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“Harmonization By Doing (HBD)” 2011 Think Tank Meeting
March 16-17, 2011 Tokyo, Japan
Due to the sever earthquake this time in Japan, we regret to
inform that we decided to cancel the 2011 Think Tank Meeting.
We hope that you will kindly understand the situation.
As for registration fee, we will forward details to you separately as soon as we could.
March 16th (Wednesday)：Iron Gate Memorial Hall
- Click underlined title then open PDF file in another window.
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| Title | Presenter | ||
|---|---|---|---|
| 13:00-13:40 | Introduction of HBD | Yoshinobu Hirayama(MHLW･Councillor for Pharmaceutical Affairs, Minister's Secretariat) | |
| Kazuo Ogino(JFMDA･Chairman) | |||
| Mitchell Krucoff (Duke Clinical Research Institute) |
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| 13:40-15:25 | Advances in Japan-USA regulatory processes (WG4) Moderator: Carole Carey (FDA) Kentaro Azuma (MHLW) |
Introduction and Progress | Carole Carey (FDA) Kentaro Azuma (MHLW) |
| Concept Paper | Gary Thompson (Abbott) |
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| GCP Update and Next Steps: poster board | Neal Fearnot (Cook) Kazuo Yano (Asahi Kasei Kuraray Medical) |
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| STED POC Progress | Brad Hossack (Boston Scientific) Noriko Yasuda ( Toray Medical) |
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| Comparisons of Data Integrity / Reliability Assessment in Japan and the USA | Chie Iwaishi (Cordis, J&J) Kazuo Tomida (Hitachi) |
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| Results of Future Focus for WG4 Questionnaire | Brad Hossack (Boston Scientific) |
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| Panel Discussion | Modulator: Michael Gropp (Medtronic) Mime Egami (Tokyo Women's Medical University) |
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| 15:25-15:40 | Break | ||
| 15:40-16:20 | Issues, needs and limitations of Japan-USA research infrastructure (WG3) Moderator: John Alexander (Duke Clinical Research Institute) Yoshihiro Arakawa (University of Tokyo) |
Top five challenges facing the global clinical research infrastructure ? an academic perspective |
John Alexander (Duke Clinical Research Institute) |
| The current Japanese clinical research infrastructure ? Lessons from the pharmaceuticals industry |
TBA | ||
| Initial results from first ever survey on costs of medical devices clinical trials in Japan | Izumi Fukuzawa (BIOMET JAPAN) |
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| Discussion on HBD Working Group 3 (Clinical Research Infrastructure) ? Looking forward |
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| 16:20-17:00 | New Discussion Point Moderator: Eric Chen (FDA) Yuka Suzuki (PMDA) |
Research proposal regarding orphan device development | Eric Chen (FDA) |
| Current status of orphan device in Japan | Kentaro Azuma (MHLW) Kohei Ohtsuki (PMDA) |
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| Panel Discussion | |||
| 17:00-17:30 | Free time | ||
| 17:30-19:30 | Reception：Sanjo Conference Hall | ||
March 17th (Thursday)：Iron Gate Memorial Hall
| Title | Presenter | ||
|---|---|---|---|
| 09:30-10:10 | CDRH & PMDA | Jeffrey Shuren (FDA･CDRH Director: prerecorded) |
|
| Hideo Utsumi(PMDA･Executive Director) | |||
| 10:10-11:10 | Post-market directions in Japan-USA (WG2) Moderator: Eric Chen (FDA) Takashi Nakatani (National Cerebral and Cardiovascular Center) Kazuhiro Sase (Juntendo University) |
Initial Goals of WG2 and INTERMACS | Eric Chen (FDA) |
| Accomplishments and JMACS | Takeshi Nakatani (National Cerebral and Cardiovascular Center) |
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| Harmonization By Data -Proposed direction for WG2 | John Laschinger (FDA) |
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| Discussion | |||
| 11:10-11:25 | Break | ||
| 11:25-12:25 | Collaborative Scheme | The overview / history of the collaborative Scheme | Carole Carey ( FDA) |
| The experiences / lessons learned from the Scheme - PMDA perspective | Mami Ho (PMDA) |
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| The experiences / lessons learned from the Scheme - FDA perspective | Kenneth Cavanaugh (FDA) |
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| The experiences from Industry side | Neal Fearnot (Cook) Kazuo Kawahara (Terumo) Lucy Tan (Medtronic) |
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| Panel discussion | |||
| 12:25-13:25 | Lunch | ||
| 13:25-13:55 | Options & Opportunities for Global Clinical Trials: Concept to Proof of Concept (WG1) Moderator: Mitchell Krucoff (Duke Clinical Research Institute) Bram Zuckerman (FDA) |
Our new mission - educational ‘incubator’ to facilitate global clinical trials | Koji Ikeda (PMDA) |
| Update on participation in scientific sessions:US side (TCT, CRT) |
Mitchell Krucoff (Duke Clinical Research Institute) |
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| Update on participation in scientific sessions: Japan side (CVIT, Kamakura Live) and future direction of WG1 activities | Shigeru Saito (Shonan Kamakura General Hospital) |
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| Discussion | |||
| 13:55-14:35 | “Scientific Session” Part.1 Device Lag & DES: How Far Has Harmonization Come? Moderator: Shigeru Saito (Shonan Kamakura General Hospital) Bram Zuckerman (FDA) |
Introduction: the overview of DES introduction (from Y2004) & Lessons learned/experiences from DES trials/development | Shigeru Saito (Shonan Kamakura General Hospital) |
| Models of Convergence: From Poolable to Single Protocol to “Japan First” | Mitchell Krucoff (Duke Clinical Research Institute) |
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| Regulatory Convergence and future progress of DES development | Koji Ikeda (PMDA) |
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| Discussion | |||
| 14:35-14:50 | Break | ||
| 14:50-16:10 | “Scientific Session” Part.2 Percutaneous Valves: A New “Device Lag” Challenge Part 2-I: Mitral Valve Moderator: Mitchell Krucoff (Duke Clinical Research Institute) Masato Nakamura (Toho University Ohashi Medical Center) |
Introduction：current situation facing “device lag” | Fumiaki Ikeno (Stanford University) |
| Key Patient Descriptors & Endpoints for MV: Same or Different in Japan & USA | John Laschinger (FDA) |
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| Site-Based Research Infrastructure for MV In Japan and USA | Gary Thompson (Abbott) |
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| Medical & Surgical Comparators for Percutaneous Mitral Valves: A Cultural Perspective In Japan and USA | Stanton Rowe (Edwards) |
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| Discussion | |||
| “Scientific Session” Part.2 Percutaneous Valves: A New “Device Lag” Challenge Part 2-II: Aortic Valve Moderator: Koji Ikeda (PMDA) Susan Alpert (Medtronic) |
Introduction：current situation facing “device lag” | Fumiaki Ikeno (Stanford University) |
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| Key Patient Descriptors & Endpoints for TAVI:Same or Different in Japan & USA | John Laschinger (FDA) |
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| Site-Based Research Infrastructure for TAVI In Japan and USA:A Critical “Partnership” | Jodi Akin (Edwards) |
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| Comments/expectations from physicians | Yoshiki Sawa (Osaka University) |
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| Discussion | |||
| 16:10-16:30 | Closing Session | Toshiyoshi Tominaga(PMDA) Kuniko Shoji(JFMDA) |
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