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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S45] Gene Therapy – Learn from the Cases

Session Chair(s)

Sumimasa  Nagai, MD, PhD

Sumimasa Nagai, MD, PhD

  • Senior Assistant Professor, Translational Research Center
  • The University of Tokyo 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.


Takashi  Kojima, MD, PhD

Practice of Oncolytic Virus - Correspondence to Cartagena Protocol -

Takashi Kojima, MD, PhD

  • Department of Gastrointestinal Oncology
  • National Cancer Center Hospital East, Japan
Tetsuya  Ishihama

Development Outline of HGF Plasmid for Conditional Approval and Future Development Plan in Japan

Tetsuya Ishihama

  • Director of Clinical Development Department
  • AnGes, Inc., Japan
Takaaki  Yoshida

Points to Consider in the Development of Gene Therapy in Japan

Takaaki Yoshida

  • Reviewer, Office of Cellular and Tissue-based Products
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan