Evolving Role of Patients in the Pharmaceutical Landscape: a Two—way Street Enabled by Innovation

Description: The pharmaceutical landscape is rapidly evolving, with patients moving from passive recipients to active collaborators throughout the drug development continuum. The paradigm shifts from developing treatments “for patients” to creating them “with patients,” integrating patient preferences and real-world data. The enhanced patient involvement in clinical trial design, endpoint selection, and regulatory decision-making shapes a change of paradigm.

This session will explore the role of patients in drug development and look into the future where digital technologies and artificial intelligence (AI) could enable a dynamic, bi-directional relationship between patients and the pharmaceutical industry, fundamentally reshaping how medicines are developed, evaluated, and accessed. The session will include an EMA Speaker who will present the latest EMA Position Paper on Patient Engagement in Decision-making (PED), summarizing key recommendations and the outcomes of the public commenting process, a Patient Representative who will share their perspective on the evolving role of patients, highlighting real-world experiences, challenges, and opportunities for meaningful engagement in drug development and regulatory processes and a Sanofi Speaker who will showcase Sanofi’s experience implementing PED in the rare diseases environment, presenting concrete metrics, case studies, and lessons learned from structured patient engagement.

The session will conclude with a panel discussion, inviting audience questions and exploring how to ensure a productive, bi-directional relationship between patients, regulators, and industry.