Ronald Fitzmartin PhD, MBA

Ron serves as Senior Informatics Advisor, Center for Biologics Evaluation and Research, Food and Drug Administration. In this capacity, Ron contributes to the development and implementation of strategy and guidance related to the electronic submissions and standardized data in support of the regulatory review of medical products. Specific focus areas include study data standards; Identification of Medicinal Products; and ICH M11: electronic Structured Harmonised Protocol.

Prior to FDA, Ron was Managing Partner at Decision Analytics LLC. In addition, he was V.P., Informatics & Knowledge Management at Daiichi Sankyo, Inc. Other positions included V.P., Biostatistics, Data Management and Informatics at Daiichi Medical Research, Inc. and Group Executive Director, Biostatistics & Clinical Operations at Purdue Pharma.

Ron has been a regular speaker, session, and meeting chair at numerous DIA and other industry meetings. In 2005, Ron was the DIA Annual Meeting Program Chair, Washington, DC. In 2006, Ron was elected DIA’s President-elect and served as President from 2007-to 2008. During Ron's tenure as President, DIA established offices in India and China. Currently, Ron serves on the editorial board for the DIA journal (Therapeutic Innovation & Regulatory Science), as well as a DIA Honorary Fellow.

Ron received a PhD in statistics from the University of Maryland, an MBA from the University of New Haven, and a BS (political science) & MS (statistics) from Southern Connecticut State University.