Thank you for attending the 2018 US Interchange. You will find a link to each of the presentation slides from the event below.
Note: Presentations are subject to copyright and may not be used without written consent of CDISC or its affiliates.
Session 1: Opening Plenary and First Keynote Address
Opening Remarks
David R. Bobbitt, CDISC President and CEO; and Stephen Pyke, GSK, CDISC Board Chair
Keynote Presentation - CDISC Standards in the Real World
Jonathan Chainey, Roche
State of the CDISC Union - Bringing Clarity to Data (Standards Overview Video)
David R. Bobbitt, CDISC President and CEO
Session 2: Evolving Standards
Evolution of the CDISC Standards
Peter Van Reusel, CDISC
Changing Data and Metadata Exchange in Clinical Research
Sam Hume, CDISC
Semantic Technology and Linked Data for Clinical Research Standards
Frederik Malfait, Nurocor
Session 3: Second Keynote Address
Precisely Practicing Medicine from 700 Trillion Points of Clinical and Clinical Trials Data
Atul Butte, MD, PhD, Priscilla Chan and Mark Zuckerberg Distinguished Professor, University of California San Francisco
Session 4, Track A: Linking to Other Standards and Dictionaries
WHODrug, with a Focus on the New B3/C3 Formats
Malin Jakobsson, Uppsala Monitoring Centre
The ADaM Universe of Mapping Specs, Datasets, Define-XML and Beyond
Valerie Williams, ICON Clinical Research
Delivering LOINC Codes in the Future: Bridging Gaps within the Clinical Lifecycle (Paper)
Diane Piper, Shire
Session 4, Track B: Creating Clarity
Myths and Truths: The World of Standards, Pre/post Coordinating Controlled Terminology, LOINC, UCUM and Standardized Lab Units
Kit Howard and Bess Leroy, CDISC
CDISC Standards Updates: Preview of 2019
Diane Wold, CDISC
Who to Ask about Submission Questions
Helena Sviglin, FDA-CDER and Diane Wold, CDISC
Session 4, Track C: Toward B2E Automation: Data Warehousing
A Practical Approach to Automating End to End Standards
Steve Kirby, Reata Pharmaceuticals Inc. and Mario Widel, Covance
Maximizing the Use of Patient Data Warehouse via Visual Analytics (Paper)
Simson Alex and Sandy Lei, Johnson & Johnson
What’s New in SHARE 2: Featuring a New Model, API, and Content
Anthony Chow, CDISC
Session 5, Track A: Implementation: Beginning to End (B2E)
Enforcing Standards in an Organization: A Practical 5-Step Approach (Paper)
Priscilla Gathoni and Dany Guerendo Christian, AstraZeneca
Developing, Implementing and Governing End-to-End Data Standards at Gilead
Dhananjay Chhatre, Gilead
Data Transfer System from Electronic Medical Record used for Clinical Trials
Yoshihiro Aoyagi, National Cancer Center Hospital East, Japan
Session 5, Track B: Newcomers Session: Overview of CDISC Standards
CDASH and SDTM, and Why You Need Both
Kit Howard, CDISC
Controlled Terminology/Questionnaires, Ratings and Scales
Erin Muhlbradt, National Cancer Institute - Enterprise Vocabulary Service [C]
ODM and Extensions
Sally Cassells, Next Step Clinical Systems
Session 5, Track C: Toward B2E Automation: Machine Learning
Machine Learning Approach to SDTM Mapping
Sam Tomioka, Sunovion Pharmaceuticals
Automated Annotation of a Blank CRF Using ML/NLP
Saranga Ram, Ratilan Technologies, Inc. and Eric Weising, Symbiance
Challenges in Mapping Specific Autologous CAR-T Therapy Data into SDTM – A Case Study (Paper)
Mark Mendenhall and Jinlin Wang, Kite Pharma, a Gilead Company
Session 6, Track A: Implementation: Organization
Raising the Bar for Data Standardization: How to Ensure Your Submission Data Supports the Automated Review Process at FDA and PMDA
Max Kanevsky and Sergiy Sirichenko, Pinnacle 21
Challenges of CDISC Implementation and Submission to both Japan PMDA and FDA (Paper)
Yumiko Asami, Daiichi Sankyo Co., Ltd. and Janet Reich, Amgen Inc.
Where is my GPS?: A Process Roadmap for Overcoming Data Integration Humps (Paper)
Dorothy Dlamini, Bayer Pharmaceutical AG
Session 6, Track B: Newcomers Session: Overview of CDISC Standards (continued)
ADaM Overview
Sandra Minjoe, PRA Health Sciences
Data Exchange Standards (RDF/OWL/XML)
Sam Hume, CDISC
Introduction to TA Standards, Review of Published TA standards
Jon Neville, CDISC
Session 6, Track C: Implementation: Tooling and Define-XML
How the Define-XML Framework Can Help you Manage Begin-to-End Data Traceability in an MDR (Paper)
Judith Goud, Nurocor
Visual Define-XML Editor (Paper)
Dmitry Kolosov, Independent
Do’s and Don’ts of Define-XML
David Roulstone, Pinnacle 21
Session 7, Track A: Implementation: Pre-Clinical Standards
Implementing SEND at Pfizer - Challenges and How They Were Overcome
Keli Arnold, Christopher Eley, and Leslie Lorello, Pfizer
The Making of SEND: Delivery Through Inter-Organizational Collaboration
Lou Ann Kramer, CDISC and William Houser, FDA
Preparing for SEND
Roman Radelicki, SGS
Session 7, Track B: New Implementation Use Cases: Observational/Post-Marketing Studies
Application of the SDTM Standard to a Public Health Dataset
Thomas Forrester, Frontier Science Technology and Research Foundation
Challenges and Opportunities: Using CDISC Standards for Observational Data
Jon Neville, CDISC
Data Utilization in RWD in Public Health and CDISC Standards (Paper)
Hiroshi Mizushima and Satoshi Ueno, National Institute of Public Health, Japan
Session 7, Track C: Implementation: Analysis and Validation
A Look at What Is Coming: CDISC Conformance Rules for ADaMIG v1.0 and ADaMIG v1.1 (Paper)
Trevor Mankus, PRA Health Sciences and Alyssa Wittle, Covance
Incremental Changes: ADaMIG v1.2 Update (Paper)
Nancy Brucken, Syneos Health and Deb Goodfellow, Covance
An Anatomy of Efficacy Analysis Datasets in Oncology (Paper)
Ke Xiao, Boehringer-Ingelheim
Session 8: Regulatory Session
PMDA: Yuki Ando; FDA: Ta-Jen Chen, Eileen Navarro Almario and Vaishali Popat
Session 9: Roundtable Discussion
PMDA: Yuki Ando; FDA: Ron Fitzmartin, Lisa Lin, Lilliam Rosario, Helena Sviglin and Jack Zhang; Jonathan Chainey, Roche; Paul Slagle, Syneos Health; Gary Walker, IQVIA and Peter Van Reusel, CDISC