20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to harmonize common data models, development of a RWD safety approach for iSPY2+ OneSource project, and application of practical ontologies to fundamental issues in eSource. Pharm.D. U. of Michigan, Fellowship Drug R&D