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) |