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Research Field Cancer, Clinical trials, Diagnostics & prognostics, Drug discovery

No Biomarker, No Trial?

The way we have developed cancer drugs to date is far from optimal and, in most instances, results in failure (1). The stark truth is that the majority of drug discovery and development activity yields little benefit to patients, while exposing them to potentially toxic drugs and wasting billions of dollars in the process. With the majority of experimental cancer drugs falling down at the costly mid-to-late stages of clinical development (Phase II or III clinical trials), we’ve reached a stage where something has to give. We need to bring critical decision points forward, ideally into the initial stages of clinical development (Phase I), before costs, timelines and patient numbers escalate. The shrewd application of biomarkers in early-phase clinical development can help us to make these critical go/no-go decisions in time.

Biomarkers come in many flavors

A biomarker is defined by the FDA as “a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.” Under the umbrella term of “biomarkers”, there are many different flavors. One of the most commonly adopted biomarker classification systems is that suggested by Bradley (2), which categorizes biomarkers (with some minor modifications) as follows:

  • Pharmacodynamic
  • Proof of mechanism (PoM)
  • Proof of principle (PoP)
  • Proof of concept (PoC)
  • Predictive biomarkers (sometimes known as patient stratification, selection or enrichment biomarkers)
  • Safety biomarkers

These biomarker categories are explained in more detail below.

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About the Authors

James Ritchie

James says that he wants to live in a world where the word “cancer” no longer holds any fear, and he has dedicated his professional career to achieving this aim, having been involved in cancer drug discovery and development since 2001. His experience has spanned the entire continuum from early discovery through to pivotal clinical development and he is currently the drug development scientist at Cancer Research UK’s Centre for Drug Development. The remit of the CDD is the translation and early clinical development of new anti-cancer agents covering everything from small molecules to immune and cellular based therapies.

Sidath Katugampola

Growing up in a family of medical professionals, I soon realized that doing on-call at nights did not fit in with my love for a good work–life balance. More importantly, it also made me question how medicines work and why they often work better for some people than others. This curiosity led me to study Pharmacology at Southampton University. I received a Ph.D from the University of Cambridge and spent the next 10 years working at Pfizer UK, six of those years working in Biomarkers and Translational Medicine. I have been fortunate to carry on with this passion over the last four years at Cancer Research UK and continue looking answers to my childhood questions.

Paul Jones

Paul has a lifelong fascination for biology, studying genetics and gaining a PhD in molecular toxicology before embarking on a series of post-doctoral positions on a variety of receptor signalling mechanisms. On gaining an R&D position in GE Healthcare Medical Diagnostics he became a passionate born-again drug developer. For the last nine years Paul has pursued this interest at Cancer Research UK on the translation of novel small molecules, biologicals, cell therapies, imaging agents and radiotherapies into first-in-man clinical trials.

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