This year's conference includes presentations from several FDA employees as well as as special FDA Panel Discussion:
- Steve Wilson, Statistical Review and Data Standards: It’s Gettin’ Better All The Time
- Ron Fitzmartin, Update on Data Standards
- Alan Shapiro, Innovation and Regulatory Review: What is JumpStart?
- Jimmy Wong, R Shiny Clinical Review Tools on the Horizon
- Lillian Qiu and Hon-Sum Ko, Pilot Meta-Analysis of HPA Axis Suppression Studies on Topical Corticosteroids using ADaM Datasets derived from Legacy Data
FDA Panel Discussion
Title: Use of Data and Metadata at FDA: How Has it Changed, Where is it Going?
Abstract: We will be talking with FDA representatives from different parts of the CDER organization about what they do with the material we submit to them. The panel includes those with background in statistical review, medical reviewer, JumpStart, and policy. Three of the panelists will be presenting prior to the panel on related topics.
Time: Wednesday, 10:45 AM - 11:35 AM, Location: Key Ballroom 9-11
|Ron Fitzmartin, Ph.D., MBA
Sr. Advisor, Office of Strategic Programs, CDER / FDA
|Eileen Navarro Almario, MD, FACP
Associate Director for Clinical Affairs, CDER / FDA
|Alan Shapiro, MD, Ph.D., FAAP
Medical Officer, Office of Computational Sciences, CDER / FDA
|Steve Wilson, Dr.P.H., CAPT USPHS
Director, Division of Biometrics III, FDA/OMPT/CDER/OTS/OB
|Weiya Zhang, Ph.D.
Statistical Reviewer, Division of Biometrics III, FDA/OMPT/CDER/OTS/OB
Senior ADaM Consultant, Accenture Accelerated R&D Services