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Transforming Experimental Neural Functioning Variables into FDA Validated Biomarkers [Hybrid]

Pictured: Sara Jane Webb

Sara Jane Webb

This talk will focus on the acquisition and analytic rational, progress, and challenges in developing neuroimaging biomarkers for use in clinical trials under the FDA Biomarker Qualification process. I will describe reasons why biomarkers are needed to improve clinical trials for neurodevelopmental disorders as well highlight current progress in use for neurodegenerative disorders. Examples from the NIMH U19 Autism Biomarkers Consortium for Clinical Trials will be discussed in depth, highlighting early stage investigation into how EEG biomarker related to social functioning associate with adaptive social ability and autistic-social -communicative behaviors, the importance of consideration of age and sex/gender, and the challenges of identifying meaningful strata from neuroimaging markers. Lastly, I will discuss outstanding considerations for quantifying biomarkers focusing on rigor and reproducibility and contexts of future use.