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Session 4 Track C: Developing Oligonucleotides with Current CMC Guidelines and an Introduction to EPOC
Session Chair(s)
Nigel R. Richardson, PhD
Head Analytical Technology & Automation, CMC Analytical
GlaxoSmithKline, United Kingdom
Learning Objective :
At the conclusion of this on session, participants should be able to:
- Evaluate the impact resulting from the application of current small molecule regulatory guidance to oligonucleotide development
- Identify and understand where within the industry, work is on-going to share prior knowledge to build a path to consensus and shared understanding for future oligonucleotide specific guidance
Speaker(s)
Stating Materials
William F. Kiesman, PhD
Biogen, Inc., United States
Senior Director
ID Testing
Nadim Akhtar, PhD
AstraZeneca, United Kingdom
Principle Scientist
Panelist
Rohit Tiwari, PhD
Eli Lilly & Company, United States
Director, Global Regulatory Affairs-CMC
Panelist
Lubo Nechev, PhD
Alnylam Pharmaceuticals, United States
Chief CMC Officer
Panelist
Hiroshi Takeda, PhD, MS
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Technical Officer