Global CGT clinical development: funding, trials, and approvals

Navigating global cell and gene therapy development requires coordinated planning across financial, operational, and regulatory domains. This discussion explores methods to secure resources, design efficient trials, and meet approval requirements while preserving predictive validity and program readiness.

Key takeaways

• Identify funding strategies that support global CGT program advancement
• Optimize trial design to meet diverse regulatory expectations
• Align translational data and predictive validity across multiple regions
• Address operational and logistical challenges in multinational studies
• Implement frameworks to accelerate program progression from discovery to clinic