Full Name
Ethan Chen
Job Title
Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
Food and Drug Administration
Speaker Bio
Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions
and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining
the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics Architect, including
Data Management and Business Intelligence programs. While leading the CDER Division of Data
Management Service and Solution, Ethan had successfully implemented the eCTD electronic submission
mandate in 2017 for NDAs, BLAs and ANDAs, and again in 2018 for Commercial INDs and DMFs
(excluding DMF Type III). Ethan has over 20-years’ experience in Data Management, Enterprise
Architecture, Solution Development and System Integration. Ethan received a BS from Shanghai Jiao
Tong University, an MSE from Temple University and a MBA from University of Maryland at College
Ethan Chen