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Program Committee
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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 CSO
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 Chief, Branch I, DPMA1, OLDP, OPQ, CDER
FDA, United States -
David H. Schubert
DH Schubert Regulatory Solutions LLC, United States -
Pengfei Song, PhD Senior Clinical Phamacology Reviewer in Oncology, CDER
FDA, United States -
James Wild, PhD Pharmacologist, CDER
FDA, United States -
Rosanne Seguin, PhD
McGill University, Canada -
Scott Henry, PhD Vice President, Nonclinical Development
Ionis Pharmaceuticals, Inc., United States
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