Bridging the Gap Between Preclinical and Clinical Evaluation of Therapeutic Candidates

Session 3

Biomarker Applications in Drug Development: Predicting Response and Risk of Adverse Events

Nicholas C. Dracopoli, Ph.D.
Bristol-Myers Squibb, Princeton, New Jersey

The development of targeted therapeutics requires diagnostic tools to predict individual response to therapy to maximize drug efficacy and minimize the risk or severity of adverse events. These diagnostic tools include novel pharmacodynamaic (PD) markers for exploration of PK/PD relationships and to adjust dose and schedule, predictive markers for drug efficacy and risk of on- or off-target adverse events, and prognostic markers to predict the likely course of disease progression and adjust therapies appropriately. New molecular profiling methodologies allow comprehensive analysis of single nucleotide polymorphisms (SNPs), gene expression, and protein profiles for the discovery of novel genomic and dynamic biomarkers. Application of these technologies in pre-clinical and exploratory clinical development permits discovery of candidate markers in Phase I and IIa that can be independently replicated in Phase IIb, III and IV studies. In this presentation, examples will be given of gene expression profiles to enrich efficacy of selected oncology drugs, and for SNPs or haplotypes to predict increased risk of adverse events in patients treated with highly active antiretroviral therapy (HAART).

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