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项目委员会
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Jim Zisek Director, Global CMC Regulatory Affairs
GlaxoSmithKline, United States -
Robert T. Dorsam, PHD Associate Director, Pharmacology/Toxicology, Office of Generic Drugs, CDER
FDA, United States -
Daniel Capaldi, PHD Vice President, Analytical and Process Development
Ionis Pharmaceuticals, Inc, United States -
Arthur A. Levin, PHD Distinguished Scientist
Avidity Biosciences, United States -
Jan Kevin Losos, PHD Director, Safety Assessment Projects
GlaxoSmithKline, United States -
Saraswathy V. Nochur, PHD, MSC Chief Regulatory Officer
Alnylam Pharmaceuticals, United States -
Ramesh Raghavachari, PHD Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER
FDA, United States -
David H. Schubert
United States -
Pengfei Song, PHD Senior Clinical Phamacology Reviewer in Oncology, CDER
FDA, United States -
James Wild, PHD, MS Pharmacologist, CDER
FDA, United States -
Rosanne Seguin, PHD
McGill University, Canada -
Scott Henry, PHD Senior Vice President, Nonclinical Development
Ionis Pharmaceuticals, Inc., United States
