How Sleep Biomarkers Improve Clinical Development in Depression Trials

For teams developing a therapy for major depressive disorder (MDD), sleep physiology is one of the most powerful objective measures and predictive biomarkers. But many teams are still underusing sleep during development, missing valuable insights into patient selection, stratification and early response prediction. This webinar explores how sleep biomarkers can strengthen clinical development in depression and why they warrant earlier consideration in trial strategy.

Sleep is a cardinal symptom of MDD. However, disrupted sleep also increases the burden of depressive symptoms, and depression itself, as well as standard of care treatments, leading to significant changes in sleep architecture. This bidirectional relationship makes sleep a uniquely sensitive lens on MDD and treatment-resistant depression.

Many current depression trials measure sleep through patient-reported outcomes such as the Pittsburgh Sleep Quality Index (PSQI) or Insomnia Severity Index (ISI), which are useful for validating the clinical meaningfulness of sleep improvements but are limited in the predictive insight they provide. This webinar explores what becomes possible with objective, quantitative sleep data: predicting treatment responders, early responders and placebo responders, all before standard efficacy signals emerge.

Emerging evidence suggests that quantitative sleep measures, including features of sleep microarchitecture that extend beyond conventional sleep staging, can stratify patient populations, predict treatment response and capture pharmacodynamic signals that traditional endpoints miss entirely.

The featured speakers will discuss the evidentiary standards required to bring these endpoints to regulators. They’ll also explore practical ways on how to: evaluate FDA-cleared EEG wearables for PSG-equivalent sleep staging, incorporate them into decentralized designs, keep patients engaged over weeks of follow-up and build the data package that supports both regulatory and commercial use of sleep findings.

Register for this webinar to learn how sleep biomarkers can improve clinical development in depression through better stratification, earlier response prediction and stronger objective endpoint strategy.

Speakers

Jacob Donoghue, MD, PhD, CEO, Beacon Biosignals

Dr. Jacob Donoghue is the Co-Founder and CEO of Beacon Biosignals, founded in 2019 with the mission of decoding sleep to advance brain health. He leads the company’s efforts to transform how psychiatric, neurological and sleep disorders are diagnosed and treated using AI-powered sleep EEG analytics. Under his leadership, Beacon has built a platform that combines FDA-cleared wearable EEG devices with advanced analytics to identify digital neurobiomarkers, supporting precision medicine in clinical trials and diagnostics. Dr. Donoghue received his MD from Harvard Medical School and PhD in Neuroscience from MIT, where his research focused on how neuroactive compounds modulate brain network activity. His scientific work spans neurophysiology, neuropharmacology and machine learning for neural signal analysis.

Message Presenter

David Matthews, PhD, President of Life Sciences, Beacon Biosignals

David Matthews, PhD, leads Beacon Biosignal’s Clinical Trials and Real World Data businesses as Chief Business Officer, where he has grown Beacon to support 40+ concurrent Phase I-IV trials across psychiatry and neurology with primary, secondary and exploratory endpoints with at-home FDA-cleared EEG and AI-powered analytics. Prior to Beacon, Dave served as the Chief Commercial Officer at BrightInsight, a Software-as-Medical-Device platform for biopharma and a Partner at Boston Consulting Group (BCG), co-leading the Biopharma and Medical Devices verticals on R&D, Commercial and Strategy topics. As a Neuroscientist, he has published in machine learning, bioinformatics, brain imaging, neurophysiology and health economics, with awards and funding from the NSF and the NIH. He holds a PhD in Computational Neurobiology from UC San Diego and the Salk Institute and a BA from Princeton University.

Message Presenter

Georgina Kontou, PhD, Neuroscientist, Beacon Biosignals

Georgina Kontou, PhD, is a Neuroscientist at Beacon Biosignals, where she focuses on leveraging sleep EEG insights to help biopharma partners de-risk and accelerate drug development. Georgina holds a PhD in Neuroscience from UCL, where she investigated how mitochondrial distribution in inhibitory neurons modulates brain network activity. She subsequently completed a postdoctoral fellowship at the AstraZeneca–Tufts Laboratory for Basic and Translational Neuroscience, contributing to early-stage drug discovery programs. Georgina later transitioned into life science consulting, working with ClearView Healthcare Partners and Kx Advisors (a BGB Group company). There, she partnered with pharmaceutical companies on a broad range of strategic initiatives, from go-to-market planning with commercial teams to evidence generation strategies supporting clinical development.

Message Presenter