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Session 8: Hot Topics
Session Chair(s)
Patrik Andersson, PHD
Principal Scientist, Discovery Safety Specialist, AstraZeneca R&D, Sweden
Representative Invited
BfArM, Germany
The Hot Topics session will provide an overview of three areas that will provide clarity and likely influence the way of working with oligo projects. 1. An overview of the draft ICH S13 draft guideline on nonclinical safety of oligonucleotides that shortly after the meeting will be published for public consultation; 2. How will the regulatory roadmaps for New Approach Methodologies (NAMs) influence oligo R&D and 3. How can use of AI be applied to oligo therapeutics to increase throughput and success rate of oligo projects.
Learning Objective : At the conclusion of this session, participants should be able to: - Mention key themes in the draft ICH S13 guideline on nonclinical safety for oligos
- Discuss specific situations where a NAMs approach could be applied to an oligo project
- Suggest potential areas in the oligo project Drug Discovery and Development value chain where application AI could add significant value
Speaker(s)
Representative Invited
Head of Unit, Parallel Import, Parallel Distribution and Standard Marketing, BfArM, Germany
ICH S13
Representative Invited
Senior Advisor for New Approach Methodologies, CDER, FDA, United States
NAMs