概要
11th DIA Cell and Gene Therapy Products Symposium in Japan
The Future Pioneered by Japanese Innovation
The DIA Cell Therapy and Gene Therapy Symposium in Japan has been a forum for discussion of topics centered on the industrialization and implementation of regenerative medicine and gene therapy, and last year marked its 10th anniversary. This year, as we embark on a new chapter, the world’s first two iPS cell products have been approved, heightening expectations that innovations originating in Japan will spread across the globe. This year’s symposium will continue to serve as a “forum for dialogue” where we can collectively consider the challenges and guidelines needed to further accelerate this trend - where drug discovery innovation is no longer merely flowing from the world to Japan, but is now moving in both directions, from Japan to the world.
To ensure this serves as a valuable opportunity to jointly envision the future of regenerative medicine and gene therapy, our agenda features these four sessions, including two focused on iPS cells. We hope to share through these sessions the latest achievements and insights and together envision “the future opened up by Japanese innovation.”
- Unraveling Case Studies of iPS Cell Commercialization : The Path from Development to Commercialization and Strategies
- The Goals of iPS Cell Products and Approaches to Development : Division of Labor and Collaboration Between Academia and Industry (What Is the Ideal Model?)
- How to Set Reasonable Clinical End Points for Gene Therapy in Rare Disease Clinical Trials?
- Behind the Scenes of Regulatory Shaping : Using the Debate on Viral Safety as an Example
Furthermore, this year we plan to invite researchers from academia and industry who are leading R&D in regenerative medicine and gene therapy, as well as representatives from the government and regulatory authorities who support these efforts, to present the latest topics through keynote speeches and other sessions.
This Symposium will be held in a hybrid format. To provide a more engaging “forum for dialogue,” we will set up an in-person venue at the Nihonbashi Life Science HUB and host a networking event designed to facilitate open discussion. We will also offer online participation to accommodate as many attendees as possible, and plan to distribute presentation materials and stream video recordings of the lectures after the Symposium concludes.
We sincerely look forward to your participation.
プログラム委員会
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Sumimasa Nagai, MD, PhD Institute for Advancement of Clinical and Translational Science(iACT)
Kyoto University Hospital, Japan -
Yuta Fujii Regulatory Compliance Office, Regulatory Affairs Dep.
Otsuka Pharmaceutical Co., Ltd. , Japan -
Ikuo Kawauchi Senior Expert,International Standards Promotion Office,Intellectual Property Div
FUJIFILM Holdings Corporation, Japan -
Akiyo Fujikawa Senior Director of Regulatory Affairs
Aurion Biotech Japan, LLC, Japan -
Ryutaro Hirasawa CMC Regulatory Affairs, Associate Director
Daiichi Sankyo Co., Ltd., Japan -
Akiko Ikeda, RPh Regulatory affairs
T Cell Noveau Inc., Japan -
Ryuji Kato Associate Professor
Tokai National Higher Education and Research System, Nagoya University, Japan -
Akihiro Kume Advisor, Corporate Planning Office
BREXA Advan Inc., Japan -
Atsushi Nishikawa Reviewer, Office of Cellular and Tissue-based Products
Pharmaceuticals and Medical Devices Agency (PMDA), Japan -
Kiyoshi Okada, MD, PhD Professor , Deputy Director, Regenerative Medicine Support Office, Future Medica
the University of Osaka & the University of Osaka Hospital, Japan -
Hiroyuki Suda, MSc VP, Clinical Development Strategy
KORTUC Inc., Japan -
Gentaro Tajima, MS Director, Regulatory Affairs
Ultragenyx Japan K.K., Japan -
Maki Tanaka General Manager, Project Management Department
Takara Bio Inc., Japan -
Yasuko Terao, PhD Head, External Scientific Engagement, R&D Japan Region,
Takeda Pharmaceutical Co., Ltd., Japan -
Satoshi Yasuda, PhD Head, Division of Cell-Based Therapeutic Products
National Institute of Health Sciences, Japan -
Mika Yoshimatsu Head of CMC Development
T Cell Nouveau Inc., Japan -
Hiroto Asou Reviewer, Office of New Drug IV
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
