Bridging the Gap Between Preclinical and Clinical Evaluation of Therapeutic Candidates

Session 3

Introduction to Biomarkers for Assessment of Responses to Therapies

Carl C. Peck, M.D.
University of California San Francisco

Although used for many decades in drug development and regulation, optimal utilization of biomarkers in bridging the gap between preclinical and clinical evaluation of therapeutic candidates requires functional definitions of the key terms biomarker, clinical endpoint, and surrogate endpoint, conveniently published by the NIH Biomarkers Definitions Working Group1. This permits understanding of causal and non-causal roles that biomarkers play in disease progression and diagnosis. Linking biomarkers with clinical benefits requires rigorous scientific investigations to rule out spurious relationships and employment of strict criteria for strength, specificity, consistency and plausibility of causation. Best practices by drug developers and regulators concerning these issues will be introduced with examples.

References

1. “Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin Pharm Ther 2001, 69 (3): 89-95.

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