Biomarker Assay Development 2011

More information on Biomarker Assay Development

FEATURED PRESENTATION

Safety Biomarkers in Action: Pre-Clinical to Clinical Translation
Calvert Louden, M.D., Senior Director of Pathology, Johnson & Johnson Pharmaceuticals
In toxicology (safety) the paradigm of mechanisms, models and markers is relevant to both safety and efficacy. However, the challenges for safety are significant and there is a strong emphasis to develop and employ new Safety Biomarkers (SBM). These new SBMs could contribute significantly to these challenges and be more informative if they can (1) distinguish between adaptive and toxic response (injury); (2) be predictive as well as diagnostic for injury that is minimal, progressive or reversible; (3) influence the selection of monitorable safety biomarkers for Phase 1 and beyond; (4) provide insights into the possible mode of action/mechanism of toxicity.