Overview
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”
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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.
Who should attend?
Program Committee
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Daisaku Sato, PhD, MPharm • Chief Management Officer & Associate Centre Director for Advanced Evaluation
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Yasuko Terao, PhD • Director, External Collaboration and Portfolio Management Department
Janssen Pharmaceutical K.K., Japan -
Teruyo Arato, PhD • Professor, Clinical Research and Medical Innovation Center
Hokkaido University Hospital, Japan -
Masaki Kasai, PhD • Principal Reviewer, Office of Cellular and Tissue-basaed Products
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Satoru Hayata, MS • Head of Center, Rare Diseases Medicine Development Centre
GlaxoSmithKline K.K., Japan -
Keiji Miyamoto • Principle, Regulatory Affairs Group, Post-Marketing Regulatory Affairs Dept.
Daiichi Sankyo Co., Ltd., Japan -
Sumimasa Nagai, MD, PhD • Senior Assistant Professor, Translational Research Center
The University of Tokyo Hospital, Japan -
Hiromi Okabe, PhD • Manager, Global Regulatory Management Group, New Drug Regulatory Affairs Dept.
Daiichi Sankyo Co., Ltd., Japan -
Masafumi Onodera, MD, PhD • Head, Department of Human Genetics / Chief, Division of Immunology
National Center for Child Health and Development, Japan -
Hiroyuki Suda, MSc • Senior Director, Clinical Operation Department
Oncolys BioPharma Inc., Japan -
Yoshie Tsurumaki • Senior Incubator Program Manager, CTL019 Incubator Dept, Oncology Dev. & MA Dept
Novartis Pharma K.K., Japan -
Akiko Ikeda, RPh • Senior Manager, Policy Intelligence Dept., Integrated Market Access Division
Janssen Pharmaceutical K.K., Japan -
Yoji Sato, PhD • Head, Division of Cell-Based Therapeutic Products
National Institute of Health Sciences, Japan
