Clinical Chemistry

It’s Time to get Savvy About Biomarkers

After the brief summer break, the conference season is now back in full swing, and one meeting that caught my eye this week was a three-day event that focused on biomarkers in clinical trials, held in London.

In the past, biomarkers were largely used to determine whether a patient responded to a treatment, but they are now used widely to assist drug development, and have gained significant attention in the R&D process. Many researchers hope they will help to improve clinical trial decision-making and contribute to a reduction in late-stage failure rates.

At the London meeting, which took place from September 19-21, the prime focus was on oncology. Presenters focused on topics like how to ensure operational success in implementing and managing biomarkers within oncology trials, integrating fit-for-purpose biomarker studies in early-phase oncology trials, partnerships for providing support for discovery of biomarker patterns in cancer, and early assessment of response to therapy. The overall message was that greater understanding of how cellular immortality contributes to cancer progression allows an opportunity for exploiting underlying molecular mechanisms into safe and effective new therapies.

“When identified at an early stage, biomarkers can provide an important tool for diagnosing disease types and stages, predicting the outcomes of different therapies, as well as monitoring pharmaceutical development,” noted Carl-Johan Ivarsson, CEO at Qlucore. In a company press release issued earlier this month, he stated that a biomarker is any characteristic that can be objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.

When examined in molecular terms, biomarkers include the subset of markers that may be discovered using genomics and proteomics or imaging technologies, he explained. Biomarkers could develop a major role in medicinal biology because they can help with early diagnosis, disease prevention, drug target identification, drug response, etc, and gene-based biomarkers may turn out to be an effective way of studying human disease.

Ivarsson is a participant in BioCARE (Biomarkers in Cancer Medicine), a research initiative at the Universities of Lund and Gothenburg in Sweden, which is investigating the role of biomarkers in cancer research. The project is focusing on different tumors in order to pursue the identification and validation of biomarkers as both diagnostic and therapeutic targets, and also to facilitate the identification of cancer sub-populations based on clinical behavior and treatment response in tumors.

BioCARE is using “omics” platforms, biobanks, and collaboration with cancer researchers to identify and analyze new biomarkers related to cancer, along with the complex networks that these biomarkers inhabit. The organizers hope the program will have a major impact on how cancer is diagnosed, treated and managed in the next five to 10 years.

Looking ahead, the 5th Annual Biomarkers Summit will take place in London from January 16-17, 2012. It will cover biomarker development and discovery validation, and will include technological and regulatory updates and advice. Research in diabetes, oncology, immunology, and neurodegenerative and respiratory diseases will be discussed

Find out more about Biomarker solutions from Randox


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