Biomarkers in Drug Discovery and Development
About this webinar:
Biomarkers have been defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes and pharmacologic responses to therapeutic intervention. In drug discovery and development, biomarkers carry the promise of allowing better decision making, identifying unfavourable properties (safety biomarkers) or confirming the expected efficacy profile of new drugs (efficacy biomarkers) early in the development before the progression to human studies. The drug development process is often associated with high levels of attrition, since many drug candidates fail because of preclinical or clinical safety issues.
The need for good biomarkers is therefore essential to identify preclinical effects that could be translated into humans (translational biomarkers); in addition, biomarkers can often be used in the approval process for a drug or treatment, as part of the risk assessment definition. Aptuit can provide analytical and biological biomarkers validation (e.g. by using different animal models or setting up specific studies) as well as measurement of biomarkers in several animal species by using different platforms: the interpretation of data is provided by using a multidisciplinary approach in which biomarkers results are related to other end-points (histopathology, histo/immunostaining, morphometric evaluations, toxicokinetic data, clinical signs, electron microscopy, gene expression, etc.) measured in complex studies.