9th DIA Cell and Gene Therapy Products Symposium in Japan

Development of Next-Generation Cell and Gene Products - Issues in Development of Existing Products and Prospects for Practical Application of Next Generation Products -

戻る Agenda

Session 1 : Ethical Perspectives and Ind-Aca-Gov Initiatives on Providing Out-of-Specification Autologous Cell Products

Session Chair(s)

Masafumi Onodera, MD, PHD

Director, Center of Gene Cell Therapy Promotion,

National Center for Child Health and Development, Japan

Yoshie Tsurumaki

HEALIOS K.K., Japan

Speaker(s)

Initiatives to Address Patient Access to Out-of-Specification Products

Yayoi Kitawaki, MS

Novartis Pharma K.K., Japan

Department Head, Neuroscience, GTx Development Unit

About Theme (1) (Safety which Corresponds to a Problem of Access and Establishment of a Quick Approval System to Drug Losses and Medical Products of a Short Supply, etc.).

Akira Iino

Ministry of Health, Labour and Welfare, Japan (MHLW), Japan

Medical Device Evaluation Division

First Results of Out-of-Specification Tisagenlecleucel in Japanese Patients With R/R B-ALL and R/R DLBCL

Koji Kato

Kyushu University, Japan

Faculty of Medical Sciences Department of Clinical Medicine Associate Professor

Kiyoshi Okada, MD, PHD

the University of Osaka & the University of Osaka Hospital, Japan

Professor , Deputy Director, Regenerative Medicine Support Office, Future Medica