Section 1 (Gene Therapy)

In the Section 1, we evaluate efficacy and safety of vectors used in gene therapy.

Drug of Gene Therapy

• List of Gene Therapy Clinical Study Protocols Approved in Japan
• Current Status of Gene Therapy Products in Japan (Nov.2010)

ICH

• The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Gene Therapy Discussion Group (GTDG)   * We participate in the Discussion Group.
  • ICH Considerations on Oncolytic Viruses (Sep. 17, 2009)
  • ICH Considerations on Viral/Vector Shedding (General Principles to Address Virus and Vector Shedding) (Jun.11, 2009)
  • ICH Considerations on General Principles to Address the Risk of Inadvertent Germline Integration of Gene Therapy Vectors (Oct. 25, 2006)
• Symposia on ICH GTDG Activities and Current Topics in Gene Therapy (Jun, 2009)
  • "Overview of ICH GTDG Activities and Current Topics in Gene Therapy" by Dr Klaus Cichutek (PEI, EMEA)
  • "ICH Considerations on General Principles to Address the Risk of Inadvertent Germline Integration of Gene Therapy Vectors and Current Topics on Gene Therapy in USA" by Dr Beth Hutchins (PhRMA)
  • "Summary of 3 Topics in Japanese; Oncolytic Viruses, Germline Integration and Viral/Vector Shedding" by Dr Teruhide Yamaguchi (NIHS) [in Japanese]
  • "ICH Activities - Regional Topics" by Dr Andreas Marti (Swiss Medic, EFTA)
  • "ICH Considerations on Viral/Vector Shedding; and Overview of Gene Therapy Activity in Canada" by Dr Anthony Ridgway (Health Canada)

Guidelines

• Guidelines

Members

Section Chief	Eriko Uchida, Ph.D.
Research Assistant	Satoko Matsuyama
Visiting Scientist	Mieko Kogi, Ph.D. (Professor in Kanazawa Institute of Technology)