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Bethesda North Marriott Hotel and Conference Center

Oct 28, 2019 7:00 AM - Oct 30, 2019 12:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Session 2 Track C: Recently Approved Oligonucleotide Drugs

Session Chair(s)

G. Susan  Srivatsa, PhD

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.


Jennifer A. Franklin, PhD

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

Benjamin  Stevens, PhD, MPH

ONPATTRO® (Patisiran) A First-in-Class RNA Interference (RNAi) Therapeutic

Benjamin Stevens, PhD, MPH

GlaxoSmithKline, United States

Director CMC Policy and Advocacy

René  Thürmer, PhD


René Thürmer, PhD

Federal Institute for Drugs and Medical Devices, Germany

Deputy Head of the Unit Pharmaceutical Biotechnology BfArM

Lawrence  Perez, PhD


Lawrence Perez, PhD

FDA, United States

Senior Pharmaceutical Quality Assessor, CDER

Ian  Dobson


Ian Dobson

Health Canada, Canada

Team Leader, Evaluator

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