Making repurposing programs viable in indications where traditional models stall: lessons from the ReMEdi study in ME/CFS
Repurposing-target indications usually have populations the traditional site-based model isn't built to reach, endpoints that lack objective measurement, and a commercial profile that won't carry a standard site footprint. Promising assets stall on the study side, not the science. The Phase 2 ReMEdi RCT, sponsored by Tiefenbacher Group, ran a different operational model in ME/CFS: fully decentralized recruitment, remote endpoint capture, and integrated wearable data. This panel discussion covers what the operating model required, what worked, and what was harder than expected.
In this panel, Meri Beckwith, Co-CEO of Lindus, Dr. Simon Bock, Clinical and Market Access, Portfolio & Innovation Manager at Tiefenbacher Group and Dr. Beata Godlewska, Principal Investigator for the ReMEdi trial, sit down to discuss how modern trial design is expanding what's feasible. Drawing on their experience running the ReMEdi study in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), they'll discuss how innovative trial design strategies enabled them to capture regulatory-grade data in a population historically excluded from research, how digital endpoints and wearables are providing more granular, remote, and patient-centric data, and how these methodological choices help sponsors work through the operational hurdles that commonly cause programs to stall.
The conversation will also cover the regulatory challenges and economic considerations that shape drug repurposing strategies, including how feasibility and commercial attractiveness factor into development decisions.
What you'll learn
- Why the traditional CRO operating model doesn't fit most repurposing programs in underserved indications
- What an alternative operating model needs to keep a repurposing program viable on its commercial profile
- How regulatory-grade data integrity is maintained in a decentralized, digital-first study, with ReMEdi-specific benchmarks shared where available
Register here
Meet the panel
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