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SESSION 2 - Concept of Comparability in Cell and Gene Products
Session Chair(s)
Masaki Kasai, PhD
Review Director, Office of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Keiji Miyamoto
Principal Post-Marketing Regulatory Affairs Dep., 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
Reviewer, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
The Concept of Comparability in Cell and Gene Therapy
Yoji Sato, PhD
Deputy Director General, National Institute of Health Sciences, Japan
Comparability in Manufacturing and Characterization of Regenerative Medical Products
Shin Kawamata, MD, PhD
Director, R&D Center for Cell Therapy, Translational Research Center for Medical Innovation(TRI), Japan
Comparability Test for Cellular Products in the Case of Addition of Manufacturing Site
Masafumi Onodera, MD, PhD
Director, Center of Gene Cell Therapy Promotion,, National Center for Child Health and Development, Japan
Points to Consider of Comparability in Viral Vectors
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