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Session 6A: Thinking Ahead: Oligonucleotide Drug-Device Combination Products
Session Chair(s)
Mohan K. Sapru, PhD, MS
CMC Lead, Office of Pharmaceutical Quality, CDER
FDA, United States
The session is aimed to broadly discuss oligonucleotide drug-device combination products, an emerging trend in oligonucleotide-based therapeutics, from industry and regulatory perspectives. Specifically, the presentations and panel discussion will focus on:
Learning Objective :
Speaker(s)
Development Considerations for Oligonucleotide Combination Products
Bret Coldren, PhD
Ionis Pharmaceuticals , United States
Director, Pharmaceutical Development
Human Factors Studies - Related Considerations in Combination Product Design and Development
Quynh Nhu Nguyen, MS
FDA, United States
Associate Director for Human Factors, DMEPA, CDER
Panel Discussion
All Session Speakers, United States
Panelist
Ryan McGowan
AstraZeneca, United States
Associate Director, Combination Products
Panelist
Mike Stelmah
Alnylam Pharmaceuticals, United States
Director, Regulatory Affairs, CMC & Combination Products