Biography 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 regulations and guidance. He co-chaired the AAPS Crystal City V and VI Workshops on the US 'FDA Draft Revised Guidance on Bioanalytical Method Validation' and 'Biomarkers'. He is actively involved in the Land O'Lakes Bioanalytical Conference and American Association of Pharmaceutical Scientists (AAPS, named Fellow in 2014). Mark has over 100 peer-reviewed publications, and numerous invited podium presentations. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis.
Keywords: ICH-M10; guidance; pivotal; regulation; scope.