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FDA/PhUSE CSS Conference Proceedings: FDA/PhUSE US Computational Science Symposium 2017
March 19-21, 2017, Silver Spring, Maryland, 33 papers
FDA/PhUSE CSS 2012   FDA/PhUSE CSS 2013   FDA/PhUSE CSS 2014   FDA/PhUSE CSS 2015   FDA/PhUSE CSS 2016   FDA/PhUSE CSS 2017  

[Original source: http://www.phuse.eu/css-2017-presentations-posters]

FDA/PhUSE US Computational Science Symposium 2017: Best Papers and honorable mentions

Electronic Study Data Submission for New Drug Application in Japan
  Ken Sakushima, PMDA, FDA/CDER/OSP; Hiroshi Sakaguchi, PMDA; TJ Chen FDA/CDER/OSP (Winning Poster in Posters)
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 (Winning Poster in Posters)
The NonClinical SEND Fit for Use Pilot: An FDA Perspective
  Elaine Thompson, Ph.D., FDA; Paul Brown, Ph.D., FDA; Patricia Brundage, Ph.D., FDA; Robert Dorsam, Ph.D., FDA; David Epstein, FDA; Jessica Hawes, Ph.D., FDA; Belinda Hayes, Ph.D., FDA; John Ho, FDA; Imran Khan, Ph.D., FDA; Stephanie Leuenroth-Quinn, Ph.D., FDA; Timothy McGovern, Ph.D., FDA; Matthew Whittaker, Ph.D., FDA; Lilliam Rosario, Ph.D., FDA (Winning Poster in Posters)

Posters

Posters
tweet!  Tagging the TAUGs:Making SDTM Content Easier to Find and Use
  Richard Addy, Chiltern
Pages: 1 Size: 201 Kb 
tweet!  Development and Use of R Package for Noncompartmental Analysis
  Kyun-Seop Bae, University of Ulsan College of Medicine; Jee Eun Lee, FDS
Pages: 1 Size: 1158 Kb 
tweet!  Linked Data & Graph Database Working Group
  Scott Bahlavooni, d-Wise
Pages: 1 Size: 1123 Kb 
tweet!  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
Pages: 1 Size: 1911 Kb 
tweet!  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
Keywords: poster conference session meeting symposium research presentation
Pages: 1 Size: 807 Kb 
tweet!  Programming Role in In-Licensing Projects
  Asif Karbhari, M.S., AstraZeneca Pharmaceuticals
Pages: 1 Size: 253 Kb 
tweet!  Data Standards and FDA’s Animal Rule Studies
  Laura Kaufman, Eagle Pharmaceuticals; Jacquice Davis, PointCross Life Sciences
Pages: 1 Size: 583 Kb 
tweet!  Standardization of Adjudication Outcomes Data Modelling using CDISC standards
  Aparna Kulkarni, Novartis; Jacques Lanoue, Novartis
Pages: 1 Size: 318 Kb 
tweet!  End to End Standards driven Process for Oncology Studies
  Kevin Lee, Clidata Insight; Peng Yang, Clindata Insight
Pages: 1 Size: 448 Kb 
tweet!  Fixing the Transport Format
  Geoff Low, Medidata Solutions
Pages: 1 Size: 65 Kb 
tweet!  Scalable and Efficient Biomarker Visualisation Techniques for Early-Phase Clinical Trials
  Amy Matcho, Janssen Research & Development, LLC; Nicole Thorne, Janssen Research & Development, LLC
Pages: 1 Size: 511 Kb 
tweet!  Roadmap for Managing Multiple CRO Vendors
  Veena Nataraj, MS, Shire; Karin LaPann, MS Shire
Pages: 1 Size: 3268 Kb 
tweet!  Standard Analyses and Displays for Common Data in Clinical Trials – The Journey Continues!
  Mary Nilsson, Eli Lilly and Company; Nhi Beasley, FDA
Pages: 1 Size: 611 Kb 
Winning Poster
tweet!  Electronic Study Data Submission for New Drug Application in Japan
  Ken Sakushima, PMDA, FDA/CDER/OSP; Hiroshi Sakaguchi, PMDA; TJ Chen FDA/CDER/OSP
Pages: 1 Size: 1438 Kb 
tweet!  A Contribution to Better Systems – The Test Data Factory (TDF) Project
  Peter Schaefer, VCA-Plus; Nancy Brucken, inVentiv Health; Cynthia Stroupe, UCB
Pages: 1 Size: 791 Kb 
tweet!  A User Guide for the PhUSE GitHub Repository
  Jared Slain, MPI Research
Pages: 1 Size: 447 Kb 
tweet!  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
Pages: 1 Size: 501 Kb 
Winning Poster
tweet!  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
Pages: 1 Size: 2150 Kb 
tweet!  Dynamic SMQ Search for Safety Signal Detection Using Spotfire
  Xiangyun Wang, Statistical Programming and Analysis, Genentech, Inc; Roland Morley, PD Drug Safety, Genentech, Inc.; Chen Huang, PD Drug Safety, Genentech, Inc.
Pages: 1 Size: 467 Kb 
tweet!  Simple Tweaks to Improve the Readability of Define.XML
  Ying Yan, M.S., Genentech; Peggy Wen, MD, Genentech
Pages: 1 Size: 466 Kb 
tweet!  Optimizing Synergies between Data and Document Anonymization
  Peggy Zorn, MMS Holdings; Rashmi Dodia, MMS Holdings; Ravi Yandamuri, MMS Holdings
Pages: 1 Size: 297 Kb 
tweet!  Developing ADaM Dataset for Cardiovascular Outcome Studies
  Joanne Zhou, GlaxoSmithKline; Rakesh Kumar, GlaxoSmithKline; David Wade, GlaxoSmithKline; David Chen, GlaxoSmithKline
Pages: 1 Size: 283 Kb 
tweet!  Adventures in Developing a Novel Visualization System to Help Reviewers at CDER: from Concept to Implementation
  Rashedul Hasan, PhD, Office of Translational Science; Sviglin Helena, MPH, Office of Computational Science; Mitra Rocca, Diplm, Office of Translational Science
Pages: 1 Size: 407 Kb 
tweet!  Pilot Meta-Analysis for HPA Axis Suppression Studies through ADaM Datasets from derived Legacy Data
  Lillian (Aijun) Qiu, FDA; Hon-Sum Ko, FDA
Pages: 1 Size: 233 Kb 
tweet!  Gender Differences in Hospitalization or Death due to Heart Failure as Related to Glycemic Contril in the ACCORD Trial
  Tejas Patel, CDER/FDA; Bereket Tesfaldet, CDER/FDA; Eileen Navarro, CDER/FDA; Helena Sviglin, CDER/FDA; Keith Burkhart, CDER/FDA; Frank Pucino, CDER/FDA; Karim Calis, CDER/FDA; Neha Amin, NIH/NHLBI; Jerome Fleg, NIH/NHLBI; Ruth Kirby, NIH/NHLBI; Jue Chen, NIH/NHLBI; Eric Leifer, NIH/NHLBI; Gyorgy Csakom, NIH/NHLBI; George Sopko, NIH/NHLBI; Lawton Cooper, NIH/NHLBI; Sean Coady, NIH/NHLBI; Henry Chang, NIH/NHLBI; Patrice Desvigne-NIckens, NIH/NHLBI; Lijuan Liu, NIH/NHLBI; Yves Rosesnberg, NIH/NHLBI; Ahmed Hasan, NIH/NHLBI; Charu Gandotra, Howard University Hospital, Michelle Fennessy, Ohio State University; Subha Raman, Ohio State University
Pages: 1 Size: 812 Kb 
tweet!  Cardiovascular Outcomes and All-Cause Mortality Stratified by Degree of HDL-C Raising and/or Triglyceride Lowering in AIM-HIGH Trial
  Tejas Patel, CDER/FDA; Bereket Tesfaldet, CDER/FDA; Eileen Navarro, CDER/FDA; Helena Sviglin, CDER/FDA; Keith Burkhart, CDER/FDA; Frank Pucino, CDER/FDA; Karim Calis, CDER/FDA; Neha Amin, NIH/NHLBI; Jerome Fleg, NIH/NHLBI; Ruth Kirby, NIH/NHLBI; Jue Chen, NIH/NHLBI; Eric Leifer, NIH/NHLBI; Gyorgy Csakom, NIH/NHLBI; George Sopko, NIH/NHLBI; Lawton Cooper, NIH/NHLBI; Sean Coady, NIH/NHLBI; Henry Chang, NIH/NHLBI; Patrice Desvigne-NIckens, NIH/NHLBI; Lijuan Liu, NIH/NHLBI; Yves Rosesnberg, NIH/NHLBI; Ahmed Hasan, NIH/NHLBI; Charu Gandotra, Howard University Hospital, Michelle Fennessy, Ohio State University; Subha Raman, Ohio State University
Pages: 1 Size: 1153 Kb 
tweet!  Data Quality Findings from JumpStart
  DeYett Law, Office of Computational Science; Crystal Allard, Office of Computational Science; Mary Doi, Office of Computational Science; Lilliam Rosario, Office of Computational Science; Barbara Witczak, Office of Computational Science; Jesse Anderson, Office of Computational Science; Kathryn Matto, IBM; Austin Taylor, IBM; Jeno Pizarro, IBM; Margo Cohen, IBM
Pages: 1 Size: 652 Kb 
tweet!  Target Mapping to SDTM Enables Legacy Data Reuse without full Conversion
  Bereket Tesfaldet, MATIG CDER/OTS/OCS and DCVS/NHLBI/NIH; Helena Sviglin, MATIG CDER/OTS/OCS and DCVS/NHLBI/NIH; Tejas Patel, MATIG CDER/OTS/OCS and DCVS/NHLBI/NIH; Eileen Navarro Almario, MATIG CDER/OTS/OCS and DCVS/NHLBI/NIH
Pages: 1 Size: 520 Kb 
tweet!  Baseline Liver Laboratory Tests across Clinical Trial Populations
  Bereket Tesfaldet, MATIG CDER/OTS/OCS and DCVS/NHLBI/NIH; Helena Sviglin, MATIG CDER/OTS/OCS and DCVS/NHLBI/NIH; Tejas Patel, MATIG CDER/OTS/OCS and DCVS/NHLBI/NIH; Eileen Navarro Almario, MATIG CDER/OTS/OCS and DCVS/NHLBI/NIH
Pages: 1 Size: 633 Kb 
Winning Poster
tweet!  The NonClinical SEND Fit for Use Pilot: An FDA Perspective
  Elaine Thompson, Ph.D., FDA; Paul Brown, Ph.D., FDA; Patricia Brundage, Ph.D., FDA; Robert Dorsam, Ph.D., FDA; David Epstein, FDA; Jessica Hawes, Ph.D., FDA; Belinda Hayes, Ph.D., FDA; John Ho, FDA; Imran Khan, Ph.D., FDA; Stephanie Leuenroth-Quinn, Ph.D., FDA; Timothy McGovern, Ph.D., FDA; Matthew Whittaker, Ph.D., FDA; Lilliam Rosario, Ph.D., FDA
Pages: 1 Size: 1762 Kb 
tweet!  Deployment of the Demographic Subgroup Analysis Service
  Mary Doi, MD, MS, FDA/OCS; Joy Li, MS, FDA/OCS; Daniel Choi, MPH, IBM; Austin Taylor, BS, IBM; Jamal Horne, IBM
Pages: 1 Size: 1214 Kb 
tweet!  Developing Standardized Clinical Review Tools Using Shiny In R
  Jimmy Wong, FDA
Pages: 1 Size: 650 Kb 
tweet!  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
Pages: 1 Size: 632 Kb 
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