Susan Schaeffer

System Thinking to Drive Patient Engagement: Walking the Talk

Susan Schaeffer, Julie Gerberding, Ivor Horn, Kathy Hudson, Bray Patrick-Lake, Janet Woodcock, Arthur Allen, Syra

Regulatory leaders, including FDA Director Janet Woodcock, and biopharmaceutical executives like Merck's Julie Gerberding discussed how the 21st Century Cures Act and PDUFA reauthorizations have institutionalized patient input to reshape drug development protocols. Panelists highlighted that early engagement reduces costly trial amendments while shifting metrics from clinical markers to patient-reported outcomes, as evidenced by approvals for conditions like multiple sclerosis and Duchenne muscular dystrophy. Despite challenges regarding diversity and internal cultural shifts, the consensus emphasizes that integrating lived experience into benefit-risk assessments accelerates innovation and aligns industry practices with patient needs.