But, as KCAS’ Proveen Dass told Outsourcing-pharma, developing an effective biomaker strategy across the entire pharmaceutical development cycle can be a considerable challenge.
He explained that, whether in the lab, during preclinical development or in patient selection for clinical trials, appropriate use of biomaker analysis is the critical factor in helping drugmakers accelerate development and cut costs.
Dr Dass added that, while US Food and Drug Administration (FDA) guidelines mean biomarker validation can be a lengthily process, dividing development according to the specific stage of the process can make it more efficient.
“For example, in early stages of drug development we need a qualified assay, yes no categorical data, as compared to a fully validated assay in clinical trials.”