Singlicate analysis: should this be the default for biomarker measurements using ligand-binding assays?

Regulated ligand-binding assays (LBAs) must undergo stringent validation in order to provide sufficient confidence in the data. Enormous amount  of time, expense and effort are consumed to develop a new drug and get it released for use. If the drug candidate meets with late stage failure, the losses can be disastrous. Therefore, pharmaceutical companies are constantly seeking ways to improve effectiveness in the drug development process with reduced costs and time. Advances in our understanding of biology and disease mechanisms have led to a rapidly growing interest in using biomarkers to enhance the drug discovery/development process. Traditionally, biomarkers have been widely analyzed in clinical laboratories for disease diagnosis, prognosis and strategizing therapeutic interventions. Biomarkers have also been used in later-stage clinical studies as an effective adjunct to assess drug efficacy and toxicity. In recent years, exploratory biomarkers have been increasingly utilized to help pharmaceutical companies make internal decisions on early stage clinical studies such as proof of concept, go-no-go decision and mechanism of action by offering rapid turnaround and fit-for-purpose method validation strategies in nonregulated environments [1].