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Navigating Expedited Approval Pathways in Japan for Global Development Strategy

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Navigating Expedited Approval Pathways in Japan for Your Global Development Strategy

An ISCT Asia Regional Executive Committee Webinar
Sponsored by the Foundation for Biomedical Research and Innovation at Kobe



About the Webinar
Recent progress of regenerative medicine is remarkable in worldwide and collaboration between industry, academia, and regulation is going to be more important for the practical application in clinical development. There are several differences in approval process in Japan from that in other countries.

In Japan, the 1st CAR-T treatment (tisagenlecleucel) was approved in 2019 based on two multinational clinical trials. Dr. Hirose will show us his experience for the practical application from the viewpoint of foreign-affiliated pharmaceutical company.

Several expedited regulatory review projects for innovative regenerative medical products, such as Kymriah, developed in Japan as well as US/EU. Dr. Nagai will introduce the Japanese regulatory pathways and regenerative medical products that were granted marketing authorization in this particular country.

Satoshi Takahashi, MD, PhD, 
Past Regional Vice-President, ISCT Asia Regional Executive Committee
Associate Professor, Institute of Medical Science University of Tokyo, Japan


Tohru Hirose, PhD, 
Director, Division Head, Global Drug Development Division Novartis Pharma K.K., Japan

Presentation: Development of Chimeric Antigen Receptor T-cell (CAR-T) treatment in Japan

Tohru Hirose will share insights about building bridges, through the story of one of the most successful cell therapy products to date. Get a firsthand viewpoint on how a CAR-T treatment (tisagenlecleucel), originating from the University of Pennsylvania in the United States, made its way to Japan. Learn about practical considerations from the viewpoint of an international pharmaceutical company working with regional regulatory authorities

Sumimasa Nagai, MD, PhD, 
Senior Assistant Professor and Deputy Director, Translational Research Center, The University of Tokyo Hospital, Japan

Presentation: Regulatory approvals of regenerative medical products in Japan

Sumimasa Nagai will discuss regulatory pathways in Japan, and introduce us to several regenerative medicine products that have been granted marketing authorization in Japan. Learn about key factors to consider when interacting between commercial and regulatory perspectives, which will help when making key scientific, regulatory, operational, and economic decisions that will benefit your company.


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