Strategic paths for biomarker qualification

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 ...

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...

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...

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

Fit, Simplicity and Risk: Multiple Paths to Strategic IT Change

The dominant rational approach to rr-centered strategic change derives from the positioning literature in business strategy. It assumes a single best path to successful organizational transformation. Three cases are used to show that, in practice, there are multiple alternadve paths. The strategic IT and business strategy literatures are critiqued in terms of the process of fit so as to explain...