FOSTERING CUTTING-EDGE

TO ADVANCE

CDISC INTERNATIONAL INTERCHANGE 26 - 30 September 2016 Bethesda North Marriott Hotel & Conference Center

INNOVATION

RESEARCH

THANK YOU TO OUR SPONSORS!

4th Year GLOBAL DIAMOND SPONSOR

GLOBAL RUBY SPONSOR

RUBY SPONSOR

WIFI SPONSOR

CONFERENCE ANNOUNCEMENTS

BREAKFAST 08:00 - 09:10 White Oak A

AM BREAK 10:30 - 11:00 Mon & Tues: Glen/Brookside Foyers; Fri: Middlebrook Foyer

LUNCH 13:00 - 14:00 Mon & Tues: White Oak A; Fri: Middlebrook Foyer

PM BREAK 15:30 - 16:00 Mon & Tues: Glen/Brookside Foyers; Fri: Middlebrook Foyer

MONDAY TUESDAY & FRIDAY!

AM BREAK 09:30 - 10:00 Wed; 10:00 - 10:30 Thurs Foyer A - H

LUNCH 12:00 - 14:00 Wed; 12:00 - 13:30 Thurs

WEDNESDAY & THURSDAY!

BREAKFAST 07:00 - 08:00 Wed; 07:30 - 08:30 Thurs Salon E - H

EMERALD SPONSOR

SPONSOR

WIFI INFORMATION! NETWORK NAME: EDETEK! PASSWORD: CDISC2016!

PM BREAK 15:30 - 16:00 Foyer A - H

Salon E - H

AUTHORIZED EDUCATION COURSES

08:00 - 18:15 REGISTRATION Lower Level

SEND IMPLEMENTATION 09:00!%!17:00!Gi#e%Frausing,%Data%Standards%Decisions!

09:00 - 18:00 CDISC AUTHORIZED EDUCATION COURSES

SDTM THEORY & APPLICATION 09:00!%!17:00!Shannon%Labout,%CDISC%

SDTM FOR MEDICAL DEVICES 09:00!%!17:00!Kit%Howard,%CDISC%

CONTROLLED TERMINOLOGY 09:00!%!13:00!Erin%Muhlbradt,%%NCI%EVS%

ADaM PRIMER 14:00!%!18:00!Mario%Widel,%%Eli%Lilly%

MONDAY, 26 SEPTEMBER

Oakley Glen Echo Forest Glen White Oak B White Oak B

08:00 - 18:15 REGISTRATION Lower Level

SEND IMPLEMENTATION 09:00!%!17:00!Gi#e%Frausing,%Data%Standards%Decisions!

09:00 - 17:00 CDISC AUTHORIZED EDUCATION COURSES

SDTM THEORY & APPLICATION 09:00!%!17:00!Shannon%Labout,%CDISC%

SDTM FOR MEDICAL DEVICES 09:00!%!17:00!Kit%Howard,%CDISC%

ODM IMPLEMENTATION 09:00!%!17:00!Sally%Cassells,%Next%Step%Clinical%Systems,%LLC%

ADaM THEORY & APPLICATION 09:00!%!17:00!Mario%Widel,%%Eli%Lilly%

TUESDAY, 27 SEPTEMBER

Oakley Glen Echo Forest Glen Great Falls Middlebrook

09:00 - 13:00 SHARE WORKSHOP (by pre-registration only) Linden Oak

08:00 - 17:30 REGISTRATION Lower Level

DEFINE-XML 09:00!%!17:00!Sally%Cassells,%%Next%Step%Clinical%Systems,%LLC

09:00 - 17:00 CDISC AUTHORIZED EDUCATION COURSES

HEALTHCARE LINK & eSOURCE WORKSHOP 09:00!%!13:00!Dr.%Michael%Ibara,%CDISC%

CDASH IMPLEMENTATION 09:00!%!17:00!Shannon%Labout,%CDISC%

FRIDAY, 30 SEPTEMBER

Great Falls Timberlawn Middlebrook

14:00 - 17:00 UNLOCKING A GLOBAL LANGUAGE FOR SMARTER RESEARCH SYMPOSIUM Oakley

14:00 - 18:00 BRIDG Information Session (by pre-registration only) Linden Oak

18:00 - 20:00 CONFERENCE REGISTRATION Foyer C

INTERCHANGE CONFERENCE

07:00 - 17:00 CONFERENCE REGISTRATION Foyer C

THE FUTURE OF MEDICAL RESEARCH AND ROLE OF STANDARDS: FORMING CONNECTIONS TOWARDS COMPLEMENTARY SYSTEMS Dr.%Robert%Califf,%FDA%Commissioner%

08:00 - 09:30 SESSION 1 OPENING PLENARY: KEYNOTE ADDRESSES

VALUE OF STANDARDS IN PRECISION MEDICINE AND ONCOLOGY Dr.%Warren%Kibbe,%Deputy%Director,%NCI;%Director,%CBIIT%

FROM BIG DATA TO SMART DATA Dr.%Sean%Khozin,%Senior%Medical%Officer,%Office%of%Hematology%and%Oncology%Products,%FDA%

WEDNESDAY, 28 SEPTEMBER

Salon A - D

10:00 - 12:00 SESSION 2 SECOND PLENARY: VALUE OF STANDARDS IN DATA SHARING AND RESEARCH FROM BEGINNING TO END

Salon A - D

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%

SDTM TRIAL SUMMARY DOMAIN: PUTTING TOGETHER THE TS PUZZLE KrisSn%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%

14:00 - 15:30 SESSION 3 (TRACK A): SDTM

Salon A - C 14:00 - 15:30 SESSION 4 (TRACK B): ADaM

Salon D

12:00 - 14:00 LUNCH AND SHARE SHOWCASE (visit with our exhibitors) Salon E - H

Chair:%Dr.%Nicole%Harmon,%CDISC%COO%

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

Chair:%Shannon%Labout,%CDISC Chair:%Nate%Freimark,%ADaM%Team%Leader%

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%

07:30 - 17:00 EXHIBITION OPEN Foyer A - H

Panel%Discussion%to%Follow,%Including:%Dr.%Lisa%LaVange,%FDA/CDER/BiostaSsScs;%Dr.%Vaishali%Popat,%FDA/OND;%Dr.%Laura%Lee%Johnson,%FDA/CDER/BiostaSsScs;%Dr.%Eileen%Navarro,%FDA/CDER/OCS;%Dr.%Rob%Dicicco,%GlaxoSmithKline;%and%Arline%Nakanishi,%Amgen

TRANSCELERATE STANDARDS GOVERNANCE Lindsey%Kolezar%and%Carrie%Ann%Young,%TransCelerate%Data%Standards%ImplementaSon%Sub]Team

16:00 - 17:30 SESSION 5 (TRACK A): STANDARDS GOVERNANCE

Salon A - C 16:00 - 17:30 SESSION 6 (TRACK B): DEFINE-XML

Salon D

Chairs:%Rachael%Zirkle,%Eli%Lilly%and%Brooke%Hinkson,%Merck%

Chair:%Sam%Hume,%CDISC%

PROCESS AND CONSIDERATIONS ON HOW TO UPGRADE YOUR COMPANY’S BASE CDISC VERSION Sco#%Getzin%and%Isaac%Swanson,%Eli%Lilly%

CDISC STANDARDS GOVERNANCE LESSONS LEARNED AT ABBVIE Ana%Ramanarayanan,%Abbvie%

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,%Xclinical%

THURSDAY, 29 SEPTEMBER07:30 - 17:00 CONFERENCE REGISTRATION Foyer C

08:30 - 10:00 SESSION 7 (TRACK A): SHARE & METADATA REPOSITORIES

Salon A - C 08:30 - 10:00 SESSION 8 (TRACK B): CDISC & PhUSE COLLABORATIVE ACTIVITIES

Salon D

Chair:%Sco#%Getzin,%Eli%Lilly% Chairs:%Dr.%Stephen%Wilson,%FDA/CDER%BiostaSsScs,%and%Barrie%Nelson,%CDISC%

18:00 - 19:30 EVENING NETWORKING RECEPTION Salon E - H

08:00 - 16:00 EXHIBITION OPEN Foyer A - H

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,%InVenSv%Health%

WORKING GROUP UPDATE: NONCLINICAL TOPICS RELATED TO CDISC Fred%Wood,%Accenture

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

ADOPTING A CDISC DATA MODEL TO BUILD A CLINICAL DATA WAREHOUSE Jaskiran%Singh,%NIH%

10:30 - 12:00 SESSION 9 (TRACK A): CLINICAL DATA WAREHOUSE & EHR CDISC DATASETS

Salon A - C 10:30 - 12:00 SESSION 10 (TRACK B): CDISC THERAPEUTIC AREA STANDARDS

Salon D

Chair:%Jennifer%Price,%BioClinica% Chair:%Rhonda%Facile,%CDISC%

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%

12:00 - 13:30 LUNCH AND SHARE SHOWCASE (visit with our exhibitors) Salon E - H

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%

CFAST PROGRAM UPDATE Rhonda%Facile,%CDISC%

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%

13:30 - 15:30 SESSION 11 FIRST CLOSING PLENARY: PLANNING, PREPARATION AND VALIDATION OF SUBMISSION DATA

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%SoluSons

EXTENSION STUDIES: CDISC SUBMISSION CHALLENGES AND SCENARIOS Aishwarya%Balajee,%Zifo%

GENERATION OF DEFINE-XML UPFRONT WHILE GENERATING SDTM Deepali%Gupta,%eClinical%SoluSons%

Panel%Discussion%to%Follow,%Including:%Virginia%Hussong,%FDA/OBI;%Lisa%Lin,%FDA/OBI;%Hiroshi%Sakaguchi,%Japan%PMDA;%Helena%Sviglin,%FDA/OCS;%and%Dr.%Stephen%Wilson,%FDA/CDER%BiostaSsScs

Chair:%Dr.%Ron%FitzmarSn,%FDA/CDER/OSP,%and%Dr.%Yuki%Ando,%Japan%PMDA%

Salon A - D

16:00 - 17:00 SESSION 12 SECOND CLOSING PLENARY: THE FUTURE OF CDISC

Chair:%Dr.%David%Hardison,%CDISC%Board%Chair;%and%Dr.%Pierre]Yves%LasSc,%CDISC%Board%Past]Chair%

Salon A - D

STATE OF THE CDISC UNION Dr.%Rebecca%Kush,%CDISC%President%and%CEO,%and%Dr.%Nicole%Harmon,%CDISC%COO!

Panel%Discussion,%Including:%Dr.%Lilliam%Rosario,%FDA/OCS;%Benjamin%Vali,%FDA/CDER%BiostaSsScs;%Dr.%Jose%Galvez,%NIH;%Dr.%Kiyoteru%Takenouchi,%CDISC%Board%Member;%Alexander%Bragat,%NYU%Langone%Medical%Center;%Dr.%Charles%Cooper,%BD%Life%Sciences

SAVE THE DATE!

2017 CDISC EUROPE INTERCHANGE

24 - 28 April 2017 London, United Kingdom

2017 CDISC JAPAN INTERCHANGE

13 - 15 June 2017 Tokyo, Japan

2017 CDISC INTERNATIONAL INTERCHANGE

13 - 17 November 2017 Austin, Texas, USA

COWBOY UP FOR ONCOLOGY DATA STANDARDS

02 March 2017 Austin, Texas, USA

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Press Release

1610 Medical Drive, Suite 300, Pottstown, PA 19464 Telephone: 610.970.2333 www.dataceutics.com © DataCeutics 2015. All rights reserved.

DataCeutics Supports The Perkiomen School Through the Educational

Improvement Tax Credit Program

March 30, 2016 Pottstown, PA – This year The Perkiomen School received $153,122 in funds, from more than a dozen different area companies, to be used for scholarships and educational programming for students across Pennsylvania attending the school. This is a 24% increase from the previous year. Eligible businesses contributing to a Scholarship Organization, an Educational Improvement Organization, and/or a Pre-Kindergarten Scholarship Organization through the Educational Improvement Tax Credit (EITC) programs receive tax credits. DataCeutics, headquartered in Pottstown, has been a loyal supporter of The Perkiomen School through the EITC program since 2013, contributing over $25,000 to the school community. These funds provide critical support to a robust financial aid program that attracts a financially diverse student body that enjoy and contribute to the educational community. Karl Welsh, Director of Development at The Perkiomen School, says, “It is fantastic that a company providing clinical research and functional services to the medical industry can also extend its reach, philanthropically, by partnering with an educational organization to increase the number of well-deserving students afforded the opportunity to a meaningful education. EITC is a program with profound impact.” The Perkiomen School is a boarding and day school located in Pennsburg, Pennsylvania for students in Grades 6-12. The Perkiomen School challenges each of its 350 students, from 23 countries and 10 states, to risk becoming their best as they participate in a rich educational program of academics, sports, arts, clubs, special trips, and community service opportunities. The Perkiomen School is grateful for the support it receives from area businesses. Partnering businesses contribute directly to its vibrancy of its student body and the rigor of its educational programming. More information can be found on the school’s website at www.perkiomen.org. Questions regarding making a gift to the school can be directed to Christe Thompson, The Director of The Perkiomen Fund, at CThompson@perkiomen.org.

DataCeutics

DataCeutics is a Functional Service Provider and Outsourcing Partner who is committed to quality. The

foundation of our clinical research services are built upon our strong technical expertise in Biostatistics,

Data Transformations, and Statistical Programming. We couple our unparalleled passion for excellence

with our experience in our core proficiencies across multiple therapeutic areas and disease states. This

provides our clients with significant positive outcomes in all phases of their clinical trials and proven value

in each sponsor engagement.

• Biostatistics

• SAS® Statistical Programming

• CDISC CDASH/SDTM and ADaM Services

• Standards Implementation

• Statistical Computing Environment (SCE) Support

• Clinical Study Report Auditing

www.cdisc.org #INTX16 www.unlockcures.org