Scientific Officer, Executive Director BioAgilytix Durham, North Carolina
RNA therapeutics such as anti-sense oligonucleotides (ASOs) and siRNAs are a promising novel therapeutic modality in the field of genetic diseases. Anti-drug antibody (ADA) assessment is a critical part of clinical studies that measure the safety and efficacy of these therapeutics. This presentation will detail the challenges involved in measuring anti-drug antibody (ADA) responses to RNA therapeutics, and the strategies that can be used to make sure the ADA assays meet regulatory expectations.
Learning Objectives:
Participants will learn about RNA therapeutics and how they are being used to treat genetic diseases
Participants will gain an understanding of how to design anti-drug antibody assays to measure immune responses to RNA therapeutics
Upon completion, participants will be able to understand the challenges involved in ADA assay validation and important considerations in sample analysis
