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Session 10 Track 1: Clinical Pharmacology of Oligonucleotides
Session Chair(s)
Hobart Rogers, PHARMD, PHD
Pharmacologist, CDER, FDA, United States
Mark Rogge
Adjunct Professor, University of Florida, United States
This session will explore the various clinical pharmacology aspects that are primarily unique to RNA-oligonucleotides. Topics will include: regulatory considerations regarding clinical pharmacology studies, transitioning to first-in-human studies, and the importance of pharmacodynamic biomarkers. Overall, this session will provide various viewpoints on the unique challenges encountered in the clinical development of oligonucleotides.
Learning Objective : At the conclusion of this session, participants should be able to:- Distinguish between EMA and FDA Clinical Pharmacology Guidelines in relation to oligonucleotides
- Recognize the various challenges in the development of pharmacodynamic biomarkers in clinical studies
- Appraise the clinical pharmacology issues unique to oligonucleotides compared to small molecules and biologics
Speaker(s)
Carolien Versantvoort, PHD
Senior Clinical Pharmacokinetics Assessor, Medicines Evaluation Board, Netherlands
An Overview of EMA’s Clinical Pharmacology Assessment of Oligonucleotides
Hobart Rogers, PHARMD, PHD
Pharmacologist, CDER, FDA, United States
Clinical Pharmacology Aspects of Oligonucleotides
Xiao Hu, PHD, MSC
Vice President, DMPK and Clinical Pharmacology , Wave Life Sciences, United States
Application of Model Informed Drug Development in Clinical Pharmacology for Oligonucleotides
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