Development and Application of Biomarkers

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Key points

Care of individuals with neurodevelopmental disorders is undergoing a transformative change. With advances in genetics and neuroscience, we are moving from being a field of observation and description alone to developing mechanism-based treatments and even prevention. However, several mechanism-based studies However, several mechanism-based studies in genetically defined neurodevelopmental disorders NDDs such as Fragile X, Tuberous Sclerosis and Rett Syndrome have failed to reach the predefined efficacy endpoints despite promise in animal models.

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Given this recent history of failed clinical trials, there is an urgent need to develop and validate biomarkers in order to accelerate progress in future trials. These are needed to track drug effects on brain systems directly in order to solidify translational models, establish effect on the target organ brain , determine whether there are subgroups of patients more likely to respond to a novel treatment, and potentially to optimize dosing.

Biomarkers Make Their Mark on Current Research and Drug Development Trends

Some of the biomarkers include electrophysiological e. There are several challenges for validating novel biomarkers for NDDs.

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First, many potential biomarkers change with development; thus, it will be critical to understand the developmental trajectories of these measures to apply them in a trials context. Second, the neurodevelopmental disorders under consideration are primarily rare genetic diseases.

Multi-disciplinary efforts that encompass investigators with basic neuroscience, genetics, imaging, electrophysiology, data science and clinical trial expertise may be necessary to overcome these challenges. In this Research Topic, we will highlight basic, translational and clinical research studies that investigate a broad range of biomarkers with potential utility for translational drug development programs for neurodevelopmental disorders across the life span.

Important Note : All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements.

Biomarker Terminology: Speaking the Same Language

Andreas Scherer. Biomarker Services: Access to biobank samples e.

Neuroimaging and CSF Biomarker Development Program

Identification and validation of biomarkers for drug response. Testing and comparison of biomarker assays.

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