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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
![Vidhya Gopalakrishnan, PhD](/_Images/member/Generic_Image_Missing-Profile.jpg)
CMC Strategies for Late-Stage Development of siRNA Oligonucleotides
Vidhya Gopalakrishnan, PhD
Quark Pharmaceuticals, Inc, United States
Senior Vice President, Pharmaceutical Development
![Panel Discussion](/_Images/member/Generic_Image_Missing-Profile.jpg)
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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