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Biomarker assays supporting clinical development through validated ELISA and MSD multiplex platforms to help understand the drug’s efficacy and safety profile.
Biomarkers assays are becoming increasingly important in clinical development. These assays can be used to aid selection of a lead candidate and to understand the mechanism of action of a drug, as a surrogate / pharmacodynamics (PD) marker for monitoring clinical efficacy. Biomarker assays are also useful for identifying intermediate endpoints of success to decrease follow-up time.
The use of a specific biomarker assay, or multiplex assays for many analytes, to give early indication of drug efficacy, reducing attrition rates and optimizing clinical development programs. This can help to alleviate pressures due to time and resources.
To support your submission efficacy claims, robust and meaningful data across complex sample matrices and anticoagulants must be obtained from validated or fit-for-purpose quantitative biomarker assays.
The use of specific biomarkers as endpoints is justified where they have been well characterized and shown to predict relevant clinical outcomes across a variety of treatments and populations. Where this is not the case, the use of biomarkers must be confirmed through comprehensive evaluation and re-evaluation.
Our dedicated biomarker assay team have validated a range of biomarker assays using enzyme-linked immunosorbent assay (ELISA) and electrochemiluminescence (ECL) platforms. The assays include both singleplex and multiplex platforms in multiple matrices, such as plasma, serum, cerebrospinal fluid (CSF) for use in Good Laboratory Practice (GLP) compliant preclinical and clinical development programs.
With our experience in using biomarkers as surrogate endpoints in clinical research for disease states including metabolic, inflammatory, CNS, and cardiac, we can help you to obtain interim evidence about the safety and efficacy of therapeutic treatments. Our experts have the knowledge necessary to interpret results, providing insight about the drug response. The data from these studies can help you to design smaller, more efficient studies, reducing the number of subjects and shortening the time to approval of new treatments.
By selecting Intertek, you gain a partner with extensive experience in biomarker assays. Our centre of excellence, founded in 1999 located in San Diego, California, USA, is recognized as one of the leading biomarker assay laboratories in the world. Through close collaboration with MSD over the years we have gained significant knowledge in validating a wide range of multiplex biomarkers (V-PlexTM). To support your global clinical development programs we offer biomarker expertise from our centre of excellence in San Diego with additional support from our European GLP facility.