Jeffrey Shuren
Showing 1–2 of 2 transcripts.
- Milken Institute1h 0m
Flipping the Script: Designing the System to Deliver for Patients
Annie Kennedy, Gigi Hirsch, Marcus Schabacker, Andy Schmeltz, Jeffrey Shuren, Marcus Wilson
Leaders from patient advocacy groups, regulators, and industry convened to address critical misalignments between regulatory data standards, payer requirements, and patient outcomes, driving a shift toward patient-led research and value-based care models. Through collaborative frameworks like FDA's Patient and Caregiver Connection and MIT's learning health systems, stakeholders are overcoming data fragmentation by integrating real-world evidence into device approvals and reimbursement decisions. This collective effort establishes a new paradigm where patient preferences directly influence benefit-risk assessments, ensuring medical innovations effectively reach the right patients at the right time while promoting equitable access.
- Milken Institute1h 0m
Regulating Medical Innovation in the Digital Age
Lisa Suennen, William Carson, Aneesh Chopra, Sohini Chowdhury, Lucia Savage, Jeffrey Shuren, Lisa Sunin, Jeff Sheeran, Bill Carson
A panel of industry leaders and FDA officials analyzed the surge in digital healthcare investment, which has exceeded $40 billion, while addressing regulatory hurdles that slow the development of Software as a Medical Device. Key discussions highlighted the FDA's "Pre-Cert" pilot program and the critical need for interoperability standards like FHIR to reduce data costs and overcome fragmentation in telemedicine and direct-to-consumer markets. Despite breakthroughs such as the first digital medicine approval, experts emphasized that legacy frameworks struggle to accommodate rapid software iteration, opaque deep learning algorithms, and complex data privacy requirements across 57 state and federal jurisdictions.