This session explores how patient preference studies (PPS) are transforming regulatory strategies in drug development, aligning with the upcoming ICH E22 guideline - the first international guideline related to Patient Experience Data. Our regulatory, industry, and patient panelists will discuss how systematically incorporating patient perspectives enhances trial design, benefit-risk assessments, and regulatory decision-making. Speakers will highlight the evolution from qualitative patient needs assessment to quantitative preference measurement, showcasing how these methodological advances support global development pathways. This panel will discuss how PPS can harmonize patient-focused approaches across regulatory frameworks, potentially accelerating approvals and improving access to therapies.