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Session 4 (Nonclinical, CMC and Clinical Development Tracks): Registration, Continental Breakfast, Recap from Day 1 and Poster Session
Session Chair(s)
Jim Zisek
Director, Global CMC Regulatory Affairs
GlaxoSmithKline, United States
This meeting offers a unique opportunity for industry and regulators to discuss the successes, challenges, and “pearls of wisdom” in oligonucleotide therapy development. In this session, the track chairs will present a recap of important developments from day 1 of the meeting. As part of another forum to share and discuss recent advances in the field, attendees will have a chance to view posters which will encompass clinical and nonclinical issues.
Speaker(s)
Clinical Track
John E. Kraus, MD, PhD
GlaxoSmithKline Research & Development, United States
Head of Medical Governance, Neurosciences Therapy Area Unit
Nonclinical Track
James Wild, PhD
FDA, United States
Pharmacologist, CDER
CMC Track
Emma Wright, PhD
NITTO DENKO Avecia Inc, United States
Senior Director, Process Development
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