August 13, 2025
Title: Using RWE for Label Expansion From The Health System Perspective
Wednesday, August 13, 2025
1:00PM EDT | 5:00PM UTC | 7:00PM CEST
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Description
Post-approval research is evolving beyond safety surveillance to become a strategic driver of label expansion, access, and long-term value. This webinar explores how innovative HEOR and RWE approaches are transforming Phase 4 trial design—enabling manufacturers to generate fit-for-purpose evidence that aligns with both regulatory and commercial objectives. Join us as leading clinical researchers from health systems share real-world insights on how they’re designing and executing Phase 4 studies in partnership with biopharma and med tech sponsors. From leveraging routinely collected clinical data to integrating synthetic control arms, speakers will discuss practical strategies for generating credible, scalable, and actionable evidence. Learn how health systems are uniquely positioned to contribute data and scientific rigor to post-approval research, helping sponsors validate outcomes, demonstrate effectiveness in real-world settings, and ultimately support label expansion and market differentiation.
Learning Objectives
- How to use synthetic control arms to improve efficiency, comparability, and support label expansion in post-approval studies
- Designing flexible, pragmatic protocols to better reflect real-world clinical practice
- Aligning Phase 4 evidence with payer, provider, and policy expectations using fit-for-purpose data
- Leveraging health system perspectives and collaboration to strengthen Phase 4 trial design and execution
Moderator:
Myla Maloney, MBA, BCMAS, Chief Growth Officer, Applied Sciences, Premier, Charlotte, NC, USA
Speakers:
Vani Nilakantan, PhD, System Vice President, Research, Common Spirit, The Colony, TX, USA
Amy Elliott, Chief Clinical Research Officer, Avera Health, Sioux Falls, SD, USA
Sponsored by Corporate Partner, Premier
Please note: On the day of the scheduled webinar, the first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled Webinar. Reservations are on a first-come, first-served basis.