SCHEDULE

IN THIS ISSUEWednesday’s Professional Posters ............................... 2DIA Exhibitors ........................ 3DIA Hotel Winners ................. 7

CELEBRATETHE PAST–

INVENTTHE FUTURE

DIA

DAILYD I A 2 0 1 450TH ANNUAL MEETING

Issue # 4 | JUNE 18, 2014, SAN DIEGO

WEDNESDAYExhibitor Registration

7:00AM – 5:00PMSDCC Exhibit Hall A Lobby

Attendee & Speaker Registration7:00AM – 5:00PM

SDCC Sails Pavilion

Speaker Preparation Room7:00AM – 5:00PM

SDCC Sails Pavilion (behind Speaker Registration)

Member Lounge 7:00AM – 5:00PM

SDCC Sails Pavilion

Cyber Café/Career Center 7:00AM – 5:00PM

SDCC Sails Pavilion

Baggage Check7:00AM – 6:30PM

SDCC Exhibit Hall D Lobby

Professional Poster Session #27:15AM – 4:00PM

SDCC Sails Pavilion

Business Center8:00AM – 5:00PM

SDCC Exhibit Hall D Lobby

Exhibit Hall Hours9:00AM – 4:00PM

SDCC Exhibit Halls A-C

THURSDAYMember Lounge

7:00AM – 12:30PMSDCC Sails Pavilion

Cyber Café/Career Center 7:00AM – 12:30PMSDCC Sails Pavilion

Baggage Check7:00AM – 1:00PM

SDCC Exhibit Hall D Lobby

Attendee & Speaker Registration8:00AM – 11:00AM SDCC Sails Pavilion

Speaker Preparation Room8:00AM – 11:00AM SDCC Sails Pavilion

(behind Speaker Registration)

CDER Town Hall, Part 1 of 29:00AM – 10:30AM

SDCC Room 6B

CDER Town Hall, Part 2 of 210:45AM – 12:15PM

SDCC Room 6B

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A panel discussion moderated by Susan Cantrell (Senior Vice President and Managing Director, DIA Americas), Collaboration in R&D: What’s New for TransCelerate BioPharma? (Session 202) reviewed the genesis and purpose of TransCelerate BioPharma Inc., a collaborative nonprofit entity formed to develop solutions for overcoming costly inefficiencies in pharmaceutical R&D.

TransCelerate was formed in 2012 by ten member companies with ten new member companies joining in 2013. Members of TransCelerate’s Board of Directors and Operations Committee served as panelists: TransCelerate Chief Executive Officer Dalvir Gill, PhD; John W. Hubbard, PhD (Senior Vice President & Worldwide Head of Development Operations, Pfizer, Inc.) and Lynn G. Marks, MD (Senior Vice President, Projects, Clinical Platforms and Sciences, GlaxoSmithKline).

While a rotating slide show highlight-ed accomplishments from TransCeler-ate’s five original initiatives, panelists discussed why this collaborative organi-zation is so important, why it has been successful and the challenges ahead.

TransCelerate quickly identified clinical trial efficiency as an area for im-

Collaboration in R&D: What’s New?

provement. “There are areas that we’ve been working on in industry for years and we haven’t been able to move the needle much,” John explained. “We believe that if we can find a common solution then we can bring down the cost of drug development.”

We have to reduce the burden on in-vestigative sites, Dalvir said, so they can concentrate more on enrolling patients into clinical trials and concentrate less on redundant bureaucratic paperwork and processes. “All of us have been to investigative sites and we’re driving them crazy,” John confirmed. “The feedback we’re getting from the investigator com-munity is very supportive.”

The panel’s overview of the first five TransCelerate initiatives included successful GCP training certification of more than 41,000 researchers, and of 70 companies certified to train even more; a new model for risk-based moni-toring; and a supply network to source comparator drugs between member companies for use in other companies’ clinical trials, a source of considerable pride for the organization because many doubted this could ever happen.

Susan asked how TransCelerate’s member companies have gotten past the competition part of a very com-petitive industry. “We can all do this individually. What’s the benefit of doing this collectively?” Lynn asked. “Forget about winning individually – let’s win collectively and we can advance faster.”

“For the betterment of all, we find consensus,” Dalvir concurred.

Dalvir also pointed out an important TransCelerate byproduct: People who were in competition with each other now work together for their mutual benefit. “I think you can probably pick up that there’s a lot of passion around this,” John said. “You can feel the com-mitment and the energy building.”

“We’ve facilitated a ‘braver new world’ for clinical research,” Dalvir suggested. “And at the end of the day what we’re doing will benefit patients because we’re getting drugs to market faster.”

Panel discussion of What’s New For TransCelerate BioPharma?

Attendees listen to Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA (inset) speak during Introducing CDER’s Office of Pharmaceutical Quality on Tuesday afternoon.

2 JUNE 18, 2014, SAN DIEGOANNUAL MEETING DAILY

Selected global presenters will share their research results through today’s Professional Poster Session from 7:15AM – 4:00PM in the Sails Pavilion. Discover tomorrow’s hot topics from the following poster presentations on display today:

W01: Evaluation of Operating Char-acteristics of MMRM Analysis Using All Available Longitudinal Data at Interim Compared to ANCOVA: Weining Robie-son, AbbVie Inc.

W02: Recent Developments in Scaled Average Bioequivalence: Pascal Gui-bord, Algorithme Pharma Inc., Canada

W03: An Overview of Both Current Best Available and Next Generation of Drug Therapies for the Treatment of De-pression: Annette Williams, Quintiles Inc.

W04: Health Literacy Assessment, Usability Testing, and Revision of a Eu-ropean Union Risk Management Plan Public Summary: Karen Lockwood, Eli Lilly and Company

W05: Coordination of a Multi-site Cell and Gene Therapy Study in an Academic Medical Center: A Success Story: Bambi Grilley, Baylor College of Medicine

W06: An Innovative Way of Providing Timely Responses to Questions Related to Ingredients/Allergens: Irene Sheng, Bristol-Myers Squibb Company

Wednesday’s Professional PostersW07: Evaluating and Supporting the

Increasing Patient Need for Delivery of Clinical Trial Supplies Direct to Their Homes: Esther Sadler-Williams, Catal-ent Pharma Solutions, Inc., UK

W08: New Business Acumen Tool Guides Strategic Thinking: Learn How to Increase Your Value to the Compa-ny and to the Industry: Ilyssa Levins, Center For Communication Compliance (CCC)

W09: Complexity in Protocol Design: Does it Lead to Better Clinical Trial Outcomes?: Rebecca Hummel, CNS Healthcare

W10: Corporate Integrity Agreement and Its Impact on Industry: Abhishek Harde, Cognizant Technology Solutions Corporation

W11: Giving Clinical Trial Start Up A Project Management Make-Over: Reducing Cycle Times Through Critical Path Focus: Ben Quartley, Covance Inc., UK

W12: The Impact of Regulatory Reform in Mexico on Pharmaceutical Product Approval Rates: Raul Vinueza, Data-Pharma LLC

W13: So How DO You Implement eSource: Practical Tips for Enhancing Efficiency, Data Visibility, and Site Inter-actions: Ed Seguine, Clinical Ink

W14: Duloxetine Feeding Tube Study: Medical Information Example of Collaboration with Laboratory Scientists to Deliver Answers: Andrew Buchanan, Eli Lilly and Company

W15: Targeting the Best Sites with an Analytical Site Selection Model Using Multiple Metrics: Elizabeth Nielsen, Quintiles Inc.

W16: Central Recruitment Method-ologies in a Global Clinical Research Study of a Pediatric Autism Spectrum Disorder (ASD) Program: Allan Spera, Forest Research Institute

W17: Evaluation of Shipping Systems to Maintain Sample Integrity in Clinical Research: Mona Vimal, Gilead Scienc-es, Inc.

W18: A Comparison of MedDRA SMQs Relative to Individual Preferred Terms for Signal Detection on a Large Insurance Claims Database: Christo-pher Bone, GlaxoSmithKline, UK

W19: Introducing and Conducting Traditional Chinese Medicine Trials in the US: Challenges, Obstacles, and Po-tential Solutions: John Li, ICON Clinical Research

W20: Coherence of Observed-to-Ex-pected Disproportionality Methods Used for Pharmacovigilance at a Critical Threshold: Geoffrey Gipson, Janssen Pharmaceuticals, Inc.

W21: Enhancing Project Management Tracking to Facilitate the Protocol Devel-opment Process: Tracey Miller, Leidos Biomedical, Frederick National Labs

W22: Continued Tradition of Suc-cess: Critical Components of the Gen-zyme/Sanofi Oncology/MCPHS Univer-sity Post-PharmD Fellowship: Christina Gallagher, MCPHS University

W23: Assessment of Violations Cited by OPDP in Untitled and Warning Letters Issued from 2004-2013: Phil Reveal, Meda Pharmaceuticals, Inc.

W24: Accelerating Patient Recruit-ment Using In-Depth Market Research Insights: Collected via a 3rd Party - From Clinical Trial Site Staff: Jeff Jamer, Merck & Co., Inc.

W25: Implementing a Standard Report Set for Risk Based Monitoring Domains: Christine Riley-Wagenmann, NextGen CDS

W26: Investigation of Association Between COPD Treatment and Cardiac Events With or Without Treatment for Co-Existing Disease: Ayako Takizawa, Nippon Boehringer Ingelheim Co., Ltd., Japan

W27: Reinventing the Study Build Pro-cess to Promote Consistency, Increase Build Efficiencies, and Reduce Overall Timelines: Caroline Lin, Novella Clinical

W28: Collaborative Development of an Open Source Repository for Stan-dardized Analysis Using Cloud Ser-vices: Hanming Tu, Accenture

W29: Quality of Japanese Clinical Trials and Proposed Strategy for the Trial Sites: Toshiyoshi Tominaga, Osaka City University, Japan

W30: A Collaboration to Facilitate the Development of Antibacterial Agents for Unmet Need: Streamlining Clinical Trial Protocols: Charles Knirsch, Pfizer Inc.

W31: Global Regulatory Consider-ations for Biosimilar Approval: Holly Groelle, PPD

W32: Impact of FDA Breakthrough Therapy Designation on the Regulato-ry Timelines of Chronic Lymphocytic Leukemia (CLL) Therapies: Alex Wei, Ernest Mario School of Pharmacy, Rut-gers University

W33: An Extension of Likelihood Ratio Test-Based Method for Signal Detection in a Drug Class with Application to FDA’s AERS Database: Yueqin Zhao, FDA

W34: Maintaining Effective Pharma-covigilance Oversight: The Role of Re-mote Auditing: Alun Tanner, Remedion Consulting LLC

W35: Data Empowered Decision Making in a Pharmaceutical Company: Project Libraries and Workflows - Real Life Experience: Mikhail Samsonov, R-Pharm, Russian Federation

W36: Sample Size Re-Estimation Can Be Very Inefficient: David Bristol, Statis-tical Consulting Services, Inc.

W37: So You Hired a CRO…Now What? Advancing Clinical Research by Leveraging Government Sponsor Re-lationships with CROs: Jessica Kloda, Technical Resources International, Inc.

W38: Office of Prescription Drug Pro-motion (OPDP) Enforcement Overview From 1997 to 2013: Cyril Carrere, Thom-son Reuters (Scientific) Ltd., France

W39: Enrollment of Pregnant Women in Medication Safety Research: Mother To Baby Pregnancy Studies: Jennifer Zellner, University of California San Diego

W40: A Model for Centralized Moni-toring: Reducing Costs While Ensuring Compliance, Risk Mitigation and Quali-ty: Badhri Srinivasan, Quintiles Inc.

W41: Customer Satisfaction and Communication Methods Used in Conducting Large Multi-Center Clinical Trials: Barbara Del Curto, VA Coopera-tive Studies Program

W42: Easy as A,B,C? Adapting Pediatric Protocol Designs from Existing Adult Data and Study Templates: Rona Grunspan, Premier Research Group Ltd.

W43: The Construction and Promotion of Medication-Used Safety Education for Traditional Chinese Medicine in Taiwan: Tsung-Ta Wu, Department of Chinese Medicine and Pharmacy, Taiwan

W44: Patterns of Regulatory Approval for Targeted and Immunotherapeutic Compounds Indicated for the Treatment of Metastatic Melanoma in the US and EU: Jonathan Nguyen Diep, Rutgers, The State University of New Jersey

W45: Retrospective Chart Review Studies: Key Considerations for Full-filling Safety Reporting Requirements: Dara Stein, MSc, Senior Research Scientist, UBC: An Express Scripts Company, Canada

Solution Provider presentations will be featured in the Innovation Theater located in the rear of the Exhibit Hall near aisle 1200. Please plan to join us as the following companies showcase their solutions and expertise.

9:45AM: Session 325: Appirio Innovation Theater: The Big R&D Leap: Accelerating Pharmaceutical Innovation and Discovery Through Crowdsourcing: Time is a major resource we all wish we could manipulate to drastically speed up discovery. Researchers have a constant desire to discover, vett, analyze, rule out, and overall, simply go faster in their world of R&D. And though there is no such time machine or “easy button,” a newer methodology being applied to pharmaceutical R&D is saving substantial time and enabling researchers to go much faster than ever before – crowd-sourcing. Ragu Bharadwaj discusses how pharmaceutical organizations are using innovation communities like topcoder and the principles of crowd-sourcing challenges to greatly accelerate early stage research and late stage clinical result research and analysis.

11:45AM: Session 351: SAS/JMP Innovation Theater: Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP: International guidelines suggest that clinical trial data should be actively monitored to ensure data quality. Traditional on-site review is time consuming, expensive, and as is true for any manual effort, limited in scope and prone to error. In contrast, risk-based monitoring (RBM) employs centralized review of trial data to determine if sites should receive more ex-tensive review. We demonstrate the RBM and fraud detection capabilities of JMP Clinical to assess clinical trial data quality.

12:30PM: Session 352: SAS Innovation Theater: Data Transparency and Sharing: Research Benefits, Risks and the Future: Whether called data transparen-cy or data sharing, there’s a movement to give more researchers greater access to patient-level clinical trial data. The goal is to create an environment for innovation in clinical research. Join this presentation to discuss what’s being done, including exploring the value to the overall health care system of creating a multi-sponsor environ-ment that gives researchers access to larger pools of data.

Today’s Innovation Theater Schedule

3ANNUAL MEETING DAILYJUNE 18, 2014, SAN DIEGO

Exhibiting As .................................. Booth#

3vue, LLC .................................................... 1902

A-B-CAccell Clinical Research ............................. 2411Accelovance .................................................. 638Accenture .................................................... 1025Accovion GmbH ............................................ 307Accurate Clinical Research ........................... 718ACM Global Central Lab ............................. 2425ACRP ............................................................. 332ActiGraph .................................................... 2046Acurian, Inc. ................................................ 1811Adaptive Clinical Systems ............................ 546Adicon Clinical Laboratory Inc. ................... 1600Advanced Bio-Logic Solutions (ABL) ......... 2537Advanced Clinical ......................................... 716

Aerotek ........................................................ 1605Alfresco Software, Inc. .................................. 533Almac ............................................................ 832Anaheim Clinical Trials ................................ 2142Ansafone Contact Centers ............................ 818APCER Pharma Solutions, Inc. ..................... 930Appian Corporation ..................................... 2521Appirio Inc. .................................................. 1345Applied Clinical Trials/ Pharmaceutical Executive .......................... 408Aptiv Solutions ............................................ 1711ArisGlobal .................................................... 1013Arizona State University ................................ 320Artcraft Health Education .............................. 433Asia CRO Alliance ......................................... 605Asociacion Mexicana para la Investigacion Clinica, A.C. (AMIC) ........... 1147Aspire IRB ................................................... 2144AssurX Inc. .................................................... 646August Research ........................................... 509Author-It ....................................................... 2633Axiom Real-Time Metrics Inc. ..................... 1817Axis Clinical Trials........................................ 2525BARC Global Central Laboratory .................. 622Barrington James ........................................ 1346BBK Worldwide ........................................... 2309Beckloff Associates, Inc. ............................... 531BioClinica .................................................... 1725Biocom ........................................................ 2632Biomedical Systems ................................... 1225

DIA Exhibitor List and Floor Plan DIA 2014 Annual Meeting

San Diego, CA

Exhibit Hall Hours

Wednesday, June 189:00AM – 4:00PM

BioPharm Insight ......................................... 2450BioPhase Solutions ..................................... 2511BioPoint ......................................................... 748Biorasi ......................................................... 2625bioskin GmbH ............................................. 2230Blinded Diagnostics .................................... 2047Blue Chip Patient Recruitment .................... 2513Blue Sky Broadcast ...................................... 621Bracket ........................................................ 1001Brand Institute, Inc. ....................................... 501BRANY........................................................... 700Brillance SP. ZO.O. ........................................ 502C3i, Inc. ....................................................... 2120CAHG ............................................................ 326Camargo Pharmaceutical Services .............. 505Cambridge Healthtech Institute .................... 323Canfield Scientific, Inc. ................................. 319Cardio Analytics Ltd. ................................... 1331Cardiocore .................................................. 2211Cardiovascular Imaging Technologies ......... 527Catalent ....................................................... 1831CDISC ......................................................... 2146Celerion ......................................................... 625Cenduit, LLC ............................................... 2325Center for Information and Study on Clinical Research Participation (CISCRP) ............................. 1144CenterWatch ................................................. 614Chesapeake IRB ......................................... 2406Chexx Inc. ..................................................... 830Chiba University Hospital ............................ 2523Chiltern International, Inc. ........................... 2225Cincinnati Children’s Clinical Trial Services ................................. 520Cincinnati Children’s Research Foundation ................................. 518Citeline Inc. ................................................. 2000CITI Program - University of Miami ............... 632Clariness ....................................................... 649ClinDatrix, Inc. ............................................. 1942ClinEdge, LLC ............................................... 308Clinical Conductor ........................................ 421Clinical Contract Research Association (CCRA) ................................. 1333Clinical Ink ..................................................... 624Clinical Reference Laboratory .................... 1215Clinical Research Advantage ........................ 515Clinical SCORE ............................................. 333Clinical Trials & Surveys Corp ....................... 734ClinicalConnection, Inc. .............................. 2533clinicalRSVP .................................................. 330Clinlogix ....................................................... 1041ClinPlus/DZS Clinical Services ..................... 514ClinTec International Ltd. ............................ 1201Clinverse, Inc............................................... 2432CluePoints, Inc. ............................................. 733CMIC HOLDINGS Co., Ltd. ........................... 917CNRI-San Diego and Los Angeles ............. 1947

CNS Network ................................................ 304Compass IRB .............................................. 1137CompleWare ............................................... 2319Comprehend Clinical .................................. 2532Consent Solutions, Inc. ................................. 517Contact Canada ...........................................MP2Contract Pharma ........................................... 423ConvergeHEALTH by Deloitte..................... 2005Conversis .................................................... 2535CORE ............................................................ 800Corporate Translations ................................ 1139CoSign by ARX ........................................... 2420Cote Orphan Consulting, LLC .................... 1435Court Square Group, Inc. ........................... 2349Covance Inc. ............................................... 2031Covigilant .................................................... 1801CPRD ............................................................. 447CRF Health .................................................. 1837CROMSOURCE............................................. 710CROS NT ..................................................... 1810CSSi ............................................................ 1318CTI Clinical Trial & Consulting Services ..... 2316Cu-Tech, LLC ............................................... 2131Cytel Inc. ....................................................... 725

D-E-F Data Matrix .................................................. 1601Data Reduction Systems Corporation ........ 2400Datapharm Australia Pty Ltd ......................... 730DATATRAK International, Inc. ..................... 1719Datatrial ....................................................... 1339DatStat, Inc. ................................................. 2520DaVita Clinical Research ............................. 1606DIA ........................................................... 1531DIA Patient Advocate Fellowship ................ 1739Doctor Evidence, LLC ................................. 2522Dohmen Life Science Services ................... 2221Dora Wirth Languages ................................ 1436Dr. Ebeling & Assoc. GmbH ......................... 611DrugDev ...................................................... 1745DSG, Inc. ..................................................... 2025DSP Clinical Research .................................. 316DUCK FLATS Pharma ................................. 2417d-Wise Technologies ................................... 2407EastHORN Clinical Services in CEE, Ltd. ... 1243eClinicalHealth Ltd. ..................................... 2001ECLINSO ..................................................... 2431EDETEK, Inc. ............................................... 2043

Pull-Out

Section

(continued on page 4)

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4 JUNE 18, 2014, SAN DIEGOANNUAL MEETING DAILY

(continued from page 3)

Elite Research Institute ................................. 300Elite Research Network, LLC ........................ 630EMB Statistical Solutions, LLC ................... 1919EMC Corporation ........................................ 1521Emerson Process Management ................... 534endpoint ...................................................... 2125ENNOV ........................................................ 2517

Entimo AG ................................................... 1219ePharmaSolutions ....................................... 1705EPS Corporation ......................................... 1105ERT .............................................................. 1005Eurofins ....................................................... 2635Europe, Middle East & Africa/Asia Clinical Research (EMEACR) ..................... 943European Medicines Agency ...................... 1530EUROTRIALS .............................................. 2430Everest Clinical Research ............................. 619Exco InTouch ............................................... 2116ExecuPharm, Inc. ........................................ 2448ExL Pharma ................................................... 511Exostar .......................................................... 443Experis Clinical Practice ............................... 610Exponent ..................................................... 2449EXTEDO, Inc. ................................................ 835Falcon Consulting Group ............................ 2510FDA CDER ................................................... 1532FDAnews ....................................................... 523Flex Databases ........................................... 2302Foresight Group International AG ................. 945Formedix Inc. .............................................. 1843Fresenius Medical Care North America ...... 2607Fresenius Medical Care-Clinical Studies Group ............................................ 604Future State ................................................. 2634

G-H-I Galderma Research & Development, LLC ... 445GCP ClinPlus Co., Ltd. ................................ 2609George Washington University ..................... 441Global Instrumentation LLC ........................ 2348Global Language Solutions ........................ 1704GlobalCare Clinical Trials, LTD ................... 1847goBalto, Inc. ................................................ 1442GP Strategies .............................................. 2038Green Key Resources ................................. 2143Greenphire .................................................... 705Guangzhou KingMed Center for Clinical Laboratory Co. Ltd. ....................... 331Hangzhou Tigermed Consulting Co., Ltd. .. 1501HCL America Inc ......................................... 2504Health Decisions, Inc. ................................. 1045HealthCarePoint .......................................... 2249Hibernia College Dublin .............................. 1344High Point Clinical Trials Center ................. 1200Hurley Consulting Associates Ltd. ................ 541IB Technology Solutions Inc. ...................... 2543iCardiac Technologies ................................ 2506ICON plc ...................................................... 1305IDT Australia ................................................ 2350ImageWare Systems, Inc. ............................. 336Imperial ....................................................... 2217IMS Health ................................................... 1119Inamed GmbH............................................. 1604INC Research .............................................. 1313Industry Standard Research ....................... 2616Informa Business Information ....................... 547Infotehna Inc. ................................................ 504INNOPHARMA S.r.L. ................................... 2136Innovative Print & Media Group .................. 2606Innovo Commerce LLC ................................. 935Integrated Clinical Systems, Inc. ................ 2004Integrated Development

Associates Co., Ltd. ................................... 542IntegReview IRB ............................................ 311International Dermatology Research, Inc. .... 631Intertek Scientific & Regulatory Consultancy ............................................. 2626IntraLinks, Inc. ............................................... 519inVentiv Health Clinical................................ 1423Investigational Cancer Therapeutics - MD Anderson ................... 2604Investigator Databank ................................. 1745IPHARMA / ChemDiv .................................. 2615IRB Services ................................................ 1441

J-K-L JANIX CRO .................................................. 1030Jazz Pharmaceuticals Inc. ............................ 425JMAC Partners ............................................ 1840Joulé Clinical Staffing Solutions ................. 2137K2/SCNA ..................................................... 2646KCR ............................................................. 1502Kelly Scientific Resources ........................... 1136Klein Hersh International ............................. 2037KoNECT ...................................................... 1534Kuantum CRO and Logistics ........................ 848LabConnect, LLC ........................................ 2231LabCorp Clinical Trials ................................ 2115Lambda Therapeutic Research Inc. ............. 545Langland ..................................................... 2001LaserShip .................................................... 2622Life Science Connect .................................. 2531Lionbridge Life Sciences .............................. 937Logos Technologies Inc. ............................. 2017LORENZ Life Sciences Group ...................... 530Lovelace Scientific Resources .................... 2530

M-N-OMakroCare................................................... 2405Mandala International ................................... 430MASIMO ........................................................ 721

Massachusetts College of Pharmacy and Health Sciences .............. 1038MasterControl ............................................. 2320MaxisIT Inc. ................................................. 2121McGuire Research Institute......................... 2041MedDRA MSSO ............................................ 711Medical Staffing Network Healthcare, LLC - Clinical Research .......... 334Medical Vigilance Solutions, Cincinnati Children’s .................................. 640Medicines Evaluation Unit .......................... 1434Medidata Solutions Worldwide ................... 2105MEDIX ......................................................... 2611MedNet Solutions, Inc................................... 924Medpace Inc. .............................................. 2507MedPoint Digital, Inc. .................................... 310Medrio, Inc. ................................................. 2548MedSource .................................................. 1314MedTrials ....................................................... 309Merge eClinical ........................................... 1319MESM Ltd .................................................... 2512META Solutions, Inc. ................................... 2404M-Files ........................................................... 409Microsoft Corporation ................................. 1125Microsystems .............................................. 2423Mission3 ...................................................... 1939MMG ............................................................ 1505MNX ............................................................. 2627MonitorForHire.com .................................... 2630Montrium, Inc. ............................................... 407Moravia .......................................................... 413Morningside Translations .............................. 620Mortara Instrument, Inc. ................................ 900MotherToBaby Pregnancy Studies conducted by OTIS ....................... 701MUSA ............................................................ 820myClin ........................................................... 608NCGS Incorporated .......................... 1541, 1640NDA Group .................................................. 1500

Exhibit Hall Hours

Wednesday, June 189:00AM – 4:00PM

San Diego Convention Center

5ANNUAL MEETING DAILYJUNE 18, 2014, SAN DIEGO

NeoGenomics Laboratories .......................... 850Neuroscience Trials Australia ..................... 1343New England IRB .......................................... 810New Orleans Center for Clinical Research ... 934NextDocs ..................................................... 1931Nextrials, Inc. ............................................... 1044NNIT ............................................................ 2545Nova Language Services Ltd. ..................... 1337Novasyte, LLC ............................................. 1342Novella Clinical .............................................. 931November Research Group .......................... 419Novotech ..................................................... 1236Ocasa Logistics Solutions .......................... 1641OmniComm Systems, Inc. .......................... 2205Online Business Applications ..................... 2008OpenClinica ................................................ 1804Optum ........................................................... 831Oracle Corporation ....................................... 805Orlando Clinical Research Center .............. 2335Otto Trading Inc .......................................... 1336

P-Q-RPacific BioLabs .............................................. 434Palm Beach CRO ........................................ 2236Paragon International, Inc. ............................ 704Paragon Solutions ....................................... 2021PAREXEL International ................................ 1823Path-Tec ......................................................... 508PatientPoint ................................................... 825PCM TRIALS................................................ 2045Penn Pharma ................................................ 719PerkinElmer, Inc. ........................................... 512Pharma Start ............................................... 1141Pharmaceutical eConsulting ......................... 415Pharmaceutical Outsourcing .......................MP1Pharmaceutical Packaging Professionals .. 2624Pharmaceuticals and Medical Devices Agency (PMDA) .......................... 1437PharmaCircle .............................................. 2305

Pharmalink Consulting Inc. ......................... 2516PharmaLive ................................................... 525PharmaSeek Companies ............................ 2018PharmaSys, Inc. .......................................... 1034PharmaVOICE ............................................. 1037Pharm-Olam International Ltd. .................... 1109Philips Respironics ...................................... 2527Phlexglobal Inc. ............................................. 405PHT Corporation ......................................... 1204Pilgrim Quality Solutions ............................... 636Planet Pharma ............................................. 1140PleaseTech Ltd. ........................................... 1740POPSICUBE .................................................. 749PPD ............................................................. 1805PRA ............................................................. 1623Praxis Communications, LLC ..................... 2402PRC Clinical ................................................ 2401Precept Life Sciences ................................... 322Precision for Medicine ................................ 1431Premier Research ....................................... 2011Pretium Pty Ltd. ............................................. 702PRL Central Laboratory Services .................. 431Projecis, Inc. .................................................. 524Promedica International ................................ 948PROSAR ...................................................... 2307Proswell Medical Company .......................... 849ProTrials Research, Inc. .............................. 1504PSC Biotech Corporation ........................... 1338PSKW .......................................................... 2500Q2 Business Intelligence .............................. 318QlikTech Inc. .................................................. 401QPS, LLC ..................................................... 2505Quality and Compliance Consulting, Inc. ... 2418Quality Associates, Inc. ............................... 1036Quanticate, Inc. ........................................... 1039QuantifiCare .................................................. 324Queensland Clinical Trials Network ............ 1540

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Exhibit Halls A – D

Calling All DIA 2015 ExhibitorsToday is the perfect day to begin writing tomor-row’s success story: Please stop by the Spargo booth in the Exhibit Hall to pick up your Exhibit Booth application for next year’s DIA 2015 51st Annual Meeting in Washington, DC.

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6 JUNE 18, 2014, SAN DIEGOANNUAL MEETING DAILY

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Quest Diagnostics Clinical Trials ................ 2410Quintiles ........................................................ 905QUMAS ....................................................... 2145Quorum Review IRB .................................... 2030Randstad Pharma ....................................... 2330Real Staffing Group ....................................... 618Reed Technology ........................................ 2435Regxia Inc. .................................................. 1944Research Across America ........................... 2334Research Presentation Strategies Inc. ......... 418ResearchDx ................................................... 801ReSolution Latin America ........................... 2246Rho, Inc. ........................................................ 427RJR Consulting, Inc. ................................... 1901RPM Alliance ................................................. 535RWS Group ................................................. 2617Rx Supply Solutions ...................................... 325Rx Trials Inc. ................................................ 2413RxLogix Corporation ..................................... 724

S-T-U SAGE ........................................................... 1838Samarind Limited .......................................... 540SanaClis ........................................................ 642SAS Institute Inc. ......................................... 1323Scarritt Group, Inc. ...................................... 2039Schlafender Hase GmbH ............................ 2034Schulman Associates IRB ........................... 1909

SCI-C ............................................................. 544SDL ................................................................ 435SensoScientific, Inc. .................................... 2623Seoul National University Hospital Clinical Trials Center .................................. 522Sharp Clinical Services ................................. 634Sidus Biodata ................................................ 437Small Planet Events .................................... 2539SOA Software, Inc. ........................................ 644Society for Clinical Research Sites - SCRS ............................................. 1900Sonic Clinical Trials ..................................... 1347Southern Star Research .............................. 1446Sparta Systems ........................................... 2419Spaulding Clinical Research ......................... 338Speaking Books ...........................................MP6Spectra Clinical Research ........................... 2238SPRI Clinical Trials - Global .......................... 602Springer....................................................... 2608SQN ............................................................. 1335SRI International .......................................... 1042Statistics & Data Corporation (SDC) .......... 2201

Exhibit Hall Hours

Wednesday, June 189:00AM – 4:00PM

Stefanini ...................................................... 2040Sterling IRB ................................................. 2612Stiris Research Inc. ..................................... 2301Streck, Inc. .................................................... 510Sylogent ........................................................ 815Symbio, LLC ................................................ 1240Symphony Clinical Research ........................ 922Synchrogenix ................................................ 422Synergy Research Centers ........................... 306Synowledge .................................................. 616SynteractHCR ............................................. 1731Target Health Inc. ........................................ 1935Tarius A/S .................................................... 1800Tata Consultancy Services .......................... 1405Technical Resources International, Inc. ........ 601TecHorizon .................................................... 710TechTrials .................................................... 1101Telerx ........................................................... 1031TFDA / Center for Drug Evaluation, Taiwan ..1536That's Nice LLC ........................................... 2140The Clinical Resource Network .................... 426The Clinical Trial Company ......................... 1432The Patient Recruiting Agency ................... 1146the Uppsala Monitoring Centre ................... 1208The Weinberg Group .................................. 2519Theorem Clinical Research ......................... 1245Therapak Corporation ................................... 802Therapath Neuropathology Clinical Trials .. 2244Therapeutics Inc. .......................................... 720Thomson Reuters ........................................ 1706ThreeWire, Inc. .............................................. 617TKL Research, Inc. ...................................... 2631Total Root Concepts, Inc. .............................. 327Trac Services Ltd. ........................................ 1438TransPerfect ................................................ 1925Trievr, Inc ..................................................... 1946Trifecta ......................................................... 1131UBC ............................................................... 923Unanet ........................................................... 335University of California, San Diego Extension ......................................... 732University of Florida Online MS in Pharmaceutical Outcomes & Policy .......... 731University of Maryland Online MS in Regulatory Science ................................ 312University of the Sciences............................. 750University of Utah Clinical Research Services ..................................... 305Upsher-Smith Laboratories, Inc. ................... 537

V-W-X-Y-Z Valesta Clinical Research Solutions ........... 2526Value Health Solutions Inc. ......................... 1237Veeva Systems, Inc. .................................... 2240Verified Clinical Trials .................................. 1246Veristat, Inc. ................................................... 633Verizon .......................................................... 438Viracor-IBT Laboratories ............................... 600VirtualScopics ............................................. 1905Vitalograph, Inc. .......................................... 1700Wayferry ...................................................... 1444WCCT Global ................................................ 821WebbWrites, LLC ........................................ 1941Whitsell Innovations, Inc. .............................. 920Wingspan Technology Inc. ......................... 2139WIRB-Copernicus Group ............................ 1205Woodley Equipment Company................... 1430World Courier, Inc. ...................................... 2331Worldwide Clinical Trials Holdings Inc ....... 1231WoundMatrix, Inc. ......................................... 539XClinical GmbH ........................................... 2433XenoBiotic Laboratories, Inc. ...................... 1602Xerimis Inc. .................................................... 321Xtrials Research Services ........................... 1239Xybion Corporation ..................................... 2613Y-Prime Inc. ................................................... 404Zifo ................................................................ 346Zigzag Associates Ltd ................................. 1845Zinc Ahead, Inc. .......................................... 2647

i n n o v a t i o n

academia K N O W L E D G E s c i e n c eTECHNOLOGY bios imi larsp h a r m a c o v i g i l a n c e

P E R S P E C T I V ESee you next year.C O L L A B O R A T I O N global w o r l d w i d e I N T E G R I T Yc l i n i c a l t r i a l s m e m b e r s h i p

i n n o v a t i o n

academia K N O W L E D G E s c i e n c eTECHNOLOGY bios imi larspatient initiatives RESEARCH

m e d i c i n e sI N D U S T R Y f o r u m S co p e l e a r n i n g 51st Annual Meeting

DIA 2015 J U N E 1 4 - 1 8 | WA S H I N G TO N , D C

diahome.org/DIA2015

General Call for AbstractsOpens: August 4

Deadline: September 16

NEW! Call for Hot TopicsOpens: December 1

Deadline: January 21

Call for Professional Posters

Opens: January 26Deadline: March 3

Call for Student PostersOpens: August 4

Deadline: March 31

15001_FP_14001_FinalProgram.indd 2 5/9/2014 11:25:01 AM

7ANNUAL MEETING DAILYJUNE 18, 2014, SAN DIEGO

www.pharm-olam.com

We are hiring

Visit us in booth 1109

Celebrating Our 20th Anniversary

312-14 POI 7.5"x4.75" Ads.indd 3 6/10/14 2:32 PM

Patient Fellow BoothAs patients and their advocates grow more deeply integrated with the medical product development and review process, we are pleased to spotlight these DIA 2014 Patient Fellows and invite you to visit them in the Patient Fellow Booth (#1739) to discuss potential connections and collaborations. Today’s spotlight:

All speakers must check in with the Speaker Preparation Room (in the Sails Pavilion, behind Speaker Regis-tration) before presenting. This room will be open from 7:00AM – 5:00PM on Wednesday, June 18, and from 8:00 – 11:00AM on Thursday, June 19.

Please arrive at your assigned room 20 minutes prior to start time. Upon arrival, please confirm that the proper visual presentation is loaded on the room computer. We recommend that you carry an electronic copy of your presentation (on USB) for backup purposes only. Uploading or editing presentations may not be done in the meeting room.

The Speaker Training Room (Room 33C) provides a mock meeting room with a head table, podium and screen, where you can practice your presen-tation alone or with your fellow pre-senters. Please sign up at Speaker

Attention Speakers

Route 1: Red Hotel .................................................................................... Pickup LocationWestin Gaslamp Quarter .............................Curbside, 1st Avenue and E StreetSofia Hotel Lobby ..............................................Entrance at Broadway AvenueBristol Hotel ...................................Sofia Hotel, Broadway Ave Lobby EntranceWestgate Hotel ..............................Sofia Hotel, Broadway Ave Lobby EntranceWestin San Diego ............................Curbside, Broadway Avenue at Columbia

Route 2: Yellow Hotel .................................................................................... Pickup LocationEmbassy Suites Downtown .................................... Curbside, Pacific HighwayHampton Inn Downtown ..........................................................Lobby EntranceResidence Inn Downtown .................................Hampton Inn, Lobby EntranceW San Diego ............................................................Curbside, Lobby Entrance

Route 3: Blue Hotel .................................................................................... Pickup LocationHotel Indigo ...........................................Curbside, 9th Avenue Lobby Entrance US Grant Hotel ........................................Curbside, 4th Avenue and BroadwayHorton Grand Hotel....................................... Curbside, 3rd and Island Avenue

Hotels within walking distance of the SDCC: Hard Rock Hotel, Hilton San Diego Bayfront, Hilton San Diego Gaslamp, Manchester Grand Hyatt, Omni, Marriott Gaslamp, and Marriott Marquis.

Wednesday, June 18Hours ...........................................................................................Frequency 6:45-10:00AM ....................................................................................15 Minutes10:00AM-3:30PM...............................................................................No Service3:30-6:30PM .....................................................................................15 MinutesLast Bus Departs Hotels ........................................................................ 5:30PM

Thursday, June 19 Hours ...........................................................................................Frequency 7:30-9:00AM ......................................................................................15 Minutes9:00AM-12:30PM...............................................................................30 MinutesLast Bus Departs Hotels ...................................................................... 11:30AM

For Shuttle Information or to Pre-Schedule ADA Pick-up, call 877-884-2455 during convention shuttle hours.

Parent Project Muscular DystrophySharon Hesterlee

Tuberous Sclerosis AllianceSteven Roberds

Tuberous Sclerosis Canada Cathy Evanochko

US Too InternationalSanford Jeames

TargetCancerJim Palma

Complimentary Shuttle InformationPlease allow up to 20 minutes (including waiting and riding time under normal peak traffic conditions) to travel from your hotel to the San Diego Convention Center (SDCC), located on West Harbor Drive. Delays may occur due to circumstances beyond our control.

Registration to use this room. Speaker Training Sessions are available from 9:45 – 10:15AM on Wednesday.

Speaker training supported by the DIA Professional Education, Training & Development Community.

Benefits of Staying at a DIA HotelAttendees booking rooms through the DIA housing bureau were entereed into drawings for prizes donated by the hotels. DIA thanks its hotel partners for their support.

San Diego Marriott MarquisDinner for two at Marina Kitchen or Tequila Grill• Betty Chung, Novartis• June Bray, Forest Research Institute• Liz Wool, QD-Quality and Training Solutions Inc.

W San Diego Hotel$75 Certificate to Hotel Restaurant • Holly Leonard, EMD Serano• Lesley Wargo, Galderma Research• Mick Ribeiro, Novartis Vaccines• Julie Huang, Forrest Labs

Hard Rock Hotel Spa Treatment Certificate • Theresa Carlson, Boston Scientific Corporation

The Bristol Hotel Certificate Dinner for two at Hotel Restaurant• Kristin Neff, InVivo Therapeutics• Alexander Kalin, Mitsubishi Pharma• John Bancroft, CROS NT

Manchester Grand Hyatt Dinner for 2 at Hotel Restaurant • Maria Rocha, Sunovion Pharmaceuticals Inc.Certificate for Spa Treatment• Lisa Cowan, Pretium Pty Ltd

Scan to find out more!

2014DIA RESOURCE GUIDE

Introductory offer ends June 30

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