2014 CDISC International Interchange Conference Program

Transcription

1 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

2 Global Diamond Sponsor: Ruby Sponsors: WiFi Sponsor: WiFi Network Name: TAKE Life Sciences WiFi Password: cdisc2014 Wednesday Morning Breakfast Sponsor:

3 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 :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 :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

4 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 10:00 10:30 BREAK Keynote Speaker General Peter Chiarelli, One Mind Keynote Speaker Dr. Eileen Navarro Almario, FDA State of CDISC Union Dr. Rebecca Kush, CDISC 10:30 12:15 Session 2 Second Opening Plenary Dr. Martha Brumfield, Critical Path Institute Dr. Mayumi Shikano, Japan PMDA Session Chair: Dr. David Hardison, Dr. Ron Fitzmartin, FDA Wayne Kubick, CDISC Chair-Elect, CDISC Board 12:15 13:30 LUNCH Adoption of CDISC Standards Dr. Kenneth Getz, Tufts University School of Medicine 12:00 13:30 EXHIBITS

5 WEDNESDAY 12 Nov 2014 Interchange Conference Session 3 (Track One) 13:30 15:00 Session 4 (Track Two) New Approaches to Research Session Chair: Wayne Kubick, CDISC The Marriage of Clinical Trial Data and Real World Data in the Evidence Generation Life Cycle Dr. David Hardison, ConvergeHEALTH by Deloitte De-identification Methods for Clinical Trials Data: Meeting Privacy Obligations for Clinical Trials Transparency Initiatives Dr. Khaled El Emam, Privacy Analytics Everything You Wanted to Know about SDTM Session Chair: Dan Godoy, MedImmune Everything You Always Wanted to Know About Leading an SDS Sub-team but Were Afraid to Ask And Then be Volunteered Stetson Line, Amgen 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

6 WEDNESDAY 12 Nov 2014 Interchange Conference Session 5 (Track One) 15:30 17:30 Session 6 (Track Two) CDISC Implementation Stories Session Chairs: Drs. David Jordan, TransCelerate, and Rebecca Kush, 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 CDISC Related PhUSE Projects Standards Governance Session Chair: Landen Bain, CDISC 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 18:00 19:30 EVENING RECEPTION AND NETWORKING EVENT Gary Walker, Quintiles, and Scott Bahlavooni, Biogen Idec

7 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 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 Session 8 (Track Two) Considerations in Creating ADaM Datasets from SDTM Datasets Session Chair: Nate Freimark, Theorem Clinical Research 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

8 THURSDAY 13 Nov 2014 Interchange Conference 10:30 12:00 Session 9 (Track One) Implementation of Therapeutic Area Standards Session Chair: Bron Kisler, CDISC Implementation of Oncology-Specific SDTM Domains Jacintha Eben, SGS Life Science Services Session 10 (Track Two) CDISC for Safety Monitoring, Devices and Epidemiology Session Chair: Kit Howard, CDISC 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 Building Efficacy Analysis Dataset by Implementing ADaM: An Oncology Phase III Case Study Susan Zhao, Medivation Inc Device Studies: A Case Study Janice Englund, Theorem Clinical Research 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 12:30 13:30 LUNCH A Statistician s View on CDASH Ben Vali, FDA NETWORK WITH EXHIBITORS Bingo Prize Drawing (at 13:15)

9 THURSDAY 13 Nov 2014 Interchange Conference 13:30 15:00 Session 11 15:00 15:30 BREAK Embracing Change for Patients Session Chair: Sam Hume, CDISC 15:30 17:30 Session 12 Closing Keynote and Panel Session Chairs: Dr. Rebecca Kush and Wayne Kubick, 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 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 :00 12:00 SDTM for Medical Devices Course 09:00 17:00 CDASH Implementation Course 09:00 17:00 ADaM Implementation Course

10 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 June 2015 Conference, Training and Workshops CDISC International Interchange Chicago, IL 9 13 November 2015 Conference, Training and Workshops

11 Exhibitors:

12 S C H E D U L E A T A G L A N C E Monday, 10 November :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 :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 :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 :30 17:00 Conference Registration 08:00 17:30 Conference Sessions Friday, 14 November :00 12:00 SDTM for Medical Devices Course 09:00 17:00 CDASH Implementation Course 09:00 17:00 ADaM Implementation Course