Securing regulatory approval for novel genome editing modalities presents unique challenges, with unclear expectations around preclinical pharmacology, toxicity and analytics from agencies. Join this workshop to explore how late-stage and commercial companies are structuring IND packages, bridging preclinical and clinical data, and collaborating directly with regulators. Gain robust strategies to accelerate your program into the clinic.

Workshop highlights:

• Examining how late-stage companies structure IND packages for novel genome editing modalities, helping you build stronger regulatory submissions faster
• Identifying which preclinical outcomes most reliably predict clinical success, enabling you to design more robust studies that satisfy regulatory scrutiny
• Exploring commercial-stage regulatory strategies across new genome editing tools, giving you a roadmap to navigate approval pathways with greater confidence
• Engaging regulators directly in panel discussion to surface industry best practices, empowering you to foster more productive agency relationships for your program