/AKT inhibitors Chia-Chi (Josh) Lin, National Taiwan University Hospital, Taipei, Taiwan 11:40-12:20PM Closing remark Ann-Lii Cheng, National Taiwan University Hospital, Taipei, Taiwan 一. 課程綱要 序 課程題目 綱要說明 1. Opening remark The Phase I Center operates under the leadership of Dr. Ann-Lii (Andrew) Cheng and Dr. James Chih-Hsin Yang and consists of a team of highly trained staff with extensive experience in oncology phase I trials research. 2. Keynote Speech: Early Phase Trials in the Future - Basic Researcher's Perspective Presentation on the developments and findings on early phase trials in japan, through discussion to find more methods and comments. 3. Development of novel agents in Asian cancers: Experiences sharing for conducting PD-1/PD-L1 inhibitors PD-1/PD-L1 inhibitors clinical trial from Japan, comparing the differences between Japan and Taiwan. 4. Oncology phase I trials in Merck KGaA With the point -of-views from a medicine company, to offer experiences applied in other countries or regions, trying to find the best way applied in Taiwan. 5. Completed phase I trial of alectinib: Presenter Experiences sharing for conducting phase I trial of alectinib from Japan, comparing the differences between Japan and Taiwan. 6. Completed phase I trial of alectinib: Discussant Experiences sharing for conducting phase I trial of alectinib from Japan, comparing the differences between Japan and Taiwan. Through discussion to find more methods and comments. 7. Japan / Taiwan phase I trial models: Japanese investigator’s perspectives 8. Japan / Taiwan phase I trial models: Taiwanese Safety is always the first priority in early Phase investigator’s perspectives I studies. Key issue including study rationale, study design, dose selection, safety monitor and Safety is always the first priority in early Phase I studies. Key issue including study rationale, study design, dose selection, safety monitor and ethnic concern. Adequate pre-clinical data is necessary to support the conduction of early Phase I studies. Early phase I trial of each investigational product differs according to its characteristics. The balance between patient safety and facilitating new drug development is also important. 序 課程題目 綱要說明 ethnic concern. Adequate pre-clinical data is necessary to support the conduction of early Phase I studies. Early phase I trial of each investigational product differs according to its characteristics. The balance between patient safety and facilitating new drug development is also important. 9. Japan / Taiwan phase I trial models: Statistician’s perspectives Experiences sharing for designing phase I trials. 10. Wrap up on day one Wrap up on day one, through discussion to find more methods and comments. 11. Highlight on day one Highlight on day one, through discussion to find more methods and comments. 12. Development of novel agents in Asian cancers: Experiences sharing for conducting phase I trial IGF1R inhibitors of IGF1R inhibitors. 13. Development of novel agents in Asian cancers: Experiences sharing for conducting phase I trial MET inhibitors of MET inhibitors. 14. Oncology phase I trials in Boehringer Ingelheim With the point -of-views from a medicine company, to offer experiences applied in other countries or regions, trying to find the best way applied in Taiwan. 15. Completed phase I trial of TLC388: Presenter Experiences sharing for conducting phase I trial of TLC388. 16. Completed phase I trial of TLC388: Discussant Experiences sharing for conducting phase I trial of TLC388 from Japan, comparing the differences between Japan and Taiwan. Through discussion to find more methods and comments. 17. Development of novel agents in Asian cancers: Experiences sharing for conducting phase I trial CDK inhibitors of CDK inhibitors. 18. Development of novel agents in Asian cancers: Experiences sharing for conducting phase I trial PI3K/AKT inhibitors of PI3K/AKT inhibitors. 19. Closing remark Through discussion to find more methods and comments. 二. 講師簡歷 序 1. 現職 學歷 （含單位／職稱／年資） （含校名／系所／年屆） Ann-Lii Cheng Director, Department of Ph.D. Graduate Institute of Oncology, National Taiwan Clinical Medicine University Hospital, Taipei, College of Medicine, 講師姓名 經歷 （含單位／職稱／年資） Director, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan 2002- present 2. 3. 4. 5. 6. National Taiwan University Sep 1991- Jun 1994 Ph.D. Graduate Institute of Kumamoto University 2001 Professor Department of Medical Oncology Kinki University Faculty of Medicine 2007- present Kazuto Nishio Professor and Chairman, Ph.D. Graduate Institute of Department of Genome Wakayama Medical Biology, Kinki University University School of Medicine 1994 2006-present Director, Department of Ph.D. Graduate Institute of James Medical Research, Chih-Hsin Clinical Medicine National Taiwan College of Medicine, Yang, University Hospital, Taipei, National Taiwan Taiwan University Aug 2013- present Sep1996-Jan 2000 Taiwan 2002- present Professor Department of Medical Oncology Kinki University Faculty of Medicine 2007- present Professor and Chairman, Department of Genome Biology, Kinki University School of Medicine 2006-present Professor, Graduate Institute of Oncology, Graduate Institute of Clinical Pharmacy Graduate Institute of Clinical Medicine College of Medicine, National Taiwan University Aug 2009- present Clinical Assistant Chia-Chi Ph.D. Graduate Institute of Clinical Assistant Professor, Department of Clinical Medicine Professor, Department of (Josh) Lin Urology, Urology, College of Medicine, National Taiwan National Taiwan National Taiwan University Hospital, Taipei, University Hospital, Taipei, University Taiwan Taiwan Jul 2000- Jun 2006 Feb 2013- present Feb 2013- present M.D. School of Medicine, Attending physician, Jih-Hsiang Lee Attending physician, Department of oncology, Medical College, National Department of oncology, National Taiwan Taiwan University, Taiwan National Taiwan University Hospital, Sep 1993-Jun 2000 University Hospital, Taiwan Taiwan Feb., 2012- present Feb., 2012- present Kazuhiko Nakagawa
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