Kevin Carl

TL;DR: This was a pilot process, and the experience gained will both facilitate better understanding of how the qualification process will probably evolve and clarify the minimal requirements necessary to evaluate the performance of biomarkers of organ injury within specific contexts.

TL;DR: Gene and protein expression analysis, in-situ hybridization and immunohistochemistry provide mechanistic evidence to support the use of four previously described nephrotoxicity markers for detecting kidney injury to guide regulatory decision making in drug development.

TL;DR: It is important during the biomarker evaluation process that stakeholders seek agreement on which critical experiments are needed to test that a biomarker meets specific performance claims, how new biomarker and traditional comparators will be measured and how the resulting data will be merged, analyzed and interpreted.

TL;DR: A selection of case studies from the first 5 years of the US Food and Drug Administration's voluntary exploratory data submission programme, which also involves collaboration with the European Medicines Agency, are discussed, and general lessons are highlighted.

TL;DR: Identification and validation of genomic and other biomarkers are becoming important components of drug-development strategies, and recent successes show the power of personalized approaches to change the benefit-risk paradigm for new drugs.