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4th DIA Cell and Gene Therapy Products Symposium in Japan

All prices are exclusive of 10% Japanese consumption tax

SESSION 2 - Concept of Comparability in Cell and Gene Products

Session Chair(s)

Masaki  Kasai, PhD

Masaki Kasai, PhD

  • Principal Reviewer, Office of Cellular and Tissue-basaed Products
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Keiji  Miyamoto

Keiji Miyamoto

  • Principle, Regulatory Affairs Group, Post-Marketing Regulatory Affairs Dept.
  • Daiichi Sankyo Co., Ltd., Japan
The manufacturers of regenerative medicines make changes during the development and after approval, for the purposes of improving the process, scale-up, site-changes, and so on. As an approach to explain comparability, some cases are appropriate to follow the biotechnological products, while some cases are not, then the extent of requirement to demonstrate comparability is an issue. In this session, we will have speakers who will share their insights and experiences. The panel discussion will follow to figure out the general considerations and approaches to the current issues.

Speaker(s)

Akiyoshi  Kunieda

The Concept of Comparability in Cell and Gene Therapy

Akiyoshi Kunieda

  • Reviewer, Office of Cellular and Tissue-based Products
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoji  Sato, PhD

Comparability in Manufacturing and Characterization of Regenerative Medical Products

Yoji Sato, PhD

  • Head, Division of Cell-Based Therapeutic Products
  • National Institute of Health Sciences, Japan
Shin  Kawamata, MD, PhD

Comparability Test for Cellular Products in the Case of Addition of Manufacturing Site

Shin Kawamata, MD, PhD

  • Director, R&D Center for Cell Therapy
  • Translational Research Center for Medical Innovation(TRI), Japan
Masafumi  Onodera, MD, PhD

Points to Consider of Comparability in Viral Vectors

Masafumi Onodera, MD, PhD

  • Director, Center of Gene Cell Therapy Promotion,
  • National Center for Child Health and Development, Japan

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