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DIA/FDA Oligonucleotide-Based Therapeutics Conference

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Session 4 Track 3: CMC Perspective on Early and Late Stage Oligonucleotide Programs

Session Chair(s)

Firoz Antia, PhD

Firoz Antia, PhD

  • Head of Oligonucleotide Development
  • Biogen, United States
In recent years, a number of oligonucleotide therapeutics have received market license authorizations in the US, Canada, Europe and other countries. There is also an increasing number of oligonucleotides entering clinical trials worldwide. This session will present recent experience with the review of CMC dossiers of early and late-stage oligonucleotide programs. Presentations from Alnylam and Ionis will be followed by a panel discussion that may include representatives from the FDA and BfArM.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Gain perspective on CMC strategies for single and double stranded oligonucleotides
  • Understand current CMC expectations for market license authorizations
  • Design CMC plans for early-stage programs for longer term success

Speaker(s)

Melissa Marschel, MS

siRNA Lifecyle: Successful Regulatory Strategies

Melissa Marschel, MS

  • Director, Regulatory Affairs
  • Alnylam Pharmaceuticals, United States
Tracey Burr, PhD, MSc

Regulatory Interactions and Intelligence for Development and Late Phase Programs

Tracey Burr, PhD, MSc

  • Director, CMC Regulatory Affairs
  • Ionis Pharmaceuticals, United States
Lawrence Perez, PhD

Panelists

Lawrence Perez, PhD

  • Senior Pharmaceutical Quality Assessor, CDER
  • FDA, United States
René Thürmer, PhD

René Thürmer, PhD

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

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