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Session 10 Track 2: Non-Clinical Safety Assessment of Oligonucleotides
Session Chair(s)
Representative Invited
GlaxoSmithKline R&D, United Kingdom
Paul C. Brown, PhD
Associate Director for Pharmacology and Toxicology, OND, CDER
FDA, United States
This session will provide updates on two areas of regulated nonclinical safety assessment (genotoxicity and developmental and reproductive toxicology (DART) evaluation) and experience of characterizing these hazards for therapeutic oligonucleotides (ONTs), as well as a novel application of Artificial Intelligence (AI) to improve the safety of this modality.
Learning Objective : - Describe the typical approaches taken for evaluating the genotoxicity and carcinogenicity of therapeutic oligonucleotides
- Explain the characteristics of therapeutic oligonucleotides that warrant consideration for whether typical small molecule approaches to Developmental and Reproductive Toxicology (DART) evaluation are appropriate
- Describe the structural determinants of therapeutic oligonucleotides that are amenable to employing AI/ML models
Speaker(s)
Results of the EFPIA Oligo Working Group Industry Survey on Genotoxicity Evaluation of Therapeutic Oligonucleotides and Carcinogenicity Strategy
Representative Invited
GlaxoSmithKline R&D, United Kingdom
Key Considerations for DART Assessment of Oligonucleotides
Representative Invited
Eli Lilly, United States
Artificial Intelligence and Machine Learning Utility in Safety Assessments of Therapeutic Oligonucleotides
Chris Hart, PhD
Creyon Bio, Inc. , United States
CEO & Co-Founder
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