Mark E Arnold

Mark E. Arnold, Ph.D. is owner and Principal of Bioanalytical Solution Integrations, LLC., consulting with biotech and pharma companies to advance their portfolios bringing new therapies to patients in need. In that role, he collaboratively develops the bioanalytical scientific and regulatory strategy to meet current and future client needs for ligand-binging, cell-based and LC-MS/MS assays to quantify drugs and metabolites, antidrug antibodies and biomarkers in animal and clinical biological samples to support pharmacokinetic and pharmacodynamic assessments. Mark was previously Executive Director of the Bioanalytical Sciences Department of the Bristol-Myers Squibb Co. and Director of Science for the Scientific Affairs Department of Labcorp Drug Development. He received a B.S. in biology from Indiana University of Pennsylvania and Ph.D. in pharmacology from the University of Pittsburgh. For more than 38 years, Dr. Arnold has been involved in the field of bioanalysis, including the review and interpretation of regulations and guidance as they apply to the evolving field of bioanalysis. He was co-chair of both the AAPS Crystal City V and VI Workshops on the ‘FDA Draft Revised Guidance on Bioanalytical Method Validation’ and ‘Biomarkers’, respectively. He has been actively involved in the Land O’Lakes Bioanalytical Conference, Clinical and Pharmaceutical Solutions through Analysis, and the American Association of Pharmaceutical Scientists (AAPS, 2023 Scientific Advisory Chair, 2018 Bioanalytics Track Chair for PharmSci360) and is an AAPS Fellow (2014). Dr. Arnold has over 100 peer-reviewed publications, and numerous invited podium presentations.