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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](/_Images/member/Generic_Image_Missing-Profile.jpg)
Panel Discussion
All Session Speakers, United States
Panelist
Ryan McGowan
AstraZeneca, United States
Associate Director, Combination Products
![Mike Stelmah](/_Images/member/Generic_Image_Missing-Profile.jpg)
Panelist
Mike Stelmah
Alnylam Pharmaceuticals, United States
Director, Regulatory Affairs, CMC & Combination Products
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