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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)
CMC Strategy
Linda Engle, PhD
Biogen, United States
Principal Scientist, Technical Development/Associate Director, CMC Gene Therapy
Lessons Learned from Comparability
Reena Patel, PhD
Janssen Pharmaceuticals, United States
Director, Analytical Development – Cell & Gene Therapy, Vaccines
Rapid Microbiological Methods
Bernice Westrek-Esselink
MSD Netherands, Netherlands
Associate Director, Operations, COE Microbiology