Ask the Experts: biomarkers
In this first post, we ask our experts what sparked their interests in dedicating their research and careers to investigating biomarkers.
What began your interest in Biomarkers?
John Allinson, Head of Biomarker Strategy, Drug Development Services, LGC Group (Fordham, UK):
“I started my career in Clinical Pathology studying Biochemistry, Haematology, Microbiology, Histology and Cytology where I could also concentrate in the various analytical techniques practically. I was fortunate to begin working in a clinical laboratory at a time of great technological change but where there was also a great interest and focus on quality of results.
In a large laboratory of this type in the UK, every day you learn about new biomarkers, the various techniques to measure them, and the physiology in normal and (many) different disease states. I was also interested in business and management and so joined the CRO industry in 1994 to manage the largest central laboratory in the UK. Here, I became involved in developing bespoke biomarker services as it was obvious that my experience and knowledge learned in the clinical arena was of great value to what is required of biomarkers in drug development.
Since then, I have continually been trying to influence the adoption of good scientific and clinical practice in the development and validation of Biomarker assays.”
Patrick Bennett, Executive Director, PPD (VA, US):
“Metabolomics was what sparked my interest in biomarkers. This technology allowed us to investigate the broad and challenging area of identifying untargeted metabolites as biomarkers as part of screening assays. The identified biomarkers did not have to be chemically characterized to provide benefit. However, if needed, these could then be characterized and targeted methods for those biomarkers developed.”
Devagi Mehta, Chris Stebbins, Danielle Graham and Lauren Stevenson, Biogen (Cambridge; MA, US):
“At Biogen, we develop stage-appropriate biomarker plans for each of our drug development programs, beginning in discovery and continuing through post-marketing. These plans endeavor to incorporate clinically translatable biomarkers that demonstrate target engagement and pharmacodynamic activity, monitor safety concerns, evaluate disease progression, and stratify patient populations.
It is our main goal to use biomarkers to enable scientifically driven decision making at all stages of a drug program. Keeping this in mind, biomarker assays are developed and implemented using a fit-for-purpose philosophy, always focused on the scientific rationale and context of use. Critically, we believe biomarkers often have the greatest impact in early decision-making, providing the scientific evidence to support future investments in the drug development path.”
Click here to return to ‘Ask the Experts – Biomarkers’ to read other instalments part of this series.
