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Session 2A (Nonclinical Track): Oligonucleotide Clinical Pharmacology
Session Chair(s)
Richard Stephen Geary, PhD
Senior Vice President, Drug Development
Ionis Pharmaceuticals, Inc., United States
Jian Wang, PhD
Global Head of Translational/Oncology Regulatory Science, Strategy & Excellence
AstraZeneca, United States
The development of oligonucleotide therapeutics requires pharmacokinetic and clinical pharmacology assessments that provide a framework for regulatory decisions. This session will focus on the clinical pharmacology of oligonucleotide products, recommended assessments, and current regulation. Presentations include one from the FDA addressing current regulatory practices governing the clinical pharmacology of oligonucleotides and a presentation reviewing clinical pharmacology decisions in the early development of Mipomersen. The session will continue with two complementary presentations, one from Pharma and one from the FDA discussing real-world measurements and pertinent factors to consider in the important calculation of animal-to-human dose scaling.
Speaker(s)
Clinical Pharmacology Considerations in Development of Antisense Oligonucleotide Based Therapeutics
Jian Wang, PhD
AstraZeneca, United States
Global Head of Translational/Oncology Regulatory Science, Strategy & Excellence
Clinical Pharmacology Decisions in Early Development
Richard Stephen Geary, PhD
Ionis Pharmaceuticals, Inc., United States
Senior Vice President, Drug Development
Animal to Human Dose Scaling for Oligonucleotides: Pertinent Factors
John S. Grundy, PhD
Ionis Pharmaceuticals, Inc., United States
Vice President, DMPK & Toxicology
A Question of Scale: Equating Oligonucleotide Doses Between Species
Ronald Wange, PhD
FDA, United States
Associate Director for Pharm/Tox, OND, CDER
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