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Monoclonal Antibodies
Session Chair(s)
Richard M Lewis, PhD
CEO
Access BIO, United States
Monoclonal antibodies will be an important target for the development of biosimilar therapeutic products. This session will offer an example of the development of a monoclonal for the European market and some insights into the structure function relationship of monoclonal antibodies with respect to their evaluation of biosimilarity. The session will include a panel discussion of these issues and include the presenters and FDA.
Speaker(s)
Case Study
Stanley SeungSuh Hong, PhD
Celltrion Healthcare, Korea, Republic of
Senior Advisor
Technical Importance of Understanding Structural Activity Relationship
Cecil J. Nick, MS
Parexel Consulting, United Kingdom
FTOPRA, Vice President (Technical)
Panel Discussion - Additional Speaker
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
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