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Session 2 Track 2: Pro-Arrhythmic Risk of Oligonucleotide Therapeutics: Is New Guidance Needed?
Session Chair(s)
Xuan Chi, PhD
Supervisory Pharmacologist
CDER, FDA, United States
Tod Harper, PhD
Scientific Associate Director
Amgen, United States
To date, the proarrhythmic assessment of oligonucleotide therapeutics has been influenced by existing International Conference on Harmonization (ICH) E14 and S7B guidance. However, oligonucleotide therapeutics exhibit distinctive physiochemical characteristics that may impact their proarrhythmic risk profile. Accumulating nonclinical and clinical data in this space may further inform future guidance development and regulatory decisions. This session will provide 1) a retrospective overview of the past practices used to conduct proarrhythmic assessment of oligonucleotide therapeutics in both nonclinical and clinical studies; 2) potential future recommendations to evaluate pro-arrhythmic risk of oligonucleotide therapeutics; and 3) FDAs perspective and experience with proarrhythmic risk assessment of oligonucleotide therapeutics.
Learning Objective : - Recognize practices previously used to evaluate pro-arrhythmic risk both in nonclinical and clinical studies, and their correlation
- Debate the need for harmonized recommendations for evaluation of pro-arrhythmic risk of oligonucleotide therapeutics
- Discuss considerations for future recommendations to evaluate pro-arrhythmic risk of oligonucleotide therapeutics
Speaker(s)
A Scientific Review of the Low Proarrhythmic Risk of Oligonucleotide Therapeutics
Hugo Vargas, PhD
Amgen Inc., United States
Executive Director
Future Recommendations: Update from ICH E14/S7B IWG
Derek Leishman, PhD
Eli Lilly and Company, United States
Vice President, Translational and Quantitative Toxicology
FDA Clinical and Nonclinical Perspectives and Experience with Evaluation of Pro-arrhythmic Risk After Exposure to Oligo-based Products
Wendy Wu, PhD
FDA, United States
Pharmacologist
FDA Clinical and Nonclinical Perspectives and Experience with Evaluation of Pro-arrhythmic Risk After Exposure to Oligo-based Products
Lars Johannessen, MSc
FDA, United States
Senior Clinical Analyst
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