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2014 CDISC International Interchange
Conference Program
Embracing a Changing Landscape Standards to Connect Research and Patient Care
B e t h e s d a N o r t h M a r r i o t t H o t e l a n d C o n f e r e n c e C e n t e r N o r t h B e t h e s d a , M D
Global Diamond Sponsor:
Ruby Sponsors:
WiFi Sponsor:
WiFi Network Name: TAKE Life Sciences WiFi Password: cdisc2014
Wednesday Morning Breakfast Sponsor:
T H E I N T E R C H A N G E S C H E D U L E
MONDAY
10 Nov 2014
09:00 – 17:00 BRIDG Deep Dive Implementation Course
09:00 – 17:00 ODM Implementation Course
09:00 – 17:00 SDTM Theory & Application Course (Day 1 of a 2-Day Training)
09:00 – 17:00 SEND Implementation Course (Day 1 of a 2-Day Training)
08:30 – 17:00 CDISC Fellows and New Team Member Training (By Invitation Only)
TUESDAY
11 Nov 2014
09:00 – 17:00 SDTM Theory & Application Course (Day 2 of a 2-Day Training)
09:00 – 17:00 SEND Implementation Course (Day 2 of a 2-Day Training)
09:00 – 12:00
Dataset-XML Course
09:00 – 12:00
Controlled Terminology Course
13:00 – 17:00 Define-XML Course
13:00 – 17:00 CDISC Healthcare Link Course
16:00 – 18:00 CDISC Advisory Council Meeting (By Invitation Only – For Platinum Member Organizations)
18:30 – 22:30 Exhibition Booth Setup
18:30 – 20:30
Early Conference Registration
WEDNESDAY 12 Nov 2014
Interchange Conference
07:30 – 17:00
08:00 – 17:00
Conference
Registration
Exhibits Open
08:30 – 10:00
Session 1 Opening Plenary: Embracing a Changing Landscape Session Chair: Dr. Pierre-Yves Lastic, Chair, CDISC Board
Keynote Speaker – General Peter Chiarelli, One Mind
Keynote Speaker – Dr. Eileen Navarro Almario, FDA
State of CDISC Union – Dr. Rebecca Kush, CDISC
10:00 – 10:30 BREAK
10:30 – 12:15
Session 2 Second Opening Plenary Session Chair: Dr. David Hardison, Chair-Elect, CDISC Board
Dr. Martha Brumfield, Critical Path Institute
Dr. Mayumi Shikano, Japan PMDA
Dr. Ron Fitzmartin, FDA
Wayne Kubick, CDISC
12:15 – 13:30
LUNCH Adoption of CDISC Standards Dr. Kenneth Getz, Tufts University School of Medicine
12:00 – 13:30 EXHIBITS
WEDNESDAY 12 Nov 2014
Interchange Conference
13:30 – 15:00
Session 3 (Track One) New Approaches to Research Session Chair: Wayne Kubick, CDISC
Session 4 (Track Two) Everything You Wanted to Know about SDTM Session Chair: Dan Godoy, MedImmune
The Marriage of Clinical Trial Data and Real World Data in the Evidence Generation Life Cycle Dr. David Hardison, ConvergeHEALTH by Deloitte
Everything You Always Wanted to Know About Leading an SDS Sub-team but Were Afraid to Ask… And Then be Volunteered Stetson Line, Amgen
De-identification Methods for Clinical Trials Data: Meeting Privacy Obligations for Clinical Trials Transparency Initiatives Dr. Khaled El Emam, Privacy Analytics
Associated Persons Domains – Who, What, Where, When, Why, How? Alyssa Wittle, Theorem Clinical Research
Smart Clinical Program Design Information Model
Laszlo Vasko, AstraZeneca
SDTM Based Clinical Data Repository to Meet Reporting and Analysis Across Clinical Development Robert O’Connor, Infinity Pharmaceuticals, Inc.
15:00 – 15:30 BREAK
WEDNESDAY 12 Nov 2014
Interchange Conference
15:30 – 17:30
Session 5 (Track One) CDISC Implementation Stories Session Chairs: Drs. David Jordan, TransCelerate, and Rebecca Kush, CDISC
Session 6 (Track Two) CDISC Related PhUSE Projects – Standards Governance Session Chair: Landen Bain, CDISC
The following speakers will each present on implementation of CDISC standards in their organizations:
ARIAD, Elena Davison Boehringer-Ingelheim, Chengxin Li Genentech/Roche, Elizabeth Nicol and Frederik Malfait Theorem Clinical Research, Mark Penniston Sanofi, Brooke Hinkson Eli Lilly, Carrie Vosmeier Translational Research Informatics Center, Dr. Masanori
Fukushima and Takako Jyouno Panel discussion to follow presentations
PhUSE Standard Scripts for Analysis and Reporting Frank Senk, AstraZeneca
Delivering Statistical Results as an RDF Data Cube: A Simple Use Case to Illustrate the Process of an RDF Data Cube Creation and the Link to the RDF Representation of the CDISC Standards Marcelina Hungria, DIcore Group, LLC
Creating RDF from CDASH Mitra Rocca, FDA
A Sponsor and CRO: Governing and Implementing Standards as Partners Gary Walker, Quintiles, and Scott Bahlavooni, Biogen Idec
18:00 – 19:30 EVENING RECEPTION AND NETWORKING EVENT
THURSDAY
13 Nov 2014 Interchange Conference
08:00 – 10:00
07:30 – 17:00 Conference Registration
08:00 – 16:00 Exhibits Open
Session 7 (Track One) CDISC Standards from the Start Session Chairs: Rhonda Facile and Dr. Rebecca Kush, CDISC
Session 8 (Track Two) Considerations in Creating ADaM Datasets from SDTM Datasets Session Chair: Nate Freimark, Theorem Clinical Research
The following speakers will share their experience using CDISC standards from the start:
Mark Wheeldon, Formedix Veena Nataraj, Shire Julie Smiley, SOA Software Trisha Simpson, UCB Dr. Rob Dicicco, GSK Kelsey Thompson, Oracle Dr. Wim Verreth, SGS Life Science Services
Panel discussion to follow presentations Panelists:
Landen Bain, CDISC Shannon Labout, CDISC Dr. Ron Fitzmartin, FDA Ben Vali, FDA Laszlo Vasko, AstraZeneca
Implementation of CDISC ADaM in the Pharmacokinetics Department Dr. Joanna Magielse, SGS Life Sciences
Checking for SDTM and ADaM Compliance: The Need for Human Involvement Kristin Kelly, Fred Wood, Sandra Minjoe and Jerry Salyers, Accenture Life Sciences Best Practices for CDISC ADaM Validation Checks: Past, Present and Future Shelley Dunn, d-Wise
Standards Around Questionnaire Data from Collection to SDTM and ADaM Karin LaPann, PRA Health Sciences; and Nancy Brucken, inVentiv Health Clinical, LLC
10:00 – 10:30 BREAK
THURSDAY 13 Nov 2014
Interchange Conference
10:30 – 12:00
Session 9 (Track One) Implementation of Therapeutic Area Standards Session Chair: Bron Kisler, CDISC
Session 10 (Track Two) CDISC for Safety Monitoring, Devices and Epidemiology Session Chair: Kit Howard, CDISC
Implementation of Oncology-Specific SDTM Domains Jacintha Eben, SGS Life Science Services
Integrating CDISC Initiatives to Reduce Safety Monitoring Timelines While Improving Subject Safety and Overall Study Quality Rafael Smets, SGS Life Sciences
Implementation of CDISC Therapeutic Area Standards: Oncology Kevin Lee, Accenture
Device Studies: A Case Study Janice Englund, Theorem Clinical Research
Building Efficacy Analysis Dataset by Implementing ADaM: An Oncology Phase III Case Study Susan Zhao, Medivation Inc
Trial Development of Clinical and Epidemiological Research Data Repository System Using the CDISC ODM Yoshiteru Chiba, UMIN Center (The University of Tokyo Hospital)
Application of a Therapeutic Area Standard to Develop a New Clinical Outcome Assessment Instrument for Multiple Sclerosis
Enrique Aviles, Critical Path Institute
12:00 – 13:30 LUNCH A Statistician’s View on CDASH
Ben Vali, FDA
12:30 – 13:30 NETWORK WITH EXHIBITORS Bingo Prize Drawing (at 13:15)
THURSDAY
13 Nov 2014 Interchange Conference
13:30 – 15:00
Session 11 Embracing Change for Patients Session Chair: Sam Hume, CDISC
Recent FDA Guidance and CDISC Activities Dr. Ron Fitzmartin, FDA
CFAST at Year 2: Overview & Lessons Learned Rhonda Facile, CDISC, and John Owen, Johnson & Johnson
CFAST: Innovative Approaches to Standards Development
Jon Neville, Critical Path Institute, and Dr. Diane Wold, GSK
Panel Discussion and Q & A
15:00 – 15:30
BREAK
15:30 – 17:30
Session 12 Closing Keynote and Panel Session Chairs: Dr. Rebecca Kush and Wayne Kubick, CDISC
The I-Spy Experience: eSource Checklist for Breast Cancer
Dr. Laura Esserman, University of California, San Francisco
Opening Remarks for Regulatory Panel Discussion
Dr. Steve Wilson, FDA
Panel Discussion - Regulators Invited
Dr. Laura Esserman, UC San Francisco Dr. Steve Wilson, FDA Dr. Ron Fitzmartin, FDA Dr. Eileen Navarro Almario, FDA Dr. Mayumi Shikano, Japan PMDA Dr. Pierre-Yves Lastic, Sanofi Dr. Margaret Haber, NIH Enrique Aviles, C-Path Dr. Doug Warfield, FDA Lisa Lin, FDA
FRIDAY
14 Nov 2014
09:00 – 12:00 SDTM for Medical Devices Course
09:00 – 17:00 CDASH Implementation Course
09:00 – 17:00 ADaM Implementation Course
SAVE THE DATE!
CDISC European Interchange
Basel, Switzerland 4 – 8 May 2015
Conference, Training and Workshops Call for Abstracts Open until 5 January 2015
CDISC Japan Interchange
Tokyo, Japan 22 – 26 June 2015
Conference, Training and Workshops
CDISC International Interchange
Chicago, IL 9 – 13 November 2015
Conference, Training and Workshops
www.cdisc.org/interchange
S C H E D U L E A T A G L A N C E
Monday, 10 November 2014
09:00 – 17:00 BRIDG Deep Dive Implementation Course
09:00 – 17:00 ODM Implementation Course
09:00 – 17:00 SDTM Theory & Application Course (Day 1 of a 2-Day Training)
09:00 – 17:00 SEND Implementation Course (Day 1 of a 2-Day Training)
08:30 – 17:00 CFAST Program Orientation (By Invitation Only – CDISC Fellows and CFAST Team Members)
09:00 – 17:00 BRIDG Deep Dive Implementation Course
Tuesday, 11 November 2014
09:00 – 17:00 SDTM Theory & Application Course (Day 2 of a 2-Day Training)
09:00 – 17:00 SEND Implementation Course (Day 2 of a 2-Day Training)
09:00 – 12:00 Dataset-XML Course
09:00 – 12:00 Controlled Terminology Course
13:00 – 17:00 Define-XML Course
13:00 – 17:00 CDISC Healthcare Link Course
16:00 – 18:00 CDISC Advisory Council Meeting (By Invitation Only – Platinum Members)
18:30 – 22:30 Exhibition Booth Setup
18:30 – 20:30 Early Conference Registration
Wednesday, 12 November 2014
07:30 – 17:00 Conference Registration
18:00 – 17:00 Exhibit Opens
08:30 – 17:30 Conference Sessions
18:00 – 19:30 Evening Reception and Networking Event
Thursday, 13 November 2014
07:30 – 17:00 Conference Registration
08:00 – 17:30 Conference Sessions
Friday, 14 November 2014
09:00 – 12:00 SDTM for Medical Devices Course
09:00 – 17:00 CDASH Implementation Course
09:00 – 17:00 ADaM Implementation Course
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