7th Annual Conference in Japan for Asian New Drug Development

Day 1 Monday, April 15, 2013

• 10:00AM - 10:20AM

  Welcome and Opening Remarks

  Speaker(s):

  • Tatsuo Kurokawa, PhD
    Professor, Division of Drug Development & Regulatory Sciences
    Keio University, Japan
  • Ling Su, PhD
    Strategic Advisor, Life Sciences
    Sidley Austin LLP, China
• 10:20AM - 11:40AM

  Key Note Session

  
  Session Chair(s):

  • Tetsuomi Takano, RPh
    Senior Director, Head of Asian Development Strategy
    Astellas Pharma Inc., Japan

  Speaker(s):

  • Medicine Development in Japan
    Kihito Takahashi, MD,PhD
    Vice President, Japan Development & Medical Affairs Division
    GlaxoSmithKline K.K., Japan
  • Outlook for Pharma R&D and Market in China: From RDPAC Viewpoint
    Joseph Cho
    Managing Director
    R&D-based Pharmaceutical Association Committee, China
• 1:00PM - 3:00PM

  Session 1-1: Perspectives of Respective Regulatory Agencies in Clinical Data Evaluation for Drug Approval

  
  Session Chair(s):

  • Mark Bach
    Vice President and Head, Asia Pacific Medical Sciences
    Janssen, Pharmaceutical Companies of Johnson & Johnson, Singapore
  • Yasuto Otsubo
    Reviewer, Office of New Drug II
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan

  Utilization of East Asian Clinical Data in Asian Drug Development - Part 1: In the first part, we will take a close look at the recent regulatory agency collaboration in East Asia, and would like to ask agency representatives from China, Korea, Taiwan and Japan to present key factors which the regulatory agency think very important when they assess the East Asia multi regional clinical trial (MRCT) data acceptability for NDA, which have been generated in respective regions. We would also like to ask them to think about how those key factors would be changing in the near future from respective stand point.

  Speaker(s):

  • Clinical Data Evaluation for Drug Approval - Observations from China
    Ling Su, PhD
    Strategic Advisor, Life Sciences
    Sidley Austin LLP, China
  • Clinical Data Evaluation for Drug Approval : Korean Perspective
    Mee Ryung Ahn, PhD
    Deputy Director, Oncology and Antibiotic Products Division, Drug Evaluation Dept
    Ministry of Food and Drug Safety (MFDS), Korea, Republic of
  • Clinical Data Evaluation for Drug Approval in Taiwan - Focusing on BSE
    Li-Li Su
    Reviewer, Division of Pharmaceutical Sciences
    Center for Drug Evaluation, Taiwan
  • PMDA’s Perspectives in Global Clinical Data Evaluation for Drug Approval
    Yoshiaki Uyama, PhD
    Director, Review Planning Division, Office of Review Management
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
• 3:45PM - 4:45PM

  Drug Development Strategy Utilizing East Asian Clinical Data: Industry Perspective

  
  Session Chair(s):

  • Masahiro Takeuchi, DrSc,MPH
    Professor, Biostatistics and Pharmaceutical Medicine
    Kitasato University School of Pharmacy, Japan
  • Akio Uemura, PhD
    Director and Head, Regulatory Affairs
    Allergan Japan K.K., Japan

  Utilization of East Asian Clinical Data in Asian Drug Development - Part 2: In the second part of the session, we would like to ask speakers from the pharmaceutical industry to discuss their strategies and future visions of new drug development in East Asia, e.g. using case studies of drugs that obtained approvals in Japan based upon Asian MRCTs.

  Speaker(s):

  • Multiregional Clinical Trials (MRCTs) in Asia for Japanese NDA
    Masaya Kato, PhD
    Manager, Regulatory Affairs
    Otsuka Pharmaceutical Co., Ltd., Japan
  • Strategy on Planning of Multi regional Clinical Trials (MRCTs) in East Asia
    Shigeru Nakaji
    Planning & Administration Director, Medical & Development Division
    Astellas Pharma China Inc., China
• 4:45PM - 6:00PM

  Session 1: Panel Discussion

  Speaker(s):

  • Mark Bach
    Vice President and Head, Asia Pacific Medical Sciences
    Janssen, Pharmaceutical Companies of Johnson & Johnson, Singapore
  • Yasuto Otsubo
    Reviewer, Office of New Drug II
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Ling Su, PhD
    Strategic Advisor, Life Sciences
    Sidley Austin LLP, China
  • Mee Ryung Ahn, PhD
    Deputy Director, Oncology and Antibiotic Products Division, Drug Evaluation Dept
    Ministry of Food and Drug Safety (MFDS), Korea, Republic of
  • Li-Li Su
    Reviewer, Division of Pharmaceutical Sciences
    Center for Drug Evaluation, Taiwan
  • Yoshiaki Uyama, PhD
    Director, Review Planning Division, Office of Review Management
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Day 2 Tuesday, April 16, 2013

• 9:00AM - 12:00PM

  Development Strategies That Consider The Health Care Setting in Each Country

  
  Session Chair(s):

  • Stewart Geary, MD
    Vice President, Chief Medical Officer, Director, Corporate Medical Affairs HQ
    Eisai Co., Ltd., Japan
  • Yoshihiko Ono, RPh
    Executive Director, Head of Regulatory Affairs, Japan Development
    MSD K.K., Japan

  The ultimate goal of clinical development is to make medical products available to patients as soon as safety and efficacy have been confirmed. Despite recent success in speeding data collection and early approval through global clinical trials in recent years, this goal will only be half met if patients are not able to get access to new products in daily medical practice. Although we need to have a comprehensive understanding of the broad medical environment surrounding health care services such as health insurance and drug pricing in each country in order to supply products smoothly, there is still insufficient discussion about the differences in health care systems as they relate to access to medicines compared with topics directly associated with regulatory approval such as ethnic differences. This session will provide an opportunity for exchanging opinions on differences in the broad health care environment in China, Korea, and Taiwan and have a constructive discussion about development strategies that speed the access of patients to medicines.

  Speaker(s):

  • Overview
    Koichi Miyazaki
    Associate Director, Asia Development Dept
    Daiichi Sankyo Co., Ltd., Japan
  • The reform of health care system and medical administration in China
    Yutaka Masada
    CEO
    Beijing Rifengtaida International Medical Technology Consulting Company, Japan
  • The broad health care environment in Korea
    Masashi Fukuyama
    Director, External Relations Department
    Kyowa Hakko Kirin Co., Ltd., Japan
  • Development strategies that consider the healthcare policy in Taiwan
    Jackie Tieng
    Head of Marketing
    Takeda Pharmaceuticals Taiwan Ltd., Taiwan
• 11:30AM - 12:00PM

  Session 2: Panel Discussion

  Speaker(s):

  • Stewart Geary, MD
    Vice President, Chief Medical Officer, Director, Corporate Medical Affairs HQ
    Eisai Co., Ltd., Japan
  • Yoshihiko Ono, RPh
    Executive Director, Head of Regulatory Affairs, Japan Development
    MSD K.K., Japan
  • Koichi Miyazaki
    Associate Director, Asia Development Dept
    Daiichi Sankyo Co., Ltd., Japan
  • Yutaka Masada
    CEO
    Beijing Rifengtaida International Medical Technology Consulting Company, Japan
  • Masashi Fukuyama
    Director, External Relations Department
    Kyowa Hakko Kirin Co., Ltd., Japan
  • Jackie Tieng
    Head of Marketing
    Takeda Pharmaceuticals Taiwan Ltd., Taiwan
• 1:30PM - 3:00PM

  Workshop 1: Exploring Best Practices on Development Regulatory Affairs Related to Multi regional Clinical Trials (MRCTs) in China, Korea, and Taiwan (2nd)

  
  Session Chair(s):

  • Kosuke Mitsui
    Sub-leader, Dept of "Small Global" Clinical Development
    Otsuka Pharmaceutical Co., Ltd., Japan
  • Kensuke Morimoto
    Manager, Clinical Development Group, Asia Development Dept., R&D Div.
    Daiichi Sankyo Co., Ltd., Japan

  The DIA Annual Conference in Japan for Asian New Drug Development was established in Tokyo in May 2007. At that time, not many people in Japan were involved in Asian multinational clinical studies, Asian local clinical studies outside Japan, or Asian development regulatory aff airs. Now, several years later, there are more experienced individuals in Japan, and we have much more opportunities for collaboration with Asian countries. However, we need to ask ourselves an important question: Are our capabilities sufficiently advanced such that we can demonstrate adequate performance in the actual tasks required for Asian drug development individually? Answering this question was the leading motivation for holding the first tutorial session of DIA Japan at the DIA 6th Annual Conference in Japan for Asian New Drug Development, held in April 2012. The session chair and panelists shared their best practices on development regulatory affairs (at Tutorial Session 1) and clinical development (at Tutorial Session 2) related to multi regional clinical trials (MRCTs) in China, Korea, and Taiwan. Each session lasted for 90 minutes. Approximately half of the time during each session was allocated to answering questions from the audience, and it was very encouraging to see attendees forming long lines to ask questions.

  Speaker(s):

  • Yuko Kikuchi
    Senior Manager, Asia Clinical Regulatory Manager
    Eisai Co., Ltd., Japan
  • Min Kim
    Country Director
    EPS International (Korea) Limited, Korea, Republic of
  • Yumiko Kobayashi
    Manager and Regulatory Leader, Regulatory Affairs Group, Asia Development Dept
    Daiichi Sankyo Co., Ltd., Japan
  • Satoshi Kokubo, DVM,PhD
    Associate Director, Asian Clinical Development
    Astellas Pharma Inc., Japan
  • Isao Sasaki, PhD
    Director, Regulatory Affairs-Japan, Global Regulatory Affairs
    Astellas Pharma Inc., Japan
  • Tetsuomi Takano, RPh
    Senior Director, Head of Asian Development Strategy
    Astellas Pharma Inc., Japan
• 3:45PM - 5:15PM

  Workshop 2: Exploring Best Practices on Clinical Development related to Multi Regional Clinical Trials (MRCTs) in China, Korea, and Taiwan (2nd)

  
  Session Chair(s):

  • Yuko Kikuchi
    Senior Manager, Asia Clinical Regulatory Manager
    Eisai Co., Ltd., Japan
  • Tetsuomi Takano, RPh
    Senior Director, Head of Asian Development Strategy
    Astellas Pharma Inc., Japan

  The interactive tutorial sessions on new drug development in China, Korea, and Taiwan, which were very well received in last year’s conference (cf. Therapeutic Innovation & Regulatory Science 47 (1) 133-139, 2013), are again scheduled as “workshop” for the afternoon of Day 2 of this 7th Annual Conference. Panelists who have day-to-day experience in new drug development in Asia will lead the workshop, which will be particularly helpful to those who are planning to fi le IND/NDA in the region, who are interested in regulations and clinical development operations in East Asia, or who are already working on the front line of clinical development. The panelists will share their best practical know-how and tips on development regulatory affairs (at Workshop Session 1) and clinical development (at Workshop Session 2) related to MRCTs in China, Korea, and Taiwan from viewpoints of Japanese pharmaceutical companies and contract research organizations (CROs). Examples of China CDE panel meetings, consultations with regulatory agencies, updated regulatory information related to clinical trial (e.g. requirements for NDA submissions), along with some other topics, will be covered in Session 1. Selections of CROs and vendors, considerations on local IND holders, points to consider in conducting MRCTs in China, Korea, and Taiwan, audit findings to clinical study sites, exportation of blood samples from the region, and other topics will be covered in Session 2. Participants will have ample time for Questions and Answers and will be able to obtain valuable information. Please join us at this insightful workshop.

  Speaker(s):

  • Judy Kai
    Executive Director
    Asklep Inc., Japan
  • Min Kim
    Country Director
    EPS International (Korea) Limited, Korea, Republic of
  • Satoshi Kokubo, DVM,PhD
    Associate Director, Asian Clinical Development
    Astellas Pharma Inc., Japan
  • Kosuke Mitsui
    Sub-leader, Dept of "Small Global" Clinical Development
    Otsuka Pharmaceutical Co., Ltd., Japan
  • Kensuke Morimoto
    Manager, Clinical Development Group, Asia Development Dept., R&D Div.
    Daiichi Sankyo Co., Ltd., Japan