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[V6-S1] Challenges and Issues to Product Development for Gene Therapy
Session Chair(s)
Masafumi Onodera, MD, PHD
Director, Center of Gene Cell Therapy Promotion,, National Center for Child Health and Development, Japan
In recent years, the development of products for genetic therapy became popular all over the world, and concrete discussions on commercialization have been carried out recently in Europe and US. On the other hand, in using genetically modified products, Japan and the EU have ratified the Cartagena Protocol, and in Japan it is necessary to consider environmental impacts on biosafety based on regulations by Japan original law. In this session, we focus on the differences in the system of Japan, the US and Europe, and discuss the point to be cleared for conducting clinical trials in Japan when we submit the Cartagena Law type 1 usage application. We discuss issues to be considered for future practical application.
Speaker(s)
Teruhide Yamaguchi, PHD
Professor, Nihon Pharmaceutical University / Kanazawa-Instituite of Technology, Japan
Comparison of Regulations on Biosafety in Japan, the US and Europe and Issues in Japan
Hiroyuki Suda, MSC
VP, Clinical Development Strategy, KORTUC Inc., Japan
Points to Consider in the Cartagena Law Type 1 Usage Application (Point of View from a Company)
Kazunobu Oyama, PHD
Senior Vice President, ONODERA GT Pharma, Inc., Japan
Points to Consider for Creating Cartagena Type 1 Usage Application (From PMDA Point of View)