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Session 3: Bridging the Gap for CMC Assessments Comparability Through Risk-based Control Strategies – Part 2
Session Chair(s)
Mia Kiistala
Owner, Principal Consultant, Aurora CMC Consulting, Finland
Anthony Bevivino, PHD
Associate Principal Scientist, Merck & Co., Inc., United States
Cortney Lawrence, PHD
Research Scientist, Global Regulatory Affairs CMC Biotechnology, Eli Lilly and Company, United States
Continue the conversation on this topic with three additional experts.
Speaker(s)
Linda Engle, PHD
Principal Scientist, Technical Development/Associate Director, CMC Gene Therapy, Biogen, United States
CMC Strategy
Reena Patel, PHD
Director, Analytical Development – Cell & Gene Therapy, Vaccines, Janssen Pharmaceuticals, United States
Lessons Learned from Comparability
Bernice Westrek-Esselink
Associate Director, Operations, COE Microbiology, MSD Netherands, Netherlands
Rapid Microbiological Methods
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