Roundtable Discussion: Addressing Immunogenicity & Safety Concerns to Enable Durable Gene Editing Therapeutic Outcomes & Regulatory Approval
- Identifying immunogenic responses to CRISPR components and developing mitigation strategies to prevent immune rejection and enable sustained therapeutic efficacy
- Implementing safety monitoring frameworks to detect genotoxicity, off-target effects, and immune activation ensuring patient safety throughout clinical development
- Navigating regulatory expectations for immunogenicity assessment and long-term safety follow-up to accelerate approval pathways while maintaining durability standards