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Leveraging biomarkers in the clinical field isn’t a new concept. In fact, their value has been well documented in treatments for patients and in the development of new precision medicines. However, we have so much more to gain by better utilising the technology to guide clinical trial design for companies working with biomarkers in several disease areas. As with many aspects of R&D though, as the technology grows in scope and complexity, having access to the right expertise at the right time is critical to ensuring the most effective treatments are reaching patients.
Different biomarkers play different roles; some provide insights on the biological activity of targets and their modulation, whilst others can stratify patient populations or stage patients within their disease to support with study recruitment of the most appropriate patient populations and inform the selection of trial metrics and endpoints. Ensuring you are working with a good biomarker strategist from the outset of trial development will ensure programs are as efficient as possible at every stage.
As a biomarker-led approach becomes the gold standard in R&D, however, many companies have adopted a scatter-gun approach to gain as many insights into biomarker assays as possible. And more markers mean more invasive tests for the patients taking part in a trial. A smart strategy will focus on a targeted selection of the most informative and valuable biomarkers and will utilise enhanced technologies to interrogate each sample through multiplex assays. This approach of course streamlines analyses but importantly, it also limits the patient burden as much as possible.
Taking a biomarker led approach could be especially beneficial in heterogenous diseases such as non-alcoholic steatohepatitis (NASH), a type of non-alcoholic fatty liver disease (NAFLD), which causes inflammation and accumulation of fat and fibrous (scar) tissue in the liver. The disease is prevalent in the United States - affecting between 3% and 12% of adults – and incidence is increasing.
Currently, the standard practice for identifying NASH is through a highly invasive liver biopsy. Sometimes several biopsies are necessary for staging the condition, adding to the patient burden and risk. Furthermore, the interpretation is subjective, and limited sample size coupled with the heterogeneity of the disease can also limit the chance of a definitive diagnosis. With so many people needing accurate diagnosis and treatment, prognostic markers or risk stratification markers are urgently needed to support the development of effective therapeutics.
There has been some progress in the field – numerous studies have attempted to identify biomarkers for disease staging, progression and potential regression which could provide valuable insights on the efficacy of emerging therapeutics, and biomarkers are increasingly being utilised to guide trial management in some studies, but there is still a way to go.
NASH is just one example of a disease area that could greatly benefit from a biomarker-led research approach, and where strong, strategic partnerships between pharma and CROs, that leverage the necessary expertise and resources, will be critical to finding effective treatments and ultimately improving patient outcomes.
This strategy of balancing patient-centricity with a targeted biomarker focus, is at the heart of the holistic approach our scientists at Nexelis take to finding flexible and creative solutions for our partners working across immunology, oncology, metabolic and infectious diseases. We harness more than 30 years’ experience to recommend the best assays to use, and to establish best practices to improve both program efficiencies and overall outcomes.