SESSION 1 OPENING PLENARY: KEYNOTE ADDRESSES
THE FUTURE OF MEDICAL RESEARCH AND ROLE OF STANDARDS: FORMING CONNECTIONS TOWARDS COMPLEMENTARY SYSTEMS
Dr. Robert Califf, FDA Commissioner
FROM BIG DATA TO SMART DATA
Dr. Sean Khozin, Senior Medical Officer, Office of Hematology and Oncology Products, FDA
CANCER MOONSHOT, DATA SHARING, STANDARDS, PRECISION ONCOLOGY
Dr. Warren Kibbe, Deputy Director, NCI; Director, CBIIT
SESSION 2 SECOND PLENARY: VALUE OF STANDARDS IN DATA SHARING AND RESEARCH FROM BEGINNING TO END
GLOBAL DATA SHARING
Dr. Barbara Bierer, Harvard MRCT
NIAID/DIVISION OF AIDS: STATISTICAL AND DATA MANAGEMENT CENTER VIEW
Dr. Heather Ribaudo, Center for BiostaSsScs in AIDS Research (CBAR), ACTG/IMPAACT SDMC
IMPLEMENTING CDISC FOR NUTRITION RESEARCH
Stephane Auger, Danone
USING CDISC TO SUPPORT THE HEALTHY BIRTH, GROWTH & DEVELOPMENT KNOWLEDGE INTEGRATION (GATES FOUNDATION PROJECT)
Thomas Peppard, Certara
SESSION 3: SDTM
SDTM TRIAL SUMMARY DOMAIN: PUTTING TOGETHER THE TS PUZZLE
Kristin Kelly, Accenture
SDTM EXPOSURE DOMAINS (EC & EX) PAST, PRESENT, FUTURE
Janet Reich, Amgen
THE 4 R’S OF SDTM REVIEW: HOW UCB MOVED FROM TASK TO VALUE!
Jenny Boyce and Sushama Belkhode, UCB
WHAT IS NEW IN SDTM IG V3.3 AND BEYOND
Barrie Nelson, CDISC
SESSION 4: ADaM
ADaM: PAST, PRESENT AND FUTURE
Nate Freimark, ADaM Team Leader
INCREASING WORKGROUP TRANSPARENCY: ADaM IG V1.2 UPDATE AND NEW TEAM WORKING PROCESS REVIEW
Brian Harris, MedImmune
ADaM DATA MAPPING: RETROFIT FROM SDTM/ADM TO ADaM
Sandy Lei, Johnson & Johnson
FDA USE OF ADaM
Dr. Stephen Wilson, FDA/CDER BiostaSsScs
SESSION 5: STANDARDS GOVERNANCE
TRANSCELERATE STANDARDS GOVERNANCE
Lindsey Kolezar and Carrie Ann Young, TransCelerate Data Standards Implementation Sub-Team
PROCESS AND CONSIDERATIONS ON HOW TO UPGRADE YOUR COMPANY’S BASE CDISC VERSION
Scott Getzin and Isaac Swanson, Eli Lilly
CDISC STANDARDS GOVERNANCE LESSONS LEARNED AT ABBVIE
Ana Ramanarayanan, Abbvie
SESSION 6: DEFINE-XML
DEFINE-XML AS A LIVING DOCUMENT
Sally Cassells, Next Step Clinical Systems, LLC
LESSONS LEARNED WHEN CREATING DEFINE-XML FOLLOWING THE DEFINE-XML V2.0 SPECIFICATION
Gary Cunningham, Griesser Group
INTEGRATED DESIGN OF eCRFS AND SDTM DATASETS WITH ODM-XML AND DEFINE-XML
Dr. Philippe Verplancke, Xclinica
SESSION 7: SHARE & METADATA REPOSITORIES
DIRECTIONS AND PRIORITIES OF THE CDISC SHARE STEERING COMMITTEE
Dr. Lauren Becnel, CDISC
UNDERSTANDING THE POTENTIAL OF SHARE: A VISUAL BUSINESS CASE AND TECHNICAL USE CASE
Peter Van Reusel, Business and Decision
SDTM METADATA: THE OUTPUT IS ONLY AS GOOD AS THE INPUT
Mihaela Simion d-Wise
METADATA ON THE GO: ACHIEVING METADATA ACCURACY AND CONSISTENCY CONTINUALLY
Swapna Pothula, SGS
SESSION 8: CDISC & PhUSE COLLABORATIVE ACTIVITIES
OVERVIEW OF THE PhUSE COMPUTATIONAL SCIENCE COLLABORATION (CSSC)
Chris Decker, d-Wise and PhUSE FDA Liaison
THE STATE OF THE PhUSE STUDY DATA REVIEWER’S GUIDE
Helena Sviglin, FDA/OCS
WORKING GROUP UPDATE: OPTIMIZING THE USE OF DATA STANDARDS
Jane Lozano, Eli Lilly
WORKING GROUP UPDATE: STANDARD ANALYSES AND CODE SHARING
Nancy Brucken, InVentiv Health
WORKING GROUP UPDATE: NONCLINICAL TOPICS RELATED TO CDISC
Fred Wood, Accenture
SESSION 9: CLINICAL DATA WAREHOUSE & EHR CDISC DATASET
ADOPTING A CDISC DATA MODEL TO BUILD A CLINICAL DATA WAREHOUSE
Jaskiran Singh, NIH
REMODELING OF DATA COLLECTION STANDARDS CONTENT AND STRUCTURE TO ENABLE AUTOMATION OF STUDY DATABASE BUILD USING ROCHE STUDY BUILDER TO IMPROVE EFFICIENCY AND METADATA QUALITY
Karla Kaczorowski and Catherine Abogado, Genentech/Roche
MOVING FROM DATA COLLECTION TO DATA VISUALIZATION AND ANALYTICS: LEVERAGING CDISC SDTM STANDARDS TO SUPPORT DATA MARTS
Terek Peterson, Chiltern
STUDYING HOW TO OPTIMIZE PROCEDURES TO CONVERT STANDARDIZED EHR DATA INTO CDISC DATASET: AN EXPERIMENT
Dr. Masafumi Okada, UMIN
eSOURCE STAKEHOLDERS GROUP
Mitra Rocca, FDA/OTS and Dr. Michael Ibara, CDISC
SESSION 10: CDISC THERAPEUTIC AREA STANDARDS
TA STANDARDS DEVELOPMENT TRENDS
Dr. Diane Wold, CDISC
FDA-CDER FORMAL TESTING AND ACCEPTANCE PROCESS FOR STUDY DATA STANDARDS
Ta-Jen Chen, FDA/OSP
PMDA AND THE CFAST TA PROJECT: AN UPDATE
Hiroshi Sakaguchi, Japan PMDA
DATA STANDARDS FOR PEDIATRIC SOLID TUMORS
Dr. Samuel Volchenboum, University of Chicago
TAGGING THE TA USER GUIDES: MAKING SDTM TA CONTENT EASIER TO FIND AND USE
Richard Addy, Chiltern
SESSION 11 FIRST CLOSING PLENARY: PLANNING, PREPARATION AND VALIDATION OF SUBMISSION DATA
STUDY DATA STANDARDS: TECHNICAL REJECTION OF SUBMISSIONS
Ron Fitzmartin, PhD, MBA, Sr. Advisor, Office of Business Informatics, FDA
THE DO’S AND DON’TS: AN SDTM VALIDATION PERSPECTIVE
Tom Guinter, Pinnacle 21
THE DOG ATE MY SUBMISSION (OR VALIDATING REGULATORY SUBMISSIONS USING DEFINE-XML)
Ben Fine, Etera Solutions
EXTENSION STUDIES: CDISC SUBMISSION CHALLENGES AND SCENARIOS
Aishwarya Balajee, Zifo
GENERATION OF DEFINE-XML UPFRONT WHILE GENERATING SDTM
Deepali Gupta, eClinical Solutions
SESSION 12 SECOND CLOSING PLENARY: THE FUTURE OF CDISC
STATE OF THE CDISC UNION
Dr. Rebecca Kush, CDISC President and CEO, and Dr. Nicole Harmon, CDISC COO