Webinar

Endpoint strategy for repurposing programs in indications without validated biomarkers: lessons from the ReMEdi study in ME/CFS

May 20, 2026

11:00 AM ET / 4:00 PM BST

1 Hour

Repurposing offers a compressed path to Phase 2, but endpoint strategy is often the gating factor. Many indications that attract repurposing interest are those without validated biomarkers, where subjective patient-reported outcomes alone can leave programs vulnerable to noise and regulatory scrutiny. Layering digital measures introduces validation, integration, and presentation challenges most teams haven't built playbooks for. ReMEdi paired ePROs with continuous wearable monitoring and remote functional testing in a fully decentralized Phase 2 repurposing study. This panel discussion covers the framework for selecting and validating digital measures, when continuous monitoring earns its place, and how the composite-endpoint angle is taking shape with regulators.

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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.

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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.

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What you'll learn

A framework for selecting and validating digital endpoints in indications without validated biomarkers, with detail on how the ReMEdi team approached validation and regulator presentation
The composite-endpoint approach, combining subjective PROs with objective digital/wearable-derived measures, as a forward-looking model for regulatory submissions in biomarker-poor indications
Practical design principles for remote and hybrid study designs that maintain regulatory-grade rigor across repurposing programs in underserved conditions
Operational proof points on enrollment timelines, retention, and data completeness in a decentralized repurposing study, with ReMEdi-specific benchmarks shared where available

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Register here

Meet the panel

Meri Beckwith

Co-CEO

Lindus

Moderator

Meri is a former life sciences and healthtech venture capital investor, with an MSc in Biology from the University of Oxford. Serving on the boards of health and biotech companies, he saw CROs repeatedly fail to deliver clinical trials on time and on budget. After participating in a COVID-19 vaccine trial, he saw how fragmented integrated technology, poor patient experience and operational problems at sites cascaded up to the cost and timeline overruns he experienced as an investor. He founded Lindus to fix these problems and provide a more accountable, predictable model for research.

Dr. Beata Godlewska

Principal Investigator

University of Oxford

Panelist

Beata is a Senior Clinical Researcher and Honorary Consultant Psychiatrist at the University of Oxford's Department of Psychiatry, where she has worked since 2007. She received her medical degree and PhD from the University of Gdańsk in Poland before moving to Oxford. Her research focuses on the psychopharmacology of mood disorders, including major depressive disorder and bipolar disorder, with a particular focus on early detection and treatment-resistant forms of these conditions, and on the biological mechanisms of antidepressant drug action. Alongside this, her work has extended into understanding the underlying biology of ME/CFS with a view to future treatment development, which informs her approach as Principal Investigator on ReMEdi. She has maintained clinical practice throughout her academic career, working as an Honorary Consultant Psychiatrist within the Mood Disorders Treatment Clinic since 2010, and brings that combined research and clinical perspective to leading ReMEdi's clinical conduct in a fully remote setting.

Dr. Simon Bock

Clinical and Market Access, Portfolio & Innovation Manager

Tiefenbacher Group

Panelist

Simon is Clinical and Market Access, Portfolio & Innovation Manager at Tiefenbacher Group, where his work spans portfolio planning, study conception, regulatory correspondence, market access, and digital health innovation. His background combines pharmaceutical industry experience with nearly eight years of community pharmacy practice at Priv. Adler Apotheke in Hamburg, an unusual combination that informs how he evaluates whether a development programme will translate into something patients can actually access. At Tiefenbacher, he represents the sponsor on the ReMEdi programme, a fully virtual Phase 2 trial in ME/CFS, and contributes to the broader portfolio strategy for repurposing-led development in neglected and underserved indications, where commercial attractiveness and patient access have to be designed in from the outset rather than bolted on at launch.

Register to attend

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