Biomarkers as drug development tools: discovery, validation, qualification and use
The 21st Century Cures Act, approved in the USA in December 2016, has encouraged the establishment of the national Precision Medicine Initiative and the augmentation of efforts to address disease prevention, diagnosis and treatment on the basis of a molecular understanding of disease. The Act adopts into law the formal process, developed by the FDA, of qualification of drug development tools, including biomarkers and clinical outcome assessments, to increase the efficiency of clinical trials and encourage an era of molecular medicine. The FDA and European Medicines Agency (EMA) have developed similar processes for the qualification of biomarkers intended for use as companion diagnostics or for development and regulatory approval of a drug or therapeutic. Biomarkers that are used exclusively for the diagnosis, monitoring or stratification of patients in clinical trials are not subject to regulatory approval, although their qualification can facilitate the conduct of a trial. In this Review, the salient features of biomarker discovery, analytical validation, clinical qualification and utilization are described in order to provide an understanding of the process of biomarker development and, through this understanding, convey an appreciation of their potential advantages and limitations.
Response to 'Evolving M-protein pattern in patients with smoldering multiple myeloma: impact on early progression'
Response to 'Evolving M-protein pattern in patients with smoldering multiple myeloma: impact on early progression', Published online: 25 May 2018; doi:10.1038/s41375-018-0155- ... more
Coppery inks paint an underwater rainbow
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Previous studies suggested that MeCP2 competes with linker histone H1, but this hypothesis has never been tested in vivo. Here, we performed chromatin immunoprecipitation followed by sequencing (ChIP-seq) of Flag-tagged-H1.0 in mouse forebrain excitatory neurons. Unexpectedly, Flag-H1.0 and ... more
Olympus Microscopy has partnered with the Nature Publishing Group to present the Neurotechniques Collection. This compilation of articles will draw together some of the groundbreaking research that has recently been published in Nature Reviews Neuroscience and Nature Methods. Sponsored by O ... more