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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S38] Regenerative Medical Products - Learn from the Latest Approved Products -

Session Chair(s)

Daisaku  Sato, PhD, MPharm, RPh

Daisaku Sato, PhD, MPharm, RPh

  • Chief Management Officer & Associate Centre Director for Regulatory Science
  • Pharmaceuticals and Medical Devices Agency (PMDA), 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.


Yoshihiro  Yoshikawa

Strategy, Issues, and Challenges - the Case of Stemirac

Yoshihiro Yoshikawa

  • General Manager, Research & Development Center for Regenerative Medicine
  • Nipro Corporation, Japan
Yayoi  Kitawaki, MS

Development Strategy and Challenges for Practical Application in Kymriah

Yayoi Kitawaki, MS

  • Senior Japan Program Head, Oncology Development Unit, Japan Development
  • Novartis Pharma K.K., Japan
Yoshiaki  Maruyama, PhD

Evaluation of Regenerative Medical Products - General Considerations -

Yoshiaki Maruyama, PhD

  • Review Director, Office of Cellular and Tissue-based Products
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan