2015 CDISC International

Interchange

“Smarter Research to Unlock Cures”

09-13 November 2015

Fairmount Chicago Millennium Park Chicago, Illinois

INTERCHANGE SCHEDULE

MONDAY

09 Nov 2015

09:00 – 18:00

CDASH Implementation Course

09:00 – 18:00

BRIDG Deep Dive Course

09:00 – 13:00

Healthcare Link Course

14:00 – 18:00

Controlled Terminology Course

17:00 – 18:30

CDISC Advisory Council Meeting (By Invitation Only – For Platinum Member Organizations)

18:00 – 22:30

Exhibition Booth Setup

18:00 – 20:00

Early Conference Registration

TUESDAY 10 Nov 2015

Interchange Conference

07:30 – 17:00

08:00 – 17:00

Ø Conference

Registration

Ø Exhibits Open

08:30 – 10:00

Session 1 Opening Plenary: CDISC at 15 Years: Celebrating our Past, Empowering Our Future

Opening Remarks – Dr. Rebecca Kush, CDISC President & CEO

Internal Directions to Produce External Solutions

– Dr. Nicole Harmon, CDISC Executive Director

21st Century Cures Legislation: Modernizing Drug Development in

Pursuit of Cures – Stephen Smith, Chief Patient Advocate, Medidata Solutions

The Work We Do Saves Lives, But We Must Do More – Trisha Simpson, UCB

State of CDISC Union: Empowering Our Future

– Dr. Rebecca Kush, CDISC President & CEO

The CDISC Fellowship Experience

– Christine Fleeman, UCB; Tasneem Shahmalak, Chiltern

10:00 – 10:30 BREAK

10:30 – 12:00

Session 2 Regulatory and Alliance Perspectives on CDISC Session Chair: Bron Kisler, CDISC VP Strategic Alliances

International & Regulatory Presentations, Followed by a Panel

Discussion

§ Dr. Yuki Ando, Japan PMDA

§ Dr. Eileen Navarro Almario, FDA

§ Dr. Stephen Wilson, FDA

§ Joyce Sensmeier, Integrating the Healthcare Enterprise (IHE)

§ Lisa Spellman, ISO TC215, AHIMA

12:00 – 13:30 LUNCH Visit the E2C Demonstration in the Imperial Ballroom Foyer! 12:00 – 13:30 EXHIBITS

13:30 – 15:00

Session 3 (Track One) SHARE and Metadata Repositories Session Chair: Jonathan Chainey, Roche

Session 4 (Track Two) SEND: Nonclinical eStudy Data Standards Development, Forging New Paths Session Chair: Lou Ann Kramer, Instem

The SHARE Roadmap: Next Steps for SHARE

Sam Hume, CDISC VP SHARE Technology & Services

SEND: History and Basics Dr. Frederick E. Wood, Jr., Accenture

SHARE Steering Committee

Dave Evans, SHARE Steering Committee Representative

Getting from SDTM to SEND Roman Radelicki, SGS Life Science Services

Define.xml 2.0: Not Just for Submission – A Use Case Eileen Gardenhire, Celgene Corporation

Marcelina Hungria, DIcore Group, LLC

SEND for Developmental and Reproductive Toxicity and for Dermal/Ocular Irritation Data Gitte Frausing, Data Standards Decisions Aps

Implementation and Management of Clinical Metadata in Novartis MDR System Archana Bhaskaran, Novartis

Genetic Toxicology – In Vivo and In Vitro William Houser, Bristol-Myers Squibb

Panel Discussion SEND Controlled Terminology – The Lexicon of Nonclinical Mary L. Harris, Eli Lilly and Company

Panel Discussion Including:

§ Michael Wasko, PDS

15:00 – 15:30 BREAK

15:30 – 17:30

Session 5 (Track One) The Coalition for Accelerating Standards and Therapies (CFAST) Session Chair: Rhonda Facile, CDISC VP, Standards Development

Session 6 (Track Two) The Analysis Data Model (ADaM) and Study Data Tabulation Model (SDTM) Session Chair: John Troxell, Accenture

The J-CFAST Organization in Japan Dr. Mayumi Shikano, PMDA

ADaM Example for a Complex Efficacy Analysis Dataset Sandra Minjoe, Accenture

Data Standards, Considerations & Conventions within TA User Guides Jerry Salyers, Kristin Kelly and Fred Wood, Accenture

CDISC ADaM Implementation for Japan PMDA Submission Yumiko Asami, Daiichi Sankyo

Reflections on ADaM & TA User Guides Dr. Diane Wold, CDISC Sr. Director, Standards Development & Modeling

Auto-Generations with CDISC Data Standards Chengxin Li, Boehringer Ingelheim

Implementation of Diabetes ADaM Standards at Lilly Rachael Zirkle and Isaac Swanson, Eli Lilly and Company

Overview and Creation of Analysis Results Metadata with SAS Yohei Takanami, Takeda

CDASH & TA User Guide Development Lorraine Spencer, Takeda

Panel Discussion Including:

• Benjamin Vali, FDA

A Development Story: Virology v1.0 & v2.0 Laura Butte and Jon Neville, Critical Path Institute

Swan Dive into Biomedical Concepts Gloria Jones, Johnson & Johnson The Prostate Cancer Project & SHARE: A Model for Future TA Standards Development John Owen, CDISC Project Manager and Anthony Chow, CDISC SHARE Metadata Curator

18:00 – 19:30 EVENING NETWORKING EVENT

Wednesday 11 Nov 2015

Interchange Conference

07:30 – 17:00

08:00 – 16:00

Ø Conference

Registration

Ø Exhibits Open

08:30 – 10:00

Session 7

Second Opening Plenary

Session Chair: Dr. Rebecca Kush, CDISC President & CEO

Keynote Address – Dr. Rob Califf, FDA Deputy Commissioner

Panelists:

§ Dr. David Hardison, ConvergeHEALTH by Deloitte, CDISC Board Chair-Elect

§ Dr. Doug Peddicord, ACRO, CDISC Board

§ Dr. Lynn Hudson, Critical Path Institute

10:00 – 10:30 BREAK

10:30 – 12:30

Session 8 Smarter Research with eSource and Standards Session Chair: Dr. Michael Ibara, CDISC Head of Digital Healthcare

Proof of Concept Retrieve Form Data Capture from Epic to REDCap

– Amy Nordo, Duke University

Integrating Research and Care with eSource Checklist

– Sue Dubman, University of California San Francisco

Trial Development of Clinical Research Data Using CDISC ODM

– Yoshiteru Chiba, UMIN Center, University of Tokyo

TransFoRm and ODM Extension for Hand-Helds

– Dr. Brendan Delaney, King’s College London

The Use of EHRs to Support Research in Japan

– Dr. Michio Kimura, Hamamatsu University

UCB’s Pilot Study Using EHRs – Trisha Simpson, UCB

Panelists:

§ Dr. Rob Califf, FDA Deputy Commissioner

§ Dr. Stephen Wilson, FDA

§ Joyce Sensmeier, IHE, CDISC Board

§ John Speakman, New York University, CDISC Board

§ Samuel Volchenboum, University of Chicago

12:30 – 14:00 LUNCH 12:30 – 14:00 EXHIBITS

14:00 – 15:30

Session 9 (Track One) Implementation Lessons & Metrics Session Chair: Gary Walker, Quintiles

Session 10 (Track Two) Standards from the Start Session Chair: Shannon Labout, CDISC VP, Education

A Global CRO’s Journey to Innovation through CDISC Standards Tammy Jackson, PPD

A Practical Perspective on Strategic Use of CDISC Protocol Representation Model Version 1.0 Angela Johnson, GE Healthcare

Case Study: Impact of Implementing CDISC Standards in an Organization – Metrics Results Mark Penniston, Chiltern

Implementing the CDISC Standards into an Existing CTMS by Using an Integrated Workflow Approach Ueng-Cheng Yang, Institute of Biomedical Informatics

It’s a Standard, So It’s Simple, Right? Misconceptions and Organizational Challenges of Implementing CDISC at a CRO Susan Boquist, PAREXEL

CDASH: A Model to Support Data Management, Traceability and Standards Development Mike Ward, Eli Lilly

CRF to SDTM: A Practical CDISC Implementation Ed Chappell, Formedix

Achieving Quality Management with Better Protocols: Starting with Standards and Simulating Designs James Streeter, Oracle

Panel Discussion Including:

• Benjamin Vali, FDA

15:30 – 16:00 BREAK

16:00 – 17:00

Session 11 Closing Plenary: The Future of CDISC – CDISC 2020 Session Chairs: Dr. Nicole Harmon, CDISC Executive Director, and Dr. Pierre-Yves Lastic, Sanofi, CDISC Board Chair

Panelists:

§ Dr. Stephen Wilson, FDA

§ Dr. Eileen Navarro Almario, FDA

§ Benjamin Vali, FDA

§ Dr. Yuki Ando, Japan PMDA

§ Paula Brown Stafford, Quintiles, CDISC Board Past-Chair

§ Mike Glickman, Computer Network Architects, Inc., CDISC Board

§ Dr. Charles Cooper, Becton Dickinson Diagnostics, CDISC Board

§ Dr. Kiyoteru Takenouchi, TRI, CDISC Board

§ Dr. David Hardison, ConvergeHEALTH by Deloitte, CDISC Board Chair-Elect

THURSDAY

12 Nov 2015

09:00 – 18:00

SDTM Theory & Application Course (Day 1 of a 2-Day Training)

09:00 – 18:00

SDTM Theory & Application for Medical Devices Course (Day 1 of a 2-Day Training)

09:00 – 18:00

SEND Implementation Course (Day 1 of a 2-Day Training)

09:00 – 18:00

ODM Implementation Course

FRIDAY 13 Nov 2015

09:00 – 18:00

SDTM Theory & Application Course (Day 2 of a 2-Day Training)

09:00 – 18:00

SDTM Theory & Application for Medical Devices Course (Day 2 of a 2-Day Training)

09:00 – 18:00

SEND Implementation Course (Day 2 of a 2-Day Training)

09:00 – 18:00

Define-XML Course

09:00 – 18:00

ADaM Implementation Course

SAVE THE DATE!

Cowboy Up! An Evening of Live Music Collaborating

for PTS & Mental Health Research

03 March 2016 Austin, Texas

2016 CDISC Europe Interchange

25 – 29 April 2016 Vienna, Austria

2016 CDISC Japan Interchange

30 May – 03 June 2016

Tokyo, Japan

OUR SPONSORS

Special Thanks to Our Global Diamond Sponsor!

Ruby Sponsors:

Breakfast Sponsor:

EXHIBITORS

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EDUCATION