Strategic paths for 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...

The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path.

The qualification of biomarkers of drug safety requires data on many compounds and nonclinical and clinical studies. The cost and effort associated with these qualifications cannot be easily covered by a single pharmaceutical company. Intellectual property associated with safety biomarkers is also held by many different companies. Consortia between different pharmaceutical companies can overcom...

Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease.

BACKGROUND Regulatory qualification of a biomarker for a defined context of use provides scientifically robust assurances to sponsors and regulators that accelerate appropriate adoption of biomarkers into drug development. METHODS The Coalition Against Major Diseases submitted a dossier to the Scientific Advice Working Party of the European Medicines Agency requesting a qualification opinion ...

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

Qualification opinion on ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials