On this episode of Molecular Moments, Chad Briscoe speaks with Dr. David Berkowitz, Director of the Division of Chemistry at
Clinical research benefits from innovative biomarker solutions that deploy a broad range of technology, methodologies, and matrices to test for novel biomarkers. More and more companies are relying on biomarkers to assess the efficacy, safety, and mechanism of action of drugs to make “go” or “no go” decisions regarding their continued development. That means that the data must be of the highest quality possible. This will help ensure objective measurement and evaluation of characteristics that indicate normal biological processes, pathogenic progresses, or pharmacologic responses to a therapeutic intervention.
As biomarkers continue to gain traction in clinical research, it is essential that their validity is continuously evaluated and re-evaluated. Biomarker validity is integrally tied to biomarker performance and therefore, there has been movement towards standardization for a validation path within the industry. Validation includes proof of concept, experimental validation, analytical performances validation, and protocol standardization. Applied to clinical research, biomarkers have the potential to accelerate the speed of drug development and mitigate ineffective treatments. That said, they are not to be confused with clinical endpoints.
As a laboratory specializing in large molecule bioanalysis, BioAgilytix’s biomarker assay expertise is virtually unrivaled. Together we have experience working with over 500 biomarkers in singleplex and multiplex formats for a wide range of disease states.
Leveraging this established expertise in biomarker assay development, biomarker assay validation, and sample testing for biomarkers and bioassays, we provide a diverse range of simple to highly complex assays for both routine and esoteric use, across a wide range of technologies many matrices including serum, plasma, and tissue homogenates. We also accommodate study sizes with low-, medium-, or high-volume sample biomarker testing requirements.
In fact, BioAgilytix has developed a robust biomarker menu which includes over 600 biomarkers spanning a diverse range of disease states.
Whether we leverage biomarkers from this extensive, ever-growing menu to streamline the time and cost needed for biotherapeutics development or collaborate with customers to develop and validate their novel biomarker assays, we are able to help identify a solution that meets the unique needs of the project, no matter the disease state or phase of development.
The platforms used in biomarker analysis vary based on whether we are dealing with exploratory biomarkers, which help our customers understand the pharmacodynamics or mechanism of action of the compound hypothesis generation, or confirmatory biomarkers, which support pivotal determinations of efficacy. BioAgilytix helps our customers make the optimal choice in this “fit for purpose” approach, typically leveraging the platforms below.
Biomarker validation can be confusing. Learn more about how BioAgilytix and the industry are progressing to come to some level of consensus as an industry on guidance and best practices in a blog post from BioAgilytix Founder and Board Member, Dr. Afshin Safavi.
Because the uses for biomarkers are quite diverse, they require a contract laboratory partner with a breadth and depth of specialty expertise. BioAgilytix has unmatched experience in developing biomarkers that are safe, easy to measure, cost-effective, consistent across sample groups, sensitive to severity, and analytically stable – and validating those biomarkers for everything from exploratory to regulated studies. Our comprehensive approach helps you ensure both the clinical and commercial success of your drug candidate in an efficient and cost-effective manner.
Our experts understand the complexities that must be addressed in biomarker studies, and will help you determine the optimal analytical equipment platform to yield high-quality data results. We support biomarkers for oncology, metabolic, autoimmune, neurology, and other disease states, and can offer these services under GLP, GMP, and GCP to meet your regulatory requirements.