Regulatory engagement strategies for early-stage developers

Proactive regulatory engagement is critical for advancing cell and gene therapy programs. This discussion outlines best practices for early interactions, communication of translational data, and alignment on clinical trial requirements to support program success.

Key takeaways

• Define frameworks for early and productive regulatory interactions
• Align preclinical and translational data with regulatory expectations
• Establish clear communication strategies for safety, dose selection, and biomarkers
• Anticipate regulatory requirements to streamline first-in-human study readiness
• Integrate feedback loops that enhance program decision-making and predictive validity