Biomarker Assays Development Support Services

Biomarkers assays are becoming increasingly important in clinical development and biologics testing. These assays can be used to aid the 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 can provide an early indication of drug efficacy. This information can help to reduce attrition rates and optimize clinical development programs, which in turn, can help to ease pressures related to development timelines 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 various treatments and populations. Where this is not the case, the use of biomarkers must be confirmed through comprehensive evaluation and re-evaluation.
 
Preclinical and Clinical Development Programs, Strategies and Guidance – Compliant with Good Laboratory Practice (GLP)

Our dedicated biomarker assay team has 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 obtain interim evidence about the safety and efficacy of therapeutic treatments. Our experts have the knowledge necessary to interpret results, providing insight into the drug response. The data from these studies can help you design smaller, more efficient studies, reducing the number of subjects and shortening the time to approve new treatments according to guidelines.
 
With Intertek’s bioanalytical services, you gain a partner with extensive experience in biomarker assays, testing, and guidelines. Through close collaboration with MSD over the years, we have gained significant knowledge in validating a wide range of multiplex biomarkers (V-Plex^TM). To support your global clinical development programs, we offer bioanalysis and biomarker expertise from our European GLP / GCP facility based in Manchester, UK.