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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
Executive Director, CMC RegulatoryAffairs, Ionis Pharmaceuticals, Inc., United States
ONPATTRO® (Patisiran) A First-in-Class RNA Interference (RNAi) Therapeutic
Benjamin Stevens, MPH
Senior Director, Regulatory Affairs CMC Policy and Advocacy, Alnylam Pharmaceuticals, United States
Panelist
René Thürmer
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM, Federal Institute for Drugs and Medical Devices, Germany
Panelist
Lawrence Blas Perez, PhD
Senior Pharmaceutical Quality Assessor, CDER, FDA, United States
Panelist
Ian Dobson
Team Leader, Evaluator, Health Canada, Canada
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