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

Exhibitors:

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