2017 International Interchange Presentations

Thank you for attending the 2017 International Interchange in Austin, Texas. You will find presentations from the conference below.

Note: Presentations are subject to copyright and may not be used without written consent of CDISC or its affiliates. All content included in these presentations is for educational and informational purposes only. References to any specific commercial product, process, or service, or the use of any corporation name are for the information of our members, and do not constitute endorsement, recommendation, or favoring by CDISC or the CDISC community.

SESSION 1: OPENING PLENARY & KEYNOTE ADDRESS

OPENING REMARKS
David R. Bobbitt, CDISC President and CEO
OPENING REMARKS
Dr. David Hardison, CDISC Board Chair
KEYNOTE PRESENTATION: IMPACT OF COLLABORATING VS COMPETING TO ACHIEVE SUCCESS IN CLINICAL RESEARCH
Paula Brown Stafford and Lisa T. Grimes, Managing Directors, Habergeon LLC
CDISC: WHAT’S NEW & WHAT’S NEXT
Shannon Labout, CDISC Interim Chief Standards Officer
UPDATE FROM GLOBAL CDISC COORDINATING COMMITTEES (3Cs)
E3C Update - Peter Van Reusel, E3C
AP3C Update - Dr. Zibao Zhang, AP3C
J3C Update - Yoshiteru Chiba, J3C
C3C Update - John Wang, C3C

SESSION 3, TRACK C: CDISC FOR NEWCOMERS - OVERVIEW OF CDISC IN THE WORLD OF DATA STANDARDS

WHO/WHEN: CDISC HISTORY AND EVOLUTION
Rhonda Facile, CDISC; and Dr. Stephen Wilson, CDISC
WHY: THE PURPOSE AND BENEFIT OF STANDARDS
Dr. Wenjun Bao, JMP Life Sciences; and Peter Van Reusel, Innovion
HOW: COPS, TOOLS AND PROCESSES REVIEW
Dr. Diane Wold, CDISC

SESSION 4, TRACK A: SUBMISSION - SDTM, SEND, ADaM & DEFINE-XML

INCREASE QUALITY AND REDUCE SDTM DEVELOPMENT TIME WITH A MOCK STUDY DATA SIMULATOR
Terek Peterson, Chiltern
SDTM TO ADaM + STANDARD SAFETY REPORTING CODE = EFFICIENT A&R: A MIDDLE-TO-END APPROACH
Valerie Williams, ICON Plc
DATA INTEGRATION OUGHT TO BE AUTOMATED!
Sandy Lei, Johnson & Johnson
BUILDING A COMPLIANT CDISC DATASET THROUGH METADATA PROGRAMMING
Frank Senk, GCE Solutions

SESSION 4, TRACK B: GOVERNANCE - STANDARDS GOVERNANCE, VERSIONING & TRANSLATIONS

STANDARDS VERSION MANAGEMENT: LESSONS LEARNED FROM UPGRADING A COMPANY’S BASE CDISC VERSIONS
Keith Hibbetts, Eli Lilly
CHALLENGES FACING STANDARDS GOVERNANCE AND HOW TO ADDRESS THEM
Diane Piper, Shire
CHALLENGES IN CREATING JAPANESE TRANSLATION OF CDISC ADaM IG
Yumiko Asami, Daiichi Sankyo
BRIDGING THE GAP BETWEEN LEGACY AND CDISC STANDARDS
Bill Qubeck, d-Wise

SESSION 4, TRACK C: CDISC FOR NEWCOMERS - CONNECTED CDISC STANDARDS

CONTROLLED TERMINOLOGY & QUESTIONNAIRES
Erin Muhlbradt, NCI-EVS
OPERATIONAL DATA MODEL (ODM) - XML
Sally Cassells, Next Step Clinical Systems
CDASH AND SDTM: WHY YOU NEED BOTH
Kit Howard, CDISC
ANALYSIS DATA MODEL (ADaM)
Nate Freimark, Greisser Group

SESSION 5, TRACK A: SHARE & METADATA REPOSITORIES

SHARE 2.0
Dr. Lauren Becnel, CDISC
MERCK’S MDR SYSTEM IMPLEMENTATION JOURNEY
Mike Hamidi, Merck
METADATA REPOSITORIES, VERSION CONTROL AND STANDARDS GOVERNANCE LEVERAGING CDISC XML TECHNOLOGY
Philippe Verplancke, XClinical
INFORMATION ARCHITECTURES FOR END-TO-END DATA STANDARDS ADOPTION - A TRANSCELERATE PERSPECTIVE
Frederik Malfait, TransCelerate BioPharma
METADATA REPOSITORY IMPLEMENTATION
Barrie Nelson, NuroCor

SESSION 5, TRACK B: CDISC & PhUSE

OVERVIEW OF THE PhUSE COMPUTATIONAL SCIENCE SYMPOSIUM
Chris Decker, d-Wise
IN-DEPTH REPORT FROM THE NONCLINICAL WORKING GROUP
William Houser, Bristol-Myers Squibb
IN-DEPTH REPORT FROM THE OPTIMIZING DATA STANDARDS WORKING GROUP
Mike Hamidi, Merck; and Todd Bazin, Biogen

SESSION 5, TRACK C: CDISC FOR NEWCOMERS - STANDARDS DEVELOPMENT PROCESS

OVERVIEW OF STANDARDS DEVELOPMENT AND GOVERNANCE
Bess LeRoy, CDISC
REVIEW OF PUBLISHED THERAPEUTIC AREA STANDARDS
John Owen and Jon Neville, CDISC

SESSION 6, TRACK A: DEVELOPMENT & IMPLEMENTATION OF THERAPEUTIC AREA STANDARDS

CONSTRUCT REGISTRY DATABASE OF RARE DISEASES CONSIDERING CDISC STANDARDS
Dr. Satoshi Ueno, National Center of Neurology and Psychiatry
HIV PREVENTION AND TREATMENT PROJECT
Bess LeRoy, CDISC; and Amy Palmer, CDISC
HUNTINGTON’S DISEASE V1.0 PROJECT
Dr. Volker Kern, Critical Path Institute; and Jon Neville, CDISC
CLINICAL TRIAL REGISTRATION (CTR) 2 PROJECT UPDATE
John Owen, CDISC

SESSION 6, TRACK B: INNOVATION

ODM 2.0
Dr. Sam Hume, CDISC
WORK WITH DEFINE-XML - PAST, PRESENT AND FUTURE
Sheng Zhang, FMD K&L
CDISC STANDARDS FACILITATION OF BIG DATA ANALYTICS IN SUPPORT OF RISK-BASED MONITORING
Jon Roth, Biorasi
EHRs: ARE WE THERE YET
Trisha Simpson, UCB

SESSION 6, TRACK C: CDISC FOR NEWCOMERS - 2018 DEVELOPMENTS - SHARE, LABS & LOINC

WHAT IS SHARE, HOW CAN IT BE USED, AND WHAT IS IN THE FUTURE?
Anthony Chow, CDISC
AN OVERVIEW OF LOINC
Dr. Swapna Abhyankar, Regenstrief Institute
MAPPING COMMON RESEARCH LABS TO CDISC AND LOINC
Phil Pochon, Covance

SESSION 7 FIRST CLOSING PLENARY: DATA STANDARDS FOR PATIENT-FOCUSED RESEARCH

PROJECT DATA SPHERE, PATIENT-FOCUSED RESEARCH, DATA STANDARDIZATION AND GOLDILOCKS
Dave Handelsman, Project Data Sphere
IMPACT OF PTSD STANDARD FOR CLINICAL RESEARCH
Dr. Allyson Gage, Cohen Veteran’s Bioscience
INCREASING THE RETURN ON THE RESEARCH INVESTMENT: CLINICAL RESEARCH DATA STANDARDS BEYOND REGULATORY SUBMISSION
Dr. Meredith Zozus, UAMS College of Medicine
BUILDING PEDIATRIC CANCER DATA COMMONS
Dr. Sam Volchenboum, University of Chicago