Industry perspectives on biomarker qualification

Industry perspectives on biomarker qualification

Biomarkers have the potential to expedite drug development, increase patient safety, and optimize clinical response. Yet few have achieved regulatory qualification. A survey was conducted to clarify industry's perspective on biomarker qualification and identify the most promising biomarkers for drug development. The results across toxicities/clinical areas highlight challenges in regulatory qua...

Strategic paths for biomarker qualification.

Biomarkers may be qualified using different qualification processes. A passive approach for qualification has been to accept the end of discussions in the scientific literature as an indication that a biomarker has been accepted. An active approach to qualification requires development of a comprehensive process by which a consensus may be reached about the qualification of a biomarker. Active ...

Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry

Perspectives on the pharmaceutical industry.

This paper seeks to provide an economic perspective on the pharmaceutical industry, which has come under increasing criticism on a number of issues. In the main, that criticism amounts to a rather ineffective flailing at the supply side of the market for pharmaceutical products-much of it based on inaccurate perceptions-when a more productive policy would be to strengthen the hitherto weak and ...

Recommendations for biomarker identification and qualification in clinical proteomics.

Clinical proteomics has yielded some early positive results-the identification of potential disease biomarkers-indicating the promise for this analytical approach to improve the current state of the art in clinical practice. However, the inability to verify some candidate molecules in subsequent studies has led to skepticism among many clinicians and regulatory bodies, and it has become evident...