How to measure success using biomarkers

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The answer to why some patients respond to therapy while others do not can be found in the concept of biomarkers: objective, measurable indicators of the severity or presence of disease.

Used for decades to support medical diagnosis, today, researchers utilize biomarkers in all phases of drug discovery and development. There are reasonable grounds for this as biomarkers can boost drug development success rates threefold, thereby speeding up the availability of new therapeutics.

A biomarker-driven approach offers multiple benefits, including:

  • Enable early proof-of-concept studies for new therapeutic targets, reducing drug attrition rates
  • Help determine benefit-risk profile, to facilitate and streamline regulatory decisions
  • Predict drug efficacy more quickly than traditional clinical endpoints
  • Stratify patients during enrollment with more accuracy, thereby reducing the number of patients needed to demonstrate clinical benefit
  • Use as surrogate endpoints in clinical trials

Recently, increases in biomarker development run in parallel to both advances in science and technology and the surge in precision medicine.

Precision medicines necessitate predictive biomarkers to sort patients by disease risk and prognosis, as well as to determine which patients are most likely to respond to therapy or to experience side effects.

Meanwhile, with advances and cost-efficiencies in diagnostic testing, genetic sequencing, and other technologies, scientists have concentrated on genetic biomarker candidates.

In combination with biomarker development predicated on elements circulating in blood, as well as proteins residing in tissue which are detected through imaging, there has been a substantial increase in the number of circulating biomarkers being tested.

The challenge with all this discovery exists in the validation of biomarkers to prove their clinical or predictive significance. That’s where Cerba Research steps in.

Cerba’s approach

Cerba Research works in close collaboration with clients to produce a powerful biomarker validation process to help boost the success of biomarker integration in clinical development.

That process begins with analyzing specificity throughout prevalidation and remains in place during preclinical, clinical, Clinical Laboratory Improvement Amendments (CLIA) and FDA validation.

Cerba Research has adapted to the complexities of clinical research and the surge of additional targeted therapies with innovative solutions. Cerba can apply conventional and more advanced ELISA platforms as well as demonstrating the capacity for ultra-sensitive detection, which includes single and multiplex analysis, in various disease categories.

Meanwhile, the Cerba IVD team custom-evaluates and validates new biomarkers continuously to help clients get nearer to their breakthrough treatments. Expertise extends from common clinical biology and esoteric testing to specimens and data sourcing.

With immediate access to qualified specimens from millions of patients, Cerba’s clinical pathology labs can use this data to help validate new drugs and new biomarkers, as well as assisting its clients in patient recruitment for their trials.

Cerba continually onboard the latest technologies and use data science to produce more insights and relevance to biomarkers. However, none of this takes place without learning all about a client’s products and objectives.

During preliminary discussions, Cerba helps streamline tests and methodologies used and suggests alternatives that could generate more precise results. At the same time, Cerba is willing to add or remove tests based on client feedback: the development of this standard is a real team effort.

 

Advances in biomarker development

Biomarkers can be multigene or protein panels, individual genes, or proteins, biomolecules, or even microbiota from the gut microbiome. Cerba Research is happy to have highly skilled scientists with the experience to validate and test these and other types of biomarkers.

Cerba’s methods include, but are not restricted to, flow cytometry, multiplex IHC, PCR, NGS, tissue immunohistochemistry (IHC) and cytokine and circulatory protein analysis, among others. This wealth of experience allows the company to develop and validate both standard-stock and esoteric biomarkers.

Cerba’s scientists join forces with skilled researchers and physicians — experts who treat patients every day — via collaborations with pathology and genomics labs, startups and academia.

Clients receive all-inclusive insights efficiently with all this experience and a wide range of techniques under one roof.

The importance of a global network

Delay during the transportation of specimens introduces the risk of variability. To better serve clinical research on an international level necessitates a network of instruments, platforms and experts, with the capacity to centralize the analysis and review data.

Cerba Research developed a global footprint to adapt testing for research centers worldwide. Consistent sample handling makes sure the quality of samples remains unchanged throughout the journey.

Access to over 700 labs and blood collection sites within the Cerba HealthCare Group, anchored by seven offices across five continents, enables Cerba Research to store specimens near research sites while offering global logistics to and from client sites as well as excellent data analysis.

Both global and local operations at this level require world-class logistics. The result is minimized risk for Cerba clients. Also, offering rapid sample analysis means that clients are ensured the best quality data.

Close communication, scientist to scientist

An international network of labs also means access to an extensive range of skilled laboratory researchers. In a great number of cases, clients want to confirm new tests or testing modalities.

Cerba Research shines in the development and validation of customized assays. However, whether it provides custom solutions or biomarkers from an enormous portfolio depends on the outcome of an in-depth scientist-to-scientist discussion — between Cerba’s experts and its clients.

Cerba are enthusiastic about initiating a dialog, and the company’s versatility adjusts to clients’ requirements. For instance, if a client is developing a biomarker-guided oncology trial and possesses a clear idea of their needs, Cerba can accommodate and offer good advice that adds value.

For any open-ended questions about biomarker development and validation, Cerba can provide technical, medical and pathology experts for the development of a solution. Cerba remains as flexible as possible while designing a science-based solution.

Your partner from early research through clinical trials

While this level of close communication begins in drug discovery, it continues through to the commercialization stage. Cerba supports all development and validation, from nonclinical through to Phase I-III clinical trials.

Cerba’s biomarker and companion diagnostic services are consistently in place, allowing its clients to fully enhance R&D productivity. As clinical research becomes increasingly biomarker-driven, the need for companion diagnostics and results has also increased.

The therapy and the test must be addressed in parallel, and for this reason, Cerba Research draws upon its diagnostics business unit, which is focused on benchmark validation of new devices, reagents and biomarkers, and offer qualified — and typically rare — specimens.

Thanks to the network of Cerba HealthCare diagnostics labs, the company guarantees that those tests will be consistently available for patient access when the drug is on the market.

In combination with Cerba’s central laboratory solutions (specialty lab, FCM, ICH, NGS, BioA, metabolomics), additional translational science (CDx, biobanking) and IVD (biospecimens, prospective sample collection, IVD evaluation), clients acquire additional value.

By working with just one vendor during drug development reduces the risks involved by eradicating transfers, as well as improving administrative and operational efficiency: one vendor, one contract, one point of communication for numerous services.

The road ahead

Given the promise of precision medicine for the effective treatment of debilitating diseases, Cerba expects it to remain a primary focus of clinical research for the foreseeable future. As science and technology progress, Cerba Research is on hand to offer comprehensive biomarker services, doing its part to change the face of clinical development.

About Cerba Research

For over 35 years, Cerba Research has been setting the industry standard for exemplary clinical trial conduct. Today, across five continents, with a focus on precision medicine, we are changing the paradigm of the central lab’s role in complex clinical research.

From protocol inception through development and to market, our passionate experts deliver the highest quality specialized and personalized laboratory and diagnostic solutions. Partner with us for the most efficient strategy to actualize your biotech and pharmaceutical products sooner and improve the lives of patients worldwide.


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Last updated: Aug 31, 2021 at 7:40 AM

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