In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for ...

As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the ...

Drug development involves significant risk and expense. With average development costs topping $1 billion per approved medicine and stubbornly high failure rates, pharmaceutical leaders are ...

Every decision in drug development carries weight. The right biomarker insights can make those decisions more confident and data-driven. In this white paper, experts from AstraZeneca, Johnson & ...

The Forum on Neuroscience and Nervous System Disorders hosted a public workshop on June 21-22, 2010, bringing together key stakeholders, to present promising current and emerging technologies with ...

Please provide your email address to receive an email when new articles are posted on . ADx NeuroSciences and Alamar Biosciences have announced a partnership to develop customized biomarker assays for ...

Background: The Prognostic Lung Fibrosis Consortium (PROLIFIC) was formed to develop well-qualified assays suitable for use as prognostic biomarkers within the context of clinical trials for Idiopathic ...

Objective Biomarkers and FDA-Cleared Tools While existing tools represent decades of clinical and research development, they ...

The CHAI platform extracted quantitative histomorphologic features from whole-slide images of hematoxylin and eosin–stained diagnostic biopsies. In a multi-institutional development cohort, features ...