Bray Patrick-Lake
Showing 1–2 of 2 transcripts.
- Milken Institute1h 1m
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.
- Milken Institute1h 0m
Smart on Science: How Today's Patients Are Driving Cures
Kim McCleary, Bray Patrick Lake, Joe Selby, Mace Rothenberg, Lou DiGennaro, Tony Coles, Dr. Francis Collins
Five healthcare leaders, including representatives from Pfizer, PCORI, and the NIH, convened to discuss the paradigm shift from paternalistic care models to active patient partnerships in drug development. The panel highlighted how the Precision Medicine Initiative, corporate adaptations like Pfizer's early patient integration, and PCORI's methodology have accelerated trial designs and improved outcomes by prioritizing patient-defined endpoints. Moving forward, the industry aims to leverage real-world data and shared governance to reduce the $2.2 billion cost of development while ensuring research addresses the specific needs and lived experiences of patients.