Roundtable Discussion: Engaging Regulators to Build Confidence in Novel Genome Editing Modalities & Accelerate Clinical Development Pathways
- Educating regulatory agencies on emerging modalities including prime editing, base editing, and epigenetic editing to establish shared understanding of safety and efficacy profiles
- Implementing proactive regulatory engagement strategies throughout preclinical and clinical development to address agency concerns and align on evidence requirements for novel tools
- Establishing validation frameworks for next-generation editing technologies to streamline regulatory review and build confidence in therapeutic potential