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 ...

Interest in biomarkers has exploded in recent years, driven by improvements in data collection and analysis, burgeoning interest in personalized medicine, and efforts to increase the success rate for ...

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 ...

Protein biomarkers increasingly play a vital role in advancing health research, driving drug development, and improving clinical outcomes. The close connection between protein biomarkers and human ...

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 & ...

Despite their importance, a significant number of biomarker strategies fail because they are added too late, are not feasible in real clinical settings, or are poorly aligned with clinical endpoints.

Predictive biomarkers to guide selection of first-line chemotherapy for advanced pancreatic ductal adenocarcinoma (PDAC) are an unmet clinical need. This study used the Computational Histology ...

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 ...