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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

  • 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)

Jennifer A. Franklin, PhD

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
Benjamin  Stevens, PhD, MPH

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

Panelist

René Thürmer, PhD

  • Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
  • Federal Institute for Drugs and Medical Devices, Germany
Lawrence  Perez, PhD

Panelist

Lawrence Perez, PhD

  • Review Chemist
  • FDA, United States
Ian  Dobson

Panelist

Ian Dobson

  • Team Leader, Evaluator
  • Health Canada, Canada