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Session 2 Track C: Recently Approved Oligonucleotide Drugs
Session Chair(s)
G. Susan Srivatsa, PhD
President
ElixinPharma, United States
This session will address the CMC challenges associated with the review and approval of inotersen and patisiran. Presentations will be followed by a panel discussion.
Speaker(s)
Strategies for Addressing Regulatory Agency Questions During Marketing Application Review for Oligonucleotides Drugs
Jennifer A. Franklin, PhD
Ionis Pharmaceuticals, Inc., United States
Director, CMC RegulatoryAffairs
ONPATTRO® (Patisiran) A First-in-Class RNA Interference (RNAi) Therapeutic
Benjamin Stevens, PhD, MPH
GlaxoSmithKline, United States
Director CMC Policy and Advocacy
Panelist
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
Panelist
Lawrence Perez, PhD
FDA, United States
Senior Pharmaceutical Quality Assessor, CDER
Panelist
Ian Dobson
Health Canada, Canada
Team Leader, Evaluator