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Session 7A: Recently Approved and Late-Stage Oligonucleotide Drugs
Session Chair(s)
G. Susan Srivatsa, PhD
President
ElixinPharma, United States
This session will cover recent experience with approved and late-stage oligonucleotide drugs. The first presentation will address the CMC challenges associated with the review and approval of Nusinersen, and the second will cover regulatory experience with late-stage development of an siRNA drug. There will be a panel discussion that may include representatives from the FDA and BfArM.
Learning Objective :
Speaker(s)
SPINRAZA (nusinersen) Approval: CMC Strategies and Lessons Learned
Firoz Antia, PhD
Biogen, United States
Head of Oligonucleotide Development
CMC Strategies for Late-Stage Development of siRNA Oligonucleotides
Vidhya Gopalakrishnan, PhD
Quark Pharmaceuticals, Inc, United States
Senior Vice President, Pharmaceutical Development
Panel Discussion
All Session Speakers, United States
Panelist
Olen M. Stephens, PhD
FDA, United States
Chemist Reviewer, CMC Reviewer, CDER/OPQ/ONDP
Panelist
Daniel Capaldi, PhD
Ionis Pharmaceuticals, Inc, United States
Vice President, Analytical and Process Development
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