1st Clinical Operation & Monitoring Workshop in Japan

Day 1 Thursday, January 24, 2013

• 9:30AM - 11:30AM

  Chatting Session (MCS) - Japanese Only
• 1:00PM - 1:15PM

  Welcome and Opening Remarks

  
  Session Chair(s):

  • Tatsuo Kurokawa, PhD
    Professor, Division of Drug Development & Regulatory Sciences
    Keio University, Japan
• 1:15PM - 1:25PM

  Introduction

  
  Session Chair(s):

  • Eri Sekine
    Head of Oncology Biometrics and DM Department, Oncology Development
    Novartis Pharma K.K., Japan
• 1:25PM - 3:05PM

  Key Note Session

  
  Session Chair(s):

  • Tatsuo Kurokawa, PhD
    Professor, Division of Drug Development & Regulatory Sciences
    Keio University, Japan
  • Suzuko Oikawa
    Clinical Strategy Manager, R&D
    Bristol-Myers K.K., Japan

  Key Note Session

  Speaker(s):

  • Operational Challenge in the Clinical Trials in the Era of Low Economical Growth
    Shinya Goto, MD,PhD
    Professor, Cardiology
    Tokai University School of Medicine, Japan
  • Improving Clinical Trials in the US and Japan – Past, Present and Future
    John H. Alexander, MD
    Associate Professor of Medicine, Division of Cardiology, Duke University Med Ctr
    Duke Clinical Research Institute - Duke University, United States
• 3:35PM - 5:40PM

  Session 1: SDV Innovation (Remote Monitoring, Sampling SDV)

  
  Session Chair(s):

  • Midori Fujikawa
    Clinical Research Department
    Chugai Pharmaceutical Co., Ltd., Japan
  • Mitsuo Hayashi, MSc
    Director
    MSD Co., Ltd., Japan

  More and more medical institutions propose remote monitoring with many innovative ideas based on the request of effective monitoring and SDV from pharmaceutical companies. In this session, we will share the latest information about the remote monitoring by the presentation to learn about its problems and future vision. Some pharmaceutical companies introduced Sampling SDV (S-SDV) with promoting efficiency and international standardization of the procedure of clinical study. The number of approved programs in which S-SDV was conducted has been increased in the world. On the other hand, S-SDV has not been widely spread in Japan. In this session, a company conducted S-SDV in domestic and global clinical study will present us about implementation status and problems of S-SDV. We hope this session can provide you an opportunity to consider whether you should introduce S-SDV or not. Monitoring and SDV are very important from the viewpoint of quality assurance. In this session, Pharmaceuticals and Medical Devices Agency (PMDA) will express their opinions on quality assurance as a basis of innovative SDV implementation.

  Speaker(s):

  • Development of remote SDV system in Shizouka Cancer Center
    Keita Mori
    Clinical Trial Coordination Office
    Shizuoka Cancer Center, Japan
  • Remote SDV Using Electronic Regional Medical Network System
    Akimasa Yamatani
    National Hospital Organization Kanazawa Medical Center, Japan
  • SDV Environment at the Investigational Site in US Compared to Japan
    Masayuki Shintani
    Lead CRA, Field Operation Group 3, Oncology Global Monitoring Operations
    Novartis Pharma K.K., Japan
  • PMDA’s perspective on innovative SDV
    Satoru Nakamura
    Deputy Director for GCP Inspection, Office of Conformity Audit
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Day 2 Friday, January 25, 2013

• 9:30AM - 11:30AM

  New Collaboration Style Between Pharmaceutical Company and CRO – Future View

  
  Session Chair(s):

  • Keiichi Inaizumi
    Study Manager, Japan Development & Clinical Alliance Management
    Pfizer Japan Inc., Japan
  • Kyoji Tamanoi
    Deputy General Manager, Clinical Development Division
    EPS Corporation, Japan

  The collaboration style between pharmaceutical company and CRO has been diversified into various kinds of models not only the traditional model by which pharmaceutical company manages CRO in each project. In this session, some of the new collaborative models will be introduced by pharmaceutical companies. These presentations will be useful to exchange opinions on future view of new collaboration style with everyone. The purposes of this session is to trigger an awareness of avenues for improvement of effectiveness and activity to conduct clinical studies through understanding responsibilities for each party including future collaboration style.

  Speaker(s):

  • Collaboration with Pharmaceutical Company and CRO in Astellas Case
    Hirotsune Itahana
    Senior Manager, Clinical Development Administration, Development
    Astellas Pharma Inc., Japan
  • Collaboration with Pharmaceutical Company and CRO in Pfizer Case
    Kei Yamashita
    Associate Director, Japan Development & Clinical Alliance Management
    Pfizer Japan Inc., Japan
  • Collaboration with Pharmaceutical Company and CRO in Baxter Case
    Shigeyoshi Yokokawa
    Clinical Operation Manager, Medical Affairs, Clinical Development & Operations
    Baxter Ltd., Japan
  • Shogo Nakamori
    Corporate VP, CRS, Asia Pacific
    PAREXEL International, Japan
  • Jotaro Shinagawa
    Vice President, Head of Clinical Development Services in Japan
    Quintiles Transnational Japan K.K., Japan
• 12:45PM - 2:45PM

  Session 3: Productivity of Clinical Operations and Monitoring

  
  Session Chair(s):

  • Takeshi Ebihara
    GlaxoSmithKline K.K., Japan
  • Norio Shimazaki
    Manager
    Bristol-Myers K.K., Japan

  In recent years, multinational clinical trials have become more popular and been getting standard practice, which have made clinical study practices in Japan change dramatically. In order to cope with this situation, many pharmaceutical companies are taking various actions to increase their efficiency and productivity for the clinical trials that are becoming more complicated. Similarly, many clinical trial sites are also taking various measures for efficient clinical studies. In this session, we would like to introduce these activities and have some discussions and exchange ideas among the persons in charge of clinical trials. This session aims at getting some ideas how to challenge the situations in increasingly severe clinical practices by gaining a deep understanding of each diff erent need at each respective site and its sponsors.

  Speaker(s):

  • Sharing Best Practice on Clinical Operation Process
    Norio Shimazaki
    Manager
    Bristol-Myers K.K., Japan
  • Application of Lean Six Sigma for Efficient Clinical Study
    Hirotaka Inoue, PhD,MBA
    Manager, Development & Medical Affairs Division
    GlaxoSmithKline K.K., Japan
  • From the Viewpoint of Clinical Study Site
    Toshiko Ishibashi, PhD
    Clinical Research Coordinator
    St. Luke's International Hospital, Japan
  • Current issues of data management in National Cancer Center Hospital East
    Natsuko Iwasaki
    Local Data Manager, Clinical Trial Management Office
    National Cancer Center Hospital East, Japan
• 3:15PM - 4:45PM

  Panel Discussion: Future Clinical Operations in Japan

  
  Session Chair(s):

  • Hiroshi Kosaku
    Group Corporate Officer, Corporate Planning Division
    CMIC HOLDINGS Co., Ltd., Japan
  • Suzuko Oikawa
    Clinical Strategy Manager, R&D
    Bristol-Myers K.K., Japan
  • Eri Sekine
    Head of Oncology Biometrics and DM Department, Oncology Development
    Novartis Pharma K.K., Japan
  • Toshiko Ishibashi, PhD
    Clinical Research Coordinator
    St. Luke's International Hospital, Japan

  As the globalization of clinical development has been expanding, it is the time we have to consider the future of clinical operation in terms of cost, speed and quality from a mid and long term perspective. There has been a thought that we need to look back the essence of clinical operation since the concept of “ALCOA” was introduced in Japan. On the other hand, IT environment for clinical trials – e.g. electric medical record, EDC, etc, - is changing really fast in these days. On top of this, it has become necessary for us to see it from viewpoints totally different so far. Thinking of the circumstances described above, the participants may wonder what will be required for clinical operation in Japan to efficiently develop for the future. Panel discussion will be held beyond the sectorial boarder among pharmaceutical company, CRO, clinical site, PMDA and those concerned. The discussion will be facilitated based on the common understanding of the importance of Quality assurance while the topics would be reached to current and future challenges of clinical operations including career development for those involved.

  Speaker(s):

  • John H. Alexander, MD
    Associate Professor of Medicine, Division of Cardiology, Duke University Med Ctr
    Duke Clinical Research Institute - Duke University, United States
  • Sachiko Kameo
    Director, Japan Study Management & Operations
    AstraZeneca K.K., Japan
  • Emiko Kondo
    Director, Office of Conformity Audit
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Toshio Maruyama
    Sub Manager, Clinical Development Dept 2, Monitoring Center
    EPS Co., Ltd., Japan
  • Tadayoshi Nakashima
    Associate Director, Clinical Coordination, Development Operations Dept
    Takeda Pharmaceutical Company Limited, Japan