Steve Gao
Executive Director and Head, RWE Inflammation Gilead Sciences
Seminars
Wednesday 29th October 2025
9:30 Bridging the Gap Between Surrogate Endpoints & Real-World Outcomes to Strengthen Accelerated Approvals
- Leverage RWE to validate surrogate endpoints by comparing them with long-term real-world outcomes, enhancing the reliability of accelerated approval processes
- Use advanced statistical models to demonstrate how surrogate endpoints can be predictive of actual patient outcomes in real-world settings
- Collaborate with regulatory agencies to align on the use of surrogate endpoints in RWE, ensuring faster access to treatments while maintaining clinical integrity
Monday 27th October 2025
9:00 Strategies to Streamline Collaboration, Accelerate Decision Making & Improve Real-World Evidence Acceptance Across Pharma, Regulators & Payers
Navigating payer and regulatory requirements in RWE is a high-stakes challenge, one missed step can mean delays, denied coverage, or wasted data. Regulators demand rigor, payers prioritize cost-effectiveness, yet their definitions of “acceptable evidence” rarely align. With evolving guidelines and increasing scrutiny, how can pharma generate the right data to bridge this gap?
- Unpack real-world case studies on where pharma, regulators, and payers are misaligned, and the subsequent impact
- Discuss examples of RWE-driven approvals and reimbursements that have worked, and why
- Develop practical steps to ensure RWE meets the needs of all stakeholders
