Janet Woodcock
Showing 1–2 of 2 transcripts.
- Milken Institute1h 2m
Lessons Learned from COVID-19: Are There Silver Linings for Biomedical Innovation?
Esther Krofah, Francis Collins, Richard Moscicki, Ellen Sigal, Janet Woodcock
Hosted by Faster Cures, a webinar convened NIH officials and industry leaders to analyze the COVID-19 pandemic's acceleration of biomedical innovation, highlighting achievements such as the ACTIV partnership's master protocols and the RADx initiative's diagnostic scaling. The discussion detailed how the crisis forced a shift toward competitive collaboration, decentralized trials, and the successful achievement of diverse vaccine trial enrollment, while simultaneously exposing critical infrastructure gaps in clinical trial execution and real-world data integration. Panelists concluded with a consensus that emergency-driven reforms must be institutionalized through permanent policy changes and public-private partnerships to sustain preparedness for future health threats.
- 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.