Panel: Regulatory engagement for early-stage developers

For early-stage developers, proactive regulatory engagement is critical to advancing programs efficiently into human studies. This panel examines best practices for interacting with agencies, preparing robust IND submissions, and aligning on adaptive trial designs to minimize risk and uncertainty. 

Key takeaways: 

• Engage regulators early to streamline trial approvals and accelerate FIH timelines 

• Identify and avoid common pitfalls in IND submissions 

• Address uncertainty around adaptive trial designs and regulatory expectations 

• Build strategies that reduce delays and increase predictability in early clinical development 

• Leverage regulatory feedback to strengthen translational fidelity and trial design