KCAS talks biomarker strategy development

By Claire Videau and Gareth Macdonald

- Last updated on GMT

Related tags: Food and drug administration, Pharmacology, Clinical trial

Biomarkers are critical to discovery and can help pharmaceutical firms make development a more efficient and cost effective process accord to bioanalysis services provider KCAS.

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.”

Related topics: Preclinical Research, Preclinical

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