The opportunities and challenges inherent in using protein biomarkers for new drug development

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Difficulties diagnosing disease earlier, failure to demonstrate efficacy, questions about safety and the sheer cost of testing constantly threaten new therapeutic development. But greater understanding and more widespread use of protein biomarkers have the potential to improve that narrative.

A biomarker indicates a medical state that can be measured accurately and reproducibly from outside a patient’s body. Think of measuring a patient’s blood pressure to diagnose hypertension and predict heart disease, heart attack or stroke. During drug development, a biomarker is evidence of disease at the molecular level, and a protein biomarker demonstrates that a human body reacted to a therapy. Monitoring the concentration of such proteins is a powerful tool to follow the outcome of a disease and a drug’s efficacy.

Protein biomarkers can bring clarity to invisible illnesses,…

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