Kathy Hudson
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 1m
The Promise of the Cancer Moonshot
Kathy Hudson, Anna Barker, L. Michelle Bennett, Robert Bradway, Louis DeGennaro, Isla Garraway, Lou DiGennaro, Greg Simon, Tom Caleo, Jackie Brandwin, Greg Zuckerman, Laura Kalmos Nasser, Mike Hiltik, Noah Crafts
Following the Vice President's appointment to lead "Mission Control" and a proposed $1 billion federal funding request, the Cancer Moonshot initiative seeks to accelerate cancer research by prioritizing patient outcomes over bureaucratic processes. The program targets a structural shift from competition to collaboration through new mandates for data sharing, the launch of the Genomic Data Commons, and the implementation of patient-centric clinical trial designs. By leveraging public-private partnerships and modernizing regulatory frameworks, the initiative aims to bridge the gap between clinical trial success and real-world health equity within a 15-month timeline.