Perspectives on the draft ICH M10 guidance: an interview with Mark Arnold

Mark E Arnold, PhD, is Director of Science for Covance Laboratories. In that role, he develops the bioanalytical strategy for immune-, cell-based, quantitative polymerase chain reaction (qPCR) and LC–MS/MS assays to quantify drugs and metabolites, antidrug antibodies and biomarkers in animal and clinical samples for pharmacokinetic and pharmacodynamic assessments. Mark was previously Executive Director of Bioanalytical Sciences at Bristol–Myers Squibb. He received a BS (biology) from Indiana University of Pennsylvania and PhD (pharmacology) from the University of Pittsburgh. For more than 30 years, Mark has been involved in the evolving field of bioanalysis, including the science and the review and interpretation of...