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[S38] Regenerative Medical Products - Learn from the Latest Approved Products -
Session Chair(s)
Daisaku Sato, PhD, MPharm, RPh
Director, Compliance & Narcotics Division
Ministry of Health, Labour and Welfare, Japan
Two new regenerative medical products were approved in 2018, after 3 years since last approval. Many academias and the industries are working on researches and development toward the commercialization of regenerative medical products to cure the intractable diseases. In this session, we will have speakers from the companies that had recently approved products and from PMDA. The issues to address which occurred during the development and/or after launch will be presented, in addition, reviewer’s points of view will be explained. Attendees will expect to learn the cases from the lectures and panel discussion.
Speaker(s)
Strategy, Issues, and Challenges - the Case of Stemirac
Yoshihiro Yoshikawa
Nipro Corporation, Japan
General Manager, Research & Development Center for Regenerative Medicine
Development Strategy and Challenges for Practical Application in Kymriah
Yayoi Kitawaki, MS
Novartis Pharma K.K., Japan
Head, RA Immunology Japan, Global Development Division
Evaluation of Regenerative Medical Products - General Considerations -
Yoshiaki Maruyama, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of Cellular and Tissue-based Products