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DIA/FDA Oligonucleotide-Based Therapeutics Conference
Session 2 Track C: Recently Approved Oligonucleotide Drugs
G. Susan Srivatsa, PhD
- 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.
Strategies for Addressing Regulatory Agency Questions During Marketing Application Review for Oligonucleotides Drugs
Jennifer A. Franklin, PhD
- Director, CMC RegulatoryAffairs
- Ionis Pharmaceuticals, Inc., United States
ONPATTRO® (Patisiran) A First-in-Class RNA Interference (RNAi) Therapeutic
Benjamin Stevens, PhD, MPH
- Associate Director, Regulatory Affairs CMC
- Alnylam Pharmaceuticals, United States
René Thürmer, PhD
- Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
- Federal Institute for Drugs and Medical Devices, Germany
Lawrence Perez, PhD
- Review Chemist
- FDA, United States
- Team Leader, Evaluator
- Health Canada, Canada