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Session 2 - Tumorigenicity of Cell Therapy Products Towards Consensus in Safety Assessment
Session Chair(s)
Sosuke Miyoshi, PhD
Astellas Pharma Inc., Japan
Speaker(s)
Tumorigenicity: A Matter of Non-Clinical Safety? or a Matter of Quality?
Yoji Sato, PhD
National Institute of Health Sciences, Japan
Head, Division of Drugs
Implications of Regional Tumorigenicity Requirements on the Global Development of Cell Therapy Products: Is Convergence Possible?
Katherine Tsokas, JD
Janssen Research and Development, LLC, United States
Senior Director, Global Regulatory Affairs
Pre-Clinical Evaluation of Gene-Modified T Cells
Hiroaki Ikeda, MD, PhD
Nagasaki University Graduate School of Medicine, Japan
Professor
International Cooperation for Standardization and Harmonization of Tumorigenicity Testing Methods for Stem Cell-Based Therapeutic Products
Keiji Yamamoto, DVM, PhD, MBA
Takeda Pharmaceutical Company Limited, Japan
Senior Director, Japan Drug Safety Research Laboratories
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