Webinar

Validating and presenting digital endpoints in indications without biomarkers: lessons from the ReMEdi study in ME/CFS

May 20, 2026
·
11:00 AM ET / 4:00 PM BST
·
1 Hour

Digital endpoints have moved from concept to practice, but the work of validating them, integrating them with traditional clinical data, and presenting them to regulators remains underdeveloped territory. In indications without validated biomarkers, the question gets sharper: subjective PROs alone can leave programs vulnerable to noise, and digital measures introduce challenges most teams haven't built playbooks for. ReMEdi paired ePROs with Oura ring continuous monitoring and GripAble remote functional testing in a fully decentralized Phase 2. This panel discussion covers the framework for selecting and validating digital measures, when continuous monitoring earns its place alongside PROs, and how the composite-endpoint angle is taking shape with regulators.  

‍

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

  • A framework for selecting and validating digital endpoints (including continuous-monitoring wearables and remote functional measures), with the ReMEdi team's experience presenting to regulators and how they've responded
  • The composite-endpoint approach as a model for biomarker-poor indications: layering subjective PROs with objective digital signals to support regulatory submissions
  • Practical design principles for remote study designs that maintain regulatory-grade rigor when the operational model is digital-first
  • Operational proof points on enrollment, retention, and data completeness with ReMEdi-specific benchmarks shared where available

‍

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

This is some text inside of a div block.
This is some text inside of a div block.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique. Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat. Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.