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SESSION 5 - Data Collection and Utilization for Gene Therapy Products after Launch
Session Chair(s)
Sumimasa Nagai, MD, PhD
Institute for Advancement of Clinical and Translational Science(iACT)
Kyoto University Hospital, Japan
In 2019, two gene therapy products have been approved as regenerative medicine in Japan, marking the first year of Japan’s gene therapy commercialization. Gene therapy products are the products that highly require continuous evaluation of efficacy and safety even after the launch in the market. Given the circumstances where more gene therapy products are expected to be approved in the future, pharmaceutical companies are taking an increasing interest in procedures for relevant data collection, such as scheme and contents and how to utilize them. In this session, the specialists will explain the current situation surrounding the ongoing data collection for the two gene therapies approved this year. In addition, we will discuss how to plan and prepare appropriate data collection measures for future gene therapy products.
Speaker(s)
Hematopoietic Cell Transplantation and Cellular Therapy Registry in Japan
Yoshiko Atsuta, MD, PhD
The Japanese Data Center for Hematopoietic Cell Transplantation (JDCHCT), Japan
Head
Post Marketing Strategies of Novel Gene Therapy Product Collategene
Mitsuaki Chujo, PhD
AnGes, Inc., Japan
Director, Pharmacovigilance Department
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