Accelerated by new regulatory and legal systems that came into practice in 2013, the development of regenerative medicine in Japan has attracted considerable international attention. Today, research has progressed to the point that many cell therapy products are now entering clinical development by companies both within and outside Japan. This has revealed a number of issues in the development, distribution, and post-market management of these products.
DIA Japan has brought together stakeholders involved in developing cell therapy products, particularly from industry and academia, for our annual Cell Therapy Products Symposium since 2016. Its mission then, as it is now, is to exchange insights and ideas with relevant regulatory and other government authorities in order to deepen mutual understanding and resolve issues of concern about these products. Our third annual offering adds gene therapy products to its agenda, reflecting scientific progress in this area as well as requests from these stakeholders, and has been renamed as our Cell and Gene Therapy Products Symposium.
In the keynote lecture, Professor Jun Takahashi of RIKEN will talk about product development with induced pluripotent stem (iPS) cells before commercialization, and the Cabinet Office will present its perspective on the future prospects of gene therapy products in Japan.
Evolution of Japan Environment for Cell Therapy Products, the first day of this two-day symposium, will follow the frameworks from the first and second annual symposiums and cover issues from the quality and non-clinical use of cell therapy products to commercialization and post-marketing measures. These conversations will compare the current state of regulations and related frameworks between Japan, Europe, and the US.
On day two, Challenges for Gene Therapy Product Development and Manufacture in Japan, we will explore in an educational session the current state of research and development of gene therapy products in Japan. Our deep dive session will examine country-specific concerns such as the operation of biodiversity evaluation under the Cartagena Act, which requires a strategic approach to realize the practical commercialization and application of gene therapy products. International speakers have been invited for both days to share current activities and challenges in harmonized global development.
While this program has been prepared to give you the opportunity to attend either the first day or second day independently, we invite you to participate through both days; you will notice that many topics and concerns are common between both cell and gene therapy products.
The DIA Cell Therapy/Gene Therapy Product Symposium encourages open and ongoing discussion across industry, academia, and government stakeholders. We hope this Symposium will continue to grow into the best place for exchanging knowledge and sharing insights about these products and as a highly valued networking opportunity for you and your colleagues. We look forward to your active participation in Tokyo.
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Teruyo Arato, PhD Professor, Clinical Research and Medical Innovation Center
Hokkaido University Hospital, Japan
Yoji Sato, PhD Head, Division of Drugs
National Institute of Health Sciences, Japan
Yasuko Terao, PhD Head, External Scientific Engagement, R&D Japan Region,
Takeda Pharmaceutical Co., Ltd., 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
Kazuhiro Takekita Instructor, Department of Cardiovascular Surgery, Graduate School of Medicine,
Osaka University, 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
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