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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
Vice President, Oligonucleotide and Small Molecule CMC, Denali Therapeutics, United States
CMC Strategies for Late-Stage Development of siRNA Oligonucleotides
Senior Vice President, Pharmaceutical Development, Quark Pharmaceuticals, Inc, United States
Panel Discussion
, All Session Speakers, United States
Panelist
Chemist Reviewer, CMC Reviewer, CDER/OPQ/ONDP, FDA, United States
Panelist
Vice President, Analytical and Process Development, Ionis Pharmaceuticals, Inc, United States
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