Advanced Therapies: Innovations in CMC Conference

Solutions for CMC challenges in the development and commercialization of cell therapy, gene therapy, and gene editing products.

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Session 3: Bridging the Gap for CMC Assessments Comparability Through Risk-based Control Strategies – Part 2

Owner, Principal Consultant

Aurora CMC Consulting, Finland

Associate Principal Scientist

Merck & Co., Inc., United States

Research Scientist, Global Regulatory Affairs CMC Biotechnology

Eli Lilly and Company, United States

Continue the conversation on this topic with three additional experts.

Linda Engle, PhD

Biogen, United States

Principal Scientist, Technical Development/Associate Director, CMC Gene Therapy

Reena Patel, PhD

Janssen Pharmaceuticals, United States

Director, Analytical Development – Cell & Gene Therapy, Vaccines

Bernice Westrek-Esselink

MSD Netherands, Netherlands

Associate Director, Operations, COE Microbiology

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