Presentations

Monday:

Introduction
– Crystal Allard, Special Assistant to the Director Office of Computational Science, FDA/CDER

Visualization of Nonclinical Standardized Data and the Fit for Use Pilot
Elaine Thompson, Senior Staff Fellow, Office of Computational Science, FDA/CDER

How Analysis Tools are Used for the NDA/BLA Clinical Review
– Mary Doi, Acting Deputy Director, Office Computational Science, FDA/CDER & Vaishali Popat, Associate Director of Biomedical Informatics Office of New Drugs, FDA/CDER

From CDISC to PhUSE to Approval – A Statistical Reviewer's Experience and Thoughts
Steve Wilson
Huanyu Chen
– Steve Wilson, USPHS Director, Division of Biometrics III, CDER/FDA & Huanyu (Jade) Chen, Master Statistical Reviewer, Office of Biostatistics, FDA/CDER

Download the audio file for the above presentations here.

Tuesday:

Closing Remarks – download the audio file.

Working Group Presentations

Working Group Opening Session 

Linked Data and Graph Databases

Optimizing the Use of Data Standards 

Standard Analyses and Code Sharing 

Poster Presentations

Winners are highlighted in bold text.

Poster No.Poster TitleAuthors

PP01

Tagging the TAUGs: Making SDTM Content Easier to Find and Use

Richard Addy & Stephen Kirby, Chiltern

PP02

Development and Use of R Package for Noncompartmental Analysis

Kyun-Seop Bae, University of Ulsan College of Medicine and Jee Eun Lee, FDS

PP03

Linked Data & Graph Database Working Group 

Scott Bahlavooni, d-Wise

PP04

Graphical Display of Histopathology Data from Multiple Toxicology Studies

Alan Brown, Novartis, Philip Drew, PDS Consultants, Kevin Synder FDA, Raja Ramesh, PointCross & Joyce Zandee INDS

PP05

Use of R Script to Create Trial Summary (ts.xpt) Domains for Nonclinical SEND Studies

Bob Friedman, Xybion, Anthony Fata, PDS, William Varady, Boehringer Ingelheim, William Houser, BMS; Kevin Snyder, FDA

PP06 

Programming Role in In-licensing Projects

Asif Karbhari, M.S.AstraZeneca Pharmaceuticals

PP07

Data Standards and FDA’s Animal Rule Studies

Laura Kaufman, Eagle Pharmaceuticals & Jacquice Davis, PointCross Life Sciences

PP08

Standardization of Adjudication Outcomes Data Modelling using CDISC standards                            

Aparna Kulkarni & Jacques Lanoue, Novartis

PP09

End-to-end Standards driven Process for Oncology Studies

Kevin Lee & Peng Yang, Clindata Insight

PP11

Fixing the Transport Format

Geoff Low, Medidata Solutions

PP12

Scalable and Efficient Biomarker Visualisation Techniques for Early-phase Clinical Trials 

Amy Matcho, & Nicole Thorne, Janssen Research & Development

PP13

Roadmap for Managing Multiple CRO Vendors

Veena Nataraj & Karin LaPann, MS Shire

PP14

Standard Analyses and Displays for Common Data in Clinical Trials – The Journey Continues!                          

Mary Nilsson, Eli Lilly and Company & Nhi Beasley, FDA

PP15  

Electronic Study Data Submission for New Drug Application in Japan

Ken Sakushima, PMDA, FDA/CDER/OSP,
Hiroshi Sakaguchi, PMDA & TJ Chen FDA/CDER/OSP

PP16

 A Contribution to Better Systems – The Test Data Factory (TDF) Project 

Peter Schaefer, VCA-Plus, Nancy Brucken, inVentiv Health
& Cynthia Stroupe, UCB 

PP17

A User Guide for the PhUSE GitHub Repository

Jared Slain, MPI Research

PP18

 

Reducing Duplicated Effort on Standard Analyses through Collaboration - Roadmap for Standard Analyses and Code Sharing Working Group

Hanming Tu, Accenture Accelerated R&D Services & Mat Soukup, FDA

PP19

 

Sorting Out the Paperwork – Define.xml versus Reviewer’s Guide and other Submission Documents

Sandra VanPelt Nguyen, Pfizer, Ellen Asam, Merck, Wei Dong, Cytokinetics & Annette Travalent, Eli Lilly

PP20

Dynamic SMQ Search for Safety Signal Detection Using Spotfire 

Xiangyun Wang, Statistical Programming and Analysis, Genentech, Roland Morley & Chen Huang, PD Drug Safety, Genentech

PP21

Simple Tweaks to Improve the Readability of Define.XML

Ying Yan M.S. & Peggy Wen MD, Genentech

PP22

 

Optimizing Synergies between Data and Document Anonymization

 

Peggy Zorn, Rashmi Dodia & Ravi Yandamuri, MMS Holdings

PP23

Developing ADaM Dataset for Cardiovascular Outcome Studies

Joanne Zhou, Rakesh Kumar, David Wade, & David Chen GlaxoSmithKline 

PP24

Adventures in Developing a Novel Visualization System to Help Reviewers at CDER: from Concept to Implementation

Rashedul Hasan & Mitra Rocca, Office of Translational Science & Sviglin Helena, Office of Computational Science

PP25

Pilot Meta-Analysis for HPA Axis Suppression Studies through ADaM Datasets from derived Legacy Data

Lillian (Aijun) Qiu & Hon-Sum Ko, FDA

PP26

 

Gender Differences in Hospitalization or Death due to Heart Failure as Related to Glycemic Contril in the ACCORD Trial 

Tejas Patel, Bereket Tesfaldet, Eileen Navarro, Helena Sviglin, Keith Burkhart, Frank Pucino, Karim Calis CDER/FDA, Neha Amin, Jerome Fleg, Ruth Kirby, Jue Chen, Eric Leifer, Gyorgy Csakom, George Sopko, Lawton Cooper, Sean Coady, Henry Chang, Patrice Desvigne-NIckens, Lijuan Liu, Yves Rosesnberg & Ahmed Hasan, NIH/NHLBI, Charu Gandotra, Howard University Hospital, Michelle Fennessy & Subha Raman, Ohio State University

PP27

Cardiovascular Outcomes and All-cause Mortality Stratified by Degree of HDL-C Raising and/or Triglyceride Lowering in AIM-HIGH Trial

Tejas Patel, Bereket Tesfaldet, Eileen Navarro, Helena Sviglin, Keith Burkhart, Frank Pucino, Karim Calis CDER/FDA, Neha Amin, Jerome Fleg, Ruth Kirby, Jue Chen, Eric Leifer, Gyorgy Csakom, George Sopko, Lawton Cooper, Sean Coady,  Henry Chang, Patrice Desvigne-NIckens, Lijuan Liu, Yves Rosesnberg & Ahmed Hasan, NIH/NHLBI, Charu Gandotra, Howard University Hospital, Michelle Fennessy & Subha Raman, Ohio State University

 

PP29

Data Quality Findings from JumpStart

DeYett Law, Crystal Allard, Mary Doi, Lilliam Rosario, Barbara Witczak,& Jesse Anderson, Office of Computational Science, Kathryn Matto, Austin Taylor, Jeno Pizarro, & Argo Cohen, IBM

PP30

Target Mapping to SDTM Enables Legacy Data Reuse without Full Conversion 

Bereket Tesfaldet, Helena Sviglin, Tejas Patel, Eileen Navarro Almario, for MATIG CDER/OTS/OCS and DCVS/NHLBI/NIH 

PP31

Baseline Liver Laboratory Tests across Clinical Trial Populations 

Bereket Tesfaldet, Tejas Patel, Lilliam Rosario, Eileen Navarro Almario, CDER/OTS/OCS

 

PP32

The NonClinical SEND Fit for Use Pilot: An FDA Perspective

Elaine Thompson, Paul Brown, Patricia Brundage, Robert Dorsam, David Epstein, Jessica Hawes, Belinda Hayes, John Ho, Imran Khan, Stephanie Leuenroth-Quinn, Timothy McGovern, Matthew Whittaker & Lilliam Rosario, FDA

PP33

Deployment of the Demographic Subgroup Analysis Service

Bobbie Witczak, Mary Doi MD, MS, Joy Li MS, FDA/OCS, Daniel Choi MPH, Austin Taylor BS, & Jamal Horne, IBM

PP34

Developing Standardized Clinical Review Tools Using Shiny in R

Jimmy Wong, FDA 

PP35

Development of Novel Analyses and Visualizations for Clinical Trial Review that Enhance Comprehension of Information 

Ingeborg Holt, Commonwealth Informatics, Joseph Tonning, FDA, Frank Pucino, FDA, David Fram Commonwealth Informatics, Channing Russell, Commonwealth Informatics , Geoff Gordon, Commonwealth Informactics & Ana Szarfman, FDA  

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