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[S45] Gene Therapy – Learn from the Cases
Session Chair(s)
Sumimasa Nagai, MD, PhD
Institute for Advancement of Clinical and Translational Science(iACT)
Kyoto University Hospital, Japan
In recent years, development of gene therapy products in Japan has increased and the first gene therapy product was approved in Japan. Regulatory systems that facilitate practical application of gene therapy (e.g., Cartagena consultation) was newly established. This session will present real world examples from the consultation and review processes in developing such products, from experts in industry and academia. This session will also discuss other issues to consider, such as the difference between these therapeutic products and pharmaceuticals.
Speaker(s)
Practice of Oncolytic Virus - Correspondence to Cartagena Protocol -
Takashi Kojima, MD, PhD
National Cancer Center Hospital East, Japan
Department of Gastrointestinal Oncology
Development Outline of HGF Plasmid for Conditional Approval and Future Development Plan in Japan
Tetsuya Ishihama
AnGes, Inc., Japan
Director of Clinical Development Department
Points to Consider in the Development of Gene Therapy in Japan
Takaaki Yoshida
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of Cellular and Tissue-based Products