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 ...

"In order to make this happen, what we need to think about is how we create a safety biomarker data repository to house nonclinical and clinical data," he said. "Is there a way that we can use data ...

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 ...

The world is currently undergoing a significant transformation in biomarker science. Biomarker signatures are no longer academic luxury or exploratory afterthoughts; they have matured into strategic ...