Program at-a-glance
DAY 1 | MONDAY |AUGUST 29
| 15:30-17:30： | Project Management for Supporting Academic Research Development ～For Novice Project Manager～ |
Science Hall |
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| Chair | Osamu Sugita (Hokkaido Univ. Hospital Clinical Research and Medical Innovation Center : Appointed Professor) |
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| Introduction | Akira Shimizu (Kyoto University Hospital, Institute for Advancement of Clinical and Translational Science, Department of Experimental Therapeutics : Professor) |
| Speaker | Kotone Matsuyama (Kyoto Prefectural Univ. Of Medicine : Lecturer) |
| Speaker | Shinobu Shimizu (Center for Advanced Medicine and Clinical Research Nagoya University Hospital : Lecturer) |
| Speaker | Koji Ikeda (Clinical Research, Innovation, and Education Center, Tohoku University Hospital : Professor) |
| 17:00-18:30：General Meeting of Members | Room 603, 604 (6F) |
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DAY 2 | TUESDAY | AUGUST 30
| 9:00-9:05：Welcome and Opening Remarks | Life Hall |
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| Akira Myoui (Medical Center for Translational and Clinical Research, Osaka University Hospital : Clinical Professor) |
| 9:05-10:55：Special Lecture |
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| Chair | Yoichi Nakanishi (Center for Clinical and Translational Research : Chief) |
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| Yoshiki Sawa (Osaka University Graduate School of Medicine Osaka University Faculty Of Medicine : Dean) | |
The CTSA Program Trial Innovation Network - Creating a Clinical Trials Superhighway - |
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| Speaker | Monica Ravindra Shah (Trial Innovation Network Clinical and Translation Science Awards Program, Division of Clinical Innovation National Center for Advancing Translational Sciences (NCATS) National Institutes of Health (NIH) : Director) |
ECRIN: Supporting Clinical Trials Across Borders |
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| Speaker | Jacques Demotes (European Clinical Research Infrastructure Network (ECRIN) : Director General) |
| 11:00-12:00：Seminar |
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| Chair | Takuhiro Yamaguchi (Division of Biostatistics, Tohoku University Graduate School of Medicine / Clinical Research Data Center, Tohoku University Hospital : Professor) |
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The activity for Clinical Research Support in ARO for CDISC standard |
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| Speaker | Yoshihiro Aoyagi (National Cancer Center Hospital East) |
| 12:10-13:10：Luncheon Seminar : Endeavors in Academia for Innovation |
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| Sponsor | Mitsui Sumitomo Insurance Co.,Ltd. |
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| Chair | Kazuchika Furukawa (Medical Center for Translational and Clinical Research Department of Medical Innovation, Osaka University Hospital Visiting : Associate Professor) |
Driving Organizational Change toward Open Innovation |
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| Speaker | Yuji Tokumasu (Strategic Global Partnership&Cross-Innovation Initiative,Osaka University Graduate School of Medicine / Osaka University Hospital : Professor Sub Director) |
New Compensation System for Clinical Research on Regenerative Medicine in Japan |
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| Speaker | Kiyoshi Okada (Department of Medical Innovation, Osaka University Hospital : Project Associate Professor) |
| 13:20-14:50： | Panel Discussion : Medical Research Involving Human Subjects: Is Japan an Advanced Country in Subject Protection? |
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| Chair | Norihiro Sato (Hokkaido University Hospital Clinical Innovation Center : Director, Professor) |
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| Yoichi Yamamoto (Medical Center for Translational and Clinical Research, Department of Medical Innovation, Osaka University Hospital : Vice Director) | |
Research Ethics Committee certification project and Clinical Research Act |
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| Speaker | Hiroaki Kato (Ministry of Health, Labour and Welfare Research and Development Division : Deputy Director) |
Advanced medical treatments and researches with high level of human subject protection - Challenge of Osaka University Hospital - |
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| Speaker | Yoichi Yamamoto (Medical Center for Translational and Clinical Research, Department of Medical Innovation, Osaka University Hospital : Vice Director) |
International comparison of human subject protection system: Where are we now? |
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| Speaker | Chieko Kurihara (Quality Assurance and Audit Office, National Institute of Radiological Sciences, National Institute for Quantum and Radiological Science and Technology : Senior Researcher) |
It subjects protection as seen from the eyes of the cancer patient |
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| Speaker | Miho Katagi (Smiley : Director) |
| 15:00-16:55：Cell Processing Center Seminar |
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| Chair | Atsuhiro Saito (Department of Translational Cell Therapy, Osaka University Hospiral : Specially Appointed Associate Professor) |
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Preparation of the CPC documents required for the clinical research under the Act on the Safety of Regenerative Medicine |
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| Speaker | Yasunari Kasai (Center for Cell and Molecular Therapy, Kyoto University Hospital : Chief Engineer) |
How to organize Qualification/Validation in academic Cell Processing Center (CPC) |
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| Speaker | Toshihiko Okazaki (Kyushu University Hospital Molecular and Cell Processing Center : Associate professor) |
| Panelist | Atsushi Nakao (BIOMEDICA SOLUTION INC, : Chief Executive Officer) |
| Hiroyuki Takano (Hitachi Plant Services Co.,Ltd Facility Construction & Engineering Division Facility Design & Engineering Division Process Department : Department Manager) |
| 17:00-18:00：Intellectual Property Seminar |
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| Chair | Masaho Ishino (Sapporo Medical University School of Medicine : Professor) |
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IP Strategy for Regenerative Medicine |
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| Speaker | Yuko Matsutoya (OHNO&PARTNERS : Partner) |
| 11:00-12:00：TR Education Seminar | Science Hall |
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| Chair | Yoichi Nakanishi (Center for Clinical and Translational Research : Chief) |
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Education and training for staffs at Academic Research Organization |
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| Speaker | Fumitaka Nagamura (Division of Advanced Medicine Promotion, the Institute of Medical Science, the University of Tokyo : Professor) |
| 12:10-13:10： | Project of Translational and Clinical Research Core Centers Luncheon Seminar |
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Under the auspice of Supporting Ogranization of "Project of Translational and Clinical Research Core Centers" (Foundation for Biomedical Research and Innovation) |
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| Chair | Masaaki Mizuno (Center for advanced medicine and clinical research, Nagoya University Hospital Clinical : professor) |
The securing of QMS for global expansion and the requirements for the data center |
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| Speaker | Yukiko Shiromoto (Div. of Audit / Translational Research Informatics Center, Foundation for Biomedical Research and Innovation : Head of QA) |
| Speaker | Keisuke Yuasa (Div. of e Cliｎical Solutions / Translational Research Informatics Center, Foundation for Biomedical Research and Innovation : Head of eCS) |
| 13:20-14:50：ARO Expert Committee Activities Report |
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| Chair | Akira Shimizu (Kyoto University Hospital, Institute for Advancement of Clinical and Translational Science, Department of Experimental Therapeutics : Professor) |
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| 15:00-15:55： | Regulatory Seminar |
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| Chair | Akira Myoui (Medical Center for Translational and Clinical Research, Osaka University Hospital : Vice Director, Clinical Professor) |
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Effective use of Pharmaceutical Affairs Consultation on R&D Strategy |
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| Speaker | Takeshi Sugawara (Chiba Clinical Research Center, Chiba University Hospital、Japan : MD, PhD Chiba Data Center Manager) |
| Yuchi Sato (Pharmaceuticals and Medical Devices Agency, Office of Medical Devices II : Reviewer) | |
| Kazuhiro Takekita (Pharmaceuticals and Medical Devices Agency, Office of Cellular and Tissue-based Products, Principal Reviewer) |
| 16:00-17:00：Oral Session1 |
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Aiming for Better Quality Clinical Researches |
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| Chair | Keizo Horibe (Clinical Research Center, National Hospital Organization Nagoya Medical Center : Director) |
| 17:00-18:00：Oral Session2 |
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Retention Strategies for Qualified Professionals in Academia |
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| Chair | Hideaki Hanaoka (Chiba University Hospitral : Professor) |
| 14:50-15:50：Poster Session | Senri Room |
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| 18:00-20:00：Welcome Networking Reception |
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DAY 3 | WEDNESDAY | AUGUST 31
| 9:00-10:25： | Panel Discussion : Let's Think about Enhanced Collaboration among ARO, AMED and PMDA to Acceralate Medical Innovation Originated from Academia |
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| Chair | Naoto Uemura（Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine, Professor / Department of Medical Innovation, Osaka University Hospital) |
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| Akira Myoui (Medical Center for Translational and Clinical Research, Osaka University Hospital : Vice Director, Clinical Professor) | |
How to overcome the hurdle of Medical Innovation from Academia: challenges of Academia, Government and Industry |
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| Speaker | Masuhiro Kato (University of Tokyo, TRI : Project Professor) |
AMED's efforts towards promoting the Academia derived New drugs -Focusing on the Project for Japan Translational and Clinical Research Core Centers- |
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| Speaker | Yasunori Yoshida (Japan Agency for Medical Research and Development, Department of Clinical Research and Trials : Managing Director) |
Introduction of Pharmaceutical Affairs Consultation on R&D Strategy and Its Effective Utilization |
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| Speaker | Hisashi Koike (Division of Pharmaceutical Affairs Consultation / Division of Review Management, Office of Review Management, Pharmaceuticals and Medical Devices Agency : Division Director) |
| Panelist | Kouji Ikeda (Clinical Research, Innovation, and Education Center, Tohoku University Hospital : Professor) |
| Tatsuya Ito (Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital : Lecture) |
| 10:30-12:00： | Panel Discussion : Fostering Further Strategic Collaboration between Academia and Pharmaceutical Company - Aiming to Overcome Rare Intractable Diseases - |
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| Chair | Masaru Iwasaki (University of Yamanashi : Vice President) |
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| Masaaki Mizuno (Center for advanced medicine and clinical research, Nagoya University Hospital : Clinical professor) | |
How to advance the collaboration between academia and pharmaceutical industry - From industry point of view |
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| Speaker | Kihito Takahashi (Development and Medical Affairs Division, GlaxoSmithKline K.K. : Vice President, and Senior Managing Director) |
Patient-Centricity in Rare Disease -Pilot Study for Extended Clinical Trial- |
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| Speaker | Michihiko Wada (Alexion Pharma GK : Vice President) |
How can Japan stand by and watch gene therapy products being on market in other countries? |
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| Speaker | Yasufumi Kaneda (Graduate School of Medicine, Osaka University : Professor) |
| Panelist | Osamu Inagaki (Japan Pharmaceutical Manufacturers Association, Steering Committee member, (Astellas Pharma Inc., Regulatory Science Advisor)) |
| Hidefumi Nakamura（National Center for Child Health and Development: Director for Clinical R&D） |
| 12:10-13:10：Special Seminar |
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Co-presented by Innovation Medical Association |
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| Chair | Daisuke Sugiyama (Department of Research and Development of Next Generation Medicine Faculty of Medical Sciences Kyushu University : Professor) |
Therapeutics for Rare & Neglected Diseases at NCATS: Case Studies and Lessons Learned |
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| Speaker | G. Sitta Sittampalam (NCATS / NIH : Senior Advisor to the Director) |
| 13:30-16:00：ASIA ARO Network Workshop |
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| 16:00-16:10：Closing Remarks |
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| Masaaki Mizuno (Center for advanced medicine and clinical research, Nagoya University Hospital : Clinical professor) |
| 9:00-9:55：Investigator -Initiated Clinical Trials Seminar- | Science Hall |
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| Chair | Nobuhito Saito (Univ. of Tokyo Hospital : Director) |
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Future perspective on investigator-initiated clinical trial for neurodegenerative disease |
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| Speaker | Masahisa Katsuno (Department of Neurology, Nagoya University Graduate School of Medicine : Professor) |
| 10:00-12:00：Biostatistics Seminar : Data Analysis of the Observational Study |
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| Chair | Satoshi Teramukai (Department of Biostatistics, Kyoto Prefectural University of Medicine : Professor) |
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Confounding adjustment in observational studies |
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| Speaker | Masataka Taguri (Department of Biostatistics, Yokohama City University School of Medicine : Associate Professor) |
Development of a multivariable prediction model using observational studies |
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| Speaker | Koji Oba (Department of Biostatistics, The University of Tokyo : Associate professor) |
| 9:00-12:00：Poster Viewing | Senri Room |
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