The success of the CDISC pilot program of the SDTM (Standard Data Tabulation Model)/ADaM (Analysis Dataset Model) with FDA set expectations that pharmaceutical/biotech industry sponsors will provide submission data in SDTM- and ADaM-compliant formats in the very near future. BioMarin Pharmaceutical Inc. successfully submitted the Kuvan NDA last year in SDTM format, and we are gearing towards preparing all submission datasets in SDTM- and ADaM-compliant formats. In this open forum, I’d like to share BioMarin’s approach to accomplishing this mission, and give others the opportunity to share their approaches to submitting data in these formats.