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Quality Considerations - Part 2: Panel Discussion
Session Chair(s)
Sundar Ramanan, PhD
Director, Global Biosimilars R&D Policy
Amgen Inc., United States
CMC forms the foundation for Biosimilar development. Topics will focus on the nature biosimilar profile in comparison with the reference product and what highly similar means; the nature of tools and techniques used to describe “finger printing”; equivalence acceptance criteria; role of analytical similarity in extrapolation and how does on go about addressing attributes that are outside the equivalence window.
Speaker(s)
Panelists
Joseph L Glajch
Momenta Pharmaceuticals, United States
Director, Analytical Development
Steven Kozlowski, MD
FDA, United States
Director, Office of Biotechnology Products, OPQ, CDER
Paul Tebbey, PhD, MBA
AbbVie, Inc., United States
Therapeutic Area Lead, Biotherapeutics Global Medical Affairs
Brad Jordan, PhD
Eli Lilly and Company, United States
Associate Vice President, Regulatory Policy and Strategy
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