Science thomsonreuters.com

Biomarkers are becoming an essential part of clinical development. In an exclusive new white paper—Biomarkers: an indispensable addition to the drug development toolkit—Thomson Reuters interviewed a number of the world’s leading pharmaceutical researchers to explore the role of biomarkers in improving decision-making, accelerating drug development and reducing development costs.

According to Dr Jeffrey Ross, Head of Pathology at the Albany Medical Center in New York, today you "would not even conceive" of developing a new drug without simultaneously looking for biomarkers for efficacy, safety, and to measure its pharmacodynamics. Dr Ross cited circulating tumor cells (CTCs) as an example of a biomarker at the front line of the battle against cancer. "It can give a pharmaceutical company a very early signal of efficacy," he told Thomson Reuters. "If you’re not knocking down the circulating tumor cells early in the trials, you may say, let’s save our money for the next agent."

This use of biomarkers as alternatives to clinical endpoints in drug development has helped oncology to beat the downturn in drug development experienced by other therapeutic areas. In particular, genetic and proteomic biomarkers are being used to predict an individual’s response to cancer treatment. "If we can select a population with the particular gene which we believe to be important for response to a novel therapeutic," said David Roblin, Pfizer, "then we can run a smaller clinical trial to see whether it works or not." This view was echoed by James Weatherall, AstraZeneca. "If we can start to [use] genetic or protein markers in a rigorous way, then that’s an incredibly powerful way to target the medication," he said.

And it’s not just oncology. Thomson Reuters also spoke to Dr Juan Carlos Kaski, Professor of Cardiovascular Science and Director of the Cardiovascular Biology Research Centre at St George’s University of London. Dr Kaski explained how the inflammatory biomarker C-reactive-protein (CRP) offers a new way of measuring the efficacy of statins. Dr Trevor Hansel, Medical Director of the National Heart & Lung Institute Clinical Studies Unit in London, highlighted the need for biomarkers in diseases like chronic obstructive pulmonary disease. "Finding biomarkers to improve our assessment of efficacy and safety in small numbers of patients is where all the initiatives are directed at," he told Thomson Reuters.

All these researchers highlighted how biomarkers are changing the way drugs are developed. The ultimate vision is to have access to biomarkers in all therapeutic fields, which means that industry, academia and clinicians need to work together to pool information. "Biomarkers could have such a huge impact, because you could reduce the time of your trials and improve internal decision-making," commented James Weatherall. "That means that everybody wins."

Biomarkers: an indispensable addition to the drug development toolkit—read the white paper

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