conference and exhibition integration across the clinical ... · cdm • march 18-20, 2007 •...

Program ChairKristin M. Neff, MSClinical Program Manager, Boston Scientific Corp.

Program CommitteePaul Bleicher, MD, PhDChairman and Founder, Phase Forward

Patrick GenynSenior Director Strategy & PlanningIntegrated Data Services, Global Clinical OperationsJohnson & Johnson

Rebecca D. Kush, PhDPresident, CDISC

Denise DeRenzo Lacey, MA, MSAssociate, Waife & Associates, Inc.

Johann Pröve, PhDGlobal Head Data Acquisition and ManagementBayer Vital GmbH, Germany

Stephen E. Wilson, DrPH, CAPT. USPHSDirector, Division of Biometrics III, CDER, FDA

Online Registration is now available! www.diahome.org Monitor the website for the most current details.

DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA tel: +1-215-442-6100 fax: +1-215-442-6199 email: [email protected]

Join us in celebrating the 22nd year of this hallmark meeting!

This annual meeting will deliver the latest information to attendees about the evolvingclinical data management function, as well as provide opportunities to meet andnetwork with colleagues in the industry.

This year’s CDM conference will feature a Keynote Address and FDA Update PlenarySession on the first morning. The conference will run on four parallel tracks – Data, Strategy, eClinical Technology, and Electronic Health Records and HealthInformatics – in order to address the overall clinical development environment and the dynamic role of the data manager. Session topics include, but are not limited to:

TUTORIALS

4 tutorials are being offered on Sunday, March 18. See pages 7 & 8 for details.

22nd Annual DIACLINICAL DATA MANAGEMENTConference and Exhibition

Integration Across theClinical Trial Continuum

THIS PROGRAM WAS DEVELOPED BY THECLINICAL DATA MANAGEMENTSPECIAL INTEREST AREA COMMUNITY

March 18-20, 2007Orlando, FL, USA

Buena Vista PalaceResort & Spa

Track 1 – STANDARDS AND DATANew and Emerging Standards andImplementations

Handling Data

The Case for Standards from Startup throughSubmission

Terminology and Data Standards

Standardized Data Collection

Managing Data

Track 2 – STRATEGYUsing “E” Methods to Develop eCRFs

Other Clinical Functions Interface with ClinicalData Management

Managerial Aspects in a Changing DataManagement Environment

Future of Data Managers

Emerging Regions/ Globalization CDM

Continuous Improvement of DataManagement Processes

Track 3 – ECLINICAL TECHNOLOGYIndustry Architectures & InformationManagement – Achieving Interoperability ina Federated World

People, Process, and Technology: ElectronicData Capture in Practice

Electronic Source: Untangling the Threads(Part 1 & 2)

Track 4 – ELECTRONIC HEALTH RECORDSAND HEALTH INFORMATICS

Medical Informatics Opportunities toImprove Benefit/Risk Assessment of Drugs

Health Information Technology Initiatives

EHR in Clinical Research (Part 1 & 2)

Data Transparency in the Public Interest

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Meeting Contact and Exhibit InformationMeeting attendees are welcome to visit the exhibits during the workshop and receptions.

The Drug Information Association (DIA) has been reviewed and approved as an Authorized Provider by theInternational Association for Continuing Education and Training (IACET), 1620 I Street, NW, Suite 615,Washington, DC 20006. The DIA has awarded up to 1.5 continuing education units (CEUs) to participants

who successfully complete this program and tutorials.

To receive a statement of credit, please visit www.diahome.org. Detailed instructions on how to complete your creditrequest and download your certificate will be provided onsite.

Disclosure Policy: It is Drug Information Association policy that all faculty participating in continuing education activitiesmust disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentationand (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosure will be included in thecourse materials.

Continuing Education Credit AllocationHalf-day Tutorials: .3 IACET CEUs

Conference: .9 IACET CEUs (CEUs will not be offered for the Keynote Address.)

For meeting information, contact Jessica Kusma,Program Manager at the DIA office in Horsham, PA

telephone +1-215-442-6182fax +1-215-442-6199email [email protected]

For exhibit information, contact Jeff Korn, ExhibitsAssociate at the DIA office in Horsham, PA

telephone +1-215-442-6184fax +1-215-442-6199email [email protected]

Learning ObjectivesAt the conclusion of this conference, participants should beable to:

� Recall information from the FDA on their activities andthe latest trends in data management

� Apply best practices for collecting and managing standardized data, including creating data standards forregulatory submissions

� Recognize the importance of data quality throughout thedrug development life cycle

� Identify new processes for optimizing, accessing andintegrating data

� Develop successful relationships between clinical data management and other clinical functions

� Discuss the evolution of data management and how therole of the data manager is changing

� Summarize “hot” EDC topics including process issues andthe challenges of using multiple vendors

� Describe the future of Electronic Health Records and howit impacts data management

Continuing Education Credits

Target Audience� Clinical data management professionals� Statisticians/biostatisticians� CRF and database designers� Information technology professionals� Regulatory affairs professionals� Data coordinators and reviewers

� Data monitors� Medical coders� Clinical professionals� Clinical project leaders� Clinical research professionals� Patient recruitment professionals

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About Susan EllenbergDr. Susan Ellenberg isProfessor of Biostatistics,Center for ClinicalEpidemiology andBiostatistics, and AssociateDean for Clinical Research,University of PennsylvaniaSchool of Medicine. Inaddition to her teachingand administrative dutiesshe serves as senior statisti-cian for two multicenter

clinical trials in the area of sleep research, and directs theBiostatistics Core of the Penn Center for AIDS Research.

Prior to her appointment at Penn, Dr. Ellenberg held posi-tions of increasing responsibility in the federal government.From 1993 to 2004 she served as Director, Office ofBiostatistics and Epidemiology in the Center for BiologicsEvaluation and Research (CBER) at the U.S. Food andDrug Administration; prior to that she served as the firstChief of the Biostatistics Research Branch in the Division ofAIDS, National Institute of Allergy and Infectious Diseases(1988-1993), and served in the Biometric Research Branchin the Cancer Therapy Evaluation Program, NationalCancer Institute (1982-1988). During Dr. Ellenberg’s

tenure at FDA she played a leading role in the developmentof international standards for design and analysis of clinicaltrials performed by the pharmaceutical industry, developedproductive programs for postmarketing safety surveillance ofbiological products, and coordinated the development ofpolicy for the establishment and operation of clinical trialdata monitoring committees.

Dr. Ellenberg’s research has focused on practical problems indesigning, conducting and analyzing data from clinical tri-als. She has published extensively in both statistical andmedical journals, on topics including surrogate endpoints,data monitoring committees, clinical trial designs, adverseevent monitoring, vaccine safety and special issues in cancerand AIDS trials. She is a Fellow of the American StatisticalAssociation, the Society for Clinical Trials and the AmericanAssociation for the Advancement of Science, and is an elect-ed member of the International Statistical Institute. Herbook, Data Monitoring Committees in Clinical Trials: APractical Perspective, co-authored with Drs. ThomasFleming and David DeMets, was named WileyEuropeStatistics Book of the Year for 2002.

Dr. Ellenberg received an AB from Radcliffe College and a PhD in mathematical statistics from the GeorgeWashington University.

KEYNOTEThe Future of Drug Safety: The Institute of Medicine Assessment of FDA Drug Safety Programs Presented by Dr. Susan Ellenberg, member of the Institute of Medicine committee that issued the report entitled, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," in September 2006.

Clinical Data Management SIACChris A. LeGrand, North American ChairpersonJohann Pröve, European ChairpersonDIA Contact: [email protected]

The mission of the SIAC is to:

• Establish a global forum to share, evaluate and disseminate information on the processes, standards and technologies for themanagement of clinical data;

• Encourage participation by professionals who are in the biopharmaceutical and healthcare industries;

• Promote education, training and career development of Clinical Data Management professionals;

• Promote multi-disciplinary collaboration and understanding;

• Increase the visibility and recognition of Clinical Data Management as a professional discipline or go to DIA’s websitewww.diahome.org

Special Interest Area Communities

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Conference at a Glance

New and Emerging Standards andImplementations

Pharmacogenomics Standards

Protocol Representation Standard

Crossing the BRIDG to the Future:Implementation and Case Studies of theHL7/CDISC BRIDG Model to Support

Interoperability

TRACK 1 - Standards and DataUsing “E” Methods to Develop

eCRFsWaterfall vs. Prototyping: Visualizing eCRFs

Where the Rubber Meets the Road: Finding the Path to Standards

Using “E” Methods to Develop eCRFs and ePRO

TRACK 2 - StrategyIndustry Architectures & Information

Management – AchievingInteroperability in a Federated World

The Business Case for ApplicationInteroperability

Architectural Trade-offs in Clinical Research Data RepositoriesLife Sciences Industry Architecture –

Report to Industry

Medical Informatics Opportunitiesto Improve Benefit/Risk

Assessment of Drugs

Informatics Building Blocks and Their Applications

Medical Informatics: Opportunities toImprove the Benefit-risk Assessment of Drugs

TRACK 3 - eClinical Technology TRACK 4 - EHR & Health Informatics

Handling DataElectronic Data Transfers from Unusual

Sources: A Case StudyIn Vitro Diagnostic Device Trials: Challenges

and Successes with Integrating Data from Multiple Sources

How Collaborative Review of Deliverables and Data Can Increase Quality and Decrease

Time for Completion

TRACK 1 - Standards and DataOther Clinical Functions Interfacewith Clinical Data Management

A Bridge to a Successful Study from Start to Finish – Interfacing Between

Data Management and Clinical Departments

The Expanding Role of Clinical Site Monitors

Teaming the Data Managers andStatistician: Planning and Teamwork Yields

the Best Results

TRACK 2 - StrategyPeople, Process, and Technology:

Electronic Data Capture in PracticeIntegrating the Clinical Endpoints

Adjudication Process into an EDC TrialUAT in EDC Trials and the Changing Role

for Data ManagersA Case Study in Integrating EDC with anIVR Drug Tracking and Randomization

System

Health Information Technology Initiatives

Use of eSource Data Collection forClinical Research and Relevant

Regulations

Review of the eSDI Document, Version 1

Adoption of Electronic Health Records byPhysicians in Healthcare


Sunday, March 18, 20077:30 - 8:30am Tutorial Registration and Continental Breakfast

8:30am - 12:00pm Concurrent Tutorials 1 & 2#1 Semantic Web Applications in Clinical Data Management#2 FDA – CDISC: eCTD Regulatory Submissions

10am - 3pm Exhibitor Registration and Booth Set-up

12 - 1:30pm Tutorial Registration

1:30 - 5pm Concurrent Tutorials 3 & 4#3 A Silk Purse from a Sow’s Ear: Surviving and Flourishing After Mergers or Acquisitions#4 Issues of Data Quality throughout the Data Life Cycle in Clinical Research

4 - 6pm Attendee and Speaker Registration/Exhibit Hall open

5 - 6pm Reception in the Exhibit Hall

Monday, March 19, 20077:30 - 8:30am Registration and Continental Breakfast

9:00am Exhibit Hall Opens

8:30 - 8:45am Plenary Session 1: Welcome and Opening Remarks8:45 - 9:30am KEYNOTE ADDRESS – The Future of Drug Safety: The Institute of Medicine Assessment

of FDA Drug Safety Programs

9:30 - 10am Refreshment Break in Exhibit Hall

10am - 12pm Plenary Session 2: Moving Down the e-Highway: The FDA Update/Town Hall Session

12 - 1:30pm Luncheon in Exhibit Hall

1:30 - 3pm Parallel Tracks

3 - 3:30pm Refreshment Break in Exhibit Hall


5 - 6pm Networking Reception in Exhibit Hall

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2pm Exhibit Hall Closes

3 - 3:30pm Refreshment Break


5pm Conference Adjourned

The Case for Standards from Startupthrough Submission

Creating Submission-compliantSummary Databases (ISS/ISE) in the

CDISC SDTM Format

Standards End-to-End

The Business Case for Standards End-to-End

TRACK 1 - Standards and DataManagerial Aspects in a ChangingData Management Environment

Catching the Knuckler: Helping DMProfessionals Adapt to the New Environment

Consolidation and Globalization of DataManagement Activities

Transformational Practices in Clinical DataManagement (CDM) Outsourcing

TRACK 2 - StrategyElectronic Source: Untangling

the Threads (Part 1)

ePRO, eSource and the Tangled Web

No Session ScheduledTRACK 3 - eClinical Technology TRACK 4 - EHR & Health Informatics

Terminology and Data StandardsImplementing Data Standards: Challenges from the National Institute of Neurological

Disorders and Stroke (NINDS), National Institutes of Health (NIH),

Common Data Elements (CDE) Project

NCI Enterprise Vocabulary Services (EVS):Controlled Terminology and SemanticIntegration for the Clinical Trials and

Healthcare Community

Standard Controlled Terminology: A SuccessfulCollaboration between CDISC, Government

Agencies, and Industry

TRACK 1 - Standards and DataFuture of Data Managers

Leadership Techniques and Career GrowthOpportunities for Data Management

Personnel

Potential Future Roles and Career PathOpportunities for Data Managers

Future Role of Data Managers

TRACK 2 - StrategyElectronic Source: Untangling

the Threads (Part 2)

Practical Experience of the Digital Pen andPaper Technology in Clinical Trials

The Gordian Knot: Integrating Global EHRand Global ClinicalTrials

Electronic Source Data: A Case Study

** THIS CONCLUDES TRACK 3 – ETECHNOLOGY **

Electronic Health Records in ClinicalResearch (EHR Part 1)

Enabling Research in an Electronic World

Electronic Health Record Data and TheirUse in Observational Research

A Disease Management Study Using anElectronic Medical Record-based Data

Warehouse


7:30 - 8:30am Registration and Continental Breakfast


8:30 - 10am Parallel Tracks

10 - 10:30am Refreshment Break in Exhibit Hall

10:30am - 12pm Parallel Tracks

12 - 1:30pm Luncheon in Exhibit Hall


Data Transparency in the Public InterestTRACK 4 - EHR & Health Informatics

Standardized Data Collection

Critical Path Initiative and Data CollectionStandards

Rationale and History of the CDASH Initiative

The CDASH Initiative – Progress to Date

TRACK 1 - Standards and DataEmerging Regions/Globalization CDM

Passport to Success in Global Clinical DataManagement

Strategic Outsourcing of Data Management toEmerging Regions

Global Means Next Door, Too

TRACK 2 - Strategy

Electronic Health Records (Part 2)

The New Directions (Life Sciences)Healthcare Interoperability Demo

Clinical Trial Execution Using Electronic Health Records

A Safety Surveillance Scenario

Clinical Research within an EHR Environment

TRACK 4 - EHR & Health InformaticsManaging Data

Help! I Can’t Possibly Do It All: Strategies forLarge Study Management

Integrating Data and Technology across the LifeSciences Research Value Chain

Secure Transfer of Clinical Trial Data

TRACK 1 - Standards and DataContinuous Improvement of Data

Management Processes

Using Metrics to Improve Performance in Clinical Trials Using EDC

Importance of Data Quality throughout the Drug Development Lifecycle

Paving a Rough Road to Ensure a SmoothDatabase Lock

TRACK 2 - Strategy

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Exhibit Hall Floor Plan

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Exhibitor Information

Exhibitors (as of February 6, 2007)

Almac Clinical Technologies Applied Clinical Trials Magazine ARS, Inc.Averion International Corp. C3i, Inc. CDISCClinForce, Inc. ClinPhone Inc CRF Inc. DATATRAK International DZS Software Solutions, Inc. Edgewater Technology

eResearchTechnology, Inc. etrials WorldwideGM Servizi Srl ICON Clinical Research Image Solutions, Inc.Imperial Clinical Research Services, Inc. INC Research Integrated Clinical Systems, Inc.invivodataKforce Clinical Research Staffing MedFocus, LLC Medidata Solutions Octagon Research Solutions OmniComm Systems, Inc.

Paragon Biomedical, Inc.PAREXEL International PharmaNet Phase Forward Placemart Personnel Service RPS, Inc. SpotfireStrata Synteract, Inc.TAKE Solutions Inc. Trialstat Corporation Uppsala Monitoring Centre VIASYS Healthcare Waban Software

Exhibit Hall HoursSunday, March 18 4 - 6pmThere will be an opening reception in the exhibit hall from 5 - 6pm. Monday, March 19 9am - 6pmNetworking Reception 5 - 6pm

Tuesday, March 20 9:30am - 2pm

Coffee breaks & receptions will be held in the exhibithall.

For more information, contact:Jeff Korn, Exhibits Associate telephone +1-215-442-6184email [email protected]

Sunday, March 18, 10am - 3pm – Exhibitor Registration and Booth Set-up

Sunday, March 18, 2006 (Tutorials Only)

7:30 - 8:30am Tutorial Registration and Continental Breakfast

8:30am - 12:00pm Concurrent Tutorials 1& 2

#1 Semantic Web Applications in Clinical DataManagement(.3 IACET CEUs)

Eric Neumann, PhDCo-chair, W3C Healthcare and Life Sciences, and Senior Director Product Strategy, Teranode Corporation

OverviewAs clinical studies migrate towards a more digital model, newapproaches will need to be developed and adopted to respond toinformation challenges. This is becoming especially apparent aswe move to a Translation Research paradigm, and the complexi-ty of submitted regulatory data increases. Consequently, ClinicalData Management itself will need to better handle dataintegrity, clarity, provenance, security, extensibility, and re-usability. Many of these points can be addressed using the newly emerging Semantic Web standards.

Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:

� Describe the Semantic Web and how it applies to Drug R&D � Discuss translation research: new paradigms require new

modes of information processing

� Discuss biomarkers and pharmacogenomics capture, analysis,and document preparation – viz. proposed FDA guidelines

� Translate CDISC's SDTM into an RDF compatible model –(CDISC/RCRIM demonstration)

� Explain how to re-use and mine clinical information systemsfor future projects without changing re-building databases

#2 FDA – CDISC: eCTD Regulatory Submissions(.3 IACET CEUs)

Frank T. NewbyChief Operating Officer, CDISCStephen E. Wilson, DrPH, CAPT. USPHSDirector, Division of Biometrics III, CDER, FDA

OverviewFDA issued a draft guidance in November 2003 that proposedhow the Electronic Common Technical Document or eCTDwould be submitted to the agency. In 2004, the draft guidancewas updated to include the CDISC Study Data TabulationModel or SDTM. The draft guidance was again updated in2005 to include the CDISC define .xml specification. The FDAmade the draft guidance a “final” guidance on April 19, 2006.This tutorial will provide background on SDTM-based eCTD

(continued on page 8)

1:30 - 5pm Concurrent Tutorials 3 & 4

#3 A Silk Purse from a Sow’s Ear: Surviving &Flourishing After Mergers or Acquisitions(.3 IACET CEUs)

Ronald Waife, MPHPresident, Waife & Associates, Inc.

OverviewMergers and acquisitions are a fact of life for today’s clinical devel-opment professionals. Few employees, including management, areprepared to handle the myriad of issues which a merger raises intrying to keep operations going, staff motivated, and the com-bined entity improved. This tutorial will serve as a jumpstart forthose facing or about to face the merger situation, and will pro-vide a checklist of common issues and possible alternative resolu-tions, suggested ways to prepare yourselves and reporting staff,landmines to avoid in personnel, politics and procedure, andmore. Presentation, exercises and role-plays will be used.

Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:� Identify what is and what is not important to focus on

during merger and acquisition transition periods� Recognize opportunities for making the merged function

better than the combination of the old departments� Identify opportunities to catalyze long-desired improvements

in functional processes, definitions and purposes

#4 Issues of Data Quality throughout the Data LifeCycle in Clinical Research(.3 IACET CEUs)Kaye H. Fendt, MSPHDirector, Data Quality Research Institute (DQRI)

OverviewOn June 26, 2006, FDA announced an Initiative to Modernizethe Regulation of Clinical Trials and Monitoring to better theprotection of patients and the associated data integrity. Thistutorial will outline the needs for defining, measuring, andensuring data quality in clinical research; discuss progress to dateand plan for the future in four sections as follows:Section 1: Data Quality: Medical PerspectiveSection 2: Data Quality: Statistical Perspective Section 3: Data Quality: Regulatory, and Section 4: Data Quality: Future Prospective Panel Discussion

Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:� Identify the quality issues throughout the data life cycle� Explain each discipline’s role ensuring data quality � Apply quality improvement techniques in safety data to

protect human subjects � Identify critical control points of data quality� Discuss the current state of data quality research methodology

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4 - 6pm Attendee and Speaker Registration

4 - 6pm Exhibit Hall open

5 - 6pm Reception in the Exhibit Hall

12 - 1:30pm Luncheon Break (Attendees are responsible for obtaining lunch)

12 - 1:30pm Tutorial Registration

10am - 3pm Exhibitor Registration and Set-up

as to the purpose for the development of the final guidance.Additionally, the processes that submitting companies shouldundertake to help insure a technically successful submissionwhen including SDTM-based data will be discussed as well aswhat the FDA does with that data once accepted.

Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:

� Discuss the reasoning behind the FDA development of theeCTD guidance

� Identify the structural components of the eCTD

� Describe the process steps to ensure a technically successfulSDTM submission as part of your eCTD including how tocontact the FDA and when

� Explain what the FDA actually does with an eCTD submis-sion with the focus on what is done with the data submittedin SDTM format

� Discuss what's next for the eCTD guidance

Sunday, March 18, 2007 (Tutorials Only — Tutorial #2 continued)

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8:30 - 9:30am Plenary Session 1 – Welcome and Keynote Address

9:30 - 10am Refreshment Break in Exhibit Hall

10am - 12pm Plenary Session 2 – FDA Update

Moving Down the e-Highway: The FDA Update/Town HallSession Session Co-ChairsKim W. Nitahara, MBA, MITPrincipal Consultant, META Solutions, Inc.Stephen E. Wilson, DrPH, CAPT. USPHSDirector, Division of Biometrics III, CDER, FDAOn September 29th, 2006 the Center for Drug Evaluation andResearch made the unprecedented move to withdraw three industryguidances, including the ever-popular 1999 electronic submissionguidance detailing the 21 CFR 11 compliant means for the submis-sion of electronic data. Less than 3 months later, on December18th, 2006 the Agency held a Part 15 Hearing to seek “views andinformation … on the feasibility and effect of an all-electronic sub-mission environment.” The ICH eCTD, the development of datastandards via HL7/CDISC collaboration, the FDA ElectronicGateway, and the application of new analytical tools are paving theway for the new submission and review “e-Highway.” A contract

has been awarded to design and build an HL7-BRIDG-compliantmessage for the transmission of SDTM data. The Janus RepositoryPilot with the National Cancer Institute is speeding along. A newToxVision Pilot using CDISC standardized pre-clinical data isgaining traction. Critical Path-type people, along with a large consortium of sponsors, CROs and vendors are driving hard tostandardize CRFs. Reviewers are being trained and ReviewDivisions are revving up for standard data. What is the vision? How are we going to get there? How does allof this affect you? This is a “need-to-know” opportunity for datamanagement professionals to listen, to learn and to be partnersin this important process and dialogue – please bring yourknowledge, your problems, your questions, and your solutions.

Armando Oliva, MDDeputy Director for Bioinformatics, Office of Critical PathPrograms, FDA

12 - 1:30pm Luncheon

Monday, March 19, 2007



8:45 - 9:30amKeynote AddressThe Future of Drug Safety: The Institute of Medicine Assessment of FDA Drug Safety Programs Susan S. Ellenberg, PhDProfessor of Biostatistics, Associate Dean for Clinical Research, University ofPennsylvania School of Medicine Center for Clinical Epidemiology andBiostatistics; IOM Report Committee Member

8:30 - 8:45amWelcome and Opening RemarksKristin M. Neff, MSClinical Program ManagerBoston Scientific Corp.

1:30 - 3pm TRACK 3 – eClinical Technology

1:30 - 3pm TRACK 2 – Strategy

Industry Architectures & Information Management –Achieving Interoperability in a Federated WorldSession ChairDon RosenPrincipal, Don Rosen Consulting

Pharma/Biotech companies are faced with two major problems: 1. How to integrate information and functionality across multi-ple new and legacy systems within the organization to allowholistic management of changing information and end-to-endprocesses.2. How to achieve the same interoperability with multiple andchanging partners, healthcare providers, patients and regulatoryauthorities.

These problems are being addressed in Pharma by evolving datastandards from CDISC/HL7 and with new technologies (suchas SOA/WebServices) for distributed applications pioneered inother industries. However effectively addressing the issue ofapplication interoperability within and across organizational

boundaries most likely will require, as it has in other industries,the definition of a standard Enterprise and Industry Architecturesaddressing logistics, security, workflow, etc. This session will pro-vide an understanding of the issues, implications, and trends forsuch Architectures both internally and between organizations,and describe the progress being made towards defining them forPharma.

The Business Case for Application InteroperabilityDon RosenPrincipal, Don Rosen Consulting

Architectural Trade-offs in Clinical Research DataRepositoriesTim RochfordCTO, PhaseForward

Life Sciences Industry Architecture – Report to IndustryJason Burke, MADirector of Life Sciences Strategy & Solutions, SAS Institute Inc.

Using “E” Methods to Develop eCRFsSession ChairDenise DeRenzo Lacey, MA, MSAssociate, Waife & Associates, Inc.

With compressed start-up activities and pressures to begin stud-ies as soon as possible, sponsors cannot afford to lose timedesigning eCRFs screens. When we use our “paper” processes todesign our electronic collection instruments, though, we oftenunintentionally slow the process. In this session, we will look atways of designing eCRFs and ePRO screens that take develop-ment time and the human factor into account.

Waterfall vs. Prototyping: Visualizing eCRFsDenise DeRenzo Lacey, MA, MSAssociate, Waife & Associates, Inc.

Where the Rubber Meets the Road: Finding the Path toStandards Stacy Surensky, MSDirector of Clinical Data Management, Vertex Pharmaceuticals

Migrating Paper Patient Reported Outcomes to ePROKeith W. WenzelProduct Director, ePRO, ClinPhone, Inc.

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1:30 - 3pm TRACK 1 – Standards and Data

New and Emerging Standards and ImplementationsSession ChairRebecca D. Kush, PhDPresident, CDISC

Standards have now been developed through CDISC to supportthe acquisition, exchange, reporting and archive of electronicclinical trial data. Now, there is increasing interest in enhancingthese standards to accommodate genomics data and also to bringstandardization into the protocol such that the process can bestreamlined from trial design through reporting. The addition ofenhancements or new standards demands harmonization acrossthese standards to ensure that they are complementary and syn-ergistic in terms of supporting semantic interoperability. Thissession will include presentations on genomics and protocol stan-dards and a model for standards harmonization, the BiomedicalResearch Integrated Domain Group (BRIDG) model.

Pharmacogenomics Standards – Developments within CDISCand HL7Philip M. Pochon, MAEnterprise Information Architect, Covance Global InformationTechnology

The Protocol Representation StandardCara Willoughby, MSConsultant, Global Medical Communications, Eli Lilly andCompany

Crossing the BRIDG to the Future: Implementation CaseStudies of the HL7/CDISC BRIDG Model to SupportInteroperabilityLisa Chatterjee, MSVice President, Healthcare Data Standards, Digital Infuzion, Inc.

Parallel Tracks

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3 - 3:30pm Refreshment Break in Exhibit Hall

1:30 - 3pm TRACK 4 – Electronic Health Records and Health Informatics

Medical Informatics Opportunities to Improve theBenefit-Risk Assessment of DrugsSession ChairMelvyn Greberman, MD, MS, MPH, FACPMPresident, Public Health Resources, LLC

Medical, health, and biomedical informatics include the plan-ning, development, implementation, and evaluation of systemsand methods to improve the access, analysis, understanding,organization, management, communication, and use of informa-tion, including data, in health care and research. Electronic sys-tems that use standards and information technology to facilitatethe use of health information in diverse locations and for multi-ple applications are of increasing importance to public-privatesector efforts to improve the benefit-risk assessment of drugs.Investments in applications of medical informatics by AHRQ,FDA, and NLM are speeding drug information from clinical tri-als to the public via the use of health data standards and theDailyMed Web site. The panel will discuss the current andfuture benefits of such systems, the building blocks that permithealth information to flow to the point of care, and research andimplementation investments in health informatics applications.Among issues to be addressed is the need for trained informat-cians, including healthcare providers, to go beyond basic systemimplementation and attain healthcare transformation. Realchanges are underway in many sectors. In its response to the2006 IOM report the Future of Drug Safety-Promoting andProtecting the Health of the Public, FDA recognizes the impor-tance of informatics as part of an interdisciplinary approach tobenefit and risk analysis, the postmarket assessment of drugs,

and drug safety. Among FDA efforts to facilitate the flow ofinformation is the establishment of a Bioinformatics Board in theOffice of the Commissioner to improve the collection of adverseevent reports and consumer complaints about regulated products.Additional relevant topics that will be discussed inlcude majorhealth system issues, curent Federal health information standardsactivities, and paying for performance.

J. Michael Fitzmaurice, PhD, FACMI Senior Science Advisor for Information Technology, Agency forHealthcare Research and Quality Department of Health and Human Services

Charles Safran, MD, FACMIAssociate Clinical Professor of Medicine, Harvard Medical SchoolChief, Divsion of Clinical Computing, Beth Israel DeaconessMedical Center

Armando Oliva, MDDeputy Director for BioinformaticsOffice of Critical Path ProgramsOC, FDA

Jonathan Levine, PhDSenior ScientistOffice of Critical Path Programs,OC, FDA

Stephen E. Wilson, DrPH, CAPT. USPHSDirector, Division of Biometrics IIICDER, FDA

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Parallel Tracks, continued


Handling DataSession ChairJohann Pröve, PhDGlobal Head Data Acquisition and ManagementBayer Vital GmbH

This session will address the handling of data from differentsources and the handling of data in diagnostic device trials. Inthe third presentation an improved process for data handlingwill be presented. Overall, this session will make you aware ofnon-standard situations of handling data and how to overcomeobstacles in data handling.

Electronic Data Transfers from Unusual Sources: A CaseStudyJames D. Topping, MSClinical Data Specialist II, Duke Clinical Research Institute

In Vitro Diagnostic Device Trials: Challenges andSuccesses with Integrating Data from Multiple SourcesPaulette V. Roper, MSProject Leader, Allergan, Inc.

How Collaborative Review of Deliverables and Data CanIncrease Quality and Decrease Time for CompletionCarmen WeeseAssociate Director, Data Services, INC Research

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5:00 - 6pm Networking Reception


HIT: Use of Electronic Health Records and eSourceImplications for Regulated ResearchSession ChairRebecca D. Kush, PhDPresident, CDISC

This session will first feature a renowned speaker from Harvardand representing the American Health Informatics Association(AMIA); Dr. Safran will present on the adoption of ElectronicHealth Records by physicians in healthcare. We will then hearfrom the well-respected Dr. Steve Wilson of FDA on the inter-est of FDA in encouraging the use of eSource data collection forclinical research and relevant regulations. The leader of theCDISC eSource Data Interchange Initiative (eSDI), DaveIberson-Hurst, will close the session with a review of the eSDIdocument, Version 1 of which is now posted on the CDISCwebsite, with recommendations on how to use eSource (includ-

ing Electronic Health Records) for clinical research in the contextof today's regulations

Use of eSource Data Collection for Clinical Research andRelevant RegulationsStephen E. Wilson, DrPH, CAPT, USPHSDirector, Division of Biometrics III, CDER, FDA

Review of the eSDI Document, Version 1David Iberson-HurstChief Executive Officer, Assero Limited, UK

Adoption of Electronic Health Records by Physicians inHealthcareCharles Safran, MDAssociate Clinical Professor of Medicine, Harvard Medical SchoolChief, Divsion of Clinical Computing, Beth Israel DeaconessMedical Center

3:30 - 5pm TRACK 3 – eClinical Technology

People, Process, and Technology: Electronic Data Capturein PracticeSession ChairPaul Bleicher, MD, PhDChairman and Founder, Phase Forward

People, process, and technology are the three key elementsinvolved in organizational change. This session will examineeach of these elements in the adoption of EDC throughout thepharmaceutical industry.

Integrating the Clinical Endpoints Adjudication Processinto an EDC Trial John W. SnappManager, Technical Resources, Duke Clinical Research Institute

UAT in EDC Trials and the Changing Role for DataManagersMichelle Brooks, MS, RDEDC Design Specialist, Harvard Clinical Research Institute

A Case Study in Integrating EDC with an IVR DrugTracking and Randomization SystemKim JanulisManager, Data Management, TAP Pharmaceuticals


Other Clinical Functions Interface with Clinical DataManagementSession ChairKristin M. Neff, MSClinical Program Manager, Boston Scientific Corp.

Clinical Data Management typically has close connections withother clinical functions. The success of these relationships cansometimes make or break a project! In this session, differentstrategies for optimizing these relationships will be presented.

A Bridge to a Successful Study from Start to Finish –Interfacing Between Data Management and ClinicalDepartmentsEla McElroy, MBAAssociate Director, Data Management, PharmaNet

The Expanding Role of Clinical Site MonitorsKen Light, MSSolution Partner, BusinessEdge Solutions

Teaming the Data Managers and Statistician: Planning andTeamwork Yields the Best ResultsEva R. Miller, PhDHead of Biostatistics, Almac Clinical Technologies

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8:30 - 10am TRACK 2 – Strategy

Managerial Aspects in a Changing Data ManagementEnvironmentSession ChairPatrick GenynSenior Director Strategy & Planning, Integrated Data Services,Global Clinical Operations, Johnson & Johnson

The Drug Development Industry is rapidly changing due to avariety of reasons. A number of technologies are enabling theprocesses in drug development to be more efficient, as an exam-ple; Electronic Data Capture is creating a much bigger footprinttoday in Clinical R&D and mutually accepted Clinical DataStandards are available allowing for a more efficient collectionand exchange of data. Increased complexity, cost pressures andglobalization are important trends, which has forced theIndustry to redefine the way clinical trials will be performedtoday and in the future. People are at the center of the clinicaltrial processes and must adapt quickly to these changes. Thefuture will require rethinking how to manage people and theactivities in clinical data management.

Catching the Knuckler: Helping DM Professionals Adaptto the New EnvironmentJoseph S. AndersonPrincipal Associate, Waife & Associates, Inc.

Consolidation and Globalization of Data ManagementActivitiesKaren M. MarksRegional Director - Americas Data Management CentersMerck & Co., Inc.

Transformational Practices in Clinical Data Management(CDM) OutsourcingNarender Dureja, Sr., MSGroup Project Manager, HCL Technologies Ltd.

Tuesday, March 20, 2007 Parallel Tracks



8:30 - 10am TRACK 1 – Standards and Data

The Case for Standards from Startup through SubmissionSession ChairRebecca D. Kush, PhDPresident, CDISC

Standards for data interchange have been shown to bring sub-stantial value to the clinical development process in terms of costand time savings, especially when they are implemented in thestart-up stage. In addition, standards facilitate integration of datainto knowledge warehouses and for the purpose of integratedsafety and efficacy summaries for regulatory purposes. This ses-sion will include presentations on the value of the CDISCSDTM for preparing summary databases; an overview of stan-dards to support clinical study process from end to end; and areport from Gartner on the Business Case for Standards.

Creating Submission-compliant Summary Databases(ISS/ISE) in the CDISC SDTM FormatDan CrawfordDirector-Clinical Data Strategies, Octagon Research Solutions,Inc.

Standards End-to-EndDavid Iberson-HurstChief Executive Officer, Assero Limited, UK

The Business Case for End-to-end Clinical Data StandardsCarol RozwellVice President and Distinguished Analyst, Life SciencesGartner, Inc.

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10:30am-12pm TRACK 1 – Standards and Data

Terminology and Data StandardsSession ChairKristin M. Neff, MSClinical Program Manager, Boston Scientific Corp

In recent years, there has been increased focus on the develop-ment of data standards to streamline clinical trials. This sessionincludes presentations of challenges and lessons learned whencreating data standards from three diverse perspectives.

Implementing Data Standards: Challenges from theNational Institute of Neurological Disorders and Stroke(NINDS), National Institutes of Health (NIH), CommonData Elements (CDE) ProjectSelma C. Kunitz, PhDPresident, KAI Research, Inc.

NCI Enterprise Vocabulary Services (EVS): ControlledTerminology and Semantic Integration for the ClinicalTrials and Healthcare CommunityMargaret W. HaberCo-Director, NCI Enterprise Vocabulary Services (EVS)Office of the Director, National Cancer Institute

Standard Controlled Terminology: A Successful Collaborationbetween CDISC, Government Agencies, and IndustryBron W. KislerTerminology Program Director, CDISC

10 - 10:30am Refreshment Break in Exhibit Hall

8:30-10am TRACK 4 – Electronic Health Records and Health Informatics

No Session Scheduled

8:30-10am TRACK 3 – eClinical Technology

Electronic Source: Untangling the Threads (Part 1)Session ChairDenise DeRenzo Lacey, MA, MSAssociate, Waife & Associates, Inc.

“Electronic source” covers a myriad of scenarios: using CRFs assource data in EDC trials; using electronic medical records assource data for EDC or paper trials; using electronically reporteddata (such as central lab data) for EDC or paper trials; and usingelectronic patient-reported outcomes as source data for trials.This session opens with an overview of different types of e-source and then addresses the regulatory and practical implica-tions of selected e-source options, drawing on case studies andvendor and sponsor experiences.

ePRO, eSource, and the Tangled WebDavid S. Reasner, PhDSenior Vice President, Clinical Operations & Data AnalysisSepracor Inc.

Jean Remy BehaeghelDirector of Product Management, Perceptive Informatics

Shaghig PalanjianVice President, Worldwide Technology Implementation, ContractResearch Services, PAREXEL International

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10:30am-12pm TRACK 4 – Electronic Health Records and Health Informatics

Electronic Health Records in Clinical Research (EHR Part 1)Session ChairPaul Bleicher, MD, PhDChairman and Founder, Phase Forward

As electronic health records become more widely adopted inclinical practice, many have noted their potential value in vari-ous aspects of clinical research. This session will look at earlyprojects linking observational and prospective clinical researchthrough projects performed using three established EHR systems.

Enabling Research in an Electronic WorldBrian J. McCourt, CCDMManager, Clinical Data Operations, Duke Clinical ResearchInstituteHugh DonovanGeneral Manager, Clinical Trials Business, Siemens MedicalSolutions

Electronic Health Record Data and Their Use inObservational ResearchRandall K. Spoeri, PhDDirector, Health Analytics, Cerner Corporation

A Disease Management Study Using an Electronic MedicalRecord-based Data WarehouseMark A. Dente, MDVice President, Healthcare Solutions, GE Healthcare IITS

10:30am-12pm TRACK 3 – eClinical Technology

Electronic Source: Untangling the Threads (Part 2)Session ChairDenise DeRenzo Lacey, MA, MSAssociate, Waife & Associates, Inc.

In this continuation of the previous session, participants willpresent case studies of electronic source for clinical trials.

Practical Experience of the Digital Pen and PaperTechnology in Clinical Trials Massimo Raineri, PhDHead of System Development - Biometry, Actelion

The Gordian Knot: Integrating Global EHR and GlobalClinical TrialsJonathan R. Andrus, MS, CQA, CCDM (Vice-Chair, SCDM)Vice President, Quality Assurance and Clinical Data ManagementPhoenix Data Systems, Inc.

Electronic Source Data: A Case StudyDavid Iberson-HurstChief Executive Officer, Assero Limited, UK

*** THIS CONCLUDES TRACK 3 – ECL INICAL TECHNOLOGY ***

10:30am-12pm TRACK 2 – Strategy

Future of Data ManagersSession ChairJohann Pröve, PhDGlobal Head Data Acquisition and Management, Bayer VitalGmbH, Germany

As already briefly touched upon in other sessions, this one willfocus more on the future of Data Managers and their changingrole. Data Managers in the past were mainly responsible forcleaning data while today they more and more become the onesthat know about how data are being stored, how to retrieve thedata and provide insight into study status and performance dataof external and internal staff working on trials.

Leadership Techniques and Career Growth Opportunitiesfor Data Management Personnel Munish Mehra, PhDManaging Director, Global Drug Development Experts

Potential Future Roles and Career Path Opportunities forData Managers Gregory Ambra, MSDirector, Global CDM and Clinical Systems, Baxter Healthcare

Future Role of Data ManagersBill Baker, MSDeputy Director, Clinical Data Management, Bayer Corporation

12 - 1:30pm Luncheon

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2pm Exhibit Hall Closes

3 - 3:30pm Refreshment Break


Data Transparency in the Public InterestSession ChairMichele Thomas, MBAManager, Business Planning and Development, Drug DevelopmentSciences Operations Centre, GlaxoSmithKline

Healthcare information technologies, such as electronic health-care records and computerised ordering systems, bring a newlevel of transparency to healthcare delivery system encountersand transactions. Disease registries provide epidemiologists andpublic health systems with information critical for monitoringpatterns of disease outbreak and potential epidemics.

The clinical trial registration process, such as that undertaken bythe NIH, leaders in the biopharmaceutical industry, and theWHO, makes key clinical trial information and summary resultsmore openly available.

Session presentations and discussion will focus on how the pub-lic interest is served by timely and appropriate access to and sec-ondary use of, electronic healthcare data.

Doug ClarkEpidemiologist, GlaxoSmithKline

Peter HasseDirector of National Accounts, Convergence CT

Patrick LoebsResearch Epidemiologist, RTI International

Michael GouldChildren’s Hospital of Philadelphia


Emerging Regions/Globalization CDMSession ChairPatrick GenynSenior Director Strategy & Planning, Integrated Data Services,Global Clinical Operations, Johnson & Johnson

Technology advances and increased pressures on the pharmaceuti-cal industry have resulted in a more global focus for many com-panies and a reach into overseas markets for conducting theirresearch. The benefits definitely include cost reduction but alsoinclude improved speed of executing clinical trials through, forinstance, faster subject recruitment. This clear globalization trendwill have an impact on how data management is conducted. Thissession will provide three presentations on how companies aredealing with the globalization of Clinical Data Management.

Passport to Success in Global Clinical Data ManagementZia Haque, MAManager, Data Management, PharmaNet

Strategic Outsourcing of Data Management to EmergingRegionsElizabeth B. FaulknerSenior Sourcing Director, Global Pharma R&D SourcingJohnson & Johnson Pharmaceutical Research & Development,

L.L.C.

Global Means Next Door, TooLarry A. Hauser, PhDVice President, Global Data Operations, Global DataManagement, Quintiles, Inc.



Standardized Data CollectionSession ChairRebecca D. Kush, PhDPresident, CDISC

The FDA Critical Path Initiative Opportunity List includes anopportunity focused on developing case report form standards.Work on this initiative started with drafts of the adverse eventsform and concomitant medications forms by the Association ofClinical Research Organization (ACRO). This initiative is now acollaborative effort of over a dozen organizations, in addition toACRO, FDA, CDISC. The Critical Path Initiative Opportunity,a rationale and history of the project and a progress update will

be presented and discussed in this session.

Critical Path Initiative and Data Collection StandardsArmando Oliva, MDDeputy Director for Bioinformatics, Office of Critical PathPrograms, FDA

Rationale and History of the CDASH InitiativeFrank T. NewbyChief Operating Officer, CDISC

The CDASH Initiative – Progress to Date Rhonda FacileCDASH Project Leader, CDISC

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Electronic Health Records (Part 2)Session ChairRebecca D. Kush, PhDPresident, CDISC

There has long been an interest in using electronic healthrecords (EHR) for clinical research. This year, a demonstrationof how this is feasible for different use cases, including clinicaltrial conduct (EDC with EHR), biosurveillance, safety surveil-lance, was conducted at the Health Information ManagementSystems Society (HIMSS) with 20 different organizationsinvolved from the biopharmaceutical industry. This session willinclude an overview of the New Directions Demo at HIMSSand reports on the use cases that were demonstrated, particularlyclinical trial execution and safety surveillance.

The New Directions (Life Sciences) HealthcareInteroperability Demo Didi DavisDirector, Integrating the Healthcare Enterprise, HIMSS

Clinical Trial Execution Using Electronic Health RecordsLanden C. BainHealthcare Liaison, CDISC

A Safety Surveillance Scenario Michael A. IbaraHead of Pharmacovigilance Information Management, Pfizer Inc.

Clinical Research within an EHR EnvironmentScott A. GetzinExternal Business Integrator, Eli Lilly & CompanyLinda S. King Global Clinical Data Management – Team Leader, Eli Lilly &Company


Continuous Improvement of Data Management ProcessesSession ChairKristin M. Neff, MSClinical Program Manager, Boston Scientific Corp

While the basics of Clinical Data Management often stay thesame, there are always new and innovative ways to improveprocesses and maximize project performance. This session willexplore continuous improvement around important processessuch as maintaining data quality and ensuring a successful data-base lock.

Using Metrics to Improve Performance in Clinical TrialsUsing EDCJennifer PriceSenior Director, Clinical Solutions, Phoenix Data Systems, Inc.

Importance of Data Quality throughout the DrugDevelopment LifecycleAmarilys Vega, MD, MPHMedDRA Specialist, PSI International, Inc.

Paving a Rough Road to Ensure a Smooth Database LockJosh WilsonGroup Manager, Data Services, INC Research


Managing DataSession ChairJohann Pröve, PhDGlobal Head Data Acquisition and Management, Bayer VitalGmbH, Germany

The role of the data manager has been changing over the pastdecade. This session will familiarize the audience with the man-agement of data and the different environment data managersmay find themselves trapped in. Some solutions will be presentedand discussed.

Help! I Can’t Possibly Do It All: Strategies for Large StudyManagementChip deVillafrancaSenior Product Manager, Phase Forward

Integrating Data and Technology across the Life SciencesResearch Value ChainDavid HandelsmanPrincipal Product Manager, Clinical R&D, SAS Institute Inc.

Secure Transfer of Clinical Trial DataKai WuSenior Clinical Programmer Gilead Sciences, Inc.

5:00pm Conference Adjourned


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WORKSHOPS IN THE AMERICASJANUARY 14-18, 20076th Annual Conference for Contemporary Pharmacovigilance &Risk Management StrategiesWashington, DC

JANUARY 24-25, 2007Sharing Knowledge to Improve Clinical Drug Development andRegulatory Decisions: Data/models of Diseases, Drugs,Placebo, Baseline, and DropoutsWashington, DC

FEBRUARY 6-9, 200720th Annual EDM Conference: Reconnecting the Process to theDelivery of Safe and Effective Medical ProductsPhiladelphia, PA

FEBRUARY 20-22, 200719th Annual Conference: Marketing Pharmaceuticals in a Timeof ChangeNew York, NY

MARCH 4-7, 200718th Annual Conference on Medical Communications: MedicalInformation, Medical Liaisons, Contact CentersSan Diego, CA

MARCH 5-7, 2007Statistical Methodologies in the Biopharmaceutical Sciences Bethesda, MD

MARCH 18-20, 200722nd Annual DIA CLINICAL DATA MANAGEMENT Conference and Exhibition — Integration Acrossthe Clinical Trial ContinuumOrlando, FL

APRIL 11-13, 2007QT Issues in Drug Development the Evolving Science, PracticalIssues, and Regulatory ImplicationsRockville, MD

APRIL 18-19, 2007Oligonucleotide-based TherapeuticsRockville, MD

APRIL 2007Clinical Research and Product Registration ofBiopharmaceuticals/ Vaccines in India and ChinaWest Coast

JUNE 17-21, 2007DIA 43rd Annual MeetingAtlanta, GA

TRAINING COURSES IN THE AMERICASJANUARY 18-19, 2007European Regulatory Affairs: An In-depth Review of RegistrationProcedures in the European Union San Francisco, CA

JANUARY 21-24, 2007Regulatory Affairs – Part I: The IND Phase, Part II: The CTD/NDAPhase Irvine, CA

FEBRUARY 6, 2007Development of a Clinical Study ReportPhiladelphia, PA

FEBRUARY 12-13, 2007Overview of Drug Development in JapanHorsham, PA

MARCH 5, 2007Overview of Drug DevelopmentHorsham, PA

MARCH 5-8, 2007The Leadership ExperiencePhiladelphia, PA

MARCH 12-13, 2007Project Management: Planning, Executing and ControllingProjects in Pharmaceuticals and BiotechnologyHorsham, PA

MARCH 12-14, 2007EudraVigilance: Electronic Reporting of ICSRs in the EEAHorsham, PA

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MARCH 26-28, 2007Regulatory I: The IND PhasePhiladelphia, PA

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APRIL 23-26, 2007Regulatory Affairs – Part I: The IND Phase, Part II: The CTD/NDAPhase West Chester, PA

APRIL 30-MAY 1, 2007European Regulatory Affairs: An In-depth Review of RegistrationProcedures in the European Union Horsham, PA

APRIL 30-MAY 2, 2007Fundamentals of Clinical Research MonitoringChicago, IL

APRIL 30-MAY 2, 2007Introduction to Good Clinical Practices and AuditingChicago, IL

U P C O M I N G D I A E V E N T S

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Please make a copy of this registration form for EACH of the four group registrants. Includethe names of all four group registrants on each of the forms and return them together to DIA.

Registration Fees If DIA cannot verify your membership upon receipt of registrationform, you will be charged the nonmember fee. Registration fee includes refreshment breaks,luncheons, and reception (if applicable), and will be accepted by mail, fax, or online.

MEMBER EARLY-BIRD OPPORTUNITY On or before AfterAvailable on nondiscount member fee only FEB. 26, 2007 FEB. 26, 2007

Member Fee US $1165 � US $1340 �

Join DIA now to qualify for the early-bird MEMBERSHIP

member fee! www.diahome.org/en/Membership/ US $ 130 �AboutMembership/AboutMembership

To qualify for the early-bird discount, registration form and accompanying payment must bereceived by the date above. Does not apply to government/academia/nonprofit members.

Nonmember Fee US $1470 �A one-year membership to DIA is available to those paying a NONMEMBER registrationfee. If paying a nonmember fee, please indicate if you do, or do not, want membership.

I want to be a DIA member � I do NOT want to be a DIA member �

Discount Fees MEMBER NONMEMBER*Government (Full-time) US $ 300 � US $ 430 �Charitable Nonprofit/Academia (Full-time) US $ 675 � US $ 805 �

*If paying a nonmember fee, please check one box above, indicating whether you want membership.

TutorialsAM Tutorial

8:30 AM-12 PM #1 Semantic Web Applications in Clinical Data Management US $ 375 �8:30 AM-12 PM #2 FDA – CDISC: eCTD Regulatory Submissions US $ 375 �PM Tutorials1:30 PM-5 PM #3 A Silk Purse from a Sow’s Ear: Surviving & Flourishing After

Mergers or Acquisitions US $ 375 �1:30 PM-5 PM #4 Issues of Data Quality throughout the Data Life Cycle

in Clinical Research US $ 375 �

CANCELLATION POLICY: On or before MARCH 12, 2007Administrative fee that will be withheld from refund amount: Member or Nonmember = $200 Tutorial = $50Government or Academia or Nonprofit (Member or Nonmember) = $100Cancellations must be in writing and be received by the cancellation date above.Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hoteland airline reservations. You may transfer your registration to a colleague at any timebut membership is not transferable. Please notify DIA of any such substitutions as soonas possible. Substitute registrants will be responsible for nonmember fee, if applicable.DIA reserves the right to alter the venue, if necessary. If an event is cancelled,DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

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IPUFM"

22nd Annual DIA CLINICAL DATA MANAGEMENT Conference and ExhibitionIntegration Across the Clinical Trial Continuum

March 18-20, 2007 | Buena Vista Palace Resort and Spa, Orlando, FL, USA

conference and exhibition integration across the clinical ... · cdm • march 18-20, 2007 •...

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