Outsourcing Measurable success
Jerome Sallette, chief scientific officer at Cerba Research, explains the value of biomarkers from discovery through to commercialisation, and the company’s role in validating biomarkers to confirm their clinical or predictive significance.
hy do some patients respond to therapy while others do not? The answer can be found in the concept of biomarkers: objective, measurable indicators of the presence or severity of disease. Used for decades to aid medical diagnosis, researchers today use biomarkers in every phase of drug discovery and development.
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Biomarkers can triple drug development success rates, accelerating the availability of new therapeutics. A biomarker-driven approach provides multiple benefits, including: enabling early proof-of-concept studies for novel therapeutic targets, reducing drug attrition rates, predicting drug efficacy more quickly than conventional clinical endpoints, stratifying patients during enrolment with more accuracy, reducing the number of patients needed to show clinical benefit, using surrogate endpoints in clinical trials, helping to determine benefit-risk profile and facilitating smooth regulatory decisions.
Specificity is analysed during the prevalidation stage and continues throughout the preclinical stage.
as well as proteins residing in tissue that are identified through imaging, the number of circulating biomarkers we test for has grown tremendously.
The tested formula
Cerba Research partners with clients to develop a robust biomarker validation
“A biomarker-driven approach provides multiple benefits, including: enabling early proof-of-concept studies for novel therapeutic targets, reducing drug attrition rates [and] predicting drug efficacy.”
A recent increase in biomarker development parallels both the rise in precision medicine and advances in science and technology. Precision medicines require predictive biomarkers to classify patients by disease risk and prognosis, as well as to identify patients more likely to respond to therapy or to develop side effects. Meanwhile, as genetic sequencing, diagnostic testing, and other technologies have advanced and become more cost-efficient, scientists have focused on genetic biomarker candidates. Combined with biomarker development based on components circulating in blood,
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process to help increase the success of biomarker integration in clinical development. That process starts with analysing specificity during prevalidation and continues through preclinical, clinical, Clinical Laboratory Improvement Amendments (CLIA), and FDA validation. Cerba Research has adapted to clinical research complexities and the rise of more targeted therapies with forward- looking solutions. We can apply traditional and newer ELISA platforms as well as ultra-sensitive detection capabilities, including single and multiplex analysis, in various disease categories.
Meanwhile, the Cerba IVD team continually custom-evaluates and validates new biomarkers to help clients move closer to breakthrough treatments. Expertise ranges from routine clinical biology and esoteric testing to specimens and data sourcing. Accessing qualified specimens from millions of patients in our clinical pathology labs, and using this data prospectively, helps the company validate new drugs and new biomarkers, as well as helping its clients recruit patients for their trials. Cerba continually onboards new technologies and makes wise use of data science to generate more insights and relevance to biomarkers. None of this happens, however, before learning all about a client’s products and their goals. During those preliminary discussions, Cerba helps refine tests and methodologies used and propose alternatives that could yield more precise results. At the same time, the company is willing to add or remove tests based on client feedback. Development is a true team effort.
Biomarker advances
Biomarkers can be individual genes or proteins, multi-gene or protein panels, biomolecules, or even microbiota from the gut microbiome.
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