Steve Gao

Company: Gilead Sciences

Job title: Executive Director & Head, Real-World Evidence Inflammation

Seminars:

9:30 Bridging the Gap Between Surrogate Endpoints & Real-World Outcomes to Strengthen Accelerated Approvals 9:30 am

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…Read more

day: Day 2 full

9:00 Strategies to Streamline Collaboration, Accelerate Decision Making & Improve Real-World Evidence Acceptance Across Pharma, Regulators & Payers 9:00 am

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…Read more

day: Pre-Conference Payers & Regulatory Alignment Day