Biomarkers. There was a time in the not-so-distant past when simply identifying a biomarker was considered a drug discovery success. Like the low hanging fruit initially exposed by the genomic revolution, that once common view has long since disappeared. Today, the line between the bench and the clinic is becoming increasingly blurred. Translational science has become a core element of the drug discovery paradigm, and with it has come an increasing need for an integrated, multidisciplinary approach to biomarker development.
In this month’s Editor’s Choice from Drug Discovery Today, I highlight several recent papers which, together, illustrate practical challenges and key considerations for developing a comprehensive biomarker strategy.
The first free download describes a common challenge. In the article, ‘Recent progress toward biomarker identification’,Frederic De Ceuninck, Massimo Sabatini and Philippe Pastoureau address the difficulties associated with osteoarthritis diagnosis and discuss recent research efforts to identify reliable osteoarthritis biomarkers. The authors conclude that successfully addressing this complicated disease ultimately will require addressing multiple markers to address and overcome concerns related to both sensitivity and specificity.
As explained in the second free download, ‘Clinical and biological data integration for biomarker discovery’, by Marco D. Sorani, Ward A. Ortmann, Erik P. Bierwagen and Timothy W. Behrens, biomarkers hold great potential for increasing the success rates of clinical trials. However, the authors make the case that to truly capitalize on this potential; it requires a data integration strategy which encompasses clinical and biological data in a useful wiki interface. They provide examples that illustrate the utility of data integration to explore disease heterogeneity and develop predictive biomarkers.
In the third complimentary article,‘A generic operational strategy to qualify translational safety biomarkers’,Katja Matheis et al. surmise that the value of translational safety biomarkers is well recognized but researchers are lacking a standardized approach to qualify biomarkers in clinical studies. They make the case for clear scientific guidelines to link biomarkers to clinical processes and clinical endpoints and propose the SAFE-T consortium generic qualification framework as one option.
The last of this month’s free downloads ‘The biomarker is not the end’ builds on the aforementioned articles. I wrote this paper with the bench scientist in mind, hoping to prompt early thinking and avoid likely pitfalls. Ultimately, the real value of a biomarker will be proven in its ability to deliver clinical utility and support the delivery of the right treatment to the right patient at the right time. As I explain in my article, enlisting the appropriate experts at the right stages in this process can make or break an effort to bring a biomarker-based companion diagnostic successfully into clinical practice.
Michael Nohaile, Ph.D., is the Head of Novartis Molecular Diagnostics. Previously at Novartis, Dr. Nohaile served as Head of Corporate Strategy and Pharma Strategy. He joined Novartis in 2007 from McKinsey & Company where he was a partner in the New Jersey office. At McKinsey, Dr. Nohaile worked extensively in the healthcare area with a particular focus on diagnostics and pharmaceuticals. He holds a Doctorate in Molecular and Cell Biology from UC Berkeley and was a Post-Doctoral Fellow at MIT in the Department of Biology.