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Session 4 Track 3: CMC Perspective on Early and Late Stage Oligonucleotide Programs
Session Chair(s)
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)
siRNA Lifecyle: Successful Regulatory Strategies
Melissa Marschel, MS
Alnylam Pharmaceuticals, United States
Director, Regulatory Affairs
Regulatory Interactions and Intelligence for Development and Late Phase Programs
Tracey Burr, PhD, MSc
Ionis Pharmaceuticals, United States
Director, CMC Regulatory Affairs
Panelists
Lawrence Perez, PhD
FDA, United States
Senior Pharmaceutical Quality Assessor, CDER
René Thürmer, PhD
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
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