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4th DIA Cell and Gene Therapy Products Symposium in Japan
- Development and Practical Use of Cell and Gene Therapy Products in Japan and Across the Globe -
Day 1: Cell and Gene Therapy Products; New Challenges in Global Development
Day 2: Cell and Gene Therapy Products; Reality of “From Bench to Bedside”
Accelerated by new regulatory and legal systems that came into practice in 2013, development of regenerative medicine in Japan has attracted considerable international attention. Many recent advances in the development of cell therapy products in Japan have been reported in articles not only in scientific journals but in more general publications. These advancements and reports have revealed numerous issues in the development, distribution, and post-market management of these products.
Since 2016, DIA Japan has brought together stakeholders involved in developing cell therapy products, particularly from industry and academia, for our annual Cell Therapy Products Symposium, and we announce with great pleasure that our 4th Cell and Gene Therapy Products Symposium is scheduled for December 16-17, 2019.
The mission of this Symposium – to exchange insights and ideas with relevant regulatory and other government authorities that deepen mutual understanding and resolve issues of concern around these products – has remained unchanged since 2016. But in 2018, we expanded our agenda to include gene therapy, reflecting scientific progress in this area as well as requests from these stakeholders. Our agenda for 2019 has further expanded to cover essential challenges and issues encountered in each stage of development, in a global development strategy, for these novel therapeutics.
For 2019, three key opinion leaders will deliver keynote addresses on their cutting-edge research; Professor Kounosuke Mitani, Saitama Medical University, on genome editing; Professor Koji Eto, CiRA, on platelet production from iPS cells; and Professor Hiroshi Shiku, Mie University, on CAR-T research. In addition, speakers from PMDA will be joined by speakers from FDA and EMA to share through lectures and joint panel discussions the current state of regulatory and related frameworks across Japan, Europe, and the US.
While this program presents the opportunity to attend either the first or second day independently, we invite you to participate through both days. For example, approaching the comparability of cell/gene products will be discussed on day one; day two will discuss updates on the Cartagena Act and on the concepts and requirements for long-term post-marketing follow-up.
We hope that our 4th Cell and Gene Therapy Products Symposium will continue to provide the best framework for exchanging knowledge and sharing insights about these products in Japan, and also provide high-value networking opportunities for you and your colleagues. We look forward to your active participation in Tokyo.
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Daisaku Sato, PhD, MPharm, RPh Director, Compliance & Narcotics Division
Ministry of Health, Labour and Welfare, Japan
Yasuko Terao, PhD Head, External Scientific Engagement, R&D Japan Region,
Takeda Pharmaceutical Co., Ltd., Japan
Teruyo Arato, PhD Professor, Clinical Research and Medical Innovation Center
Hokkaido University Hospital, Japan
Masaki Kasai, PhD Reviewer, Office of Cellular and Tissue-based Products,
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Satoru Hayata, MS
Sobi Japan, Japan
Keiji Miyamoto Principal Post-Marketing Regulatory Affairs Dep.
Daiichi Sankyo Co.,Ltd., Japan
Sumimasa Nagai, MD, PhD Institute for Advancement of Clinical and Translational Science(iACT)
Kyoto University Hospital, Japan
Hiromi Okabe, PhD Immunology, Regulatory Affairs Japan,Global Drug Development Division
Novartis Pharma K.K, Japan
Masafumi Onodera, MD, PhD Director, Center of Gene Cell Therapy Promotion,
National Center for Child Health and Development, Japan
Hiroyuki Suda, MSc VP, Clinical Development Strategy
KORTUC Inc., Japan
Yoshie Tsurumaki Group Manager, Cell & Gene Franchise
Novartis Pharma K.K., Japan
Akiko Ikeda, RPh Associate Director, Regulatory Development Dept.
Janssen Pharmaceutical K.K., Japan
Yoji Sato, PhD Head, Division of Drugs
National Institute of Health Sciences, Japan
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