Sleep is one of the most powerful yet underutilized biomarkers in depression drug development, with objective sleep physiology offering insights into patient stratification, treatment response prediction, and pharmacodynamic signaling that traditional endpoints and patient-reported outcomes often miss. This webinar explores how quantitative sleep measures, including features of sleep microarchitecture, can strengthen both clinical trial design and commercial strategy for MDD and treatment-resistant depression. Speakers will cover evidentiary standards for regulatory-grade sleep endpoints, practical guidance on FDA-cleared EEG wearables, and how real-world sleep data can inform prescribing guidance and market access strategy.

TORONTO, April 13, 2026 /PRNewswire/ — For teams developing a therapy for major depressive disorder (MDD), sleep physiology is one of the most powerful objective measures and predictive biomarkers. But clinical development and commercial strategy teams are still underutilizing sleep, missing valuable insights into patient selection, treatment response, and the real-world evidence that influences how drugs are prescribed and positioned post-approval. This webinar explores how objective sleep endpoints and biomarkers can strengthen clinical development and commercial planning in depression, and why they warrant earlier consideration in trial strategy.

Impaired sleep is a cardinal symptom of MDD, increasing the burden of other depressive symptoms. And depression, as well as its standard of care treatments, can significantly change sleep architecture. This bidirectional relationship makes sleep a uniquely sensitive lens for interrogating and improving MDD and treatment-resistant depression, with implications that start at early-phase trials and extend through commercial launch.

Many current depression trials measure sleep through patient-reported outcomes such as the Pittsburgh Sleep Quality Index (PSQI) or Insomnia Severity Index (ISI), which can be useful for characterizing patients’ perceptions of sleep improvements, but can be uncorrelated with patients’ underlying physiology and are susceptible to measurement instability, expectation and bias effects, data integrity gaps, and interpretation challenges. This webinar explores the power of objective, quantitative sleep physiology data as endpoints and biomarkers, including in predicting treatment responders, early responders, and placebo responders, all before standard depression efficacy signals emerge.

Quantitative sleep measures, including features of sleep microarchitecture that extend beyond conventional sleep staging, can stratify patient populations and capture pharmacodynamic signals that traditional endpoints miss entirely. For commercial teams, identifying which patients are most likely to benefit informs prescribing guidance, messaging, and market access strategy.

Register for this webinar to learn how sleep biomarkers can strengthen both clinical development and commercial strategy in depression through better stratification, earlier response prediction, and stronger evidence generation.

The featured speakers will discuss sleep impairments in clinical practice as shown in claims and survey data, the evidentiary standards required to bring objective sleep trial endpoints to regulators, pragmatic considerations for evaluating FDA-cleared EEG wearables for PSG-equivalent sleep staging, and the utility of real world physiology data in supporting both clinical and commercial objectives.

Join Andrew Krystal, MD, MS, Professor of Psychiatry and Neurology and Vice Chair for Research, UCSF; David Matthews, PhD, President of Life Sciences, Beacon Biosignals; and Georgina Kontou, PhD, Neuroscientist, Beacon Biosignals, for the live webinar on Tuesday, April 28, 2026, at 1pm EDT (10am PDT).

For more information, or to register for this event, visit How Sleep Biomarkers Improve Clinical Development and Clinical Assessment in Depression.

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