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Session 5BC: Non Clinical and Clinical Track Combination: Injection Site Reactions
Session Chair(s)
Jacobus Burggraaf, MD, PHD
CEO
Centre For Human Drug Research, Netherlands
L. Peyton Myers, PHD
Senior Pharmacology and Toxicology Reviewer; Div of Antiviral Products, CDER
FDA, United States
This joint session for clinical and nonclinical track will tackle the observation of cellular infiltration at the site of administration of oligonucleotide therapies including antisense and siRNA. Summaries of nonclinical studies will address the observed histology of the affected cells and the proposed underlying mechanisms involved in the cellular elicitation. Clinical presentations will address the observations of injection site reactions and their management in the clinic. The translation of nonclinical incidence and severity into clinical observations will also be reviewed.
Speaker(s)
Injection Site Reactions After Subcutaneous Oligonucleotide Therapy in Humans
Jacobus Burggraaf, MD, PHD
Centre For Human Drug Research, Netherlands
CEO
Characterization and Mechanistic Investigation of Non-CpG MOE ASO-Mediated Injection Site Inflammation Across Species
Sebastien Burel, PHD
Ionis pharmaceuticals, United States
Executive Director
Evolution of a Platform: Clinical Experience Improving Pro-inflammatory Characteristics of Second Generation 2’-MOE Antisense Oligonucleotides
Scott Henry, PHD
Ionis Pharmaceuticals, Inc., United States
Senior Vice President, Nonclinical Development
Panel Discussion
All Session Speakers, United States