Biomarkers in Drug Development

Biomarkers have been used for many years as indicators of biological change. In the course of drug development, biomarkers enjoy utility both as predictors

Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy, Edited by Michael R. Bleavins, Claudio Carini, Malle Jurima-Romet, and Ramin Rahbari Copyright © 2010 John Wiley & Sons, Inc.

Safety

'What is the drug doing to the patient?'

Markers of tissue damage, adverse hematology, etc. Predict/report unwanted toxicity endpoint

'What is the drug doing to the patient?'

Markers of tissue damage, adverse hematology, etc. Predict/report unwanted toxicity endpoint

Biomarkers of Pharmacodynamic (PD) endpoints: 'What is the drug doing to the patient?' Receptor modification, altered glucose levels/blood lipids Commensurate with desired efficacy endpoint

Approval

Approval

Efficacy

Biomarkers of Pharmacodynamic (PD) endpoints: 'What is the drug doing to the patient?' Receptor modification, altered glucose levels/blood lipids Commensurate with desired efficacy endpoint

Figure 1 Biomarkers in clinical medicine. Biomarkers of safety and efficacy can be used together as part of the overall data set to assist in decision making.

of possible efficacy and also as warning signs of potential toxicity (Figure 1). For efficacy endpoints, biomarkers are used to address the pharmacodynamic question "What is the drug doing to the patient?" commensurate with desired outcomes such as receptor modification or blood glucose changes. For safety endpoints, biomarkers may be used as indicators of unwanted endpoints such as tissue damage or adverse hematology.

Although these two types of biomarker serve diverse purposes, the parameters dictating their identification, development, and utility are very similar. However, there is one key aspect in which safety biomarkers differ; safety biomarkers are most useful when they predict rather than report damage. For example, an efficacy biomarker can provide rapid confirmation that the drug has hit its target, perhaps by confirmation of growth factor receptor inhibition in a skin biopsy. However, a safety biomarker of liver damage would ideally precede the damage (either in dose or time) to be of maximum use to the clinician. Despite this, biomarkers that report rather than predict can still be useful if they prevent further damage or permit cessation of treatment and subsequent recovery.

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