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Session 7 Tracks 1 and 2: Navigating the Testing Strategy for ONTs based on the Updated Q&A’s of ICH E14 and S7B
Session Chair(s)
Jennifer Sisler, PhD
Director, Eli Lilly and Company, United States
Lars Johannesen, PhD
Senior pharmacokineticist, CDER, FDA, United States
The objectives of this session are to focus on the nonclinical and clinical integrated risk assessment strategy for ONTs based on the ICH E14 and S7B QandAs for the potential risk for proarrhythmia. The first talk will provide an overview of the new QandAs, followed by a nonclinical and clinical integrated case study, and ending with how in the future, a potential strategy can be taken to leverage known data to streamline the testing strategy.
Overview of updated Q&As of ICH E14 and S7B
Lars Johannesen, FDA
Cardiac Safety of Oligonucleotide Therapeutics: Inclisiran as an Eexample with Preclinical and Clinical Evidence
YanLing He, Novartis Institutes for Biomedical Research
Charles Benson, Eli Lilly and Company
Learning Objective : At the conclusion of this session, participants should be able to: - Describe the new Q&As of E14 and S7B
- Explain a case study of an integration on nonclinical and clinical data to inform the potential risk for proarrhythmia of an ONT
- Apply a forward thinking approach for streamlining the risk assessment strategy
Speaker(s)
Overview of updated Q&As of ICH E14 and S7B
Lars Johannesen, PhD
Senior pharmacokineticist, CDER, FDA, United States
Cardiac Safety of Oligonucleotide Therapeutics: Inclisiran as an Eexample with Preclinical and Clinical Evidence
YanLing He, DrMed, PhD
Executive Director, Novartis, United States
From Unknown to Not Likely: A framework for reclassifying oligonucleotide therapeutics under the E14/S7B Q&As (R1)
Charles Benson, MD, PhD
Vice President Medical Exploratory Medicine and Pharmacology, Eli Lilly and Company, United States