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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 [email protected].
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
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