FDA/PHUSE Annual Computational Science Symposium


The 3rd Annual Computational Science Symposium was delighted to host the following presentations from FDA members and industry professionals:

Welcome to the 3rd Annual Computational Science Symposium
Chuck Cooper & Steve Wilson, FDA

What's Coming in PDUFA V 
Theresa Mullin, FDA

Computational Science Center Progress and Next Steps
ShaAvhrée Buckman, FDA

CBER Progress and Next Steps 
Mark Walderhaug, FDA

Standard Interactions: CDISC Standards and the CSS Work Groups
Wayne Kubick, CDISC

Challenges and Gaps Identified from FDA Initiatives - CDER Perspective
Chuck Cooper, FDA

CBER Perspective  
Amy Malla, FDA



The Symposium invited individuals to present posters on company achievements and developments within the industry. Twenty one posters were presented in total with five Authors also delivering interactive demonstrations.

Please click on the links below to download the posters:

Preparing Data for Submission to the FDA - It's More Than SDTM - Winning Poster
Bruce Thompson, C-TASC

An Evaluation of Data Mining Methods and Software for Adverse Events Occurring in Clinical Trials  - 1st Runner Up
Paul Schuette, FDA

Adaptive Trials and the Impact on STDM Trial Design Model - 2nd Runner Up
Nate Freimark, Theorem Clinical Research

Path to Metadata-Driven Standards Environment - Collection to Submission
Melissa Binz, Novartis Pharmaceuticals Corporation

SAS Template Programs for Building Derived Datasets, Tables and Listings
Michael Carniello, Takeda Global R&D

Automatic Version Control and Track Changes of CDISC ADaM Specifications for FDA Submission
Min Chen, Vertex Pharmaceuticals

Risk Based SDV (Source Data Verification)
Shafi Chowdhury, Shafi Consultancy

An Innovative ADaM Programming Tool for FDA Submission
Xiangchen (Bob) Cui

Achieving an 'Error Free' OpenCDISC Report - Realistic or Idealistic?
Ratnakar Gundlapalli, ICON Plc

Throwing Data Over the Wall: The Next Big Threat to Clinical Data Quality
Kit Howard, Kestrel Consultants Inc

The Clinical Data Repository Initiative at Novartis Vaccines and Diagnostics: A Revolution
Pantaleo Nacci, Novartis Vaccines and Diagnostics

Nonclinical Safety Data Integration Platform
Alain Nanzer, F.Hoffman-La Roche Ltd

Standardization in Medical Research Data: Improving Data Displays and Data Traceability
Mary Nilsson, Eli Lilly & Company

Describing Data from Capture to Operational Use to CDISC-Compliant Submission
Yun Oldshue, Takeda Global R&D

Using SAS® to Calculate Noncompartmental Urine Parameters
Vanessa Rubano, Boehringer Ingelheim Pharmaceuticals USA

Automation of Clinical Trial Reporting: From Shells to TFL Outputs Without a Single Line of SAS Code
Francois Vandenhende, Clinbay

Comparing the Risk-Benefit of SDTM Software Solutions
Michael Wall, Pharstar

Optimizing the Organizational Performance of the Clinical Trials Process Through Better Technology
Michael Whitworth, Quanticate

CDISC Standards in Reverse: A More Efficient Approach to Clinical Trials Design
Robert Woolson, Rho Inc

Business Process Management (BPM) at the FDA: The Agency's Early Experience in Implementing BPM SW Tools
Markus Yap, FDA

CDISC-AdvaMed Device Project
Fred Wood, Octagon Research Solutions

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