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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)
Hugo Vargas, PHD
Executive Director, Amgen Inc., United States
A Scientific Review of the Low Proarrhythmic Risk of Oligonucleotide Therapeutics
Derek Leishman, PHD
Vice President, Translational and Quantitative Toxicology, Eli Lilly and Company, United States
Future Recommendations: Update from ICH E14/S7B IWG
Wendy Wu, PHD
Pharmacologist, FDA, United States
FDA Clinical and Nonclinical Perspectives and Experience with Evaluation of Pro-arrhythmic Risk After Exposure to Oligo-based Products
Lars Johannessen, MSC
Senior Clinical Analyst, FDA, United States
FDA Clinical and Nonclinical Perspectives and Experience with Evaluation of Pro-arrhythmic Risk After Exposure to Oligo-based Products
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