Sponsors routinely collect patient experience data (PED) to better understand disease areas and ensure development programs meet patient needs. To advance patient-focused drug development effectively, early alignment on PED collection activities between industry, patient advocacy groups, and regulators is essential. This alignment supports the identification of what is clinically meaningful to patients, ensures the generation of fit-for-purpose data, informs regulatory decisions, and facilitates the inclusion of PED in labeling and patient-facing resources. Although regulators encourage early and frequent engagement regarding PED, industry stakeholders often face uncertainty about the timing and content of such interactions. This lack of clarity can hinder the ability to obtain actionable regulatory feedback at the appropriate time points. To facilitate strategic and timely discussions on the use of PED in product development and regulatory decision-making, resources including frameworks, and best practices documents are being developed by stakeholders. In addition, there continues to be a need for regulatory feedback and guidance on the optimal use of PED in drug development. This session will explore the realities of early sponsor-regulatory engagement around PED. Panelists will share practical insights and present tools—including BIO’s FDA-Sponsor Engagement Frameworks for Clinical Outcome Assessments (COAs) and Patient Preference Information—that can help sponsors navigate regulatory expectations and optimize their engagement strategies.