HIGHLIGHTS TUESDAY (continued on page 11) Issue # 3 | JUNE 16, 2015 Washington, DC @DrugInfoAssn #DIA2015 8:00–9:30AM #223 PMDA Town Hall Room 146C 9:00AM–4:00PM Professional Poster Session #1 Exhibit Hall Entrance A 9:30–10:30AM Professional Poster Session #1A Oral Presentations Exhibit Hall Entrance A 10:15-11:00AM DIA Membership Appreciation Meeting DIA Member Lounge 11:30AM–1:30PM Professional Poster Session #1B Oral Presentations Exhibit Hall Entrance A 12:30PM Student Poster Award Ceremony DIA Booth #1523, Exhibit Hall 2:30–3:10PM Professional Poster Session #1C Oral Presentations Exhibit Hall Entrance A Cancellation Today’s afternoon session #292, Chinese Drug Development: An Update, has been cancelled. DIA Global Chief Executive Barbara Lopez Kunz welcomed attendees to the Opening Plenary as the echo from the Selected of God choir’s opening song faded. “I hope you were all as inspired as I was by the soaring music of the Selected of God choir and the lyrics they sang, ‘You only get one shot. This opportunity comes just once in a lifetime.’ These words remind us of the urgency of the challenges we all face. And they encourage us to capitalize on every opportunity we have to advance our important work,” Barbara began. “At DIA, we are embarking on our sixth decade of accelerating global innovation in health care product development through collaboration. I believe the people who are attend- ing this conference are working in the greatest professions in the world. We are preventing and curing disease, impacting health, and saving lives.” DIA 2015: “Global Enablers” Only Get “One Shot” From top: DIA Global Chief Executive Barbara Lopez Kunz and Dr. Per Spinder, DIA President and Chair, Board of Directors, welcome attendees to the Opening Plenary. Left: Daniel Burrus delivering his Keynote Address during the Opening Plenary.
Transcript
HIGHLIGHTSTUESDAY
(continued on page 11)
Issue 3 | JUNE 16 2015Washington DC
DrugInfoAssnDIA2015
800ndash930AM223 PMDA Town Hall
Room 146C
900AMndash400PMProfessional Poster Session 1
Exhibit Hall Entrance A
930ndash1030AM Professional Poster Session 1A
Oral PresentationsExhibit Hall Entrance A
1015-1100AMDIA Membership Appreciation
MeetingDIA Member Lounge
1130AMndash130PM Professional Poster Session 1B
Oral PresentationsExhibit Hall Entrance A
1230PMStudent Poster Award Ceremony
DIA Booth 1523 Exhibit Hall
230ndash310PM Professional Poster Session 1C
Oral PresentationsExhibit Hall Entrance A
Innovation Lab Booth 2000
Visit the ERT Innovation Lab and gethands-on with our latest technologies
ertcom
CancellationTodayrsquos afternoon session 292 Chinese Drug Development An Update has been cancelled
DIA Global Chief Executive Barbara Lopez Kunz welcomed attendees to the Opening Plenary as the echo from the Selected of God choirrsquos opening song faded ldquoI hope you were all as inspired as I was by the soaring music of the Selected of God choir and the lyrics they sang lsquoYou only get one shot This opportunity comes just once in a lifetimersquo These words remind us of the urgency of the challenges we all face And they encourage us to capitalize on every opportunity we have to advance our important workrdquo Barbara began
ldquoAt DIA we are embarking on our sixth decade of accelerating global innovation in health care product development through collaboration I believe the people who are attend-ing this conference are working in the greatest professions in the world We are preventing and curing disease impacting health and saving livesrdquo
DIA 2015 ldquoGlobal Enablersrdquo Only Get ldquoOne Shotrdquo
From top DIA Global Chief Executive Barbara Lopez Kunz and Dr Per Spinder DIA President and Chair Board of Directors welcome attendees to the Opening Plenary Left Daniel Burrus delivering his Keynote Address during the Opening Plenary
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BOOTH 1020
3ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
PPD and HealthCore Collaborate to Deliver Enhanced Pre- and Post-approval Research Services
PPD and HealthCore have established a collaboration that will enable both companies to further expand their services in the pre- and post-approval research market with the aim of helping biopharmaceutical clients more quickly and cost effectively demonstrate how their products will perform and benefit patients in the real world
Through this collaboration PPD is combining its clinical trial design health economics and outcomes research (HEOR) medical affairs research and epidemiology services with HealthCorersquos strengths in HEOR innovative real-world research designs and its robust research-enabled electronic health care data environment
With the collaborative expertise of PPD and HealthCoremdashparticularly in planning designing and implementing pragmatic clinical trialsmdashthe companies hope to set a new standard for the quality cost and speed of real-world evidence generation that can help optimize patient outcomes and enable their clients to better demonstrate the true value of their products and the return on their investments in new product development
Representatives of PPD and HealthCore will be on hand throughout the DIA annual meeting at booth 2227 to discuss the collaboration further and answer any questions
For additional information go to wwwppdicom or wwwhealthcorecom
You might not have heard any recognizable sound but wersquore in the midst of a ldquobig bangrdquo ndash an explosion of wearable hardware gadgets and other new medical technologies that will if properly managed increase ways to connect people with re-search into these innovations and ways to connect these innovations with the people who most need them
Todayrsquos program features a special
Plenary Session that will illuminate the patient innovator industry and regu-latory perspective on these disrup-tions innovations opportunities and challenges 265 Disruptive Forces in Health Care Innovation Where Are They Leading Us in Room 143ABC at 130PM This panel discussion will explain the state of these technologies today and explore where they might take us tomorrow from a variety of perspectives
bull Jack Andraka the teenage scien-
tist who invented an early diagnostic test for pancreatic cancer will speak about the Innovator Role
bull Angela Dunn trends analyst healthiscool will describe the Wear-ables Role
bull Duane Schulthess MBA Manag-ing Director for VitalTransformation in Belgium will share the EU Perspective
bull Patricia Furlong BSN Found-ing President amp CEO Parent Project Muscular Dystrophy will present the Patient Role
Disruptive Forces in Health Care In-novation Where Are They Leading Us will be chaired by Jeffrey Kasher PhD President of Patients Canrsquot Wait LLC
Disruptive ldquoBig Bangrdquo in Health Care Innovation At 330PM today two sessions
will explore the expanding frontier of biomarkers companion diag-nostics combination products mHealth and web applications and related innovations that offer promise for increased return on investment in therapeutic product development
In Room 102AB 271 How Biomarkers Can Be Leveraged to Improve Return on Investment in Drug Development will explore how biomarkers appropriately used can facilitate earlier ldquono gordquo decisions reduce clinical trial costs improve your probability of success accel-erate drug development for faster time to market and even increase access to the drug once itrsquos on the market The Biomarker and Com-panion Diagnostic Lead Office of New Drugs CDER will offer the regulatory perspective on the utility
Innovations in Combinationsof biomarkers including the chal-lenges and best practices for drugtest codevelopment in clinical trial designs Other topics include the execution challenges associ-ated with incorporating biomarkers and companion diagnostics into a clinical program molecular imag-ing case studies and the benefits of imaging biomarkers in oncology clinical trials
Chair Eva Finney Director Global Project Management Merck amp Co Inc
Speakers Robert Scarimbolo Manager Molecular Imaging Bio-Clinica Rachel Yarger MBA PMP Senior Project Manager Luminex Corporation and Christopher Leptak MD PhD Biomarker and Companion Diagnostic Lead Office
(continued on page 10)
DIA 2015 Welcomes Patient Fellows
Twenty patient representatives chosen through a competitive pro-cess will develop strengthen and support their collaborations with poli-cymakers industry academia and health professionals here at our DIA Annual Meeting Meet these Patient Fellows in booth 1721 and follow DIA2015Patients for information updates
Pick up the Wednesday issue of the DIA Show Daily
to see additional DIA 2015 Patient Fellow
organizations
The 1st DIA China Drug Discovery Innovation Conference amp ExhibitionOctober 11-14 2015 Shanghai International Convention Center
This will be the 1st of a new annual offering specifically focused on the early stage of the drug discovery and development process The meeting will cover topics like drug design target discovery biology and chemistry lead optimization drug likeness translational medicine amp biomarker development DMPK and preclinical exploratory clinical trials and more A special Executive Forum and sessions on Chinese governmentrsquos innovation policies are also designed
Program Website httpen15951eventdovecom
4 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Selected Life Sciences Profes-sionals from all fields related to the mission of DIA will participate in this yearrsquos Professional Poster Program presented near Exhibit Hall Entrance A from 900AM-400PM New This Year Oral presentations where poster authors will deliver a five-minute over-view of their work
Tuesday Session 1A 930AMndash1030AM
T01 Assessing the Current Land-scape of Pharmaceutical Industry Post-Doctoral Fellowships Brittny Ann Rule PharmD MBA Rutgers The State University of New Jersey (Oral presentation at 935AM)
T02 Patient Knowledge of Safe Use of ERLA Opioid Analgesics Fol-lowing Implementation of the Class-Wide REMS Stephan Lanes PhD HealthCore Inc (Oral presentation at 942AM)
T03 Biosafety Gene Therapy Navigating the Regulatory Maze Chris Jenkins PhD MPH WIRB-Copernicus Group (Oral presentation at 949AM)
T04 Clinical Relevance and Utility of Boxed Warnings in US Prescrib-ing Information Christine M Cheng PharmD First Databank Inc (Oral presentation at 956AM)
T05 Advancing Medical Informa-tion Services To Impact Patient Care Collection Of Insights From Healthcare Practitioners Roshni Patel-Romero PharmD Genentech Usa Inc (Oral presentation at 1003AM)
T06 Impact of the Nonclinical Juvenile Animal Studies on Pediatric Medicines Information Dinah Duarte PharmD MSc INFARMED Portugual
T07 Steps on a Journey Re-Use of Analysis Scripts and Standardized Tuberculosis Trial Data Xin (Joy) Li FDA (Oral presentation at 1010AM)
T08 Can Social Listening be Used to Augment Existing Data Sources for Monitoring the Safety of Consumer Health Care Products James Blow-ers GlaxoSmithKline (Oral presenta-tion at 1017AM)
T09 Regulatory Gaps mdash Industryrsquos Perspectives on Asiarsquos Regulatory Au-thorities James Leong PhD MPharm Centre of Regulatory Excellence Duke-Nus Graduate Medical School Singapore
T10 Pharmacovigilance Industry Benchmarking on Global Methodolo-gies for Collecting and Processing Off-Label Use Reports Amanda Bowles Deloitte Consulting LLP (Oral presen-tation at 1024AM)
T11 The Case for Electronic Data Capture of Abdominal Pain in Crohnrsquos Disease A Comparison of Diary Meth-ods Leighann Litcher-Kelly PhD ERT
Tuesday Session 1B 1135AMndash132PM
T12 Feasibility of Replacing the Thorough QT (TQT) Study with Intense ECG Data Collection in Early Clinical Studies Nancy Wang PhD Celerion (Oral presentation at 1135AM)
T13 Assessing Bias in Adminis-trative Database Studies of Vaccine Completion Due to Excluding Sub-jects with Incomplete Follow-up Scott Charles Quinlan PhD HealthCore Inc (Oral presentation at 1142AM)
T14 Design and Development of an eCOA Specific Solution for Captur-ing Patient Data in Diabetes Clinical Trials Paul ODonohoe CRF Health United Kingdom (Oral presentation at 1149AM)
T15 Engage Patients with Innova-tive Global Digital Patient Platform Helen Lee Bristol-Myers Squibb Com-pany (Oral presentation at 1156AM)
T17 Utilizing Regional and National Student Recruitment Events to Maxi-mize Awareness of Post-PharmD Op-portunities in Industry Amy Monpara PharmD MCPHS University
T18 The Impact of the Establish-ment of Integrated Medicinal Product Review Office (IMPRO) in Taiwan Yan-Feng Chen Center for Drug Evalua-tion (CDE) Taiwan
T19 Drug Lag and Approval Time Metrics - Are They Good Markers to Assess the Global Regulatory Environ-ment Magdalena Bujar MSc Centre For Innovation In Regulatory Science (CIRS) United Kingdom (Oral presen-tation at 1203PM)
T20 Analyzing Global Recruit-ment Strategies to Improve Local Trial Enrollment - A Global Investigation Into ldquoWhat Works Whererdquo for Patient Recruitment and Retention Tools and Techniques Chris Frega MBA Quintil-es Inc (Oral presentation at 1210PM)
T21 Improving Hepatic-Impairment Patient Recruitement with a University Hospital Center-CRO Partnership A Benchmarking Analysis Rachida Es-salihi PhD Algorithme Pharma Inc Canada
T22 Monitoring Interactive Re-sponse Technology Vendor Imple-mented Randomization and Dosing Systems Jason McCoy MS Amgen Inc (Oral presentation at 1217PM)
T23 Evolution of a Unique Blend of Business Process and Technology to Enhance Medical Affairs Capabilities Manish Dave MBA MS Merck amp Co Inc (Oral presentation at 1224PM)
T24 Implementing CDISC Stan-dards in an Early Phase CRO Suc-cesses and Challenges Pascal Gui-bord Algorithme Pharma Inc Canada
T25 A Pitfall in the Clinical Study Enrollment of Postmenopausal Females Eunhee Chung SOUSEI-KAI Global Clinical Research Center Japan (Oral presentation at 1231PM)
T26 Survey of IRB Review of Urgent Patient Specific Protocols Bambi Grilley RPh RAC Baylor College of Medicine
T27 Lack of Inter-Ethnic Difference in QT-Susceptibility to Moxifloxacin Two Independent TQT Studies in Caucasian and Asian Populations Yang Wang FDA (Oral presentation at 1238PM)
T28 Implementing Quality Risk Management and Risk-Based Moni-toring Practical Guidelines from Sponsors and Sites Amita Malik MS Oracle Health Sciences (Oral presen-tation at 1245PM)
T29 Measurement Equivalence of the SF-36v2 on a Handheld Device and Smartphone App Susan M Dal-labrida PhD PHT Corporation (Oral presentation at 1252PM)
T30 How to Maximize Data Quality in Retrospective Chart Review Stud-ies Dara Stein MSc UBC An Ex-press Scripts Company Canada (Oral presentation at 1259PM)
T31 Benefit-Risk Assessments (BRAs) of an Established Productsrsquo Portfolio Rosa Piccirillo Patino-Paul MD IVAX (Oral presentation at 106PM)
T33 Results of An Online Survey of Stakeholders Regarding Barriers and Solutions to Clinical Trial Recruit-ment Elizabeth Mahon JD Janssen Research amp Development LLC (Oral presentation at 113PM)
T34 Process for Ensuring Clinical Trial Product Quality Janie B Rus-sell RAC National Institutes of Health (NIH) (Oral presentation at 120PM)
T42 Results Reporting to Clini-calTrialsgov and EudraCT - A Con-solidated Approach and First-hand Experiences Mathias Poensgen PhD ArisGlobal GmbH Germany (Oral presentation at 127PM)
Tuesday Session 1C 230ndash310 PM
T35 Attractiveness of PRO Mixed Modes ndash What are Patients Saying Jennifer Ross MEd MS Almac Clini-cal Technologies LLC (Oral presenta-tion at 235PM)
T36 Efficient and Innovative Clini-cal Trial Enrollment Using Online and Social Media Mark Joing MBA Nora Therapeutics (Oral presentation at 242PM)
T37 The Cost Effective Benefits of Behavioral Psychology on Improving Data Quality Shawn Levin Quintiles Transnational Corp (Oral presentation at 249PM)
T38 An Approach to Aggregate Safety Reporting of Drug and Device Constituent Parts of Combination Prod-ucts Xaymara Roman RN AbbVie Inc (Oral presentation at 256PM)
T39 Analyzing the Relative Recruit-ment Performance between Highly-Uti-lized and Low-Utilized Sites in 5 TAs in 4 Asian Countries Hyunjoo Rhee MPharm Quintiles Transnational Ko-rea Co Ltd Republic of Korea
T40 How IDMP Can Help Struc-ture Product Information Labeling Romuald Braun uanotau Switzerland (Oral presentation at 303PM)
Winning with DIAAttendees who registered for our Annual Meeting before May 14 were
entered into a random raffle drawing for a pair of tickets to see the Washing-ton Nationals play the Tampa Bay Rays on Wednesday June 17 at Nationals Park Congratulations to Dr Atif Abbas (Medical Director US Drug Safety Merck Serono) and Julie Townsend (Associate Director Regulatory Opera-tions Upsher-Smith Laboratories Inc) each of whom picked up a pair of tickets from the DIA booth for tomorrow nightrsquos ballgame
a
Click to explore the April issue
Yoursquove never seen a Global Forum like this
Click to explore the June issue
5ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Exhibiting As Booth4C Pharma Solutions LLC 1138
A-B-CAccell Clinical Research 2439Accenture 1015Accenture Business Suite 7Accovion GmbH 1344ACM Global Central Laboratory 2221ACRP 1654Acurian Inc 2235ADAMAS Consulting LLC 2644Adaptive Clinical Systems 627Advanced Clinical 1308Aerotek 1100AiCure 1235Alfresco Software Inc 753Almac 2435American Medical Writers Association 1526Ancillare LP 642APCER Pharma Solutions Inc 1545Applied Clinical TrialsPharmaceutical Executive 520ArisGlobal 2409ArisGlobal Business Suite 4Arivis 1045Arriello Ireland Limited 1457Artcraft Health 1848Asia CRO Alliance 1245Association of Biotechnology Led Enterprises ndash ABLE 1127August Research 1320Auxiliis 1238Axiom Real-Time Metrics Inc 2311BARC Global Central Laboratory 1901Barrington James 2052BBK Worldwide 2026Beijing Clinical Service Center 2640Benchmark Research 516BioClinica 1325Biomedical Systems 619BioPharm Insight 1601BioPharma Investigator 1011BioPoint Inc 2713BioPoint Inc Business Suite 5Biorasi 524bioskin GmbH 1220BioTelemetry Research (Formerly Cardiocore) 1411BIOVIA 2321Blinded Diagnostics 2735Bracket 711CAC EXICARE Corporation 1057CAHG 1142Camargo Pharmaceutical Services 1927Cambridge Healthtech Institute 639Cambridge Semantics Incorporated 1255Cancer Insight 641Canfield Scientific Inc 534Cardinal Health 1104Cardiovascular Imaging Technologies 2622Cardiovascular Research Foundation 857Catalent 2113CDISC 1849Celerion 1301Cenduit LLC 538Center for Information and Study on Clinical Research Participation (CISCRP) 2440Chesapeake IRB 1739Chexx Inc 1244Chiba University Hospital 2352Chiltern International Inc 827
DIA Exhibitor List and Floor Plan DIA 2015 Annual Meeting
Washington DC
Cincinnati Childrenrsquos Research Foundation 1322Citeline Inc 2003CITI Program - University of Miami 1802CitiusTech Inc 1906Clariness 2738CleverCap 2057ClinDatrix Inc 1002ClinEdge LLC 1845Clinical amp Contract Research Association (CCRA) 1208Clinical Ink 2011Clinical Practice Research Datalink (CPRD) 1052Clinical Reference Laboratory 2316Clinical Research Malaysia 2648ClinicalRM 2442Clinitude 2252Clinlogix 1003ClinPlusDZS Clinical Services 1610ClinTec International Ltd 1118Clinverse Inc 1703CluePoints Inc 1511Cmed Clinical Services 752CMIC HOLDINGS Co Ltd 935Cognizant Technology Solutions 2741Compass IRB 2016Compass Research LLC 2349CompleWare 620Complion 2545Comprehend Systems 2511Content Analyst Company 956Continuum Clinical 2343Contract Pharma 643ConvergeHEALTH by Deloitte 811ConvergeHEALTH by Deloitte Business Suite 2Conversis 2253CoSign by ARX 744Cote Orphan Consulting LLC 1544Court Square Group IncRegDocs365 2157Covance Inc 1835Covigilant 2726CRF Health 2427CRO Analytics 1656CROMSOURCE 1345CROS NT 1111CSSi 1811CTI Clinical Trial amp Consulting Services 1915Cu-Tech LLC 1121Cytel Inc 1611
D-E-FDAC 2327Data Matrix 2005DataArt 2639Datapharm Australia Pty Ltd 625DATATRAK International Inc 803DaVita Clinical Research 738DBMS Consulting 2744DIA 1523DIA Patient Advocate Fellowship 1721DITA Exchange 2419
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Pull-Out
Section
Dora Wirth (Languages) Ltd 1212Dr Ebeling amp Assoc GmbH 1302DrugDev 820DSG Inc 719d-Wise Technologies 1402EastHORN Clinical Services in CEE Ltd 2109eClinicalHealth Ltd 510EDETEK Inc 1855Elite Research Network LLC 1206EMB Statistical Solutions LLC 1014endpoint 927Enforme Interactive 1249ENNOV 1145Entimo AG 2220ePharmaSolutions 734EPS Holdings Inc 905ERT 2000ERT 2025Eurofins 2540European Medicines Agency 1528EUROTRIALS 1815Everest Clinical Research 2048Exco InTouch 2212ExecuPharm Inc 1043ExL Pharma 1907Exostar 1749Experis Clinical Practice 2423Exponent 742EXTEDO Inc 2519Falcon Consulting Group 727FDA CDER 1729FDAnews 2621Flex Databases 1312Foresight Group International AG 2339Formedix Inc 1223Frenova Renal Research 1004Fresenius Medical Care North America 2441Frontage Labs 2520
G-H-IGA International Inc 1256Galderma Research amp Development LLC 1851GCP ClinPlus Co Ltd 542Genpact Pharmalink 2541GenPro International 2749Gilead Sciences Inc 1056Global Center of Excellence in Clinical Trials Asan Medical Center 1651Global Center of Excellence in Clinical Trials Inje University Busan Paik Hospital 1651Global Center of Excellence in Clinical Trials Samsung Medical Center 1651Global Center of Excellence in Clinical Trials Yonsei University Health System 1651Global Institute For Research 1207Global Instrumentation LLC 1556Global Language Solutions 723GlobalCare Clinical Trials LTD 2729goBalto Inc 1241GP Strategies 1306
(continued on page 6)
6 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
(continued from page 5)
Parties amp Events
Giveaway Guide
Food amp Drink
Sights
TransportationBrought to you by BioClinica
KAI Research Inc 2740KCR 2722KCRN MampC 1945KellyOCG 1035Klein Hersh International 2034KlinEra Global Services 2110KoNECT 1651Korea Clinical Trials Global Initiative (KCGI) 1651Kuantum CRO and Logistics 1019LabAnswer 2155LabConnect LLC 911LabCorp 1835Lambda Therapeutic Research Inc 2105Langland 2046Launchpad 543Life Science Leader 2623Linical USA 2720Lionbridge Technologies 1246LMK Clinical Research Consulting 645Longboat Clinical Ltd 612LORENZ Life Sciences Group 1427Lovelace Scientific Resources 923Luto Research Limited 1213
M-N-O MakroCare 2618Mapi 754MASIMO 1340Massachusetts College of Pharmacy and Health Sciences 2153MasterControl 1809MaxisIT Inc 2535McGuire Research Institute 2107
MDCPartners 2449Med Fusion 1140MedDATA Foundation 755MedDRA MSSO 1009Medical Research Network Ltd 854Medical Vigilance Solutions Cincinnati Childrenrsquos 1039Medicines Evaluation Unit 1210Medidata Solutions Worldwide 2641Medidata Solutions Inc 2201MEDIX 1846MedNet Solutions Inc 1838Medpace Inc 1801MedPoint Digital Inc 2517Medrio Inc 1202MedSource 1935MedTrials 1346Merge eClinical 2209MESM Ltd 2042META Solutions Inc 2021MMG 2534MNX Global Logistics 1914MonitorForHirecom 1421Montrium Inc 2106Morningside Translations 1953Mortara Instrument Inc 729National Death Index 518NCGS Incorporated 2611NeoGenomics Laboratories 1251Neuroscience Trials Australia 2627New Orleans Center for Clinical Research 728Next Phase Research 2637NextDocs 2038Nextrials Inc 2717NIPER Hyderabad 1127
Green Key Resources 1947Greenphire 613Greens LTD 2156Guangzhou KingMed Center for Clinical Laboratory Co Ltd 2538HampJ CRO International Inc 2646Hangzhou Tigermed Consulting Co Ltd 746HCL America Inc 1635Health Decisions Inc 821HealthCarePoint 1757Hurley Consulting Associates Ltd 955Hurley Write Inc 2727Hydrogen International Ltd 1955iCardiac Technologies 2102ICON plc 503IDT Australia 1746ImageIQ Imaging CRO 1227IMS Health 1317Inamed GmbH 529INC Research 2303Industry Standard Research 725Informa Business Information 2354Information Builders Inc 1853Infotehna Inc 1444Innovative Print amp Media Group 1354InnovoCommerce LLC 1747Integrated Clinical Systems Inc 901Integrated Development Associates Co Ltd 1047IntegReview IRB 2420INTERLAB GmbH central lab services worldwide 1425International Dermatology Research Inc 1538Interspond LLC 2547Intertek Scientific amp Regulatory Consultancy 2516Intralinks Inc 1822inVentiv Health 1517Investigational Cancer Therapeutics - MD Anderson 1546IPHARMA ChemDiv 521
NNIT 2254Norav Medical 514Nova Language Services Ltd 1209Novella Clinical 1439November Research Group 2218Novotech 1134NSF Health Sciences 1847Nuventra Pharma Sciences 824Ocasa Logistics Solutions 2036Ohio Clinical Trials Collaborative 2442OmniComm Systems Inc 2135Online Business Applications 1314OpenClinica 635Optum 1826Oracle Health Sciences 1819Orlando Clinical Research Center 2208Otto Trading Inc 1018
P-Q-RPacific Bridge Medical 2446Palm Beach CRO 1804Paragon International Inc 1403Paragon Solutions 2204
Parallel6 1957PAREXEL International 1535PCM TRIALS 2733Pennside Partners Ltd 2518PerkinElmer Inc 513Personify 1756Pharma Start 1148Pharmaceutical eConsulting 1650Pharmaceutical Outsourcing Hall A EntrancePharmaceutical Packaging Professionals Pty Ltd 2120Pharmaceuticals and Medical Devices Agency (PMDA) 1520Pharmaceuticals Export Promotion Council of India 1127PharmApprove 2054PharmaQuest Ltd 1348PharmaSeek Companies 822PharmaSys Inc 2438PharmaVOICE 1001Pharm-Olam International Ltd 919Phlexglobal Inc 2007Pilgrim Quality Solutions 2044Planet Pharma 1149PleaseTech Ltd 1114Polar Leasing Company Inc 546Popsi Cube 539Porzio Life Sciences 1055PPD 2227PQE 1054PRA Health Sciences 1501Praxis Communications LLC 629Precision for Medicine 1351Premier Research 1711Pretium 1010
PrimeVigilance 2347PRL Central Laboratory Services 1423Proforma Giraffe Graphics Inc 2549Projecis Inc 1645PROSAR 2206Proteus Digital Health Inc 2255ProTrials Research Inc 1108PSKW LLC 1053Pyxant Labs Inc 1950Q2 Business Intelligence 1449QPS LLC 1307Quality and Compliance Consulting Inc 2417Quality Associates Inc 1607Quanticate Inc 1334QuantifiCare 527Queensland Clinical Trials Network 1000Quest Diagnostics 2628Quintiles 601Quorum Review IRB 1219Radiant Research Clinical Research Advantage 2112Randstad Pharma 2715Real Staffing Group 2620RegCheck 955Regeneron Pharmaceuticals 638Regxia Inc 1949Research Across America 2728ReSolution Latin America 2421Rho Inc 724RR Donnelley 2626RWS Group - Medical Translation Division 1350Rx Trials Inc 1400RxLogix Corporation 2521
S-TSan Diego State University - Regulatory Science Programs 1524SanaClis sro 541SAS Institute Inc 2127SAS Institute Inc JMP Division 1744Scarritt Group Inc 1844Schlafender Hase Inc 2012Schulman Associates IRB 1020SeaView Research 1944Sharp Clinical Services 1305Sidus Biodata 1745Signix Inc 2739SNBL Clinical Pharmacology Center 2448Society for Clinical Research Sites - SCRS 1548Sonic Clinical Trials 1010SOUSEIKAI Global Clinical Research Center 1946Southern California Research 2721Southern Star Research 1702Sparta Systems 826Spaulding Clinical Research 2217Speaking Books 1605SPRI Clinical Trials - Global 1021Springer 526Statistics amp Data Corporation (SDC) 1704Stefanini 2723Sterling IRB 2010Stiris Research Inc 1707Symbio LLC 1700Symogen 1856Symphony Clinical Research 2422Synchrogenix Information Strategies Inc 1105Syngene International Ltd 1127Synowledge 1540Syntel Inc 1157SynteractHCR 1335Target Health Inc 2527Tarius AS 1103Tata Consultancy Services 1909Technical Resources International Inc 1913Technology Catalysts International 2447Techorizon 1347TechSol Corporation 2642Telerx 735Teuteberg Incorporated 1948TFDA Center for Drug Evaluation Taiwan 1522
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
8 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Thatrsquos Nice LLC 1240The Clinical Resource Network 1318The Geneva Foundation 2548The Patient Recruiting Agency 2119Theorem Clinical Research 511Theorem Clinical Research Business Suite 1Therapak Corporation 1005Therapeias Health Management 641Therapeutics Inc 1341Thomson Reuters 1440ThreeWire Inc 1939TKL Research Inc 2202Total Clinical Trial Management 2725Total Root Concepts Inc 523TrakCel Limited 2747TransPerfect 1025Trial Runners 2742Trievr Inc 2103Trifecta 1921
U-V-WUBC 2401Unanet 1152University of Florida 1551University of Maryland Online MS in Regulatory Science 1147University of the Sciences 852University of Utah Clinical Trials Office 1725Uppsala Monitoring Centre 2426UTMB Sealy Center for Vaccine Development 1657Valesta Clinical Research Solutions 2629Validated Cloud 2056Veeva Systems Inc 1203Verified Clinical Trials 1109Veristat Inc 1941
(continued from page 7)
Vigilare International 1141Vince amp Associates Clinical Research 748Viracor-IBT Laboratories 2546Viroclinics Biosciences 547VirtualScopics 2320Vitalograph Inc 1406Voluntis 1447WCCT Global 2121WebbWrites LLC 953Whitsell Innovations Inc 626Wincere Inc 1144Wingspan Technology Inc 1445WIRB-Copernicus Group 701Women in Life Sciences - WILS 1356Woodley Equipment Company 1215Worldwide Clinical Trials 1311
TKL Research is an international CRO offering expertise in a full spectrum of indications as well as clinical trial management services from Phase 1 to multicenter international studies TKL serves the pharmaceutical biotech generic drug medi-cal device OTC and consumer health care indus-tries The leader in dermatological research TKL has performed over 200 dermatological clinical trials and is unrivaled in the number of dermato-logical safety studies TKL also has significant ex-perience in Phase 1-4 multinational clinical trials and differentiates itself from the competition with a strong Phase 1 safety capability and full service CRO combined into one cohesive organization
QuintilesBooth 601wwwquintilescomcareers
Quintiles CareersQuintiles is the worldrsquos largest provider of
biopharmaceutical development and commercial outsourcing services and wersquod like to meet you Please stop by the Marriott Marquis Hotel to hellip
ATTEND OUR COCKTAIL RECEPTION in the Chinatown Meeting Room
bull Monday June 15th from 6pm - 8pm
MEET OUR RECRUITING TEAM from Immunol-ogy and Internal Medicine in the Judiciary Square Meeting Room
bull Monday June 15th from 2pm - 5pmbull Tuesday June 16th from 9am - 7pmbull Wednesday June 17th from 9am - 7pm
Improve your probability of successtrade
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Your Opinion MattersComplete an evaluation for each offering
you attend for a chance to win great prizes
Access online evaluations at DIAGlobalorgDIA2015evals or stop by Evaluation Stations in the Registration
Area beginning Tuesday
Free registration to the DIA 2016 52nd Annual Meeting
$100 American Express Gift Card
Discover Safety around the World
ldquoGlobal production of FDA-regulated goods has exploded over the past ten years In addi-tion to an increase in imported finished prod-ucts manufacturers increasingly use imported materials and ingredients in their US produc-tion facilities making the distinction between domestic and imported products obsoleterdquo said FDA Commissioner Dr Margaret A Ham-burg upon the release of the FDA 2011 report Pathway to Global Product Safety and Quality ldquoThe FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face The FDA must further collaborate and leverage in order to close the gap between our import levels and our regula-tory resourcesrdquo she concluded
At 1030AM today staff from FDArsquos interna-tional posts in China Europe and India will provide exclusive updates from their respec-tive posts in Session 245 FDArsquos International Posts International Efforts Regulatory System Strengthening and Inspections presented in Room 152A Their updates will include out-reach to foreign regulators facility inspections risk-based global surveillance to protect supply chains and related topics
Chair Leslie Ball MD Assistant Commis-sioner and Deputy Director OIP OC FDA
Update from the FDA China Office S Leigh Verbois PhD Incoming Director China Office Office of International Programs OC FDA
Update from the FDA India Office Mathew T Thomas MD Acting Country Director India Of-fice Office of International Programs OC FDA
Update from the FDA European Office Donald Prater DVM Acting Regional Director Europe Office OIP OC FDA
9ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Route 1 Red Hotel Pickup LocationJW Marriott E Street EntranceGrand Hyatt 11th Street EntranceMarriott Metro Center At Hyatt 11th Street Entrance
Route 2 Yellow Hotel Pickup LocationHamilton Crown Plaza Lobby EntranceDonovan House Lobby EntranceWashington Plaza Curbside Vermont mdash Near DrivewayComfort Inn Convention Center At Washington Plaza Curbside Vermont
Route 3 Blue Hotel Pickup LocationLoews Madison Lobby EntranceWestin Washington At Loews Madison Lobby EntranceDoubletree Washington Lobby EntranceHotel Helix At Doubletree Lobby EntranceMayflower Renaissance Desales Street Entrance
Hotels within walking distance of the Walter E Washington Convention Center are Embassy Suites Convention Center Hampton
Inn Henley Park Hotel Morrison-Clark Inn Renaissance Washington DC Downtown Hotel and Marriott Marquis
Tuesday June 16 through Wednesday June 17Hours Frequency 645-930AM 15 Minutes930AM-330PM No Service330-630PM 15 MinutesLast Bus Departs Hotels 530PM
Thursday June 18 Hours Frequency 730-900AM 15 Minutes900AM-1230pm 30 MinutesLast Bus Departs Hotels 1130AM
For Shuttle Information or to Pre-Schedule ADA Pick-up call 877-865-3437 during convention shuttle hours
Complimentary Shuttle InformationPlease allow up to 20 minutes (including waiting and riding time under nor-mal peak traffic conditions) to travel from your hotel to the Walter E Wash-ington Convention Center located on Mount Vernon Place Delays may occur due to circumstances beyond our control
Discover tomorrowrsquos solutions to to-dayrsquos challenges through the products and services showcased in todayrsquos Innovation Theater sessions presented near Exhibit Hall Entrance B
945AM 225 Covance Innovation Theater Advances in Risk-Based Mon-itoring Transforming Drug Develop-ment Through Efficient Workflows Big Data and Elegant Software Discover Covancersquos risk-based monitoring (RBM) platform which provides clients with best-in-class implementation of the RBM principles put forth by FDA EMA and TransCelerate and facilitates RBM through timely secure and inte-grated access to all relevant trial data
1200PM 249 Quintiles Innova-tion Theater Transform Clinical De-velopment ndash Modernizing for Smarter Trials Because of our imperative to ldquomodernizerdquo clinical trials to de-liver medicines faster at less cost to patients who need them learn how you can gauge global capabilities to model and predict better outcomes identify appropriate investigator sites and deliver faster ldquoanalysis-readyrdquo data to identify trends and issues in near real time
100PM 250 Veeva Innovation Theater 2015 Paperless Trial Master File (TMF) Survey Trends and Insights Results from the follow-up to Veevarsquos benchmark 2014 Paperless TMF Sur-vey which analyzed the observations of TMF owners to identify the barriers business drivers and benefits of mov-ing to fully paperless TMFs How does your organization compare and why do some organizations benefit more than others
300PM 267 BBK Worldwide Innovation Theater mHealth A New Era in Patient Engagement BBK Worldwide and mHealth experts from the Landon Pediatric Foundation and CareThings discuss opportunities for patient engagement in clinical trials within mHealth and how advance-ments in apps wearables and per-sonalized content delivery are shaping a new patient engagement model and impacting the entire clinical research enterprise
See Innovation in Action Innovation Theater
We ask all Annual Meeting speak-ers to please check in at the Speaker Registration Desk when you arrive at the Convention Center to pick up your name badge Speaker registration will be open today from 700AMndash500PM The Speaker Preparation Room will also be open from 700AMndash500PM to-day this is where you will confirm that your presentation has been properly uploaded
A Speaker Training Room is also available for you to practice your pre-sentation alone or with your fellow pre-senters Please schedule your practice time when you check in at the Registra-tion Desk This Training Room will host a special Speaker Training Session coaching on podium presentation best practices from 945-1015AM today
The Speaker Registration Desk Speaker Preparation Room and Speaker Training Room are all located in the East Registration area
We ask all speakers to arrive at their assigned room 20 minutes before
Speaker Registration amp Preparationyour session scheduled start time to confirm that the proper visual presen-tation is loaded on the session room computer You cannot upload or edit your presentations in the session room you may do so however in the Speaker Preparation Room We also recommend that you carry an elec-tronic copy (via USB) of your presen-tation for backup purposes
Exhibitor PassportVisit our Exhibitors to hear about their products and services You must have 50 Exhibitors sign your card found in your attendee bag to be eligible to win bull First Prize Apple Watch Sport bull Second Prize $250 VISA Gift Card (Two)
bull Third Prize Fitbit Charge HR (Three)
Passports must be dropped off to the DIA Booth 1523 by 400pm on Wednesday June 17
The Medical Heroes Appreciation Walk organized by CISCRP (Center for Information and Study on Clinical Research Participation) on Monday morning brought over 250 people together in celebration of study volunteers and their gift of participation in clinical research
10 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
The DIA 2015 51st Annual Meeting offers a variety of over 250 education opportunities to help strengthen your understanding of the value of cross-discipline integration and to foster innovation for better health outcomes
Participants may receive up to 18 AMA PRA Category 1 Creditstrade 18 pharmacy contact hours or 18 con-tinuing education units (CEUs) 18 nursing contact hours 10 Project Man-agement Institute (PMI) professional development units or 24 International Association for Continuing Education and Training CEUs There are multiple program offering formats at the meet-ing including sessions forums work-shops symposia and one hour TURBO offerings Program offerings desig-nated for credit are clearly identified in the final program with the pertinent CME Pharmacy Nursing or PMI PDUs statements IACET CEUs are offered for all program offerings except that no continuing education credits are avail-able for the following offerings
bull Plenary Session and Keynote Addressbull Session 226 How Pharmaceutical Companies Can Engage Responsibly with Patients Online bull Session 246 Using Registries to Support Recruitment in Alzheimers Disease (AD) Prevention or Delay-of-Onset Studies bull Session 345 Power Up Give Your Brain a Breakbull Track 20 Innovation Theaterbull Track 21 Poster Presentations
Participants who would like to
Continuing Education at DIA 2015 51st Annual Meetingreceive continuing education credits for the Annual Meeting must scan their DIA name badge at each program offering to record hisher attendance Participants must scan their name badges within 45 minutes after the start time of each 15 hour program offering and within 30 minutes after the start time for the one hour TURBO offerings If a participant attends multiple offerings within the same time frame only the last scanned entry will be recorded Participants who do not scan their badge within the allotted time will not be eligible to request the available continuing education credits for that program offering
Evaluation Station ndash Your Opinion Counts
DIA will again utilize an online evaluation portal to obtain your feed-back on our program offerings You can access this portal at DIAglobalorgDIA2015evals Each evening dur-ing the Annual Meeting we will send an email to participants requesting their feedback on the offerings they attended that day
Beginning Tuesday June 16 there will also be an onsite Evaluation Sta-tion in the Attendee Registration Area (West Wing) for you to complete your evaluations while onsite Your feed-back is valued and we would really appreciate hearing from you
DIA will conduct a drawing with a chance for one participant to win a free registration to the DIA 2016 52nd Annual Meeting in Philadelphia PA Eligible participants must complete all
program offering evaluations from each educational offering they attended dur-ing the Annual Meeting time frame
DIA will also offer one winner a $100 American Express gift card from a ran-dom drawing of the participants who complete the Overall Evaluation form During the week of July 20 the winners will be announced and notified Dead-line for submitting evaluation feedback is Wednesday July 15 2015
All DIA 2015 51st Annual Meeting continuing education credit requests are processed through DIArsquos My Transcript DIArsquos My Transcript OPENS on Tuesday June 23 My Transcript allow you to request an Attendance Certificate or request CE credit(s) and download a statement of credit To ac-cess My Transcript
bull Login to My DIA at DIAglobalorgbull Enter your User ID and Passwordbull Select My Transcript from the
left side barbull Select DIA 2015 51st Annual Meeting Credit Requestbull Proceed to request an Attendance Certificate or CE credit for each offering and for each daybull Select the Credit Type or Attendance Certificate for each
offeringbull Select Continue after your credit request is completed for all requested offeringsbull Submitbull Print statement(s) of credit or Attendance Certificate All ACPE credit requests must be
submitted by Wednesday July 29 2015 so your request can be sub-mitted to the CPE Monitor Please have your NABP eProfile ID and DOB (MMDD) readily available when requesting ACPE credit If you need to obtain your NABP eProfile ID visit wwwcpemonitornet
MOBILIZE YOUR TRIAL WITH IN-HOME CLINICAL TRIAL VISITSbull Subject Conveniencebull Improves Recruitment Retention amp Compliancebull Access to Certified Mobile Research Nursesbull US amp Global Services
For RFPs or to request a capabilities presentation please contact infopcmtrialscom or call
888-628-9707 | DIA booth 2733
Our Certified Mobile Research Nurses
Set Us Apart
PCM Trials DIA Ad Half Page2015_v3indd 1 31015 518 PM
of New Drugs CDER
In Room 146C 291 CDRH Town Hall continues the Annual Meeting tra-dition of providing you with a unique opportunity to hear directly from the Director of the Center for Devices and Radiological Health (CDRH) on the state of CDRH and its vision for the future Specific topics include FDA-SIA accomplishments and activities 2017 MDUFA Reauthorization and the impact of the House Energy and Com-merce 21st Century Cures initiatives
the regulatory framework for labora-tory developed tests expedited path-ways development the future of next gen sequencing and innovative ap-proaches for companion diagnostics and personalized medicine human factors studies combination products regulation of mobile and web software applications and the impact of other new technologies on patient care
Chair Janet Jenkins-Showalter Senior Regulatory Group Director Regulatory Policy amp Intelligence Genentech A Member of the Roche Group
Panelists Jeffrey Shuren JD MD Director CDRH FDA Alberto Gutier-rez PhD Director Office of In Vitro Diagnostics amp Radiological Health CDRH and Jonette R Foy PhD Deputy Director for Engineering amp Sci-ence Review ODE CDRH
InnovationsContinued from Page 3
28th Annual EuroMeeting 6-8 April 2016 Hamburg GermanyDIAGlobalorgEuroMeeting
Save the date
DIA Europe Middle East amp AfricaKuumlchengasse 164051 Basel Switzerland
Flanked by DIA Globlal Chief Executive Barbara Lopez Kunz and Dr Per Spindler (DIA President and Chair Board of Directors) DIA welcomes our 2015 DIA Fellows Minnie Baylor-Henry RPh JD (Incoming Chair) Jennifer L Riggins PharmD Kenneth A Getz MBA and Noriaki Murao MS 2015 DIA Fellow Gaby Danan MD PhD was unable to attend
ldquoMy commitment to you at this meeting is to provide the environment that will help you seize the opportuni-ties that present themselves both here in Washington as we meet and moving forward as you return to your places of workrdquo she concluded ldquoSo I invite you to seize the opportunity that we have this week to take advantage of this lsquoone shotrsquordquo
Annual Meeting Co-Chair Christo-pher P Austin MD (Director National Center for Advancing Translational Sci-ences US National Institutes of Health) followed Barbara to the podium ldquoOur focus at NCATS is not on spe-cific diseases but on what is common among all diseasesrdquo he explained ldquoOur chosen field is remarkably if not painfully empirical because we donrsquot understand the general principles and thatrsquos what NCATS is all aboutrdquo
ldquoWe are fond of saying that transla-tional science is a team sportrdquo he said to introduce one such ldquoteamrdquo project The Tissue Chip for Drug Screening program a collaboration between the FDA and the Defense Advanced Research Projects Agency (DARPA) that has developed organ and organ systems on microchips for drug toxic-ity testing that doesnrsquot require animals or humans In the future these chips could include hormones for example to identify the difference between male and female response to drugs ldquoI really thought this was just science fiction ndash and I was wrongrdquo he confessed
ldquoOne of my favorite proverbs
comes from Japanese literature lsquoNone of us is as smart as all of usrsquo Solving the systemic and highly complex problems of translation will require that adage as a guiding principle and the DIA meeting this year promises to provide the perfect setting to establish and strengthen the connections that will help us all collectively develop innovate and advance to new solutionsrdquo he con-cluded
ldquoLike many of you this organization and its expanding influence have been essential to my lifersquos work in the phar-maceutical and biotechnology arenardquo said Per Spindler DVM MBA MSc (DIA President and Chair Board of Directors Director Biopeople Univer-sity of Copenhagen Denmark ldquoI was born in 1963 in Copenhagen the year before DIA was foundedrdquo
ldquoIn 2003 I was invited to become a member of the DIA Advisory Council of Europe and I was elected to the Board of Directors in 2007 In the recent past as member of the Board I have been instrumental in establishing our journal within therapeutic innova-tion and regulatory science ndash pro-fessional fields where DIA takes the global leadership You might say DIA and I have grown up togetherrdquo Per continued
ldquoBy the time DIA celebrates its 100th Anniversary our world will be a very different place shaped in part by the innovations that we will ad-vance here in Washington Review the program for this 51st meeting of DIA with its rich and diverse offerings and you will have no doubt that a trans-formational agenda for our industry is evolving You will also be convinced that DIA will be at the forefront of that transformationrdquo
ldquoLike Per I have greatly benefited from my association with DIA and this organization has been essential to my career and to the proficiencies I have developed in the regulatory science arenardquo began President-Elect San-dra A Milligan JD MD (Senior Vice President Global Regulatory Affairs amp Clinical Safety Merck Research Laboratories) ldquoIn 2013 I chaired the Annual Meeting in Boston and now I find myself grateful to you the mem-bership to be the next president of DIA starting July 1strdquo
ldquoOur organization brings people to-gether creating a rich mix of ideas of service to our professions and service to our patients DIA as an organization truly proves that the whole is greater than the sum of its partsrdquo Sandra concluded
Co-Chair Michael Rosenblatt MD
(Executive Vice President amp Chief Medical Officer Merck amp Co Inc) concluded the welcoming remarks ldquoDIA is the only place i know of where professionals from every aspect of RampD ndash from the laboratory to the patient ndash gather to learn and to share best practicesrdquo he began ldquoI see great value in the lively and massive ex-change of information and ideas that takes place here It illustrates some-thing i deeply believe all of us ndash and the patients we serve ndash are interde-pendentrdquo
ldquoThe patient has always been ndash and should always be ndash at the core of what we dordquo he continued ldquoBut todayrsquos patients are different They are better informed more independent more ac-tive and more engaged than ever They are interested in taking charge of their own care Many have organized them-selves into learning communitiesrdquo
ldquoLike any big social trend this renewed emphasis on the patient has created a new mindset that in turn has helped spawn exciting innova-tionsrdquo he concluded ldquoWe need only look at this conference agenda to see evidence of new and previously unlikely collaborations ndash all with re-newed focus on in the patient These are partnerships between academia industry practitioners payers and regulators aimed at speeding the ar-rival of urgently needed vaccines and cures targeting the right therapies to the right people and improving patient accessrdquo
Daniel Burrus (President amp CEO Burrus Research Associates Inc) opened his Keynote Address by refer-ring to DIA Annual Meeting attendees as ldquothe great enablersrdquo His energetic remarks encompassed the themes of collaboration and innovation through real-world and theoretical examples ldquoWe live in a world of amazing inno-vation right nowrdquo he began ldquoIn fact wersquore standing at the base of a moun-tain of innovationrdquo
Daniel presented innovation as the ability to anticipate and solve a problem before you actually have it ldquoKeeping up is a foolrsquos gamerdquo he said ldquoWho wants to keep up I want to jump aheadrdquo
ldquoWe say wersquore collaborating but are werdquo he asked ldquoAre you using your 4G phone to advance innovation or to watch Netflix Yoursquove already got amazing tools Are you underutilizing them Hint Yesrdquo
ldquoThe world needs yourdquo he said to close the Opening Plenary ldquoYoursquore the enablers of innovationrdquo
Annual Meeting Co-Chairs Dr Michael Rosenblatt (left) and Dr Christopher Austin (right) welcome attendees to the Opening Plenary
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
Global DevelopmentGlobal Launch
We Know How
Global IMPACT
PERFORMANCE DATA QUICKLIST
DEBUTING AT DIA 2015
Simplify study start-up and achieve unparalleled visibility into site performance with PDQ
Create custom performance analytics dashboards
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TO LEARN MORE
BOOTH 1020
3ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
PPD and HealthCore Collaborate to Deliver Enhanced Pre- and Post-approval Research Services
PPD and HealthCore have established a collaboration that will enable both companies to further expand their services in the pre- and post-approval research market with the aim of helping biopharmaceutical clients more quickly and cost effectively demonstrate how their products will perform and benefit patients in the real world
Through this collaboration PPD is combining its clinical trial design health economics and outcomes research (HEOR) medical affairs research and epidemiology services with HealthCorersquos strengths in HEOR innovative real-world research designs and its robust research-enabled electronic health care data environment
With the collaborative expertise of PPD and HealthCoremdashparticularly in planning designing and implementing pragmatic clinical trialsmdashthe companies hope to set a new standard for the quality cost and speed of real-world evidence generation that can help optimize patient outcomes and enable their clients to better demonstrate the true value of their products and the return on their investments in new product development
Representatives of PPD and HealthCore will be on hand throughout the DIA annual meeting at booth 2227 to discuss the collaboration further and answer any questions
For additional information go to wwwppdicom or wwwhealthcorecom
You might not have heard any recognizable sound but wersquore in the midst of a ldquobig bangrdquo ndash an explosion of wearable hardware gadgets and other new medical technologies that will if properly managed increase ways to connect people with re-search into these innovations and ways to connect these innovations with the people who most need them
Todayrsquos program features a special
Plenary Session that will illuminate the patient innovator industry and regu-latory perspective on these disrup-tions innovations opportunities and challenges 265 Disruptive Forces in Health Care Innovation Where Are They Leading Us in Room 143ABC at 130PM This panel discussion will explain the state of these technologies today and explore where they might take us tomorrow from a variety of perspectives
bull Jack Andraka the teenage scien-
tist who invented an early diagnostic test for pancreatic cancer will speak about the Innovator Role
bull Angela Dunn trends analyst healthiscool will describe the Wear-ables Role
bull Duane Schulthess MBA Manag-ing Director for VitalTransformation in Belgium will share the EU Perspective
bull Patricia Furlong BSN Found-ing President amp CEO Parent Project Muscular Dystrophy will present the Patient Role
Disruptive Forces in Health Care In-novation Where Are They Leading Us will be chaired by Jeffrey Kasher PhD President of Patients Canrsquot Wait LLC
Disruptive ldquoBig Bangrdquo in Health Care Innovation At 330PM today two sessions
will explore the expanding frontier of biomarkers companion diag-nostics combination products mHealth and web applications and related innovations that offer promise for increased return on investment in therapeutic product development
In Room 102AB 271 How Biomarkers Can Be Leveraged to Improve Return on Investment in Drug Development will explore how biomarkers appropriately used can facilitate earlier ldquono gordquo decisions reduce clinical trial costs improve your probability of success accel-erate drug development for faster time to market and even increase access to the drug once itrsquos on the market The Biomarker and Com-panion Diagnostic Lead Office of New Drugs CDER will offer the regulatory perspective on the utility
Innovations in Combinationsof biomarkers including the chal-lenges and best practices for drugtest codevelopment in clinical trial designs Other topics include the execution challenges associ-ated with incorporating biomarkers and companion diagnostics into a clinical program molecular imag-ing case studies and the benefits of imaging biomarkers in oncology clinical trials
Chair Eva Finney Director Global Project Management Merck amp Co Inc
Speakers Robert Scarimbolo Manager Molecular Imaging Bio-Clinica Rachel Yarger MBA PMP Senior Project Manager Luminex Corporation and Christopher Leptak MD PhD Biomarker and Companion Diagnostic Lead Office
(continued on page 10)
DIA 2015 Welcomes Patient Fellows
Twenty patient representatives chosen through a competitive pro-cess will develop strengthen and support their collaborations with poli-cymakers industry academia and health professionals here at our DIA Annual Meeting Meet these Patient Fellows in booth 1721 and follow DIA2015Patients for information updates
Pick up the Wednesday issue of the DIA Show Daily
to see additional DIA 2015 Patient Fellow
organizations
The 1st DIA China Drug Discovery Innovation Conference amp ExhibitionOctober 11-14 2015 Shanghai International Convention Center
This will be the 1st of a new annual offering specifically focused on the early stage of the drug discovery and development process The meeting will cover topics like drug design target discovery biology and chemistry lead optimization drug likeness translational medicine amp biomarker development DMPK and preclinical exploratory clinical trials and more A special Executive Forum and sessions on Chinese governmentrsquos innovation policies are also designed
Program Website httpen15951eventdovecom
4 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Selected Life Sciences Profes-sionals from all fields related to the mission of DIA will participate in this yearrsquos Professional Poster Program presented near Exhibit Hall Entrance A from 900AM-400PM New This Year Oral presentations where poster authors will deliver a five-minute over-view of their work
Tuesday Session 1A 930AMndash1030AM
T01 Assessing the Current Land-scape of Pharmaceutical Industry Post-Doctoral Fellowships Brittny Ann Rule PharmD MBA Rutgers The State University of New Jersey (Oral presentation at 935AM)
T02 Patient Knowledge of Safe Use of ERLA Opioid Analgesics Fol-lowing Implementation of the Class-Wide REMS Stephan Lanes PhD HealthCore Inc (Oral presentation at 942AM)
T03 Biosafety Gene Therapy Navigating the Regulatory Maze Chris Jenkins PhD MPH WIRB-Copernicus Group (Oral presentation at 949AM)
T04 Clinical Relevance and Utility of Boxed Warnings in US Prescrib-ing Information Christine M Cheng PharmD First Databank Inc (Oral presentation at 956AM)
T05 Advancing Medical Informa-tion Services To Impact Patient Care Collection Of Insights From Healthcare Practitioners Roshni Patel-Romero PharmD Genentech Usa Inc (Oral presentation at 1003AM)
T06 Impact of the Nonclinical Juvenile Animal Studies on Pediatric Medicines Information Dinah Duarte PharmD MSc INFARMED Portugual
T07 Steps on a Journey Re-Use of Analysis Scripts and Standardized Tuberculosis Trial Data Xin (Joy) Li FDA (Oral presentation at 1010AM)
T08 Can Social Listening be Used to Augment Existing Data Sources for Monitoring the Safety of Consumer Health Care Products James Blow-ers GlaxoSmithKline (Oral presenta-tion at 1017AM)
T09 Regulatory Gaps mdash Industryrsquos Perspectives on Asiarsquos Regulatory Au-thorities James Leong PhD MPharm Centre of Regulatory Excellence Duke-Nus Graduate Medical School Singapore
T10 Pharmacovigilance Industry Benchmarking on Global Methodolo-gies for Collecting and Processing Off-Label Use Reports Amanda Bowles Deloitte Consulting LLP (Oral presen-tation at 1024AM)
T11 The Case for Electronic Data Capture of Abdominal Pain in Crohnrsquos Disease A Comparison of Diary Meth-ods Leighann Litcher-Kelly PhD ERT
Tuesday Session 1B 1135AMndash132PM
T12 Feasibility of Replacing the Thorough QT (TQT) Study with Intense ECG Data Collection in Early Clinical Studies Nancy Wang PhD Celerion (Oral presentation at 1135AM)
T13 Assessing Bias in Adminis-trative Database Studies of Vaccine Completion Due to Excluding Sub-jects with Incomplete Follow-up Scott Charles Quinlan PhD HealthCore Inc (Oral presentation at 1142AM)
T14 Design and Development of an eCOA Specific Solution for Captur-ing Patient Data in Diabetes Clinical Trials Paul ODonohoe CRF Health United Kingdom (Oral presentation at 1149AM)
T15 Engage Patients with Innova-tive Global Digital Patient Platform Helen Lee Bristol-Myers Squibb Com-pany (Oral presentation at 1156AM)
T17 Utilizing Regional and National Student Recruitment Events to Maxi-mize Awareness of Post-PharmD Op-portunities in Industry Amy Monpara PharmD MCPHS University
T18 The Impact of the Establish-ment of Integrated Medicinal Product Review Office (IMPRO) in Taiwan Yan-Feng Chen Center for Drug Evalua-tion (CDE) Taiwan
T19 Drug Lag and Approval Time Metrics - Are They Good Markers to Assess the Global Regulatory Environ-ment Magdalena Bujar MSc Centre For Innovation In Regulatory Science (CIRS) United Kingdom (Oral presen-tation at 1203PM)
T20 Analyzing Global Recruit-ment Strategies to Improve Local Trial Enrollment - A Global Investigation Into ldquoWhat Works Whererdquo for Patient Recruitment and Retention Tools and Techniques Chris Frega MBA Quintil-es Inc (Oral presentation at 1210PM)
T21 Improving Hepatic-Impairment Patient Recruitement with a University Hospital Center-CRO Partnership A Benchmarking Analysis Rachida Es-salihi PhD Algorithme Pharma Inc Canada
T22 Monitoring Interactive Re-sponse Technology Vendor Imple-mented Randomization and Dosing Systems Jason McCoy MS Amgen Inc (Oral presentation at 1217PM)
T23 Evolution of a Unique Blend of Business Process and Technology to Enhance Medical Affairs Capabilities Manish Dave MBA MS Merck amp Co Inc (Oral presentation at 1224PM)
T24 Implementing CDISC Stan-dards in an Early Phase CRO Suc-cesses and Challenges Pascal Gui-bord Algorithme Pharma Inc Canada
T25 A Pitfall in the Clinical Study Enrollment of Postmenopausal Females Eunhee Chung SOUSEI-KAI Global Clinical Research Center Japan (Oral presentation at 1231PM)
T26 Survey of IRB Review of Urgent Patient Specific Protocols Bambi Grilley RPh RAC Baylor College of Medicine
T27 Lack of Inter-Ethnic Difference in QT-Susceptibility to Moxifloxacin Two Independent TQT Studies in Caucasian and Asian Populations Yang Wang FDA (Oral presentation at 1238PM)
T28 Implementing Quality Risk Management and Risk-Based Moni-toring Practical Guidelines from Sponsors and Sites Amita Malik MS Oracle Health Sciences (Oral presen-tation at 1245PM)
T29 Measurement Equivalence of the SF-36v2 on a Handheld Device and Smartphone App Susan M Dal-labrida PhD PHT Corporation (Oral presentation at 1252PM)
T30 How to Maximize Data Quality in Retrospective Chart Review Stud-ies Dara Stein MSc UBC An Ex-press Scripts Company Canada (Oral presentation at 1259PM)
T31 Benefit-Risk Assessments (BRAs) of an Established Productsrsquo Portfolio Rosa Piccirillo Patino-Paul MD IVAX (Oral presentation at 106PM)
T33 Results of An Online Survey of Stakeholders Regarding Barriers and Solutions to Clinical Trial Recruit-ment Elizabeth Mahon JD Janssen Research amp Development LLC (Oral presentation at 113PM)
T34 Process for Ensuring Clinical Trial Product Quality Janie B Rus-sell RAC National Institutes of Health (NIH) (Oral presentation at 120PM)
T42 Results Reporting to Clini-calTrialsgov and EudraCT - A Con-solidated Approach and First-hand Experiences Mathias Poensgen PhD ArisGlobal GmbH Germany (Oral presentation at 127PM)
Tuesday Session 1C 230ndash310 PM
T35 Attractiveness of PRO Mixed Modes ndash What are Patients Saying Jennifer Ross MEd MS Almac Clini-cal Technologies LLC (Oral presenta-tion at 235PM)
T36 Efficient and Innovative Clini-cal Trial Enrollment Using Online and Social Media Mark Joing MBA Nora Therapeutics (Oral presentation at 242PM)
T37 The Cost Effective Benefits of Behavioral Psychology on Improving Data Quality Shawn Levin Quintiles Transnational Corp (Oral presentation at 249PM)
T38 An Approach to Aggregate Safety Reporting of Drug and Device Constituent Parts of Combination Prod-ucts Xaymara Roman RN AbbVie Inc (Oral presentation at 256PM)
T39 Analyzing the Relative Recruit-ment Performance between Highly-Uti-lized and Low-Utilized Sites in 5 TAs in 4 Asian Countries Hyunjoo Rhee MPharm Quintiles Transnational Ko-rea Co Ltd Republic of Korea
T40 How IDMP Can Help Struc-ture Product Information Labeling Romuald Braun uanotau Switzerland (Oral presentation at 303PM)
Winning with DIAAttendees who registered for our Annual Meeting before May 14 were
entered into a random raffle drawing for a pair of tickets to see the Washing-ton Nationals play the Tampa Bay Rays on Wednesday June 17 at Nationals Park Congratulations to Dr Atif Abbas (Medical Director US Drug Safety Merck Serono) and Julie Townsend (Associate Director Regulatory Opera-tions Upsher-Smith Laboratories Inc) each of whom picked up a pair of tickets from the DIA booth for tomorrow nightrsquos ballgame
a
Click to explore the April issue
Yoursquove never seen a Global Forum like this
Click to explore the June issue
5ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Exhibiting As Booth4C Pharma Solutions LLC 1138
A-B-CAccell Clinical Research 2439Accenture 1015Accenture Business Suite 7Accovion GmbH 1344ACM Global Central Laboratory 2221ACRP 1654Acurian Inc 2235ADAMAS Consulting LLC 2644Adaptive Clinical Systems 627Advanced Clinical 1308Aerotek 1100AiCure 1235Alfresco Software Inc 753Almac 2435American Medical Writers Association 1526Ancillare LP 642APCER Pharma Solutions Inc 1545Applied Clinical TrialsPharmaceutical Executive 520ArisGlobal 2409ArisGlobal Business Suite 4Arivis 1045Arriello Ireland Limited 1457Artcraft Health 1848Asia CRO Alliance 1245Association of Biotechnology Led Enterprises ndash ABLE 1127August Research 1320Auxiliis 1238Axiom Real-Time Metrics Inc 2311BARC Global Central Laboratory 1901Barrington James 2052BBK Worldwide 2026Beijing Clinical Service Center 2640Benchmark Research 516BioClinica 1325Biomedical Systems 619BioPharm Insight 1601BioPharma Investigator 1011BioPoint Inc 2713BioPoint Inc Business Suite 5Biorasi 524bioskin GmbH 1220BioTelemetry Research (Formerly Cardiocore) 1411BIOVIA 2321Blinded Diagnostics 2735Bracket 711CAC EXICARE Corporation 1057CAHG 1142Camargo Pharmaceutical Services 1927Cambridge Healthtech Institute 639Cambridge Semantics Incorporated 1255Cancer Insight 641Canfield Scientific Inc 534Cardinal Health 1104Cardiovascular Imaging Technologies 2622Cardiovascular Research Foundation 857Catalent 2113CDISC 1849Celerion 1301Cenduit LLC 538Center for Information and Study on Clinical Research Participation (CISCRP) 2440Chesapeake IRB 1739Chexx Inc 1244Chiba University Hospital 2352Chiltern International Inc 827
DIA Exhibitor List and Floor Plan DIA 2015 Annual Meeting
Washington DC
Cincinnati Childrenrsquos Research Foundation 1322Citeline Inc 2003CITI Program - University of Miami 1802CitiusTech Inc 1906Clariness 2738CleverCap 2057ClinDatrix Inc 1002ClinEdge LLC 1845Clinical amp Contract Research Association (CCRA) 1208Clinical Ink 2011Clinical Practice Research Datalink (CPRD) 1052Clinical Reference Laboratory 2316Clinical Research Malaysia 2648ClinicalRM 2442Clinitude 2252Clinlogix 1003ClinPlusDZS Clinical Services 1610ClinTec International Ltd 1118Clinverse Inc 1703CluePoints Inc 1511Cmed Clinical Services 752CMIC HOLDINGS Co Ltd 935Cognizant Technology Solutions 2741Compass IRB 2016Compass Research LLC 2349CompleWare 620Complion 2545Comprehend Systems 2511Content Analyst Company 956Continuum Clinical 2343Contract Pharma 643ConvergeHEALTH by Deloitte 811ConvergeHEALTH by Deloitte Business Suite 2Conversis 2253CoSign by ARX 744Cote Orphan Consulting LLC 1544Court Square Group IncRegDocs365 2157Covance Inc 1835Covigilant 2726CRF Health 2427CRO Analytics 1656CROMSOURCE 1345CROS NT 1111CSSi 1811CTI Clinical Trial amp Consulting Services 1915Cu-Tech LLC 1121Cytel Inc 1611
D-E-FDAC 2327Data Matrix 2005DataArt 2639Datapharm Australia Pty Ltd 625DATATRAK International Inc 803DaVita Clinical Research 738DBMS Consulting 2744DIA 1523DIA Patient Advocate Fellowship 1721DITA Exchange 2419
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Pull-Out
Section
Dora Wirth (Languages) Ltd 1212Dr Ebeling amp Assoc GmbH 1302DrugDev 820DSG Inc 719d-Wise Technologies 1402EastHORN Clinical Services in CEE Ltd 2109eClinicalHealth Ltd 510EDETEK Inc 1855Elite Research Network LLC 1206EMB Statistical Solutions LLC 1014endpoint 927Enforme Interactive 1249ENNOV 1145Entimo AG 2220ePharmaSolutions 734EPS Holdings Inc 905ERT 2000ERT 2025Eurofins 2540European Medicines Agency 1528EUROTRIALS 1815Everest Clinical Research 2048Exco InTouch 2212ExecuPharm Inc 1043ExL Pharma 1907Exostar 1749Experis Clinical Practice 2423Exponent 742EXTEDO Inc 2519Falcon Consulting Group 727FDA CDER 1729FDAnews 2621Flex Databases 1312Foresight Group International AG 2339Formedix Inc 1223Frenova Renal Research 1004Fresenius Medical Care North America 2441Frontage Labs 2520
G-H-IGA International Inc 1256Galderma Research amp Development LLC 1851GCP ClinPlus Co Ltd 542Genpact Pharmalink 2541GenPro International 2749Gilead Sciences Inc 1056Global Center of Excellence in Clinical Trials Asan Medical Center 1651Global Center of Excellence in Clinical Trials Inje University Busan Paik Hospital 1651Global Center of Excellence in Clinical Trials Samsung Medical Center 1651Global Center of Excellence in Clinical Trials Yonsei University Health System 1651Global Institute For Research 1207Global Instrumentation LLC 1556Global Language Solutions 723GlobalCare Clinical Trials LTD 2729goBalto Inc 1241GP Strategies 1306
(continued on page 6)
6 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
(continued from page 5)
Parties amp Events
Giveaway Guide
Food amp Drink
Sights
TransportationBrought to you by BioClinica
KAI Research Inc 2740KCR 2722KCRN MampC 1945KellyOCG 1035Klein Hersh International 2034KlinEra Global Services 2110KoNECT 1651Korea Clinical Trials Global Initiative (KCGI) 1651Kuantum CRO and Logistics 1019LabAnswer 2155LabConnect LLC 911LabCorp 1835Lambda Therapeutic Research Inc 2105Langland 2046Launchpad 543Life Science Leader 2623Linical USA 2720Lionbridge Technologies 1246LMK Clinical Research Consulting 645Longboat Clinical Ltd 612LORENZ Life Sciences Group 1427Lovelace Scientific Resources 923Luto Research Limited 1213
M-N-O MakroCare 2618Mapi 754MASIMO 1340Massachusetts College of Pharmacy and Health Sciences 2153MasterControl 1809MaxisIT Inc 2535McGuire Research Institute 2107
MDCPartners 2449Med Fusion 1140MedDATA Foundation 755MedDRA MSSO 1009Medical Research Network Ltd 854Medical Vigilance Solutions Cincinnati Childrenrsquos 1039Medicines Evaluation Unit 1210Medidata Solutions Worldwide 2641Medidata Solutions Inc 2201MEDIX 1846MedNet Solutions Inc 1838Medpace Inc 1801MedPoint Digital Inc 2517Medrio Inc 1202MedSource 1935MedTrials 1346Merge eClinical 2209MESM Ltd 2042META Solutions Inc 2021MMG 2534MNX Global Logistics 1914MonitorForHirecom 1421Montrium Inc 2106Morningside Translations 1953Mortara Instrument Inc 729National Death Index 518NCGS Incorporated 2611NeoGenomics Laboratories 1251Neuroscience Trials Australia 2627New Orleans Center for Clinical Research 728Next Phase Research 2637NextDocs 2038Nextrials Inc 2717NIPER Hyderabad 1127
Green Key Resources 1947Greenphire 613Greens LTD 2156Guangzhou KingMed Center for Clinical Laboratory Co Ltd 2538HampJ CRO International Inc 2646Hangzhou Tigermed Consulting Co Ltd 746HCL America Inc 1635Health Decisions Inc 821HealthCarePoint 1757Hurley Consulting Associates Ltd 955Hurley Write Inc 2727Hydrogen International Ltd 1955iCardiac Technologies 2102ICON plc 503IDT Australia 1746ImageIQ Imaging CRO 1227IMS Health 1317Inamed GmbH 529INC Research 2303Industry Standard Research 725Informa Business Information 2354Information Builders Inc 1853Infotehna Inc 1444Innovative Print amp Media Group 1354InnovoCommerce LLC 1747Integrated Clinical Systems Inc 901Integrated Development Associates Co Ltd 1047IntegReview IRB 2420INTERLAB GmbH central lab services worldwide 1425International Dermatology Research Inc 1538Interspond LLC 2547Intertek Scientific amp Regulatory Consultancy 2516Intralinks Inc 1822inVentiv Health 1517Investigational Cancer Therapeutics - MD Anderson 1546IPHARMA ChemDiv 521
NNIT 2254Norav Medical 514Nova Language Services Ltd 1209Novella Clinical 1439November Research Group 2218Novotech 1134NSF Health Sciences 1847Nuventra Pharma Sciences 824Ocasa Logistics Solutions 2036Ohio Clinical Trials Collaborative 2442OmniComm Systems Inc 2135Online Business Applications 1314OpenClinica 635Optum 1826Oracle Health Sciences 1819Orlando Clinical Research Center 2208Otto Trading Inc 1018
P-Q-RPacific Bridge Medical 2446Palm Beach CRO 1804Paragon International Inc 1403Paragon Solutions 2204
Parallel6 1957PAREXEL International 1535PCM TRIALS 2733Pennside Partners Ltd 2518PerkinElmer Inc 513Personify 1756Pharma Start 1148Pharmaceutical eConsulting 1650Pharmaceutical Outsourcing Hall A EntrancePharmaceutical Packaging Professionals Pty Ltd 2120Pharmaceuticals and Medical Devices Agency (PMDA) 1520Pharmaceuticals Export Promotion Council of India 1127PharmApprove 2054PharmaQuest Ltd 1348PharmaSeek Companies 822PharmaSys Inc 2438PharmaVOICE 1001Pharm-Olam International Ltd 919Phlexglobal Inc 2007Pilgrim Quality Solutions 2044Planet Pharma 1149PleaseTech Ltd 1114Polar Leasing Company Inc 546Popsi Cube 539Porzio Life Sciences 1055PPD 2227PQE 1054PRA Health Sciences 1501Praxis Communications LLC 629Precision for Medicine 1351Premier Research 1711Pretium 1010
PrimeVigilance 2347PRL Central Laboratory Services 1423Proforma Giraffe Graphics Inc 2549Projecis Inc 1645PROSAR 2206Proteus Digital Health Inc 2255ProTrials Research Inc 1108PSKW LLC 1053Pyxant Labs Inc 1950Q2 Business Intelligence 1449QPS LLC 1307Quality and Compliance Consulting Inc 2417Quality Associates Inc 1607Quanticate Inc 1334QuantifiCare 527Queensland Clinical Trials Network 1000Quest Diagnostics 2628Quintiles 601Quorum Review IRB 1219Radiant Research Clinical Research Advantage 2112Randstad Pharma 2715Real Staffing Group 2620RegCheck 955Regeneron Pharmaceuticals 638Regxia Inc 1949Research Across America 2728ReSolution Latin America 2421Rho Inc 724RR Donnelley 2626RWS Group - Medical Translation Division 1350Rx Trials Inc 1400RxLogix Corporation 2521
S-TSan Diego State University - Regulatory Science Programs 1524SanaClis sro 541SAS Institute Inc 2127SAS Institute Inc JMP Division 1744Scarritt Group Inc 1844Schlafender Hase Inc 2012Schulman Associates IRB 1020SeaView Research 1944Sharp Clinical Services 1305Sidus Biodata 1745Signix Inc 2739SNBL Clinical Pharmacology Center 2448Society for Clinical Research Sites - SCRS 1548Sonic Clinical Trials 1010SOUSEIKAI Global Clinical Research Center 1946Southern California Research 2721Southern Star Research 1702Sparta Systems 826Spaulding Clinical Research 2217Speaking Books 1605SPRI Clinical Trials - Global 1021Springer 526Statistics amp Data Corporation (SDC) 1704Stefanini 2723Sterling IRB 2010Stiris Research Inc 1707Symbio LLC 1700Symogen 1856Symphony Clinical Research 2422Synchrogenix Information Strategies Inc 1105Syngene International Ltd 1127Synowledge 1540Syntel Inc 1157SynteractHCR 1335Target Health Inc 2527Tarius AS 1103Tata Consultancy Services 1909Technical Resources International Inc 1913Technology Catalysts International 2447Techorizon 1347TechSol Corporation 2642Telerx 735Teuteberg Incorporated 1948TFDA Center for Drug Evaluation Taiwan 1522
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
8 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Thatrsquos Nice LLC 1240The Clinical Resource Network 1318The Geneva Foundation 2548The Patient Recruiting Agency 2119Theorem Clinical Research 511Theorem Clinical Research Business Suite 1Therapak Corporation 1005Therapeias Health Management 641Therapeutics Inc 1341Thomson Reuters 1440ThreeWire Inc 1939TKL Research Inc 2202Total Clinical Trial Management 2725Total Root Concepts Inc 523TrakCel Limited 2747TransPerfect 1025Trial Runners 2742Trievr Inc 2103Trifecta 1921
U-V-WUBC 2401Unanet 1152University of Florida 1551University of Maryland Online MS in Regulatory Science 1147University of the Sciences 852University of Utah Clinical Trials Office 1725Uppsala Monitoring Centre 2426UTMB Sealy Center for Vaccine Development 1657Valesta Clinical Research Solutions 2629Validated Cloud 2056Veeva Systems Inc 1203Verified Clinical Trials 1109Veristat Inc 1941
(continued from page 7)
Vigilare International 1141Vince amp Associates Clinical Research 748Viracor-IBT Laboratories 2546Viroclinics Biosciences 547VirtualScopics 2320Vitalograph Inc 1406Voluntis 1447WCCT Global 2121WebbWrites LLC 953Whitsell Innovations Inc 626Wincere Inc 1144Wingspan Technology Inc 1445WIRB-Copernicus Group 701Women in Life Sciences - WILS 1356Woodley Equipment Company 1215Worldwide Clinical Trials 1311
TKL Research is an international CRO offering expertise in a full spectrum of indications as well as clinical trial management services from Phase 1 to multicenter international studies TKL serves the pharmaceutical biotech generic drug medi-cal device OTC and consumer health care indus-tries The leader in dermatological research TKL has performed over 200 dermatological clinical trials and is unrivaled in the number of dermato-logical safety studies TKL also has significant ex-perience in Phase 1-4 multinational clinical trials and differentiates itself from the competition with a strong Phase 1 safety capability and full service CRO combined into one cohesive organization
QuintilesBooth 601wwwquintilescomcareers
Quintiles CareersQuintiles is the worldrsquos largest provider of
biopharmaceutical development and commercial outsourcing services and wersquod like to meet you Please stop by the Marriott Marquis Hotel to hellip
ATTEND OUR COCKTAIL RECEPTION in the Chinatown Meeting Room
bull Monday June 15th from 6pm - 8pm
MEET OUR RECRUITING TEAM from Immunol-ogy and Internal Medicine in the Judiciary Square Meeting Room
bull Monday June 15th from 2pm - 5pmbull Tuesday June 16th from 9am - 7pmbull Wednesday June 17th from 9am - 7pm
Improve your probability of successtrade
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Your Opinion MattersComplete an evaluation for each offering
you attend for a chance to win great prizes
Access online evaluations at DIAGlobalorgDIA2015evals or stop by Evaluation Stations in the Registration
Area beginning Tuesday
Free registration to the DIA 2016 52nd Annual Meeting
$100 American Express Gift Card
Discover Safety around the World
ldquoGlobal production of FDA-regulated goods has exploded over the past ten years In addi-tion to an increase in imported finished prod-ucts manufacturers increasingly use imported materials and ingredients in their US produc-tion facilities making the distinction between domestic and imported products obsoleterdquo said FDA Commissioner Dr Margaret A Ham-burg upon the release of the FDA 2011 report Pathway to Global Product Safety and Quality ldquoThe FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face The FDA must further collaborate and leverage in order to close the gap between our import levels and our regula-tory resourcesrdquo she concluded
At 1030AM today staff from FDArsquos interna-tional posts in China Europe and India will provide exclusive updates from their respec-tive posts in Session 245 FDArsquos International Posts International Efforts Regulatory System Strengthening and Inspections presented in Room 152A Their updates will include out-reach to foreign regulators facility inspections risk-based global surveillance to protect supply chains and related topics
Chair Leslie Ball MD Assistant Commis-sioner and Deputy Director OIP OC FDA
Update from the FDA China Office S Leigh Verbois PhD Incoming Director China Office Office of International Programs OC FDA
Update from the FDA India Office Mathew T Thomas MD Acting Country Director India Of-fice Office of International Programs OC FDA
Update from the FDA European Office Donald Prater DVM Acting Regional Director Europe Office OIP OC FDA
9ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Route 1 Red Hotel Pickup LocationJW Marriott E Street EntranceGrand Hyatt 11th Street EntranceMarriott Metro Center At Hyatt 11th Street Entrance
Route 2 Yellow Hotel Pickup LocationHamilton Crown Plaza Lobby EntranceDonovan House Lobby EntranceWashington Plaza Curbside Vermont mdash Near DrivewayComfort Inn Convention Center At Washington Plaza Curbside Vermont
Route 3 Blue Hotel Pickup LocationLoews Madison Lobby EntranceWestin Washington At Loews Madison Lobby EntranceDoubletree Washington Lobby EntranceHotel Helix At Doubletree Lobby EntranceMayflower Renaissance Desales Street Entrance
Hotels within walking distance of the Walter E Washington Convention Center are Embassy Suites Convention Center Hampton
Inn Henley Park Hotel Morrison-Clark Inn Renaissance Washington DC Downtown Hotel and Marriott Marquis
Tuesday June 16 through Wednesday June 17Hours Frequency 645-930AM 15 Minutes930AM-330PM No Service330-630PM 15 MinutesLast Bus Departs Hotels 530PM
Thursday June 18 Hours Frequency 730-900AM 15 Minutes900AM-1230pm 30 MinutesLast Bus Departs Hotels 1130AM
For Shuttle Information or to Pre-Schedule ADA Pick-up call 877-865-3437 during convention shuttle hours
Complimentary Shuttle InformationPlease allow up to 20 minutes (including waiting and riding time under nor-mal peak traffic conditions) to travel from your hotel to the Walter E Wash-ington Convention Center located on Mount Vernon Place Delays may occur due to circumstances beyond our control
Discover tomorrowrsquos solutions to to-dayrsquos challenges through the products and services showcased in todayrsquos Innovation Theater sessions presented near Exhibit Hall Entrance B
945AM 225 Covance Innovation Theater Advances in Risk-Based Mon-itoring Transforming Drug Develop-ment Through Efficient Workflows Big Data and Elegant Software Discover Covancersquos risk-based monitoring (RBM) platform which provides clients with best-in-class implementation of the RBM principles put forth by FDA EMA and TransCelerate and facilitates RBM through timely secure and inte-grated access to all relevant trial data
1200PM 249 Quintiles Innova-tion Theater Transform Clinical De-velopment ndash Modernizing for Smarter Trials Because of our imperative to ldquomodernizerdquo clinical trials to de-liver medicines faster at less cost to patients who need them learn how you can gauge global capabilities to model and predict better outcomes identify appropriate investigator sites and deliver faster ldquoanalysis-readyrdquo data to identify trends and issues in near real time
100PM 250 Veeva Innovation Theater 2015 Paperless Trial Master File (TMF) Survey Trends and Insights Results from the follow-up to Veevarsquos benchmark 2014 Paperless TMF Sur-vey which analyzed the observations of TMF owners to identify the barriers business drivers and benefits of mov-ing to fully paperless TMFs How does your organization compare and why do some organizations benefit more than others
300PM 267 BBK Worldwide Innovation Theater mHealth A New Era in Patient Engagement BBK Worldwide and mHealth experts from the Landon Pediatric Foundation and CareThings discuss opportunities for patient engagement in clinical trials within mHealth and how advance-ments in apps wearables and per-sonalized content delivery are shaping a new patient engagement model and impacting the entire clinical research enterprise
See Innovation in Action Innovation Theater
We ask all Annual Meeting speak-ers to please check in at the Speaker Registration Desk when you arrive at the Convention Center to pick up your name badge Speaker registration will be open today from 700AMndash500PM The Speaker Preparation Room will also be open from 700AMndash500PM to-day this is where you will confirm that your presentation has been properly uploaded
A Speaker Training Room is also available for you to practice your pre-sentation alone or with your fellow pre-senters Please schedule your practice time when you check in at the Registra-tion Desk This Training Room will host a special Speaker Training Session coaching on podium presentation best practices from 945-1015AM today
The Speaker Registration Desk Speaker Preparation Room and Speaker Training Room are all located in the East Registration area
We ask all speakers to arrive at their assigned room 20 minutes before
Speaker Registration amp Preparationyour session scheduled start time to confirm that the proper visual presen-tation is loaded on the session room computer You cannot upload or edit your presentations in the session room you may do so however in the Speaker Preparation Room We also recommend that you carry an elec-tronic copy (via USB) of your presen-tation for backup purposes
Exhibitor PassportVisit our Exhibitors to hear about their products and services You must have 50 Exhibitors sign your card found in your attendee bag to be eligible to win bull First Prize Apple Watch Sport bull Second Prize $250 VISA Gift Card (Two)
bull Third Prize Fitbit Charge HR (Three)
Passports must be dropped off to the DIA Booth 1523 by 400pm on Wednesday June 17
The Medical Heroes Appreciation Walk organized by CISCRP (Center for Information and Study on Clinical Research Participation) on Monday morning brought over 250 people together in celebration of study volunteers and their gift of participation in clinical research
10 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
The DIA 2015 51st Annual Meeting offers a variety of over 250 education opportunities to help strengthen your understanding of the value of cross-discipline integration and to foster innovation for better health outcomes
Participants may receive up to 18 AMA PRA Category 1 Creditstrade 18 pharmacy contact hours or 18 con-tinuing education units (CEUs) 18 nursing contact hours 10 Project Man-agement Institute (PMI) professional development units or 24 International Association for Continuing Education and Training CEUs There are multiple program offering formats at the meet-ing including sessions forums work-shops symposia and one hour TURBO offerings Program offerings desig-nated for credit are clearly identified in the final program with the pertinent CME Pharmacy Nursing or PMI PDUs statements IACET CEUs are offered for all program offerings except that no continuing education credits are avail-able for the following offerings
bull Plenary Session and Keynote Addressbull Session 226 How Pharmaceutical Companies Can Engage Responsibly with Patients Online bull Session 246 Using Registries to Support Recruitment in Alzheimers Disease (AD) Prevention or Delay-of-Onset Studies bull Session 345 Power Up Give Your Brain a Breakbull Track 20 Innovation Theaterbull Track 21 Poster Presentations
Participants who would like to
Continuing Education at DIA 2015 51st Annual Meetingreceive continuing education credits for the Annual Meeting must scan their DIA name badge at each program offering to record hisher attendance Participants must scan their name badges within 45 minutes after the start time of each 15 hour program offering and within 30 minutes after the start time for the one hour TURBO offerings If a participant attends multiple offerings within the same time frame only the last scanned entry will be recorded Participants who do not scan their badge within the allotted time will not be eligible to request the available continuing education credits for that program offering
Evaluation Station ndash Your Opinion Counts
DIA will again utilize an online evaluation portal to obtain your feed-back on our program offerings You can access this portal at DIAglobalorgDIA2015evals Each evening dur-ing the Annual Meeting we will send an email to participants requesting their feedback on the offerings they attended that day
Beginning Tuesday June 16 there will also be an onsite Evaluation Sta-tion in the Attendee Registration Area (West Wing) for you to complete your evaluations while onsite Your feed-back is valued and we would really appreciate hearing from you
DIA will conduct a drawing with a chance for one participant to win a free registration to the DIA 2016 52nd Annual Meeting in Philadelphia PA Eligible participants must complete all
program offering evaluations from each educational offering they attended dur-ing the Annual Meeting time frame
DIA will also offer one winner a $100 American Express gift card from a ran-dom drawing of the participants who complete the Overall Evaluation form During the week of July 20 the winners will be announced and notified Dead-line for submitting evaluation feedback is Wednesday July 15 2015
All DIA 2015 51st Annual Meeting continuing education credit requests are processed through DIArsquos My Transcript DIArsquos My Transcript OPENS on Tuesday June 23 My Transcript allow you to request an Attendance Certificate or request CE credit(s) and download a statement of credit To ac-cess My Transcript
bull Login to My DIA at DIAglobalorgbull Enter your User ID and Passwordbull Select My Transcript from the
left side barbull Select DIA 2015 51st Annual Meeting Credit Requestbull Proceed to request an Attendance Certificate or CE credit for each offering and for each daybull Select the Credit Type or Attendance Certificate for each
offeringbull Select Continue after your credit request is completed for all requested offeringsbull Submitbull Print statement(s) of credit or Attendance Certificate All ACPE credit requests must be
submitted by Wednesday July 29 2015 so your request can be sub-mitted to the CPE Monitor Please have your NABP eProfile ID and DOB (MMDD) readily available when requesting ACPE credit If you need to obtain your NABP eProfile ID visit wwwcpemonitornet
MOBILIZE YOUR TRIAL WITH IN-HOME CLINICAL TRIAL VISITSbull Subject Conveniencebull Improves Recruitment Retention amp Compliancebull Access to Certified Mobile Research Nursesbull US amp Global Services
For RFPs or to request a capabilities presentation please contact infopcmtrialscom or call
888-628-9707 | DIA booth 2733
Our Certified Mobile Research Nurses
Set Us Apart
PCM Trials DIA Ad Half Page2015_v3indd 1 31015 518 PM
of New Drugs CDER
In Room 146C 291 CDRH Town Hall continues the Annual Meeting tra-dition of providing you with a unique opportunity to hear directly from the Director of the Center for Devices and Radiological Health (CDRH) on the state of CDRH and its vision for the future Specific topics include FDA-SIA accomplishments and activities 2017 MDUFA Reauthorization and the impact of the House Energy and Com-merce 21st Century Cures initiatives
the regulatory framework for labora-tory developed tests expedited path-ways development the future of next gen sequencing and innovative ap-proaches for companion diagnostics and personalized medicine human factors studies combination products regulation of mobile and web software applications and the impact of other new technologies on patient care
Chair Janet Jenkins-Showalter Senior Regulatory Group Director Regulatory Policy amp Intelligence Genentech A Member of the Roche Group
Panelists Jeffrey Shuren JD MD Director CDRH FDA Alberto Gutier-rez PhD Director Office of In Vitro Diagnostics amp Radiological Health CDRH and Jonette R Foy PhD Deputy Director for Engineering amp Sci-ence Review ODE CDRH
InnovationsContinued from Page 3
28th Annual EuroMeeting 6-8 April 2016 Hamburg GermanyDIAGlobalorgEuroMeeting
Save the date
DIA Europe Middle East amp AfricaKuumlchengasse 164051 Basel Switzerland
Flanked by DIA Globlal Chief Executive Barbara Lopez Kunz and Dr Per Spindler (DIA President and Chair Board of Directors) DIA welcomes our 2015 DIA Fellows Minnie Baylor-Henry RPh JD (Incoming Chair) Jennifer L Riggins PharmD Kenneth A Getz MBA and Noriaki Murao MS 2015 DIA Fellow Gaby Danan MD PhD was unable to attend
ldquoMy commitment to you at this meeting is to provide the environment that will help you seize the opportuni-ties that present themselves both here in Washington as we meet and moving forward as you return to your places of workrdquo she concluded ldquoSo I invite you to seize the opportunity that we have this week to take advantage of this lsquoone shotrsquordquo
Annual Meeting Co-Chair Christo-pher P Austin MD (Director National Center for Advancing Translational Sci-ences US National Institutes of Health) followed Barbara to the podium ldquoOur focus at NCATS is not on spe-cific diseases but on what is common among all diseasesrdquo he explained ldquoOur chosen field is remarkably if not painfully empirical because we donrsquot understand the general principles and thatrsquos what NCATS is all aboutrdquo
ldquoWe are fond of saying that transla-tional science is a team sportrdquo he said to introduce one such ldquoteamrdquo project The Tissue Chip for Drug Screening program a collaboration between the FDA and the Defense Advanced Research Projects Agency (DARPA) that has developed organ and organ systems on microchips for drug toxic-ity testing that doesnrsquot require animals or humans In the future these chips could include hormones for example to identify the difference between male and female response to drugs ldquoI really thought this was just science fiction ndash and I was wrongrdquo he confessed
ldquoOne of my favorite proverbs
comes from Japanese literature lsquoNone of us is as smart as all of usrsquo Solving the systemic and highly complex problems of translation will require that adage as a guiding principle and the DIA meeting this year promises to provide the perfect setting to establish and strengthen the connections that will help us all collectively develop innovate and advance to new solutionsrdquo he con-cluded
ldquoLike many of you this organization and its expanding influence have been essential to my lifersquos work in the phar-maceutical and biotechnology arenardquo said Per Spindler DVM MBA MSc (DIA President and Chair Board of Directors Director Biopeople Univer-sity of Copenhagen Denmark ldquoI was born in 1963 in Copenhagen the year before DIA was foundedrdquo
ldquoIn 2003 I was invited to become a member of the DIA Advisory Council of Europe and I was elected to the Board of Directors in 2007 In the recent past as member of the Board I have been instrumental in establishing our journal within therapeutic innova-tion and regulatory science ndash pro-fessional fields where DIA takes the global leadership You might say DIA and I have grown up togetherrdquo Per continued
ldquoBy the time DIA celebrates its 100th Anniversary our world will be a very different place shaped in part by the innovations that we will ad-vance here in Washington Review the program for this 51st meeting of DIA with its rich and diverse offerings and you will have no doubt that a trans-formational agenda for our industry is evolving You will also be convinced that DIA will be at the forefront of that transformationrdquo
ldquoLike Per I have greatly benefited from my association with DIA and this organization has been essential to my career and to the proficiencies I have developed in the regulatory science arenardquo began President-Elect San-dra A Milligan JD MD (Senior Vice President Global Regulatory Affairs amp Clinical Safety Merck Research Laboratories) ldquoIn 2013 I chaired the Annual Meeting in Boston and now I find myself grateful to you the mem-bership to be the next president of DIA starting July 1strdquo
ldquoOur organization brings people to-gether creating a rich mix of ideas of service to our professions and service to our patients DIA as an organization truly proves that the whole is greater than the sum of its partsrdquo Sandra concluded
Co-Chair Michael Rosenblatt MD
(Executive Vice President amp Chief Medical Officer Merck amp Co Inc) concluded the welcoming remarks ldquoDIA is the only place i know of where professionals from every aspect of RampD ndash from the laboratory to the patient ndash gather to learn and to share best practicesrdquo he began ldquoI see great value in the lively and massive ex-change of information and ideas that takes place here It illustrates some-thing i deeply believe all of us ndash and the patients we serve ndash are interde-pendentrdquo
ldquoThe patient has always been ndash and should always be ndash at the core of what we dordquo he continued ldquoBut todayrsquos patients are different They are better informed more independent more ac-tive and more engaged than ever They are interested in taking charge of their own care Many have organized them-selves into learning communitiesrdquo
ldquoLike any big social trend this renewed emphasis on the patient has created a new mindset that in turn has helped spawn exciting innova-tionsrdquo he concluded ldquoWe need only look at this conference agenda to see evidence of new and previously unlikely collaborations ndash all with re-newed focus on in the patient These are partnerships between academia industry practitioners payers and regulators aimed at speeding the ar-rival of urgently needed vaccines and cures targeting the right therapies to the right people and improving patient accessrdquo
Daniel Burrus (President amp CEO Burrus Research Associates Inc) opened his Keynote Address by refer-ring to DIA Annual Meeting attendees as ldquothe great enablersrdquo His energetic remarks encompassed the themes of collaboration and innovation through real-world and theoretical examples ldquoWe live in a world of amazing inno-vation right nowrdquo he began ldquoIn fact wersquore standing at the base of a moun-tain of innovationrdquo
Daniel presented innovation as the ability to anticipate and solve a problem before you actually have it ldquoKeeping up is a foolrsquos gamerdquo he said ldquoWho wants to keep up I want to jump aheadrdquo
ldquoWe say wersquore collaborating but are werdquo he asked ldquoAre you using your 4G phone to advance innovation or to watch Netflix Yoursquove already got amazing tools Are you underutilizing them Hint Yesrdquo
ldquoThe world needs yourdquo he said to close the Opening Plenary ldquoYoursquore the enablers of innovationrdquo
Annual Meeting Co-Chairs Dr Michael Rosenblatt (left) and Dr Christopher Austin (right) welcome attendees to the Opening Plenary
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
Global DevelopmentGlobal Launch
We Know How
Global IMPACT
3ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
PPD and HealthCore Collaborate to Deliver Enhanced Pre- and Post-approval Research Services
PPD and HealthCore have established a collaboration that will enable both companies to further expand their services in the pre- and post-approval research market with the aim of helping biopharmaceutical clients more quickly and cost effectively demonstrate how their products will perform and benefit patients in the real world
Through this collaboration PPD is combining its clinical trial design health economics and outcomes research (HEOR) medical affairs research and epidemiology services with HealthCorersquos strengths in HEOR innovative real-world research designs and its robust research-enabled electronic health care data environment
With the collaborative expertise of PPD and HealthCoremdashparticularly in planning designing and implementing pragmatic clinical trialsmdashthe companies hope to set a new standard for the quality cost and speed of real-world evidence generation that can help optimize patient outcomes and enable their clients to better demonstrate the true value of their products and the return on their investments in new product development
Representatives of PPD and HealthCore will be on hand throughout the DIA annual meeting at booth 2227 to discuss the collaboration further and answer any questions
For additional information go to wwwppdicom or wwwhealthcorecom
You might not have heard any recognizable sound but wersquore in the midst of a ldquobig bangrdquo ndash an explosion of wearable hardware gadgets and other new medical technologies that will if properly managed increase ways to connect people with re-search into these innovations and ways to connect these innovations with the people who most need them
Todayrsquos program features a special
Plenary Session that will illuminate the patient innovator industry and regu-latory perspective on these disrup-tions innovations opportunities and challenges 265 Disruptive Forces in Health Care Innovation Where Are They Leading Us in Room 143ABC at 130PM This panel discussion will explain the state of these technologies today and explore where they might take us tomorrow from a variety of perspectives
bull Jack Andraka the teenage scien-
tist who invented an early diagnostic test for pancreatic cancer will speak about the Innovator Role
bull Angela Dunn trends analyst healthiscool will describe the Wear-ables Role
bull Duane Schulthess MBA Manag-ing Director for VitalTransformation in Belgium will share the EU Perspective
bull Patricia Furlong BSN Found-ing President amp CEO Parent Project Muscular Dystrophy will present the Patient Role
Disruptive Forces in Health Care In-novation Where Are They Leading Us will be chaired by Jeffrey Kasher PhD President of Patients Canrsquot Wait LLC
Disruptive ldquoBig Bangrdquo in Health Care Innovation At 330PM today two sessions
will explore the expanding frontier of biomarkers companion diag-nostics combination products mHealth and web applications and related innovations that offer promise for increased return on investment in therapeutic product development
In Room 102AB 271 How Biomarkers Can Be Leveraged to Improve Return on Investment in Drug Development will explore how biomarkers appropriately used can facilitate earlier ldquono gordquo decisions reduce clinical trial costs improve your probability of success accel-erate drug development for faster time to market and even increase access to the drug once itrsquos on the market The Biomarker and Com-panion Diagnostic Lead Office of New Drugs CDER will offer the regulatory perspective on the utility
Innovations in Combinationsof biomarkers including the chal-lenges and best practices for drugtest codevelopment in clinical trial designs Other topics include the execution challenges associ-ated with incorporating biomarkers and companion diagnostics into a clinical program molecular imag-ing case studies and the benefits of imaging biomarkers in oncology clinical trials
Chair Eva Finney Director Global Project Management Merck amp Co Inc
Speakers Robert Scarimbolo Manager Molecular Imaging Bio-Clinica Rachel Yarger MBA PMP Senior Project Manager Luminex Corporation and Christopher Leptak MD PhD Biomarker and Companion Diagnostic Lead Office
(continued on page 10)
DIA 2015 Welcomes Patient Fellows
Twenty patient representatives chosen through a competitive pro-cess will develop strengthen and support their collaborations with poli-cymakers industry academia and health professionals here at our DIA Annual Meeting Meet these Patient Fellows in booth 1721 and follow DIA2015Patients for information updates
Pick up the Wednesday issue of the DIA Show Daily
to see additional DIA 2015 Patient Fellow
organizations
The 1st DIA China Drug Discovery Innovation Conference amp ExhibitionOctober 11-14 2015 Shanghai International Convention Center
This will be the 1st of a new annual offering specifically focused on the early stage of the drug discovery and development process The meeting will cover topics like drug design target discovery biology and chemistry lead optimization drug likeness translational medicine amp biomarker development DMPK and preclinical exploratory clinical trials and more A special Executive Forum and sessions on Chinese governmentrsquos innovation policies are also designed
Program Website httpen15951eventdovecom
4 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Selected Life Sciences Profes-sionals from all fields related to the mission of DIA will participate in this yearrsquos Professional Poster Program presented near Exhibit Hall Entrance A from 900AM-400PM New This Year Oral presentations where poster authors will deliver a five-minute over-view of their work
Tuesday Session 1A 930AMndash1030AM
T01 Assessing the Current Land-scape of Pharmaceutical Industry Post-Doctoral Fellowships Brittny Ann Rule PharmD MBA Rutgers The State University of New Jersey (Oral presentation at 935AM)
T02 Patient Knowledge of Safe Use of ERLA Opioid Analgesics Fol-lowing Implementation of the Class-Wide REMS Stephan Lanes PhD HealthCore Inc (Oral presentation at 942AM)
T03 Biosafety Gene Therapy Navigating the Regulatory Maze Chris Jenkins PhD MPH WIRB-Copernicus Group (Oral presentation at 949AM)
T04 Clinical Relevance and Utility of Boxed Warnings in US Prescrib-ing Information Christine M Cheng PharmD First Databank Inc (Oral presentation at 956AM)
T05 Advancing Medical Informa-tion Services To Impact Patient Care Collection Of Insights From Healthcare Practitioners Roshni Patel-Romero PharmD Genentech Usa Inc (Oral presentation at 1003AM)
T06 Impact of the Nonclinical Juvenile Animal Studies on Pediatric Medicines Information Dinah Duarte PharmD MSc INFARMED Portugual
T07 Steps on a Journey Re-Use of Analysis Scripts and Standardized Tuberculosis Trial Data Xin (Joy) Li FDA (Oral presentation at 1010AM)
T08 Can Social Listening be Used to Augment Existing Data Sources for Monitoring the Safety of Consumer Health Care Products James Blow-ers GlaxoSmithKline (Oral presenta-tion at 1017AM)
T09 Regulatory Gaps mdash Industryrsquos Perspectives on Asiarsquos Regulatory Au-thorities James Leong PhD MPharm Centre of Regulatory Excellence Duke-Nus Graduate Medical School Singapore
T10 Pharmacovigilance Industry Benchmarking on Global Methodolo-gies for Collecting and Processing Off-Label Use Reports Amanda Bowles Deloitte Consulting LLP (Oral presen-tation at 1024AM)
T11 The Case for Electronic Data Capture of Abdominal Pain in Crohnrsquos Disease A Comparison of Diary Meth-ods Leighann Litcher-Kelly PhD ERT
Tuesday Session 1B 1135AMndash132PM
T12 Feasibility of Replacing the Thorough QT (TQT) Study with Intense ECG Data Collection in Early Clinical Studies Nancy Wang PhD Celerion (Oral presentation at 1135AM)
T13 Assessing Bias in Adminis-trative Database Studies of Vaccine Completion Due to Excluding Sub-jects with Incomplete Follow-up Scott Charles Quinlan PhD HealthCore Inc (Oral presentation at 1142AM)
T14 Design and Development of an eCOA Specific Solution for Captur-ing Patient Data in Diabetes Clinical Trials Paul ODonohoe CRF Health United Kingdom (Oral presentation at 1149AM)
T15 Engage Patients with Innova-tive Global Digital Patient Platform Helen Lee Bristol-Myers Squibb Com-pany (Oral presentation at 1156AM)
T17 Utilizing Regional and National Student Recruitment Events to Maxi-mize Awareness of Post-PharmD Op-portunities in Industry Amy Monpara PharmD MCPHS University
T18 The Impact of the Establish-ment of Integrated Medicinal Product Review Office (IMPRO) in Taiwan Yan-Feng Chen Center for Drug Evalua-tion (CDE) Taiwan
T19 Drug Lag and Approval Time Metrics - Are They Good Markers to Assess the Global Regulatory Environ-ment Magdalena Bujar MSc Centre For Innovation In Regulatory Science (CIRS) United Kingdom (Oral presen-tation at 1203PM)
T20 Analyzing Global Recruit-ment Strategies to Improve Local Trial Enrollment - A Global Investigation Into ldquoWhat Works Whererdquo for Patient Recruitment and Retention Tools and Techniques Chris Frega MBA Quintil-es Inc (Oral presentation at 1210PM)
T21 Improving Hepatic-Impairment Patient Recruitement with a University Hospital Center-CRO Partnership A Benchmarking Analysis Rachida Es-salihi PhD Algorithme Pharma Inc Canada
T22 Monitoring Interactive Re-sponse Technology Vendor Imple-mented Randomization and Dosing Systems Jason McCoy MS Amgen Inc (Oral presentation at 1217PM)
T23 Evolution of a Unique Blend of Business Process and Technology to Enhance Medical Affairs Capabilities Manish Dave MBA MS Merck amp Co Inc (Oral presentation at 1224PM)
T24 Implementing CDISC Stan-dards in an Early Phase CRO Suc-cesses and Challenges Pascal Gui-bord Algorithme Pharma Inc Canada
T25 A Pitfall in the Clinical Study Enrollment of Postmenopausal Females Eunhee Chung SOUSEI-KAI Global Clinical Research Center Japan (Oral presentation at 1231PM)
T26 Survey of IRB Review of Urgent Patient Specific Protocols Bambi Grilley RPh RAC Baylor College of Medicine
T27 Lack of Inter-Ethnic Difference in QT-Susceptibility to Moxifloxacin Two Independent TQT Studies in Caucasian and Asian Populations Yang Wang FDA (Oral presentation at 1238PM)
T28 Implementing Quality Risk Management and Risk-Based Moni-toring Practical Guidelines from Sponsors and Sites Amita Malik MS Oracle Health Sciences (Oral presen-tation at 1245PM)
T29 Measurement Equivalence of the SF-36v2 on a Handheld Device and Smartphone App Susan M Dal-labrida PhD PHT Corporation (Oral presentation at 1252PM)
T30 How to Maximize Data Quality in Retrospective Chart Review Stud-ies Dara Stein MSc UBC An Ex-press Scripts Company Canada (Oral presentation at 1259PM)
T31 Benefit-Risk Assessments (BRAs) of an Established Productsrsquo Portfolio Rosa Piccirillo Patino-Paul MD IVAX (Oral presentation at 106PM)
T33 Results of An Online Survey of Stakeholders Regarding Barriers and Solutions to Clinical Trial Recruit-ment Elizabeth Mahon JD Janssen Research amp Development LLC (Oral presentation at 113PM)
T34 Process for Ensuring Clinical Trial Product Quality Janie B Rus-sell RAC National Institutes of Health (NIH) (Oral presentation at 120PM)
T42 Results Reporting to Clini-calTrialsgov and EudraCT - A Con-solidated Approach and First-hand Experiences Mathias Poensgen PhD ArisGlobal GmbH Germany (Oral presentation at 127PM)
Tuesday Session 1C 230ndash310 PM
T35 Attractiveness of PRO Mixed Modes ndash What are Patients Saying Jennifer Ross MEd MS Almac Clini-cal Technologies LLC (Oral presenta-tion at 235PM)
T36 Efficient and Innovative Clini-cal Trial Enrollment Using Online and Social Media Mark Joing MBA Nora Therapeutics (Oral presentation at 242PM)
T37 The Cost Effective Benefits of Behavioral Psychology on Improving Data Quality Shawn Levin Quintiles Transnational Corp (Oral presentation at 249PM)
T38 An Approach to Aggregate Safety Reporting of Drug and Device Constituent Parts of Combination Prod-ucts Xaymara Roman RN AbbVie Inc (Oral presentation at 256PM)
T39 Analyzing the Relative Recruit-ment Performance between Highly-Uti-lized and Low-Utilized Sites in 5 TAs in 4 Asian Countries Hyunjoo Rhee MPharm Quintiles Transnational Ko-rea Co Ltd Republic of Korea
T40 How IDMP Can Help Struc-ture Product Information Labeling Romuald Braun uanotau Switzerland (Oral presentation at 303PM)
Winning with DIAAttendees who registered for our Annual Meeting before May 14 were
entered into a random raffle drawing for a pair of tickets to see the Washing-ton Nationals play the Tampa Bay Rays on Wednesday June 17 at Nationals Park Congratulations to Dr Atif Abbas (Medical Director US Drug Safety Merck Serono) and Julie Townsend (Associate Director Regulatory Opera-tions Upsher-Smith Laboratories Inc) each of whom picked up a pair of tickets from the DIA booth for tomorrow nightrsquos ballgame
a
Click to explore the April issue
Yoursquove never seen a Global Forum like this
Click to explore the June issue
5ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Exhibiting As Booth4C Pharma Solutions LLC 1138
A-B-CAccell Clinical Research 2439Accenture 1015Accenture Business Suite 7Accovion GmbH 1344ACM Global Central Laboratory 2221ACRP 1654Acurian Inc 2235ADAMAS Consulting LLC 2644Adaptive Clinical Systems 627Advanced Clinical 1308Aerotek 1100AiCure 1235Alfresco Software Inc 753Almac 2435American Medical Writers Association 1526Ancillare LP 642APCER Pharma Solutions Inc 1545Applied Clinical TrialsPharmaceutical Executive 520ArisGlobal 2409ArisGlobal Business Suite 4Arivis 1045Arriello Ireland Limited 1457Artcraft Health 1848Asia CRO Alliance 1245Association of Biotechnology Led Enterprises ndash ABLE 1127August Research 1320Auxiliis 1238Axiom Real-Time Metrics Inc 2311BARC Global Central Laboratory 1901Barrington James 2052BBK Worldwide 2026Beijing Clinical Service Center 2640Benchmark Research 516BioClinica 1325Biomedical Systems 619BioPharm Insight 1601BioPharma Investigator 1011BioPoint Inc 2713BioPoint Inc Business Suite 5Biorasi 524bioskin GmbH 1220BioTelemetry Research (Formerly Cardiocore) 1411BIOVIA 2321Blinded Diagnostics 2735Bracket 711CAC EXICARE Corporation 1057CAHG 1142Camargo Pharmaceutical Services 1927Cambridge Healthtech Institute 639Cambridge Semantics Incorporated 1255Cancer Insight 641Canfield Scientific Inc 534Cardinal Health 1104Cardiovascular Imaging Technologies 2622Cardiovascular Research Foundation 857Catalent 2113CDISC 1849Celerion 1301Cenduit LLC 538Center for Information and Study on Clinical Research Participation (CISCRP) 2440Chesapeake IRB 1739Chexx Inc 1244Chiba University Hospital 2352Chiltern International Inc 827
DIA Exhibitor List and Floor Plan DIA 2015 Annual Meeting
Washington DC
Cincinnati Childrenrsquos Research Foundation 1322Citeline Inc 2003CITI Program - University of Miami 1802CitiusTech Inc 1906Clariness 2738CleverCap 2057ClinDatrix Inc 1002ClinEdge LLC 1845Clinical amp Contract Research Association (CCRA) 1208Clinical Ink 2011Clinical Practice Research Datalink (CPRD) 1052Clinical Reference Laboratory 2316Clinical Research Malaysia 2648ClinicalRM 2442Clinitude 2252Clinlogix 1003ClinPlusDZS Clinical Services 1610ClinTec International Ltd 1118Clinverse Inc 1703CluePoints Inc 1511Cmed Clinical Services 752CMIC HOLDINGS Co Ltd 935Cognizant Technology Solutions 2741Compass IRB 2016Compass Research LLC 2349CompleWare 620Complion 2545Comprehend Systems 2511Content Analyst Company 956Continuum Clinical 2343Contract Pharma 643ConvergeHEALTH by Deloitte 811ConvergeHEALTH by Deloitte Business Suite 2Conversis 2253CoSign by ARX 744Cote Orphan Consulting LLC 1544Court Square Group IncRegDocs365 2157Covance Inc 1835Covigilant 2726CRF Health 2427CRO Analytics 1656CROMSOURCE 1345CROS NT 1111CSSi 1811CTI Clinical Trial amp Consulting Services 1915Cu-Tech LLC 1121Cytel Inc 1611
D-E-FDAC 2327Data Matrix 2005DataArt 2639Datapharm Australia Pty Ltd 625DATATRAK International Inc 803DaVita Clinical Research 738DBMS Consulting 2744DIA 1523DIA Patient Advocate Fellowship 1721DITA Exchange 2419
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Pull-Out
Section
Dora Wirth (Languages) Ltd 1212Dr Ebeling amp Assoc GmbH 1302DrugDev 820DSG Inc 719d-Wise Technologies 1402EastHORN Clinical Services in CEE Ltd 2109eClinicalHealth Ltd 510EDETEK Inc 1855Elite Research Network LLC 1206EMB Statistical Solutions LLC 1014endpoint 927Enforme Interactive 1249ENNOV 1145Entimo AG 2220ePharmaSolutions 734EPS Holdings Inc 905ERT 2000ERT 2025Eurofins 2540European Medicines Agency 1528EUROTRIALS 1815Everest Clinical Research 2048Exco InTouch 2212ExecuPharm Inc 1043ExL Pharma 1907Exostar 1749Experis Clinical Practice 2423Exponent 742EXTEDO Inc 2519Falcon Consulting Group 727FDA CDER 1729FDAnews 2621Flex Databases 1312Foresight Group International AG 2339Formedix Inc 1223Frenova Renal Research 1004Fresenius Medical Care North America 2441Frontage Labs 2520
G-H-IGA International Inc 1256Galderma Research amp Development LLC 1851GCP ClinPlus Co Ltd 542Genpact Pharmalink 2541GenPro International 2749Gilead Sciences Inc 1056Global Center of Excellence in Clinical Trials Asan Medical Center 1651Global Center of Excellence in Clinical Trials Inje University Busan Paik Hospital 1651Global Center of Excellence in Clinical Trials Samsung Medical Center 1651Global Center of Excellence in Clinical Trials Yonsei University Health System 1651Global Institute For Research 1207Global Instrumentation LLC 1556Global Language Solutions 723GlobalCare Clinical Trials LTD 2729goBalto Inc 1241GP Strategies 1306
(continued on page 6)
6 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
(continued from page 5)
Parties amp Events
Giveaway Guide
Food amp Drink
Sights
TransportationBrought to you by BioClinica
KAI Research Inc 2740KCR 2722KCRN MampC 1945KellyOCG 1035Klein Hersh International 2034KlinEra Global Services 2110KoNECT 1651Korea Clinical Trials Global Initiative (KCGI) 1651Kuantum CRO and Logistics 1019LabAnswer 2155LabConnect LLC 911LabCorp 1835Lambda Therapeutic Research Inc 2105Langland 2046Launchpad 543Life Science Leader 2623Linical USA 2720Lionbridge Technologies 1246LMK Clinical Research Consulting 645Longboat Clinical Ltd 612LORENZ Life Sciences Group 1427Lovelace Scientific Resources 923Luto Research Limited 1213
M-N-O MakroCare 2618Mapi 754MASIMO 1340Massachusetts College of Pharmacy and Health Sciences 2153MasterControl 1809MaxisIT Inc 2535McGuire Research Institute 2107
MDCPartners 2449Med Fusion 1140MedDATA Foundation 755MedDRA MSSO 1009Medical Research Network Ltd 854Medical Vigilance Solutions Cincinnati Childrenrsquos 1039Medicines Evaluation Unit 1210Medidata Solutions Worldwide 2641Medidata Solutions Inc 2201MEDIX 1846MedNet Solutions Inc 1838Medpace Inc 1801MedPoint Digital Inc 2517Medrio Inc 1202MedSource 1935MedTrials 1346Merge eClinical 2209MESM Ltd 2042META Solutions Inc 2021MMG 2534MNX Global Logistics 1914MonitorForHirecom 1421Montrium Inc 2106Morningside Translations 1953Mortara Instrument Inc 729National Death Index 518NCGS Incorporated 2611NeoGenomics Laboratories 1251Neuroscience Trials Australia 2627New Orleans Center for Clinical Research 728Next Phase Research 2637NextDocs 2038Nextrials Inc 2717NIPER Hyderabad 1127
Green Key Resources 1947Greenphire 613Greens LTD 2156Guangzhou KingMed Center for Clinical Laboratory Co Ltd 2538HampJ CRO International Inc 2646Hangzhou Tigermed Consulting Co Ltd 746HCL America Inc 1635Health Decisions Inc 821HealthCarePoint 1757Hurley Consulting Associates Ltd 955Hurley Write Inc 2727Hydrogen International Ltd 1955iCardiac Technologies 2102ICON plc 503IDT Australia 1746ImageIQ Imaging CRO 1227IMS Health 1317Inamed GmbH 529INC Research 2303Industry Standard Research 725Informa Business Information 2354Information Builders Inc 1853Infotehna Inc 1444Innovative Print amp Media Group 1354InnovoCommerce LLC 1747Integrated Clinical Systems Inc 901Integrated Development Associates Co Ltd 1047IntegReview IRB 2420INTERLAB GmbH central lab services worldwide 1425International Dermatology Research Inc 1538Interspond LLC 2547Intertek Scientific amp Regulatory Consultancy 2516Intralinks Inc 1822inVentiv Health 1517Investigational Cancer Therapeutics - MD Anderson 1546IPHARMA ChemDiv 521
NNIT 2254Norav Medical 514Nova Language Services Ltd 1209Novella Clinical 1439November Research Group 2218Novotech 1134NSF Health Sciences 1847Nuventra Pharma Sciences 824Ocasa Logistics Solutions 2036Ohio Clinical Trials Collaborative 2442OmniComm Systems Inc 2135Online Business Applications 1314OpenClinica 635Optum 1826Oracle Health Sciences 1819Orlando Clinical Research Center 2208Otto Trading Inc 1018
P-Q-RPacific Bridge Medical 2446Palm Beach CRO 1804Paragon International Inc 1403Paragon Solutions 2204
Parallel6 1957PAREXEL International 1535PCM TRIALS 2733Pennside Partners Ltd 2518PerkinElmer Inc 513Personify 1756Pharma Start 1148Pharmaceutical eConsulting 1650Pharmaceutical Outsourcing Hall A EntrancePharmaceutical Packaging Professionals Pty Ltd 2120Pharmaceuticals and Medical Devices Agency (PMDA) 1520Pharmaceuticals Export Promotion Council of India 1127PharmApprove 2054PharmaQuest Ltd 1348PharmaSeek Companies 822PharmaSys Inc 2438PharmaVOICE 1001Pharm-Olam International Ltd 919Phlexglobal Inc 2007Pilgrim Quality Solutions 2044Planet Pharma 1149PleaseTech Ltd 1114Polar Leasing Company Inc 546Popsi Cube 539Porzio Life Sciences 1055PPD 2227PQE 1054PRA Health Sciences 1501Praxis Communications LLC 629Precision for Medicine 1351Premier Research 1711Pretium 1010
PrimeVigilance 2347PRL Central Laboratory Services 1423Proforma Giraffe Graphics Inc 2549Projecis Inc 1645PROSAR 2206Proteus Digital Health Inc 2255ProTrials Research Inc 1108PSKW LLC 1053Pyxant Labs Inc 1950Q2 Business Intelligence 1449QPS LLC 1307Quality and Compliance Consulting Inc 2417Quality Associates Inc 1607Quanticate Inc 1334QuantifiCare 527Queensland Clinical Trials Network 1000Quest Diagnostics 2628Quintiles 601Quorum Review IRB 1219Radiant Research Clinical Research Advantage 2112Randstad Pharma 2715Real Staffing Group 2620RegCheck 955Regeneron Pharmaceuticals 638Regxia Inc 1949Research Across America 2728ReSolution Latin America 2421Rho Inc 724RR Donnelley 2626RWS Group - Medical Translation Division 1350Rx Trials Inc 1400RxLogix Corporation 2521
S-TSan Diego State University - Regulatory Science Programs 1524SanaClis sro 541SAS Institute Inc 2127SAS Institute Inc JMP Division 1744Scarritt Group Inc 1844Schlafender Hase Inc 2012Schulman Associates IRB 1020SeaView Research 1944Sharp Clinical Services 1305Sidus Biodata 1745Signix Inc 2739SNBL Clinical Pharmacology Center 2448Society for Clinical Research Sites - SCRS 1548Sonic Clinical Trials 1010SOUSEIKAI Global Clinical Research Center 1946Southern California Research 2721Southern Star Research 1702Sparta Systems 826Spaulding Clinical Research 2217Speaking Books 1605SPRI Clinical Trials - Global 1021Springer 526Statistics amp Data Corporation (SDC) 1704Stefanini 2723Sterling IRB 2010Stiris Research Inc 1707Symbio LLC 1700Symogen 1856Symphony Clinical Research 2422Synchrogenix Information Strategies Inc 1105Syngene International Ltd 1127Synowledge 1540Syntel Inc 1157SynteractHCR 1335Target Health Inc 2527Tarius AS 1103Tata Consultancy Services 1909Technical Resources International Inc 1913Technology Catalysts International 2447Techorizon 1347TechSol Corporation 2642Telerx 735Teuteberg Incorporated 1948TFDA Center for Drug Evaluation Taiwan 1522
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
8 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Thatrsquos Nice LLC 1240The Clinical Resource Network 1318The Geneva Foundation 2548The Patient Recruiting Agency 2119Theorem Clinical Research 511Theorem Clinical Research Business Suite 1Therapak Corporation 1005Therapeias Health Management 641Therapeutics Inc 1341Thomson Reuters 1440ThreeWire Inc 1939TKL Research Inc 2202Total Clinical Trial Management 2725Total Root Concepts Inc 523TrakCel Limited 2747TransPerfect 1025Trial Runners 2742Trievr Inc 2103Trifecta 1921
U-V-WUBC 2401Unanet 1152University of Florida 1551University of Maryland Online MS in Regulatory Science 1147University of the Sciences 852University of Utah Clinical Trials Office 1725Uppsala Monitoring Centre 2426UTMB Sealy Center for Vaccine Development 1657Valesta Clinical Research Solutions 2629Validated Cloud 2056Veeva Systems Inc 1203Verified Clinical Trials 1109Veristat Inc 1941
(continued from page 7)
Vigilare International 1141Vince amp Associates Clinical Research 748Viracor-IBT Laboratories 2546Viroclinics Biosciences 547VirtualScopics 2320Vitalograph Inc 1406Voluntis 1447WCCT Global 2121WebbWrites LLC 953Whitsell Innovations Inc 626Wincere Inc 1144Wingspan Technology Inc 1445WIRB-Copernicus Group 701Women in Life Sciences - WILS 1356Woodley Equipment Company 1215Worldwide Clinical Trials 1311
TKL Research is an international CRO offering expertise in a full spectrum of indications as well as clinical trial management services from Phase 1 to multicenter international studies TKL serves the pharmaceutical biotech generic drug medi-cal device OTC and consumer health care indus-tries The leader in dermatological research TKL has performed over 200 dermatological clinical trials and is unrivaled in the number of dermato-logical safety studies TKL also has significant ex-perience in Phase 1-4 multinational clinical trials and differentiates itself from the competition with a strong Phase 1 safety capability and full service CRO combined into one cohesive organization
QuintilesBooth 601wwwquintilescomcareers
Quintiles CareersQuintiles is the worldrsquos largest provider of
biopharmaceutical development and commercial outsourcing services and wersquod like to meet you Please stop by the Marriott Marquis Hotel to hellip
ATTEND OUR COCKTAIL RECEPTION in the Chinatown Meeting Room
bull Monday June 15th from 6pm - 8pm
MEET OUR RECRUITING TEAM from Immunol-ogy and Internal Medicine in the Judiciary Square Meeting Room
bull Monday June 15th from 2pm - 5pmbull Tuesday June 16th from 9am - 7pmbull Wednesday June 17th from 9am - 7pm
Improve your probability of successtrade
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Your Opinion MattersComplete an evaluation for each offering
you attend for a chance to win great prizes
Access online evaluations at DIAGlobalorgDIA2015evals or stop by Evaluation Stations in the Registration
Area beginning Tuesday
Free registration to the DIA 2016 52nd Annual Meeting
$100 American Express Gift Card
Discover Safety around the World
ldquoGlobal production of FDA-regulated goods has exploded over the past ten years In addi-tion to an increase in imported finished prod-ucts manufacturers increasingly use imported materials and ingredients in their US produc-tion facilities making the distinction between domestic and imported products obsoleterdquo said FDA Commissioner Dr Margaret A Ham-burg upon the release of the FDA 2011 report Pathway to Global Product Safety and Quality ldquoThe FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face The FDA must further collaborate and leverage in order to close the gap between our import levels and our regula-tory resourcesrdquo she concluded
At 1030AM today staff from FDArsquos interna-tional posts in China Europe and India will provide exclusive updates from their respec-tive posts in Session 245 FDArsquos International Posts International Efforts Regulatory System Strengthening and Inspections presented in Room 152A Their updates will include out-reach to foreign regulators facility inspections risk-based global surveillance to protect supply chains and related topics
Chair Leslie Ball MD Assistant Commis-sioner and Deputy Director OIP OC FDA
Update from the FDA China Office S Leigh Verbois PhD Incoming Director China Office Office of International Programs OC FDA
Update from the FDA India Office Mathew T Thomas MD Acting Country Director India Of-fice Office of International Programs OC FDA
Update from the FDA European Office Donald Prater DVM Acting Regional Director Europe Office OIP OC FDA
9ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Route 1 Red Hotel Pickup LocationJW Marriott E Street EntranceGrand Hyatt 11th Street EntranceMarriott Metro Center At Hyatt 11th Street Entrance
Route 2 Yellow Hotel Pickup LocationHamilton Crown Plaza Lobby EntranceDonovan House Lobby EntranceWashington Plaza Curbside Vermont mdash Near DrivewayComfort Inn Convention Center At Washington Plaza Curbside Vermont
Route 3 Blue Hotel Pickup LocationLoews Madison Lobby EntranceWestin Washington At Loews Madison Lobby EntranceDoubletree Washington Lobby EntranceHotel Helix At Doubletree Lobby EntranceMayflower Renaissance Desales Street Entrance
Hotels within walking distance of the Walter E Washington Convention Center are Embassy Suites Convention Center Hampton
Inn Henley Park Hotel Morrison-Clark Inn Renaissance Washington DC Downtown Hotel and Marriott Marquis
Tuesday June 16 through Wednesday June 17Hours Frequency 645-930AM 15 Minutes930AM-330PM No Service330-630PM 15 MinutesLast Bus Departs Hotels 530PM
Thursday June 18 Hours Frequency 730-900AM 15 Minutes900AM-1230pm 30 MinutesLast Bus Departs Hotels 1130AM
For Shuttle Information or to Pre-Schedule ADA Pick-up call 877-865-3437 during convention shuttle hours
Complimentary Shuttle InformationPlease allow up to 20 minutes (including waiting and riding time under nor-mal peak traffic conditions) to travel from your hotel to the Walter E Wash-ington Convention Center located on Mount Vernon Place Delays may occur due to circumstances beyond our control
Discover tomorrowrsquos solutions to to-dayrsquos challenges through the products and services showcased in todayrsquos Innovation Theater sessions presented near Exhibit Hall Entrance B
945AM 225 Covance Innovation Theater Advances in Risk-Based Mon-itoring Transforming Drug Develop-ment Through Efficient Workflows Big Data and Elegant Software Discover Covancersquos risk-based monitoring (RBM) platform which provides clients with best-in-class implementation of the RBM principles put forth by FDA EMA and TransCelerate and facilitates RBM through timely secure and inte-grated access to all relevant trial data
1200PM 249 Quintiles Innova-tion Theater Transform Clinical De-velopment ndash Modernizing for Smarter Trials Because of our imperative to ldquomodernizerdquo clinical trials to de-liver medicines faster at less cost to patients who need them learn how you can gauge global capabilities to model and predict better outcomes identify appropriate investigator sites and deliver faster ldquoanalysis-readyrdquo data to identify trends and issues in near real time
100PM 250 Veeva Innovation Theater 2015 Paperless Trial Master File (TMF) Survey Trends and Insights Results from the follow-up to Veevarsquos benchmark 2014 Paperless TMF Sur-vey which analyzed the observations of TMF owners to identify the barriers business drivers and benefits of mov-ing to fully paperless TMFs How does your organization compare and why do some organizations benefit more than others
300PM 267 BBK Worldwide Innovation Theater mHealth A New Era in Patient Engagement BBK Worldwide and mHealth experts from the Landon Pediatric Foundation and CareThings discuss opportunities for patient engagement in clinical trials within mHealth and how advance-ments in apps wearables and per-sonalized content delivery are shaping a new patient engagement model and impacting the entire clinical research enterprise
See Innovation in Action Innovation Theater
We ask all Annual Meeting speak-ers to please check in at the Speaker Registration Desk when you arrive at the Convention Center to pick up your name badge Speaker registration will be open today from 700AMndash500PM The Speaker Preparation Room will also be open from 700AMndash500PM to-day this is where you will confirm that your presentation has been properly uploaded
A Speaker Training Room is also available for you to practice your pre-sentation alone or with your fellow pre-senters Please schedule your practice time when you check in at the Registra-tion Desk This Training Room will host a special Speaker Training Session coaching on podium presentation best practices from 945-1015AM today
The Speaker Registration Desk Speaker Preparation Room and Speaker Training Room are all located in the East Registration area
We ask all speakers to arrive at their assigned room 20 minutes before
Speaker Registration amp Preparationyour session scheduled start time to confirm that the proper visual presen-tation is loaded on the session room computer You cannot upload or edit your presentations in the session room you may do so however in the Speaker Preparation Room We also recommend that you carry an elec-tronic copy (via USB) of your presen-tation for backup purposes
Exhibitor PassportVisit our Exhibitors to hear about their products and services You must have 50 Exhibitors sign your card found in your attendee bag to be eligible to win bull First Prize Apple Watch Sport bull Second Prize $250 VISA Gift Card (Two)
bull Third Prize Fitbit Charge HR (Three)
Passports must be dropped off to the DIA Booth 1523 by 400pm on Wednesday June 17
The Medical Heroes Appreciation Walk organized by CISCRP (Center for Information and Study on Clinical Research Participation) on Monday morning brought over 250 people together in celebration of study volunteers and their gift of participation in clinical research
10 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
The DIA 2015 51st Annual Meeting offers a variety of over 250 education opportunities to help strengthen your understanding of the value of cross-discipline integration and to foster innovation for better health outcomes
Participants may receive up to 18 AMA PRA Category 1 Creditstrade 18 pharmacy contact hours or 18 con-tinuing education units (CEUs) 18 nursing contact hours 10 Project Man-agement Institute (PMI) professional development units or 24 International Association for Continuing Education and Training CEUs There are multiple program offering formats at the meet-ing including sessions forums work-shops symposia and one hour TURBO offerings Program offerings desig-nated for credit are clearly identified in the final program with the pertinent CME Pharmacy Nursing or PMI PDUs statements IACET CEUs are offered for all program offerings except that no continuing education credits are avail-able for the following offerings
bull Plenary Session and Keynote Addressbull Session 226 How Pharmaceutical Companies Can Engage Responsibly with Patients Online bull Session 246 Using Registries to Support Recruitment in Alzheimers Disease (AD) Prevention or Delay-of-Onset Studies bull Session 345 Power Up Give Your Brain a Breakbull Track 20 Innovation Theaterbull Track 21 Poster Presentations
Participants who would like to
Continuing Education at DIA 2015 51st Annual Meetingreceive continuing education credits for the Annual Meeting must scan their DIA name badge at each program offering to record hisher attendance Participants must scan their name badges within 45 minutes after the start time of each 15 hour program offering and within 30 minutes after the start time for the one hour TURBO offerings If a participant attends multiple offerings within the same time frame only the last scanned entry will be recorded Participants who do not scan their badge within the allotted time will not be eligible to request the available continuing education credits for that program offering
Evaluation Station ndash Your Opinion Counts
DIA will again utilize an online evaluation portal to obtain your feed-back on our program offerings You can access this portal at DIAglobalorgDIA2015evals Each evening dur-ing the Annual Meeting we will send an email to participants requesting their feedback on the offerings they attended that day
Beginning Tuesday June 16 there will also be an onsite Evaluation Sta-tion in the Attendee Registration Area (West Wing) for you to complete your evaluations while onsite Your feed-back is valued and we would really appreciate hearing from you
DIA will conduct a drawing with a chance for one participant to win a free registration to the DIA 2016 52nd Annual Meeting in Philadelphia PA Eligible participants must complete all
program offering evaluations from each educational offering they attended dur-ing the Annual Meeting time frame
DIA will also offer one winner a $100 American Express gift card from a ran-dom drawing of the participants who complete the Overall Evaluation form During the week of July 20 the winners will be announced and notified Dead-line for submitting evaluation feedback is Wednesday July 15 2015
All DIA 2015 51st Annual Meeting continuing education credit requests are processed through DIArsquos My Transcript DIArsquos My Transcript OPENS on Tuesday June 23 My Transcript allow you to request an Attendance Certificate or request CE credit(s) and download a statement of credit To ac-cess My Transcript
bull Login to My DIA at DIAglobalorgbull Enter your User ID and Passwordbull Select My Transcript from the
left side barbull Select DIA 2015 51st Annual Meeting Credit Requestbull Proceed to request an Attendance Certificate or CE credit for each offering and for each daybull Select the Credit Type or Attendance Certificate for each
offeringbull Select Continue after your credit request is completed for all requested offeringsbull Submitbull Print statement(s) of credit or Attendance Certificate All ACPE credit requests must be
submitted by Wednesday July 29 2015 so your request can be sub-mitted to the CPE Monitor Please have your NABP eProfile ID and DOB (MMDD) readily available when requesting ACPE credit If you need to obtain your NABP eProfile ID visit wwwcpemonitornet
MOBILIZE YOUR TRIAL WITH IN-HOME CLINICAL TRIAL VISITSbull Subject Conveniencebull Improves Recruitment Retention amp Compliancebull Access to Certified Mobile Research Nursesbull US amp Global Services
For RFPs or to request a capabilities presentation please contact infopcmtrialscom or call
888-628-9707 | DIA booth 2733
Our Certified Mobile Research Nurses
Set Us Apart
PCM Trials DIA Ad Half Page2015_v3indd 1 31015 518 PM
of New Drugs CDER
In Room 146C 291 CDRH Town Hall continues the Annual Meeting tra-dition of providing you with a unique opportunity to hear directly from the Director of the Center for Devices and Radiological Health (CDRH) on the state of CDRH and its vision for the future Specific topics include FDA-SIA accomplishments and activities 2017 MDUFA Reauthorization and the impact of the House Energy and Com-merce 21st Century Cures initiatives
the regulatory framework for labora-tory developed tests expedited path-ways development the future of next gen sequencing and innovative ap-proaches for companion diagnostics and personalized medicine human factors studies combination products regulation of mobile and web software applications and the impact of other new technologies on patient care
Chair Janet Jenkins-Showalter Senior Regulatory Group Director Regulatory Policy amp Intelligence Genentech A Member of the Roche Group
Panelists Jeffrey Shuren JD MD Director CDRH FDA Alberto Gutier-rez PhD Director Office of In Vitro Diagnostics amp Radiological Health CDRH and Jonette R Foy PhD Deputy Director for Engineering amp Sci-ence Review ODE CDRH
InnovationsContinued from Page 3
28th Annual EuroMeeting 6-8 April 2016 Hamburg GermanyDIAGlobalorgEuroMeeting
Save the date
DIA Europe Middle East amp AfricaKuumlchengasse 164051 Basel Switzerland
Flanked by DIA Globlal Chief Executive Barbara Lopez Kunz and Dr Per Spindler (DIA President and Chair Board of Directors) DIA welcomes our 2015 DIA Fellows Minnie Baylor-Henry RPh JD (Incoming Chair) Jennifer L Riggins PharmD Kenneth A Getz MBA and Noriaki Murao MS 2015 DIA Fellow Gaby Danan MD PhD was unable to attend
ldquoMy commitment to you at this meeting is to provide the environment that will help you seize the opportuni-ties that present themselves both here in Washington as we meet and moving forward as you return to your places of workrdquo she concluded ldquoSo I invite you to seize the opportunity that we have this week to take advantage of this lsquoone shotrsquordquo
Annual Meeting Co-Chair Christo-pher P Austin MD (Director National Center for Advancing Translational Sci-ences US National Institutes of Health) followed Barbara to the podium ldquoOur focus at NCATS is not on spe-cific diseases but on what is common among all diseasesrdquo he explained ldquoOur chosen field is remarkably if not painfully empirical because we donrsquot understand the general principles and thatrsquos what NCATS is all aboutrdquo
ldquoWe are fond of saying that transla-tional science is a team sportrdquo he said to introduce one such ldquoteamrdquo project The Tissue Chip for Drug Screening program a collaboration between the FDA and the Defense Advanced Research Projects Agency (DARPA) that has developed organ and organ systems on microchips for drug toxic-ity testing that doesnrsquot require animals or humans In the future these chips could include hormones for example to identify the difference between male and female response to drugs ldquoI really thought this was just science fiction ndash and I was wrongrdquo he confessed
ldquoOne of my favorite proverbs
comes from Japanese literature lsquoNone of us is as smart as all of usrsquo Solving the systemic and highly complex problems of translation will require that adage as a guiding principle and the DIA meeting this year promises to provide the perfect setting to establish and strengthen the connections that will help us all collectively develop innovate and advance to new solutionsrdquo he con-cluded
ldquoLike many of you this organization and its expanding influence have been essential to my lifersquos work in the phar-maceutical and biotechnology arenardquo said Per Spindler DVM MBA MSc (DIA President and Chair Board of Directors Director Biopeople Univer-sity of Copenhagen Denmark ldquoI was born in 1963 in Copenhagen the year before DIA was foundedrdquo
ldquoIn 2003 I was invited to become a member of the DIA Advisory Council of Europe and I was elected to the Board of Directors in 2007 In the recent past as member of the Board I have been instrumental in establishing our journal within therapeutic innova-tion and regulatory science ndash pro-fessional fields where DIA takes the global leadership You might say DIA and I have grown up togetherrdquo Per continued
ldquoBy the time DIA celebrates its 100th Anniversary our world will be a very different place shaped in part by the innovations that we will ad-vance here in Washington Review the program for this 51st meeting of DIA with its rich and diverse offerings and you will have no doubt that a trans-formational agenda for our industry is evolving You will also be convinced that DIA will be at the forefront of that transformationrdquo
ldquoLike Per I have greatly benefited from my association with DIA and this organization has been essential to my career and to the proficiencies I have developed in the regulatory science arenardquo began President-Elect San-dra A Milligan JD MD (Senior Vice President Global Regulatory Affairs amp Clinical Safety Merck Research Laboratories) ldquoIn 2013 I chaired the Annual Meeting in Boston and now I find myself grateful to you the mem-bership to be the next president of DIA starting July 1strdquo
ldquoOur organization brings people to-gether creating a rich mix of ideas of service to our professions and service to our patients DIA as an organization truly proves that the whole is greater than the sum of its partsrdquo Sandra concluded
Co-Chair Michael Rosenblatt MD
(Executive Vice President amp Chief Medical Officer Merck amp Co Inc) concluded the welcoming remarks ldquoDIA is the only place i know of where professionals from every aspect of RampD ndash from the laboratory to the patient ndash gather to learn and to share best practicesrdquo he began ldquoI see great value in the lively and massive ex-change of information and ideas that takes place here It illustrates some-thing i deeply believe all of us ndash and the patients we serve ndash are interde-pendentrdquo
ldquoThe patient has always been ndash and should always be ndash at the core of what we dordquo he continued ldquoBut todayrsquos patients are different They are better informed more independent more ac-tive and more engaged than ever They are interested in taking charge of their own care Many have organized them-selves into learning communitiesrdquo
ldquoLike any big social trend this renewed emphasis on the patient has created a new mindset that in turn has helped spawn exciting innova-tionsrdquo he concluded ldquoWe need only look at this conference agenda to see evidence of new and previously unlikely collaborations ndash all with re-newed focus on in the patient These are partnerships between academia industry practitioners payers and regulators aimed at speeding the ar-rival of urgently needed vaccines and cures targeting the right therapies to the right people and improving patient accessrdquo
Daniel Burrus (President amp CEO Burrus Research Associates Inc) opened his Keynote Address by refer-ring to DIA Annual Meeting attendees as ldquothe great enablersrdquo His energetic remarks encompassed the themes of collaboration and innovation through real-world and theoretical examples ldquoWe live in a world of amazing inno-vation right nowrdquo he began ldquoIn fact wersquore standing at the base of a moun-tain of innovationrdquo
Daniel presented innovation as the ability to anticipate and solve a problem before you actually have it ldquoKeeping up is a foolrsquos gamerdquo he said ldquoWho wants to keep up I want to jump aheadrdquo
ldquoWe say wersquore collaborating but are werdquo he asked ldquoAre you using your 4G phone to advance innovation or to watch Netflix Yoursquove already got amazing tools Are you underutilizing them Hint Yesrdquo
ldquoThe world needs yourdquo he said to close the Opening Plenary ldquoYoursquore the enablers of innovationrdquo
Annual Meeting Co-Chairs Dr Michael Rosenblatt (left) and Dr Christopher Austin (right) welcome attendees to the Opening Plenary
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
Global DevelopmentGlobal Launch
We Know How
Global IMPACT
4 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Selected Life Sciences Profes-sionals from all fields related to the mission of DIA will participate in this yearrsquos Professional Poster Program presented near Exhibit Hall Entrance A from 900AM-400PM New This Year Oral presentations where poster authors will deliver a five-minute over-view of their work
Tuesday Session 1A 930AMndash1030AM
T01 Assessing the Current Land-scape of Pharmaceutical Industry Post-Doctoral Fellowships Brittny Ann Rule PharmD MBA Rutgers The State University of New Jersey (Oral presentation at 935AM)
T02 Patient Knowledge of Safe Use of ERLA Opioid Analgesics Fol-lowing Implementation of the Class-Wide REMS Stephan Lanes PhD HealthCore Inc (Oral presentation at 942AM)
T03 Biosafety Gene Therapy Navigating the Regulatory Maze Chris Jenkins PhD MPH WIRB-Copernicus Group (Oral presentation at 949AM)
T04 Clinical Relevance and Utility of Boxed Warnings in US Prescrib-ing Information Christine M Cheng PharmD First Databank Inc (Oral presentation at 956AM)
T05 Advancing Medical Informa-tion Services To Impact Patient Care Collection Of Insights From Healthcare Practitioners Roshni Patel-Romero PharmD Genentech Usa Inc (Oral presentation at 1003AM)
T06 Impact of the Nonclinical Juvenile Animal Studies on Pediatric Medicines Information Dinah Duarte PharmD MSc INFARMED Portugual
T07 Steps on a Journey Re-Use of Analysis Scripts and Standardized Tuberculosis Trial Data Xin (Joy) Li FDA (Oral presentation at 1010AM)
T08 Can Social Listening be Used to Augment Existing Data Sources for Monitoring the Safety of Consumer Health Care Products James Blow-ers GlaxoSmithKline (Oral presenta-tion at 1017AM)
T09 Regulatory Gaps mdash Industryrsquos Perspectives on Asiarsquos Regulatory Au-thorities James Leong PhD MPharm Centre of Regulatory Excellence Duke-Nus Graduate Medical School Singapore
T10 Pharmacovigilance Industry Benchmarking on Global Methodolo-gies for Collecting and Processing Off-Label Use Reports Amanda Bowles Deloitte Consulting LLP (Oral presen-tation at 1024AM)
T11 The Case for Electronic Data Capture of Abdominal Pain in Crohnrsquos Disease A Comparison of Diary Meth-ods Leighann Litcher-Kelly PhD ERT
Tuesday Session 1B 1135AMndash132PM
T12 Feasibility of Replacing the Thorough QT (TQT) Study with Intense ECG Data Collection in Early Clinical Studies Nancy Wang PhD Celerion (Oral presentation at 1135AM)
T13 Assessing Bias in Adminis-trative Database Studies of Vaccine Completion Due to Excluding Sub-jects with Incomplete Follow-up Scott Charles Quinlan PhD HealthCore Inc (Oral presentation at 1142AM)
T14 Design and Development of an eCOA Specific Solution for Captur-ing Patient Data in Diabetes Clinical Trials Paul ODonohoe CRF Health United Kingdom (Oral presentation at 1149AM)
T15 Engage Patients with Innova-tive Global Digital Patient Platform Helen Lee Bristol-Myers Squibb Com-pany (Oral presentation at 1156AM)
T17 Utilizing Regional and National Student Recruitment Events to Maxi-mize Awareness of Post-PharmD Op-portunities in Industry Amy Monpara PharmD MCPHS University
T18 The Impact of the Establish-ment of Integrated Medicinal Product Review Office (IMPRO) in Taiwan Yan-Feng Chen Center for Drug Evalua-tion (CDE) Taiwan
T19 Drug Lag and Approval Time Metrics - Are They Good Markers to Assess the Global Regulatory Environ-ment Magdalena Bujar MSc Centre For Innovation In Regulatory Science (CIRS) United Kingdom (Oral presen-tation at 1203PM)
T20 Analyzing Global Recruit-ment Strategies to Improve Local Trial Enrollment - A Global Investigation Into ldquoWhat Works Whererdquo for Patient Recruitment and Retention Tools and Techniques Chris Frega MBA Quintil-es Inc (Oral presentation at 1210PM)
T21 Improving Hepatic-Impairment Patient Recruitement with a University Hospital Center-CRO Partnership A Benchmarking Analysis Rachida Es-salihi PhD Algorithme Pharma Inc Canada
T22 Monitoring Interactive Re-sponse Technology Vendor Imple-mented Randomization and Dosing Systems Jason McCoy MS Amgen Inc (Oral presentation at 1217PM)
T23 Evolution of a Unique Blend of Business Process and Technology to Enhance Medical Affairs Capabilities Manish Dave MBA MS Merck amp Co Inc (Oral presentation at 1224PM)
T24 Implementing CDISC Stan-dards in an Early Phase CRO Suc-cesses and Challenges Pascal Gui-bord Algorithme Pharma Inc Canada
T25 A Pitfall in the Clinical Study Enrollment of Postmenopausal Females Eunhee Chung SOUSEI-KAI Global Clinical Research Center Japan (Oral presentation at 1231PM)
T26 Survey of IRB Review of Urgent Patient Specific Protocols Bambi Grilley RPh RAC Baylor College of Medicine
T27 Lack of Inter-Ethnic Difference in QT-Susceptibility to Moxifloxacin Two Independent TQT Studies in Caucasian and Asian Populations Yang Wang FDA (Oral presentation at 1238PM)
T28 Implementing Quality Risk Management and Risk-Based Moni-toring Practical Guidelines from Sponsors and Sites Amita Malik MS Oracle Health Sciences (Oral presen-tation at 1245PM)
T29 Measurement Equivalence of the SF-36v2 on a Handheld Device and Smartphone App Susan M Dal-labrida PhD PHT Corporation (Oral presentation at 1252PM)
T30 How to Maximize Data Quality in Retrospective Chart Review Stud-ies Dara Stein MSc UBC An Ex-press Scripts Company Canada (Oral presentation at 1259PM)
T31 Benefit-Risk Assessments (BRAs) of an Established Productsrsquo Portfolio Rosa Piccirillo Patino-Paul MD IVAX (Oral presentation at 106PM)
T33 Results of An Online Survey of Stakeholders Regarding Barriers and Solutions to Clinical Trial Recruit-ment Elizabeth Mahon JD Janssen Research amp Development LLC (Oral presentation at 113PM)
T34 Process for Ensuring Clinical Trial Product Quality Janie B Rus-sell RAC National Institutes of Health (NIH) (Oral presentation at 120PM)
T42 Results Reporting to Clini-calTrialsgov and EudraCT - A Con-solidated Approach and First-hand Experiences Mathias Poensgen PhD ArisGlobal GmbH Germany (Oral presentation at 127PM)
Tuesday Session 1C 230ndash310 PM
T35 Attractiveness of PRO Mixed Modes ndash What are Patients Saying Jennifer Ross MEd MS Almac Clini-cal Technologies LLC (Oral presenta-tion at 235PM)
T36 Efficient and Innovative Clini-cal Trial Enrollment Using Online and Social Media Mark Joing MBA Nora Therapeutics (Oral presentation at 242PM)
T37 The Cost Effective Benefits of Behavioral Psychology on Improving Data Quality Shawn Levin Quintiles Transnational Corp (Oral presentation at 249PM)
T38 An Approach to Aggregate Safety Reporting of Drug and Device Constituent Parts of Combination Prod-ucts Xaymara Roman RN AbbVie Inc (Oral presentation at 256PM)
T39 Analyzing the Relative Recruit-ment Performance between Highly-Uti-lized and Low-Utilized Sites in 5 TAs in 4 Asian Countries Hyunjoo Rhee MPharm Quintiles Transnational Ko-rea Co Ltd Republic of Korea
T40 How IDMP Can Help Struc-ture Product Information Labeling Romuald Braun uanotau Switzerland (Oral presentation at 303PM)
Winning with DIAAttendees who registered for our Annual Meeting before May 14 were
entered into a random raffle drawing for a pair of tickets to see the Washing-ton Nationals play the Tampa Bay Rays on Wednesday June 17 at Nationals Park Congratulations to Dr Atif Abbas (Medical Director US Drug Safety Merck Serono) and Julie Townsend (Associate Director Regulatory Opera-tions Upsher-Smith Laboratories Inc) each of whom picked up a pair of tickets from the DIA booth for tomorrow nightrsquos ballgame
a
Click to explore the April issue
Yoursquove never seen a Global Forum like this
Click to explore the June issue
5ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Exhibiting As Booth4C Pharma Solutions LLC 1138
A-B-CAccell Clinical Research 2439Accenture 1015Accenture Business Suite 7Accovion GmbH 1344ACM Global Central Laboratory 2221ACRP 1654Acurian Inc 2235ADAMAS Consulting LLC 2644Adaptive Clinical Systems 627Advanced Clinical 1308Aerotek 1100AiCure 1235Alfresco Software Inc 753Almac 2435American Medical Writers Association 1526Ancillare LP 642APCER Pharma Solutions Inc 1545Applied Clinical TrialsPharmaceutical Executive 520ArisGlobal 2409ArisGlobal Business Suite 4Arivis 1045Arriello Ireland Limited 1457Artcraft Health 1848Asia CRO Alliance 1245Association of Biotechnology Led Enterprises ndash ABLE 1127August Research 1320Auxiliis 1238Axiom Real-Time Metrics Inc 2311BARC Global Central Laboratory 1901Barrington James 2052BBK Worldwide 2026Beijing Clinical Service Center 2640Benchmark Research 516BioClinica 1325Biomedical Systems 619BioPharm Insight 1601BioPharma Investigator 1011BioPoint Inc 2713BioPoint Inc Business Suite 5Biorasi 524bioskin GmbH 1220BioTelemetry Research (Formerly Cardiocore) 1411BIOVIA 2321Blinded Diagnostics 2735Bracket 711CAC EXICARE Corporation 1057CAHG 1142Camargo Pharmaceutical Services 1927Cambridge Healthtech Institute 639Cambridge Semantics Incorporated 1255Cancer Insight 641Canfield Scientific Inc 534Cardinal Health 1104Cardiovascular Imaging Technologies 2622Cardiovascular Research Foundation 857Catalent 2113CDISC 1849Celerion 1301Cenduit LLC 538Center for Information and Study on Clinical Research Participation (CISCRP) 2440Chesapeake IRB 1739Chexx Inc 1244Chiba University Hospital 2352Chiltern International Inc 827
DIA Exhibitor List and Floor Plan DIA 2015 Annual Meeting
Washington DC
Cincinnati Childrenrsquos Research Foundation 1322Citeline Inc 2003CITI Program - University of Miami 1802CitiusTech Inc 1906Clariness 2738CleverCap 2057ClinDatrix Inc 1002ClinEdge LLC 1845Clinical amp Contract Research Association (CCRA) 1208Clinical Ink 2011Clinical Practice Research Datalink (CPRD) 1052Clinical Reference Laboratory 2316Clinical Research Malaysia 2648ClinicalRM 2442Clinitude 2252Clinlogix 1003ClinPlusDZS Clinical Services 1610ClinTec International Ltd 1118Clinverse Inc 1703CluePoints Inc 1511Cmed Clinical Services 752CMIC HOLDINGS Co Ltd 935Cognizant Technology Solutions 2741Compass IRB 2016Compass Research LLC 2349CompleWare 620Complion 2545Comprehend Systems 2511Content Analyst Company 956Continuum Clinical 2343Contract Pharma 643ConvergeHEALTH by Deloitte 811ConvergeHEALTH by Deloitte Business Suite 2Conversis 2253CoSign by ARX 744Cote Orphan Consulting LLC 1544Court Square Group IncRegDocs365 2157Covance Inc 1835Covigilant 2726CRF Health 2427CRO Analytics 1656CROMSOURCE 1345CROS NT 1111CSSi 1811CTI Clinical Trial amp Consulting Services 1915Cu-Tech LLC 1121Cytel Inc 1611
D-E-FDAC 2327Data Matrix 2005DataArt 2639Datapharm Australia Pty Ltd 625DATATRAK International Inc 803DaVita Clinical Research 738DBMS Consulting 2744DIA 1523DIA Patient Advocate Fellowship 1721DITA Exchange 2419
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Pull-Out
Section
Dora Wirth (Languages) Ltd 1212Dr Ebeling amp Assoc GmbH 1302DrugDev 820DSG Inc 719d-Wise Technologies 1402EastHORN Clinical Services in CEE Ltd 2109eClinicalHealth Ltd 510EDETEK Inc 1855Elite Research Network LLC 1206EMB Statistical Solutions LLC 1014endpoint 927Enforme Interactive 1249ENNOV 1145Entimo AG 2220ePharmaSolutions 734EPS Holdings Inc 905ERT 2000ERT 2025Eurofins 2540European Medicines Agency 1528EUROTRIALS 1815Everest Clinical Research 2048Exco InTouch 2212ExecuPharm Inc 1043ExL Pharma 1907Exostar 1749Experis Clinical Practice 2423Exponent 742EXTEDO Inc 2519Falcon Consulting Group 727FDA CDER 1729FDAnews 2621Flex Databases 1312Foresight Group International AG 2339Formedix Inc 1223Frenova Renal Research 1004Fresenius Medical Care North America 2441Frontage Labs 2520
G-H-IGA International Inc 1256Galderma Research amp Development LLC 1851GCP ClinPlus Co Ltd 542Genpact Pharmalink 2541GenPro International 2749Gilead Sciences Inc 1056Global Center of Excellence in Clinical Trials Asan Medical Center 1651Global Center of Excellence in Clinical Trials Inje University Busan Paik Hospital 1651Global Center of Excellence in Clinical Trials Samsung Medical Center 1651Global Center of Excellence in Clinical Trials Yonsei University Health System 1651Global Institute For Research 1207Global Instrumentation LLC 1556Global Language Solutions 723GlobalCare Clinical Trials LTD 2729goBalto Inc 1241GP Strategies 1306
(continued on page 6)
6 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
(continued from page 5)
Parties amp Events
Giveaway Guide
Food amp Drink
Sights
TransportationBrought to you by BioClinica
KAI Research Inc 2740KCR 2722KCRN MampC 1945KellyOCG 1035Klein Hersh International 2034KlinEra Global Services 2110KoNECT 1651Korea Clinical Trials Global Initiative (KCGI) 1651Kuantum CRO and Logistics 1019LabAnswer 2155LabConnect LLC 911LabCorp 1835Lambda Therapeutic Research Inc 2105Langland 2046Launchpad 543Life Science Leader 2623Linical USA 2720Lionbridge Technologies 1246LMK Clinical Research Consulting 645Longboat Clinical Ltd 612LORENZ Life Sciences Group 1427Lovelace Scientific Resources 923Luto Research Limited 1213
M-N-O MakroCare 2618Mapi 754MASIMO 1340Massachusetts College of Pharmacy and Health Sciences 2153MasterControl 1809MaxisIT Inc 2535McGuire Research Institute 2107
MDCPartners 2449Med Fusion 1140MedDATA Foundation 755MedDRA MSSO 1009Medical Research Network Ltd 854Medical Vigilance Solutions Cincinnati Childrenrsquos 1039Medicines Evaluation Unit 1210Medidata Solutions Worldwide 2641Medidata Solutions Inc 2201MEDIX 1846MedNet Solutions Inc 1838Medpace Inc 1801MedPoint Digital Inc 2517Medrio Inc 1202MedSource 1935MedTrials 1346Merge eClinical 2209MESM Ltd 2042META Solutions Inc 2021MMG 2534MNX Global Logistics 1914MonitorForHirecom 1421Montrium Inc 2106Morningside Translations 1953Mortara Instrument Inc 729National Death Index 518NCGS Incorporated 2611NeoGenomics Laboratories 1251Neuroscience Trials Australia 2627New Orleans Center for Clinical Research 728Next Phase Research 2637NextDocs 2038Nextrials Inc 2717NIPER Hyderabad 1127
Green Key Resources 1947Greenphire 613Greens LTD 2156Guangzhou KingMed Center for Clinical Laboratory Co Ltd 2538HampJ CRO International Inc 2646Hangzhou Tigermed Consulting Co Ltd 746HCL America Inc 1635Health Decisions Inc 821HealthCarePoint 1757Hurley Consulting Associates Ltd 955Hurley Write Inc 2727Hydrogen International Ltd 1955iCardiac Technologies 2102ICON plc 503IDT Australia 1746ImageIQ Imaging CRO 1227IMS Health 1317Inamed GmbH 529INC Research 2303Industry Standard Research 725Informa Business Information 2354Information Builders Inc 1853Infotehna Inc 1444Innovative Print amp Media Group 1354InnovoCommerce LLC 1747Integrated Clinical Systems Inc 901Integrated Development Associates Co Ltd 1047IntegReview IRB 2420INTERLAB GmbH central lab services worldwide 1425International Dermatology Research Inc 1538Interspond LLC 2547Intertek Scientific amp Regulatory Consultancy 2516Intralinks Inc 1822inVentiv Health 1517Investigational Cancer Therapeutics - MD Anderson 1546IPHARMA ChemDiv 521
NNIT 2254Norav Medical 514Nova Language Services Ltd 1209Novella Clinical 1439November Research Group 2218Novotech 1134NSF Health Sciences 1847Nuventra Pharma Sciences 824Ocasa Logistics Solutions 2036Ohio Clinical Trials Collaborative 2442OmniComm Systems Inc 2135Online Business Applications 1314OpenClinica 635Optum 1826Oracle Health Sciences 1819Orlando Clinical Research Center 2208Otto Trading Inc 1018
P-Q-RPacific Bridge Medical 2446Palm Beach CRO 1804Paragon International Inc 1403Paragon Solutions 2204
Parallel6 1957PAREXEL International 1535PCM TRIALS 2733Pennside Partners Ltd 2518PerkinElmer Inc 513Personify 1756Pharma Start 1148Pharmaceutical eConsulting 1650Pharmaceutical Outsourcing Hall A EntrancePharmaceutical Packaging Professionals Pty Ltd 2120Pharmaceuticals and Medical Devices Agency (PMDA) 1520Pharmaceuticals Export Promotion Council of India 1127PharmApprove 2054PharmaQuest Ltd 1348PharmaSeek Companies 822PharmaSys Inc 2438PharmaVOICE 1001Pharm-Olam International Ltd 919Phlexglobal Inc 2007Pilgrim Quality Solutions 2044Planet Pharma 1149PleaseTech Ltd 1114Polar Leasing Company Inc 546Popsi Cube 539Porzio Life Sciences 1055PPD 2227PQE 1054PRA Health Sciences 1501Praxis Communications LLC 629Precision for Medicine 1351Premier Research 1711Pretium 1010
PrimeVigilance 2347PRL Central Laboratory Services 1423Proforma Giraffe Graphics Inc 2549Projecis Inc 1645PROSAR 2206Proteus Digital Health Inc 2255ProTrials Research Inc 1108PSKW LLC 1053Pyxant Labs Inc 1950Q2 Business Intelligence 1449QPS LLC 1307Quality and Compliance Consulting Inc 2417Quality Associates Inc 1607Quanticate Inc 1334QuantifiCare 527Queensland Clinical Trials Network 1000Quest Diagnostics 2628Quintiles 601Quorum Review IRB 1219Radiant Research Clinical Research Advantage 2112Randstad Pharma 2715Real Staffing Group 2620RegCheck 955Regeneron Pharmaceuticals 638Regxia Inc 1949Research Across America 2728ReSolution Latin America 2421Rho Inc 724RR Donnelley 2626RWS Group - Medical Translation Division 1350Rx Trials Inc 1400RxLogix Corporation 2521
S-TSan Diego State University - Regulatory Science Programs 1524SanaClis sro 541SAS Institute Inc 2127SAS Institute Inc JMP Division 1744Scarritt Group Inc 1844Schlafender Hase Inc 2012Schulman Associates IRB 1020SeaView Research 1944Sharp Clinical Services 1305Sidus Biodata 1745Signix Inc 2739SNBL Clinical Pharmacology Center 2448Society for Clinical Research Sites - SCRS 1548Sonic Clinical Trials 1010SOUSEIKAI Global Clinical Research Center 1946Southern California Research 2721Southern Star Research 1702Sparta Systems 826Spaulding Clinical Research 2217Speaking Books 1605SPRI Clinical Trials - Global 1021Springer 526Statistics amp Data Corporation (SDC) 1704Stefanini 2723Sterling IRB 2010Stiris Research Inc 1707Symbio LLC 1700Symogen 1856Symphony Clinical Research 2422Synchrogenix Information Strategies Inc 1105Syngene International Ltd 1127Synowledge 1540Syntel Inc 1157SynteractHCR 1335Target Health Inc 2527Tarius AS 1103Tata Consultancy Services 1909Technical Resources International Inc 1913Technology Catalysts International 2447Techorizon 1347TechSol Corporation 2642Telerx 735Teuteberg Incorporated 1948TFDA Center for Drug Evaluation Taiwan 1522
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
8 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Thatrsquos Nice LLC 1240The Clinical Resource Network 1318The Geneva Foundation 2548The Patient Recruiting Agency 2119Theorem Clinical Research 511Theorem Clinical Research Business Suite 1Therapak Corporation 1005Therapeias Health Management 641Therapeutics Inc 1341Thomson Reuters 1440ThreeWire Inc 1939TKL Research Inc 2202Total Clinical Trial Management 2725Total Root Concepts Inc 523TrakCel Limited 2747TransPerfect 1025Trial Runners 2742Trievr Inc 2103Trifecta 1921
U-V-WUBC 2401Unanet 1152University of Florida 1551University of Maryland Online MS in Regulatory Science 1147University of the Sciences 852University of Utah Clinical Trials Office 1725Uppsala Monitoring Centre 2426UTMB Sealy Center for Vaccine Development 1657Valesta Clinical Research Solutions 2629Validated Cloud 2056Veeva Systems Inc 1203Verified Clinical Trials 1109Veristat Inc 1941
(continued from page 7)
Vigilare International 1141Vince amp Associates Clinical Research 748Viracor-IBT Laboratories 2546Viroclinics Biosciences 547VirtualScopics 2320Vitalograph Inc 1406Voluntis 1447WCCT Global 2121WebbWrites LLC 953Whitsell Innovations Inc 626Wincere Inc 1144Wingspan Technology Inc 1445WIRB-Copernicus Group 701Women in Life Sciences - WILS 1356Woodley Equipment Company 1215Worldwide Clinical Trials 1311
TKL Research is an international CRO offering expertise in a full spectrum of indications as well as clinical trial management services from Phase 1 to multicenter international studies TKL serves the pharmaceutical biotech generic drug medi-cal device OTC and consumer health care indus-tries The leader in dermatological research TKL has performed over 200 dermatological clinical trials and is unrivaled in the number of dermato-logical safety studies TKL also has significant ex-perience in Phase 1-4 multinational clinical trials and differentiates itself from the competition with a strong Phase 1 safety capability and full service CRO combined into one cohesive organization
QuintilesBooth 601wwwquintilescomcareers
Quintiles CareersQuintiles is the worldrsquos largest provider of
biopharmaceutical development and commercial outsourcing services and wersquod like to meet you Please stop by the Marriott Marquis Hotel to hellip
ATTEND OUR COCKTAIL RECEPTION in the Chinatown Meeting Room
bull Monday June 15th from 6pm - 8pm
MEET OUR RECRUITING TEAM from Immunol-ogy and Internal Medicine in the Judiciary Square Meeting Room
bull Monday June 15th from 2pm - 5pmbull Tuesday June 16th from 9am - 7pmbull Wednesday June 17th from 9am - 7pm
Improve your probability of successtrade
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Your Opinion MattersComplete an evaluation for each offering
you attend for a chance to win great prizes
Access online evaluations at DIAGlobalorgDIA2015evals or stop by Evaluation Stations in the Registration
Area beginning Tuesday
Free registration to the DIA 2016 52nd Annual Meeting
$100 American Express Gift Card
Discover Safety around the World
ldquoGlobal production of FDA-regulated goods has exploded over the past ten years In addi-tion to an increase in imported finished prod-ucts manufacturers increasingly use imported materials and ingredients in their US produc-tion facilities making the distinction between domestic and imported products obsoleterdquo said FDA Commissioner Dr Margaret A Ham-burg upon the release of the FDA 2011 report Pathway to Global Product Safety and Quality ldquoThe FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face The FDA must further collaborate and leverage in order to close the gap between our import levels and our regula-tory resourcesrdquo she concluded
At 1030AM today staff from FDArsquos interna-tional posts in China Europe and India will provide exclusive updates from their respec-tive posts in Session 245 FDArsquos International Posts International Efforts Regulatory System Strengthening and Inspections presented in Room 152A Their updates will include out-reach to foreign regulators facility inspections risk-based global surveillance to protect supply chains and related topics
Chair Leslie Ball MD Assistant Commis-sioner and Deputy Director OIP OC FDA
Update from the FDA China Office S Leigh Verbois PhD Incoming Director China Office Office of International Programs OC FDA
Update from the FDA India Office Mathew T Thomas MD Acting Country Director India Of-fice Office of International Programs OC FDA
Update from the FDA European Office Donald Prater DVM Acting Regional Director Europe Office OIP OC FDA
9ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Route 1 Red Hotel Pickup LocationJW Marriott E Street EntranceGrand Hyatt 11th Street EntranceMarriott Metro Center At Hyatt 11th Street Entrance
Route 2 Yellow Hotel Pickup LocationHamilton Crown Plaza Lobby EntranceDonovan House Lobby EntranceWashington Plaza Curbside Vermont mdash Near DrivewayComfort Inn Convention Center At Washington Plaza Curbside Vermont
Route 3 Blue Hotel Pickup LocationLoews Madison Lobby EntranceWestin Washington At Loews Madison Lobby EntranceDoubletree Washington Lobby EntranceHotel Helix At Doubletree Lobby EntranceMayflower Renaissance Desales Street Entrance
Hotels within walking distance of the Walter E Washington Convention Center are Embassy Suites Convention Center Hampton
Inn Henley Park Hotel Morrison-Clark Inn Renaissance Washington DC Downtown Hotel and Marriott Marquis
Tuesday June 16 through Wednesday June 17Hours Frequency 645-930AM 15 Minutes930AM-330PM No Service330-630PM 15 MinutesLast Bus Departs Hotels 530PM
Thursday June 18 Hours Frequency 730-900AM 15 Minutes900AM-1230pm 30 MinutesLast Bus Departs Hotels 1130AM
For Shuttle Information or to Pre-Schedule ADA Pick-up call 877-865-3437 during convention shuttle hours
Complimentary Shuttle InformationPlease allow up to 20 minutes (including waiting and riding time under nor-mal peak traffic conditions) to travel from your hotel to the Walter E Wash-ington Convention Center located on Mount Vernon Place Delays may occur due to circumstances beyond our control
Discover tomorrowrsquos solutions to to-dayrsquos challenges through the products and services showcased in todayrsquos Innovation Theater sessions presented near Exhibit Hall Entrance B
945AM 225 Covance Innovation Theater Advances in Risk-Based Mon-itoring Transforming Drug Develop-ment Through Efficient Workflows Big Data and Elegant Software Discover Covancersquos risk-based monitoring (RBM) platform which provides clients with best-in-class implementation of the RBM principles put forth by FDA EMA and TransCelerate and facilitates RBM through timely secure and inte-grated access to all relevant trial data
1200PM 249 Quintiles Innova-tion Theater Transform Clinical De-velopment ndash Modernizing for Smarter Trials Because of our imperative to ldquomodernizerdquo clinical trials to de-liver medicines faster at less cost to patients who need them learn how you can gauge global capabilities to model and predict better outcomes identify appropriate investigator sites and deliver faster ldquoanalysis-readyrdquo data to identify trends and issues in near real time
100PM 250 Veeva Innovation Theater 2015 Paperless Trial Master File (TMF) Survey Trends and Insights Results from the follow-up to Veevarsquos benchmark 2014 Paperless TMF Sur-vey which analyzed the observations of TMF owners to identify the barriers business drivers and benefits of mov-ing to fully paperless TMFs How does your organization compare and why do some organizations benefit more than others
300PM 267 BBK Worldwide Innovation Theater mHealth A New Era in Patient Engagement BBK Worldwide and mHealth experts from the Landon Pediatric Foundation and CareThings discuss opportunities for patient engagement in clinical trials within mHealth and how advance-ments in apps wearables and per-sonalized content delivery are shaping a new patient engagement model and impacting the entire clinical research enterprise
See Innovation in Action Innovation Theater
We ask all Annual Meeting speak-ers to please check in at the Speaker Registration Desk when you arrive at the Convention Center to pick up your name badge Speaker registration will be open today from 700AMndash500PM The Speaker Preparation Room will also be open from 700AMndash500PM to-day this is where you will confirm that your presentation has been properly uploaded
A Speaker Training Room is also available for you to practice your pre-sentation alone or with your fellow pre-senters Please schedule your practice time when you check in at the Registra-tion Desk This Training Room will host a special Speaker Training Session coaching on podium presentation best practices from 945-1015AM today
The Speaker Registration Desk Speaker Preparation Room and Speaker Training Room are all located in the East Registration area
We ask all speakers to arrive at their assigned room 20 minutes before
Speaker Registration amp Preparationyour session scheduled start time to confirm that the proper visual presen-tation is loaded on the session room computer You cannot upload or edit your presentations in the session room you may do so however in the Speaker Preparation Room We also recommend that you carry an elec-tronic copy (via USB) of your presen-tation for backup purposes
Exhibitor PassportVisit our Exhibitors to hear about their products and services You must have 50 Exhibitors sign your card found in your attendee bag to be eligible to win bull First Prize Apple Watch Sport bull Second Prize $250 VISA Gift Card (Two)
bull Third Prize Fitbit Charge HR (Three)
Passports must be dropped off to the DIA Booth 1523 by 400pm on Wednesday June 17
The Medical Heroes Appreciation Walk organized by CISCRP (Center for Information and Study on Clinical Research Participation) on Monday morning brought over 250 people together in celebration of study volunteers and their gift of participation in clinical research
10 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
The DIA 2015 51st Annual Meeting offers a variety of over 250 education opportunities to help strengthen your understanding of the value of cross-discipline integration and to foster innovation for better health outcomes
Participants may receive up to 18 AMA PRA Category 1 Creditstrade 18 pharmacy contact hours or 18 con-tinuing education units (CEUs) 18 nursing contact hours 10 Project Man-agement Institute (PMI) professional development units or 24 International Association for Continuing Education and Training CEUs There are multiple program offering formats at the meet-ing including sessions forums work-shops symposia and one hour TURBO offerings Program offerings desig-nated for credit are clearly identified in the final program with the pertinent CME Pharmacy Nursing or PMI PDUs statements IACET CEUs are offered for all program offerings except that no continuing education credits are avail-able for the following offerings
bull Plenary Session and Keynote Addressbull Session 226 How Pharmaceutical Companies Can Engage Responsibly with Patients Online bull Session 246 Using Registries to Support Recruitment in Alzheimers Disease (AD) Prevention or Delay-of-Onset Studies bull Session 345 Power Up Give Your Brain a Breakbull Track 20 Innovation Theaterbull Track 21 Poster Presentations
Participants who would like to
Continuing Education at DIA 2015 51st Annual Meetingreceive continuing education credits for the Annual Meeting must scan their DIA name badge at each program offering to record hisher attendance Participants must scan their name badges within 45 minutes after the start time of each 15 hour program offering and within 30 minutes after the start time for the one hour TURBO offerings If a participant attends multiple offerings within the same time frame only the last scanned entry will be recorded Participants who do not scan their badge within the allotted time will not be eligible to request the available continuing education credits for that program offering
Evaluation Station ndash Your Opinion Counts
DIA will again utilize an online evaluation portal to obtain your feed-back on our program offerings You can access this portal at DIAglobalorgDIA2015evals Each evening dur-ing the Annual Meeting we will send an email to participants requesting their feedback on the offerings they attended that day
Beginning Tuesday June 16 there will also be an onsite Evaluation Sta-tion in the Attendee Registration Area (West Wing) for you to complete your evaluations while onsite Your feed-back is valued and we would really appreciate hearing from you
DIA will conduct a drawing with a chance for one participant to win a free registration to the DIA 2016 52nd Annual Meeting in Philadelphia PA Eligible participants must complete all
program offering evaluations from each educational offering they attended dur-ing the Annual Meeting time frame
DIA will also offer one winner a $100 American Express gift card from a ran-dom drawing of the participants who complete the Overall Evaluation form During the week of July 20 the winners will be announced and notified Dead-line for submitting evaluation feedback is Wednesday July 15 2015
All DIA 2015 51st Annual Meeting continuing education credit requests are processed through DIArsquos My Transcript DIArsquos My Transcript OPENS on Tuesday June 23 My Transcript allow you to request an Attendance Certificate or request CE credit(s) and download a statement of credit To ac-cess My Transcript
bull Login to My DIA at DIAglobalorgbull Enter your User ID and Passwordbull Select My Transcript from the
left side barbull Select DIA 2015 51st Annual Meeting Credit Requestbull Proceed to request an Attendance Certificate or CE credit for each offering and for each daybull Select the Credit Type or Attendance Certificate for each
offeringbull Select Continue after your credit request is completed for all requested offeringsbull Submitbull Print statement(s) of credit or Attendance Certificate All ACPE credit requests must be
submitted by Wednesday July 29 2015 so your request can be sub-mitted to the CPE Monitor Please have your NABP eProfile ID and DOB (MMDD) readily available when requesting ACPE credit If you need to obtain your NABP eProfile ID visit wwwcpemonitornet
MOBILIZE YOUR TRIAL WITH IN-HOME CLINICAL TRIAL VISITSbull Subject Conveniencebull Improves Recruitment Retention amp Compliancebull Access to Certified Mobile Research Nursesbull US amp Global Services
For RFPs or to request a capabilities presentation please contact infopcmtrialscom or call
888-628-9707 | DIA booth 2733
Our Certified Mobile Research Nurses
Set Us Apart
PCM Trials DIA Ad Half Page2015_v3indd 1 31015 518 PM
of New Drugs CDER
In Room 146C 291 CDRH Town Hall continues the Annual Meeting tra-dition of providing you with a unique opportunity to hear directly from the Director of the Center for Devices and Radiological Health (CDRH) on the state of CDRH and its vision for the future Specific topics include FDA-SIA accomplishments and activities 2017 MDUFA Reauthorization and the impact of the House Energy and Com-merce 21st Century Cures initiatives
the regulatory framework for labora-tory developed tests expedited path-ways development the future of next gen sequencing and innovative ap-proaches for companion diagnostics and personalized medicine human factors studies combination products regulation of mobile and web software applications and the impact of other new technologies on patient care
Chair Janet Jenkins-Showalter Senior Regulatory Group Director Regulatory Policy amp Intelligence Genentech A Member of the Roche Group
Panelists Jeffrey Shuren JD MD Director CDRH FDA Alberto Gutier-rez PhD Director Office of In Vitro Diagnostics amp Radiological Health CDRH and Jonette R Foy PhD Deputy Director for Engineering amp Sci-ence Review ODE CDRH
InnovationsContinued from Page 3
28th Annual EuroMeeting 6-8 April 2016 Hamburg GermanyDIAGlobalorgEuroMeeting
Save the date
DIA Europe Middle East amp AfricaKuumlchengasse 164051 Basel Switzerland
Flanked by DIA Globlal Chief Executive Barbara Lopez Kunz and Dr Per Spindler (DIA President and Chair Board of Directors) DIA welcomes our 2015 DIA Fellows Minnie Baylor-Henry RPh JD (Incoming Chair) Jennifer L Riggins PharmD Kenneth A Getz MBA and Noriaki Murao MS 2015 DIA Fellow Gaby Danan MD PhD was unable to attend
ldquoMy commitment to you at this meeting is to provide the environment that will help you seize the opportuni-ties that present themselves both here in Washington as we meet and moving forward as you return to your places of workrdquo she concluded ldquoSo I invite you to seize the opportunity that we have this week to take advantage of this lsquoone shotrsquordquo
Annual Meeting Co-Chair Christo-pher P Austin MD (Director National Center for Advancing Translational Sci-ences US National Institutes of Health) followed Barbara to the podium ldquoOur focus at NCATS is not on spe-cific diseases but on what is common among all diseasesrdquo he explained ldquoOur chosen field is remarkably if not painfully empirical because we donrsquot understand the general principles and thatrsquos what NCATS is all aboutrdquo
ldquoWe are fond of saying that transla-tional science is a team sportrdquo he said to introduce one such ldquoteamrdquo project The Tissue Chip for Drug Screening program a collaboration between the FDA and the Defense Advanced Research Projects Agency (DARPA) that has developed organ and organ systems on microchips for drug toxic-ity testing that doesnrsquot require animals or humans In the future these chips could include hormones for example to identify the difference between male and female response to drugs ldquoI really thought this was just science fiction ndash and I was wrongrdquo he confessed
ldquoOne of my favorite proverbs
comes from Japanese literature lsquoNone of us is as smart as all of usrsquo Solving the systemic and highly complex problems of translation will require that adage as a guiding principle and the DIA meeting this year promises to provide the perfect setting to establish and strengthen the connections that will help us all collectively develop innovate and advance to new solutionsrdquo he con-cluded
ldquoLike many of you this organization and its expanding influence have been essential to my lifersquos work in the phar-maceutical and biotechnology arenardquo said Per Spindler DVM MBA MSc (DIA President and Chair Board of Directors Director Biopeople Univer-sity of Copenhagen Denmark ldquoI was born in 1963 in Copenhagen the year before DIA was foundedrdquo
ldquoIn 2003 I was invited to become a member of the DIA Advisory Council of Europe and I was elected to the Board of Directors in 2007 In the recent past as member of the Board I have been instrumental in establishing our journal within therapeutic innova-tion and regulatory science ndash pro-fessional fields where DIA takes the global leadership You might say DIA and I have grown up togetherrdquo Per continued
ldquoBy the time DIA celebrates its 100th Anniversary our world will be a very different place shaped in part by the innovations that we will ad-vance here in Washington Review the program for this 51st meeting of DIA with its rich and diverse offerings and you will have no doubt that a trans-formational agenda for our industry is evolving You will also be convinced that DIA will be at the forefront of that transformationrdquo
ldquoLike Per I have greatly benefited from my association with DIA and this organization has been essential to my career and to the proficiencies I have developed in the regulatory science arenardquo began President-Elect San-dra A Milligan JD MD (Senior Vice President Global Regulatory Affairs amp Clinical Safety Merck Research Laboratories) ldquoIn 2013 I chaired the Annual Meeting in Boston and now I find myself grateful to you the mem-bership to be the next president of DIA starting July 1strdquo
ldquoOur organization brings people to-gether creating a rich mix of ideas of service to our professions and service to our patients DIA as an organization truly proves that the whole is greater than the sum of its partsrdquo Sandra concluded
Co-Chair Michael Rosenblatt MD
(Executive Vice President amp Chief Medical Officer Merck amp Co Inc) concluded the welcoming remarks ldquoDIA is the only place i know of where professionals from every aspect of RampD ndash from the laboratory to the patient ndash gather to learn and to share best practicesrdquo he began ldquoI see great value in the lively and massive ex-change of information and ideas that takes place here It illustrates some-thing i deeply believe all of us ndash and the patients we serve ndash are interde-pendentrdquo
ldquoThe patient has always been ndash and should always be ndash at the core of what we dordquo he continued ldquoBut todayrsquos patients are different They are better informed more independent more ac-tive and more engaged than ever They are interested in taking charge of their own care Many have organized them-selves into learning communitiesrdquo
ldquoLike any big social trend this renewed emphasis on the patient has created a new mindset that in turn has helped spawn exciting innova-tionsrdquo he concluded ldquoWe need only look at this conference agenda to see evidence of new and previously unlikely collaborations ndash all with re-newed focus on in the patient These are partnerships between academia industry practitioners payers and regulators aimed at speeding the ar-rival of urgently needed vaccines and cures targeting the right therapies to the right people and improving patient accessrdquo
Daniel Burrus (President amp CEO Burrus Research Associates Inc) opened his Keynote Address by refer-ring to DIA Annual Meeting attendees as ldquothe great enablersrdquo His energetic remarks encompassed the themes of collaboration and innovation through real-world and theoretical examples ldquoWe live in a world of amazing inno-vation right nowrdquo he began ldquoIn fact wersquore standing at the base of a moun-tain of innovationrdquo
Daniel presented innovation as the ability to anticipate and solve a problem before you actually have it ldquoKeeping up is a foolrsquos gamerdquo he said ldquoWho wants to keep up I want to jump aheadrdquo
ldquoWe say wersquore collaborating but are werdquo he asked ldquoAre you using your 4G phone to advance innovation or to watch Netflix Yoursquove already got amazing tools Are you underutilizing them Hint Yesrdquo
ldquoThe world needs yourdquo he said to close the Opening Plenary ldquoYoursquore the enablers of innovationrdquo
Annual Meeting Co-Chairs Dr Michael Rosenblatt (left) and Dr Christopher Austin (right) welcome attendees to the Opening Plenary
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
Global DevelopmentGlobal Launch
We Know How
Global IMPACT
5ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Exhibiting As Booth4C Pharma Solutions LLC 1138
A-B-CAccell Clinical Research 2439Accenture 1015Accenture Business Suite 7Accovion GmbH 1344ACM Global Central Laboratory 2221ACRP 1654Acurian Inc 2235ADAMAS Consulting LLC 2644Adaptive Clinical Systems 627Advanced Clinical 1308Aerotek 1100AiCure 1235Alfresco Software Inc 753Almac 2435American Medical Writers Association 1526Ancillare LP 642APCER Pharma Solutions Inc 1545Applied Clinical TrialsPharmaceutical Executive 520ArisGlobal 2409ArisGlobal Business Suite 4Arivis 1045Arriello Ireland Limited 1457Artcraft Health 1848Asia CRO Alliance 1245Association of Biotechnology Led Enterprises ndash ABLE 1127August Research 1320Auxiliis 1238Axiom Real-Time Metrics Inc 2311BARC Global Central Laboratory 1901Barrington James 2052BBK Worldwide 2026Beijing Clinical Service Center 2640Benchmark Research 516BioClinica 1325Biomedical Systems 619BioPharm Insight 1601BioPharma Investigator 1011BioPoint Inc 2713BioPoint Inc Business Suite 5Biorasi 524bioskin GmbH 1220BioTelemetry Research (Formerly Cardiocore) 1411BIOVIA 2321Blinded Diagnostics 2735Bracket 711CAC EXICARE Corporation 1057CAHG 1142Camargo Pharmaceutical Services 1927Cambridge Healthtech Institute 639Cambridge Semantics Incorporated 1255Cancer Insight 641Canfield Scientific Inc 534Cardinal Health 1104Cardiovascular Imaging Technologies 2622Cardiovascular Research Foundation 857Catalent 2113CDISC 1849Celerion 1301Cenduit LLC 538Center for Information and Study on Clinical Research Participation (CISCRP) 2440Chesapeake IRB 1739Chexx Inc 1244Chiba University Hospital 2352Chiltern International Inc 827
DIA Exhibitor List and Floor Plan DIA 2015 Annual Meeting
Washington DC
Cincinnati Childrenrsquos Research Foundation 1322Citeline Inc 2003CITI Program - University of Miami 1802CitiusTech Inc 1906Clariness 2738CleverCap 2057ClinDatrix Inc 1002ClinEdge LLC 1845Clinical amp Contract Research Association (CCRA) 1208Clinical Ink 2011Clinical Practice Research Datalink (CPRD) 1052Clinical Reference Laboratory 2316Clinical Research Malaysia 2648ClinicalRM 2442Clinitude 2252Clinlogix 1003ClinPlusDZS Clinical Services 1610ClinTec International Ltd 1118Clinverse Inc 1703CluePoints Inc 1511Cmed Clinical Services 752CMIC HOLDINGS Co Ltd 935Cognizant Technology Solutions 2741Compass IRB 2016Compass Research LLC 2349CompleWare 620Complion 2545Comprehend Systems 2511Content Analyst Company 956Continuum Clinical 2343Contract Pharma 643ConvergeHEALTH by Deloitte 811ConvergeHEALTH by Deloitte Business Suite 2Conversis 2253CoSign by ARX 744Cote Orphan Consulting LLC 1544Court Square Group IncRegDocs365 2157Covance Inc 1835Covigilant 2726CRF Health 2427CRO Analytics 1656CROMSOURCE 1345CROS NT 1111CSSi 1811CTI Clinical Trial amp Consulting Services 1915Cu-Tech LLC 1121Cytel Inc 1611
D-E-FDAC 2327Data Matrix 2005DataArt 2639Datapharm Australia Pty Ltd 625DATATRAK International Inc 803DaVita Clinical Research 738DBMS Consulting 2744DIA 1523DIA Patient Advocate Fellowship 1721DITA Exchange 2419
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Pull-Out
Section
Dora Wirth (Languages) Ltd 1212Dr Ebeling amp Assoc GmbH 1302DrugDev 820DSG Inc 719d-Wise Technologies 1402EastHORN Clinical Services in CEE Ltd 2109eClinicalHealth Ltd 510EDETEK Inc 1855Elite Research Network LLC 1206EMB Statistical Solutions LLC 1014endpoint 927Enforme Interactive 1249ENNOV 1145Entimo AG 2220ePharmaSolutions 734EPS Holdings Inc 905ERT 2000ERT 2025Eurofins 2540European Medicines Agency 1528EUROTRIALS 1815Everest Clinical Research 2048Exco InTouch 2212ExecuPharm Inc 1043ExL Pharma 1907Exostar 1749Experis Clinical Practice 2423Exponent 742EXTEDO Inc 2519Falcon Consulting Group 727FDA CDER 1729FDAnews 2621Flex Databases 1312Foresight Group International AG 2339Formedix Inc 1223Frenova Renal Research 1004Fresenius Medical Care North America 2441Frontage Labs 2520
G-H-IGA International Inc 1256Galderma Research amp Development LLC 1851GCP ClinPlus Co Ltd 542Genpact Pharmalink 2541GenPro International 2749Gilead Sciences Inc 1056Global Center of Excellence in Clinical Trials Asan Medical Center 1651Global Center of Excellence in Clinical Trials Inje University Busan Paik Hospital 1651Global Center of Excellence in Clinical Trials Samsung Medical Center 1651Global Center of Excellence in Clinical Trials Yonsei University Health System 1651Global Institute For Research 1207Global Instrumentation LLC 1556Global Language Solutions 723GlobalCare Clinical Trials LTD 2729goBalto Inc 1241GP Strategies 1306
(continued on page 6)
6 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
(continued from page 5)
Parties amp Events
Giveaway Guide
Food amp Drink
Sights
TransportationBrought to you by BioClinica
KAI Research Inc 2740KCR 2722KCRN MampC 1945KellyOCG 1035Klein Hersh International 2034KlinEra Global Services 2110KoNECT 1651Korea Clinical Trials Global Initiative (KCGI) 1651Kuantum CRO and Logistics 1019LabAnswer 2155LabConnect LLC 911LabCorp 1835Lambda Therapeutic Research Inc 2105Langland 2046Launchpad 543Life Science Leader 2623Linical USA 2720Lionbridge Technologies 1246LMK Clinical Research Consulting 645Longboat Clinical Ltd 612LORENZ Life Sciences Group 1427Lovelace Scientific Resources 923Luto Research Limited 1213
M-N-O MakroCare 2618Mapi 754MASIMO 1340Massachusetts College of Pharmacy and Health Sciences 2153MasterControl 1809MaxisIT Inc 2535McGuire Research Institute 2107
MDCPartners 2449Med Fusion 1140MedDATA Foundation 755MedDRA MSSO 1009Medical Research Network Ltd 854Medical Vigilance Solutions Cincinnati Childrenrsquos 1039Medicines Evaluation Unit 1210Medidata Solutions Worldwide 2641Medidata Solutions Inc 2201MEDIX 1846MedNet Solutions Inc 1838Medpace Inc 1801MedPoint Digital Inc 2517Medrio Inc 1202MedSource 1935MedTrials 1346Merge eClinical 2209MESM Ltd 2042META Solutions Inc 2021MMG 2534MNX Global Logistics 1914MonitorForHirecom 1421Montrium Inc 2106Morningside Translations 1953Mortara Instrument Inc 729National Death Index 518NCGS Incorporated 2611NeoGenomics Laboratories 1251Neuroscience Trials Australia 2627New Orleans Center for Clinical Research 728Next Phase Research 2637NextDocs 2038Nextrials Inc 2717NIPER Hyderabad 1127
Green Key Resources 1947Greenphire 613Greens LTD 2156Guangzhou KingMed Center for Clinical Laboratory Co Ltd 2538HampJ CRO International Inc 2646Hangzhou Tigermed Consulting Co Ltd 746HCL America Inc 1635Health Decisions Inc 821HealthCarePoint 1757Hurley Consulting Associates Ltd 955Hurley Write Inc 2727Hydrogen International Ltd 1955iCardiac Technologies 2102ICON plc 503IDT Australia 1746ImageIQ Imaging CRO 1227IMS Health 1317Inamed GmbH 529INC Research 2303Industry Standard Research 725Informa Business Information 2354Information Builders Inc 1853Infotehna Inc 1444Innovative Print amp Media Group 1354InnovoCommerce LLC 1747Integrated Clinical Systems Inc 901Integrated Development Associates Co Ltd 1047IntegReview IRB 2420INTERLAB GmbH central lab services worldwide 1425International Dermatology Research Inc 1538Interspond LLC 2547Intertek Scientific amp Regulatory Consultancy 2516Intralinks Inc 1822inVentiv Health 1517Investigational Cancer Therapeutics - MD Anderson 1546IPHARMA ChemDiv 521
NNIT 2254Norav Medical 514Nova Language Services Ltd 1209Novella Clinical 1439November Research Group 2218Novotech 1134NSF Health Sciences 1847Nuventra Pharma Sciences 824Ocasa Logistics Solutions 2036Ohio Clinical Trials Collaborative 2442OmniComm Systems Inc 2135Online Business Applications 1314OpenClinica 635Optum 1826Oracle Health Sciences 1819Orlando Clinical Research Center 2208Otto Trading Inc 1018
P-Q-RPacific Bridge Medical 2446Palm Beach CRO 1804Paragon International Inc 1403Paragon Solutions 2204
Parallel6 1957PAREXEL International 1535PCM TRIALS 2733Pennside Partners Ltd 2518PerkinElmer Inc 513Personify 1756Pharma Start 1148Pharmaceutical eConsulting 1650Pharmaceutical Outsourcing Hall A EntrancePharmaceutical Packaging Professionals Pty Ltd 2120Pharmaceuticals and Medical Devices Agency (PMDA) 1520Pharmaceuticals Export Promotion Council of India 1127PharmApprove 2054PharmaQuest Ltd 1348PharmaSeek Companies 822PharmaSys Inc 2438PharmaVOICE 1001Pharm-Olam International Ltd 919Phlexglobal Inc 2007Pilgrim Quality Solutions 2044Planet Pharma 1149PleaseTech Ltd 1114Polar Leasing Company Inc 546Popsi Cube 539Porzio Life Sciences 1055PPD 2227PQE 1054PRA Health Sciences 1501Praxis Communications LLC 629Precision for Medicine 1351Premier Research 1711Pretium 1010
PrimeVigilance 2347PRL Central Laboratory Services 1423Proforma Giraffe Graphics Inc 2549Projecis Inc 1645PROSAR 2206Proteus Digital Health Inc 2255ProTrials Research Inc 1108PSKW LLC 1053Pyxant Labs Inc 1950Q2 Business Intelligence 1449QPS LLC 1307Quality and Compliance Consulting Inc 2417Quality Associates Inc 1607Quanticate Inc 1334QuantifiCare 527Queensland Clinical Trials Network 1000Quest Diagnostics 2628Quintiles 601Quorum Review IRB 1219Radiant Research Clinical Research Advantage 2112Randstad Pharma 2715Real Staffing Group 2620RegCheck 955Regeneron Pharmaceuticals 638Regxia Inc 1949Research Across America 2728ReSolution Latin America 2421Rho Inc 724RR Donnelley 2626RWS Group - Medical Translation Division 1350Rx Trials Inc 1400RxLogix Corporation 2521
S-TSan Diego State University - Regulatory Science Programs 1524SanaClis sro 541SAS Institute Inc 2127SAS Institute Inc JMP Division 1744Scarritt Group Inc 1844Schlafender Hase Inc 2012Schulman Associates IRB 1020SeaView Research 1944Sharp Clinical Services 1305Sidus Biodata 1745Signix Inc 2739SNBL Clinical Pharmacology Center 2448Society for Clinical Research Sites - SCRS 1548Sonic Clinical Trials 1010SOUSEIKAI Global Clinical Research Center 1946Southern California Research 2721Southern Star Research 1702Sparta Systems 826Spaulding Clinical Research 2217Speaking Books 1605SPRI Clinical Trials - Global 1021Springer 526Statistics amp Data Corporation (SDC) 1704Stefanini 2723Sterling IRB 2010Stiris Research Inc 1707Symbio LLC 1700Symogen 1856Symphony Clinical Research 2422Synchrogenix Information Strategies Inc 1105Syngene International Ltd 1127Synowledge 1540Syntel Inc 1157SynteractHCR 1335Target Health Inc 2527Tarius AS 1103Tata Consultancy Services 1909Technical Resources International Inc 1913Technology Catalysts International 2447Techorizon 1347TechSol Corporation 2642Telerx 735Teuteberg Incorporated 1948TFDA Center for Drug Evaluation Taiwan 1522
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
8 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Thatrsquos Nice LLC 1240The Clinical Resource Network 1318The Geneva Foundation 2548The Patient Recruiting Agency 2119Theorem Clinical Research 511Theorem Clinical Research Business Suite 1Therapak Corporation 1005Therapeias Health Management 641Therapeutics Inc 1341Thomson Reuters 1440ThreeWire Inc 1939TKL Research Inc 2202Total Clinical Trial Management 2725Total Root Concepts Inc 523TrakCel Limited 2747TransPerfect 1025Trial Runners 2742Trievr Inc 2103Trifecta 1921
U-V-WUBC 2401Unanet 1152University of Florida 1551University of Maryland Online MS in Regulatory Science 1147University of the Sciences 852University of Utah Clinical Trials Office 1725Uppsala Monitoring Centre 2426UTMB Sealy Center for Vaccine Development 1657Valesta Clinical Research Solutions 2629Validated Cloud 2056Veeva Systems Inc 1203Verified Clinical Trials 1109Veristat Inc 1941
(continued from page 7)
Vigilare International 1141Vince amp Associates Clinical Research 748Viracor-IBT Laboratories 2546Viroclinics Biosciences 547VirtualScopics 2320Vitalograph Inc 1406Voluntis 1447WCCT Global 2121WebbWrites LLC 953Whitsell Innovations Inc 626Wincere Inc 1144Wingspan Technology Inc 1445WIRB-Copernicus Group 701Women in Life Sciences - WILS 1356Woodley Equipment Company 1215Worldwide Clinical Trials 1311
TKL Research is an international CRO offering expertise in a full spectrum of indications as well as clinical trial management services from Phase 1 to multicenter international studies TKL serves the pharmaceutical biotech generic drug medi-cal device OTC and consumer health care indus-tries The leader in dermatological research TKL has performed over 200 dermatological clinical trials and is unrivaled in the number of dermato-logical safety studies TKL also has significant ex-perience in Phase 1-4 multinational clinical trials and differentiates itself from the competition with a strong Phase 1 safety capability and full service CRO combined into one cohesive organization
QuintilesBooth 601wwwquintilescomcareers
Quintiles CareersQuintiles is the worldrsquos largest provider of
biopharmaceutical development and commercial outsourcing services and wersquod like to meet you Please stop by the Marriott Marquis Hotel to hellip
ATTEND OUR COCKTAIL RECEPTION in the Chinatown Meeting Room
bull Monday June 15th from 6pm - 8pm
MEET OUR RECRUITING TEAM from Immunol-ogy and Internal Medicine in the Judiciary Square Meeting Room
bull Monday June 15th from 2pm - 5pmbull Tuesday June 16th from 9am - 7pmbull Wednesday June 17th from 9am - 7pm
Improve your probability of successtrade
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Your Opinion MattersComplete an evaluation for each offering
you attend for a chance to win great prizes
Access online evaluations at DIAGlobalorgDIA2015evals or stop by Evaluation Stations in the Registration
Area beginning Tuesday
Free registration to the DIA 2016 52nd Annual Meeting
$100 American Express Gift Card
Discover Safety around the World
ldquoGlobal production of FDA-regulated goods has exploded over the past ten years In addi-tion to an increase in imported finished prod-ucts manufacturers increasingly use imported materials and ingredients in their US produc-tion facilities making the distinction between domestic and imported products obsoleterdquo said FDA Commissioner Dr Margaret A Ham-burg upon the release of the FDA 2011 report Pathway to Global Product Safety and Quality ldquoThe FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face The FDA must further collaborate and leverage in order to close the gap between our import levels and our regula-tory resourcesrdquo she concluded
At 1030AM today staff from FDArsquos interna-tional posts in China Europe and India will provide exclusive updates from their respec-tive posts in Session 245 FDArsquos International Posts International Efforts Regulatory System Strengthening and Inspections presented in Room 152A Their updates will include out-reach to foreign regulators facility inspections risk-based global surveillance to protect supply chains and related topics
Chair Leslie Ball MD Assistant Commis-sioner and Deputy Director OIP OC FDA
Update from the FDA China Office S Leigh Verbois PhD Incoming Director China Office Office of International Programs OC FDA
Update from the FDA India Office Mathew T Thomas MD Acting Country Director India Of-fice Office of International Programs OC FDA
Update from the FDA European Office Donald Prater DVM Acting Regional Director Europe Office OIP OC FDA
9ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Route 1 Red Hotel Pickup LocationJW Marriott E Street EntranceGrand Hyatt 11th Street EntranceMarriott Metro Center At Hyatt 11th Street Entrance
Route 2 Yellow Hotel Pickup LocationHamilton Crown Plaza Lobby EntranceDonovan House Lobby EntranceWashington Plaza Curbside Vermont mdash Near DrivewayComfort Inn Convention Center At Washington Plaza Curbside Vermont
Route 3 Blue Hotel Pickup LocationLoews Madison Lobby EntranceWestin Washington At Loews Madison Lobby EntranceDoubletree Washington Lobby EntranceHotel Helix At Doubletree Lobby EntranceMayflower Renaissance Desales Street Entrance
Hotels within walking distance of the Walter E Washington Convention Center are Embassy Suites Convention Center Hampton
Inn Henley Park Hotel Morrison-Clark Inn Renaissance Washington DC Downtown Hotel and Marriott Marquis
Tuesday June 16 through Wednesday June 17Hours Frequency 645-930AM 15 Minutes930AM-330PM No Service330-630PM 15 MinutesLast Bus Departs Hotels 530PM
Thursday June 18 Hours Frequency 730-900AM 15 Minutes900AM-1230pm 30 MinutesLast Bus Departs Hotels 1130AM
For Shuttle Information or to Pre-Schedule ADA Pick-up call 877-865-3437 during convention shuttle hours
Complimentary Shuttle InformationPlease allow up to 20 minutes (including waiting and riding time under nor-mal peak traffic conditions) to travel from your hotel to the Walter E Wash-ington Convention Center located on Mount Vernon Place Delays may occur due to circumstances beyond our control
Discover tomorrowrsquos solutions to to-dayrsquos challenges through the products and services showcased in todayrsquos Innovation Theater sessions presented near Exhibit Hall Entrance B
945AM 225 Covance Innovation Theater Advances in Risk-Based Mon-itoring Transforming Drug Develop-ment Through Efficient Workflows Big Data and Elegant Software Discover Covancersquos risk-based monitoring (RBM) platform which provides clients with best-in-class implementation of the RBM principles put forth by FDA EMA and TransCelerate and facilitates RBM through timely secure and inte-grated access to all relevant trial data
1200PM 249 Quintiles Innova-tion Theater Transform Clinical De-velopment ndash Modernizing for Smarter Trials Because of our imperative to ldquomodernizerdquo clinical trials to de-liver medicines faster at less cost to patients who need them learn how you can gauge global capabilities to model and predict better outcomes identify appropriate investigator sites and deliver faster ldquoanalysis-readyrdquo data to identify trends and issues in near real time
100PM 250 Veeva Innovation Theater 2015 Paperless Trial Master File (TMF) Survey Trends and Insights Results from the follow-up to Veevarsquos benchmark 2014 Paperless TMF Sur-vey which analyzed the observations of TMF owners to identify the barriers business drivers and benefits of mov-ing to fully paperless TMFs How does your organization compare and why do some organizations benefit more than others
300PM 267 BBK Worldwide Innovation Theater mHealth A New Era in Patient Engagement BBK Worldwide and mHealth experts from the Landon Pediatric Foundation and CareThings discuss opportunities for patient engagement in clinical trials within mHealth and how advance-ments in apps wearables and per-sonalized content delivery are shaping a new patient engagement model and impacting the entire clinical research enterprise
See Innovation in Action Innovation Theater
We ask all Annual Meeting speak-ers to please check in at the Speaker Registration Desk when you arrive at the Convention Center to pick up your name badge Speaker registration will be open today from 700AMndash500PM The Speaker Preparation Room will also be open from 700AMndash500PM to-day this is where you will confirm that your presentation has been properly uploaded
A Speaker Training Room is also available for you to practice your pre-sentation alone or with your fellow pre-senters Please schedule your practice time when you check in at the Registra-tion Desk This Training Room will host a special Speaker Training Session coaching on podium presentation best practices from 945-1015AM today
The Speaker Registration Desk Speaker Preparation Room and Speaker Training Room are all located in the East Registration area
We ask all speakers to arrive at their assigned room 20 minutes before
Speaker Registration amp Preparationyour session scheduled start time to confirm that the proper visual presen-tation is loaded on the session room computer You cannot upload or edit your presentations in the session room you may do so however in the Speaker Preparation Room We also recommend that you carry an elec-tronic copy (via USB) of your presen-tation for backup purposes
Exhibitor PassportVisit our Exhibitors to hear about their products and services You must have 50 Exhibitors sign your card found in your attendee bag to be eligible to win bull First Prize Apple Watch Sport bull Second Prize $250 VISA Gift Card (Two)
bull Third Prize Fitbit Charge HR (Three)
Passports must be dropped off to the DIA Booth 1523 by 400pm on Wednesday June 17
The Medical Heroes Appreciation Walk organized by CISCRP (Center for Information and Study on Clinical Research Participation) on Monday morning brought over 250 people together in celebration of study volunteers and their gift of participation in clinical research
10 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
The DIA 2015 51st Annual Meeting offers a variety of over 250 education opportunities to help strengthen your understanding of the value of cross-discipline integration and to foster innovation for better health outcomes
Participants may receive up to 18 AMA PRA Category 1 Creditstrade 18 pharmacy contact hours or 18 con-tinuing education units (CEUs) 18 nursing contact hours 10 Project Man-agement Institute (PMI) professional development units or 24 International Association for Continuing Education and Training CEUs There are multiple program offering formats at the meet-ing including sessions forums work-shops symposia and one hour TURBO offerings Program offerings desig-nated for credit are clearly identified in the final program with the pertinent CME Pharmacy Nursing or PMI PDUs statements IACET CEUs are offered for all program offerings except that no continuing education credits are avail-able for the following offerings
bull Plenary Session and Keynote Addressbull Session 226 How Pharmaceutical Companies Can Engage Responsibly with Patients Online bull Session 246 Using Registries to Support Recruitment in Alzheimers Disease (AD) Prevention or Delay-of-Onset Studies bull Session 345 Power Up Give Your Brain a Breakbull Track 20 Innovation Theaterbull Track 21 Poster Presentations
Participants who would like to
Continuing Education at DIA 2015 51st Annual Meetingreceive continuing education credits for the Annual Meeting must scan their DIA name badge at each program offering to record hisher attendance Participants must scan their name badges within 45 minutes after the start time of each 15 hour program offering and within 30 minutes after the start time for the one hour TURBO offerings If a participant attends multiple offerings within the same time frame only the last scanned entry will be recorded Participants who do not scan their badge within the allotted time will not be eligible to request the available continuing education credits for that program offering
Evaluation Station ndash Your Opinion Counts
DIA will again utilize an online evaluation portal to obtain your feed-back on our program offerings You can access this portal at DIAglobalorgDIA2015evals Each evening dur-ing the Annual Meeting we will send an email to participants requesting their feedback on the offerings they attended that day
Beginning Tuesday June 16 there will also be an onsite Evaluation Sta-tion in the Attendee Registration Area (West Wing) for you to complete your evaluations while onsite Your feed-back is valued and we would really appreciate hearing from you
DIA will conduct a drawing with a chance for one participant to win a free registration to the DIA 2016 52nd Annual Meeting in Philadelphia PA Eligible participants must complete all
program offering evaluations from each educational offering they attended dur-ing the Annual Meeting time frame
DIA will also offer one winner a $100 American Express gift card from a ran-dom drawing of the participants who complete the Overall Evaluation form During the week of July 20 the winners will be announced and notified Dead-line for submitting evaluation feedback is Wednesday July 15 2015
All DIA 2015 51st Annual Meeting continuing education credit requests are processed through DIArsquos My Transcript DIArsquos My Transcript OPENS on Tuesday June 23 My Transcript allow you to request an Attendance Certificate or request CE credit(s) and download a statement of credit To ac-cess My Transcript
bull Login to My DIA at DIAglobalorgbull Enter your User ID and Passwordbull Select My Transcript from the
left side barbull Select DIA 2015 51st Annual Meeting Credit Requestbull Proceed to request an Attendance Certificate or CE credit for each offering and for each daybull Select the Credit Type or Attendance Certificate for each
offeringbull Select Continue after your credit request is completed for all requested offeringsbull Submitbull Print statement(s) of credit or Attendance Certificate All ACPE credit requests must be
submitted by Wednesday July 29 2015 so your request can be sub-mitted to the CPE Monitor Please have your NABP eProfile ID and DOB (MMDD) readily available when requesting ACPE credit If you need to obtain your NABP eProfile ID visit wwwcpemonitornet
MOBILIZE YOUR TRIAL WITH IN-HOME CLINICAL TRIAL VISITSbull Subject Conveniencebull Improves Recruitment Retention amp Compliancebull Access to Certified Mobile Research Nursesbull US amp Global Services
For RFPs or to request a capabilities presentation please contact infopcmtrialscom or call
888-628-9707 | DIA booth 2733
Our Certified Mobile Research Nurses
Set Us Apart
PCM Trials DIA Ad Half Page2015_v3indd 1 31015 518 PM
of New Drugs CDER
In Room 146C 291 CDRH Town Hall continues the Annual Meeting tra-dition of providing you with a unique opportunity to hear directly from the Director of the Center for Devices and Radiological Health (CDRH) on the state of CDRH and its vision for the future Specific topics include FDA-SIA accomplishments and activities 2017 MDUFA Reauthorization and the impact of the House Energy and Com-merce 21st Century Cures initiatives
the regulatory framework for labora-tory developed tests expedited path-ways development the future of next gen sequencing and innovative ap-proaches for companion diagnostics and personalized medicine human factors studies combination products regulation of mobile and web software applications and the impact of other new technologies on patient care
Chair Janet Jenkins-Showalter Senior Regulatory Group Director Regulatory Policy amp Intelligence Genentech A Member of the Roche Group
Panelists Jeffrey Shuren JD MD Director CDRH FDA Alberto Gutier-rez PhD Director Office of In Vitro Diagnostics amp Radiological Health CDRH and Jonette R Foy PhD Deputy Director for Engineering amp Sci-ence Review ODE CDRH
InnovationsContinued from Page 3
28th Annual EuroMeeting 6-8 April 2016 Hamburg GermanyDIAGlobalorgEuroMeeting
Save the date
DIA Europe Middle East amp AfricaKuumlchengasse 164051 Basel Switzerland
Flanked by DIA Globlal Chief Executive Barbara Lopez Kunz and Dr Per Spindler (DIA President and Chair Board of Directors) DIA welcomes our 2015 DIA Fellows Minnie Baylor-Henry RPh JD (Incoming Chair) Jennifer L Riggins PharmD Kenneth A Getz MBA and Noriaki Murao MS 2015 DIA Fellow Gaby Danan MD PhD was unable to attend
ldquoMy commitment to you at this meeting is to provide the environment that will help you seize the opportuni-ties that present themselves both here in Washington as we meet and moving forward as you return to your places of workrdquo she concluded ldquoSo I invite you to seize the opportunity that we have this week to take advantage of this lsquoone shotrsquordquo
Annual Meeting Co-Chair Christo-pher P Austin MD (Director National Center for Advancing Translational Sci-ences US National Institutes of Health) followed Barbara to the podium ldquoOur focus at NCATS is not on spe-cific diseases but on what is common among all diseasesrdquo he explained ldquoOur chosen field is remarkably if not painfully empirical because we donrsquot understand the general principles and thatrsquos what NCATS is all aboutrdquo
ldquoWe are fond of saying that transla-tional science is a team sportrdquo he said to introduce one such ldquoteamrdquo project The Tissue Chip for Drug Screening program a collaboration between the FDA and the Defense Advanced Research Projects Agency (DARPA) that has developed organ and organ systems on microchips for drug toxic-ity testing that doesnrsquot require animals or humans In the future these chips could include hormones for example to identify the difference between male and female response to drugs ldquoI really thought this was just science fiction ndash and I was wrongrdquo he confessed
ldquoOne of my favorite proverbs
comes from Japanese literature lsquoNone of us is as smart as all of usrsquo Solving the systemic and highly complex problems of translation will require that adage as a guiding principle and the DIA meeting this year promises to provide the perfect setting to establish and strengthen the connections that will help us all collectively develop innovate and advance to new solutionsrdquo he con-cluded
ldquoLike many of you this organization and its expanding influence have been essential to my lifersquos work in the phar-maceutical and biotechnology arenardquo said Per Spindler DVM MBA MSc (DIA President and Chair Board of Directors Director Biopeople Univer-sity of Copenhagen Denmark ldquoI was born in 1963 in Copenhagen the year before DIA was foundedrdquo
ldquoIn 2003 I was invited to become a member of the DIA Advisory Council of Europe and I was elected to the Board of Directors in 2007 In the recent past as member of the Board I have been instrumental in establishing our journal within therapeutic innova-tion and regulatory science ndash pro-fessional fields where DIA takes the global leadership You might say DIA and I have grown up togetherrdquo Per continued
ldquoBy the time DIA celebrates its 100th Anniversary our world will be a very different place shaped in part by the innovations that we will ad-vance here in Washington Review the program for this 51st meeting of DIA with its rich and diverse offerings and you will have no doubt that a trans-formational agenda for our industry is evolving You will also be convinced that DIA will be at the forefront of that transformationrdquo
ldquoLike Per I have greatly benefited from my association with DIA and this organization has been essential to my career and to the proficiencies I have developed in the regulatory science arenardquo began President-Elect San-dra A Milligan JD MD (Senior Vice President Global Regulatory Affairs amp Clinical Safety Merck Research Laboratories) ldquoIn 2013 I chaired the Annual Meeting in Boston and now I find myself grateful to you the mem-bership to be the next president of DIA starting July 1strdquo
ldquoOur organization brings people to-gether creating a rich mix of ideas of service to our professions and service to our patients DIA as an organization truly proves that the whole is greater than the sum of its partsrdquo Sandra concluded
Co-Chair Michael Rosenblatt MD
(Executive Vice President amp Chief Medical Officer Merck amp Co Inc) concluded the welcoming remarks ldquoDIA is the only place i know of where professionals from every aspect of RampD ndash from the laboratory to the patient ndash gather to learn and to share best practicesrdquo he began ldquoI see great value in the lively and massive ex-change of information and ideas that takes place here It illustrates some-thing i deeply believe all of us ndash and the patients we serve ndash are interde-pendentrdquo
ldquoThe patient has always been ndash and should always be ndash at the core of what we dordquo he continued ldquoBut todayrsquos patients are different They are better informed more independent more ac-tive and more engaged than ever They are interested in taking charge of their own care Many have organized them-selves into learning communitiesrdquo
ldquoLike any big social trend this renewed emphasis on the patient has created a new mindset that in turn has helped spawn exciting innova-tionsrdquo he concluded ldquoWe need only look at this conference agenda to see evidence of new and previously unlikely collaborations ndash all with re-newed focus on in the patient These are partnerships between academia industry practitioners payers and regulators aimed at speeding the ar-rival of urgently needed vaccines and cures targeting the right therapies to the right people and improving patient accessrdquo
Daniel Burrus (President amp CEO Burrus Research Associates Inc) opened his Keynote Address by refer-ring to DIA Annual Meeting attendees as ldquothe great enablersrdquo His energetic remarks encompassed the themes of collaboration and innovation through real-world and theoretical examples ldquoWe live in a world of amazing inno-vation right nowrdquo he began ldquoIn fact wersquore standing at the base of a moun-tain of innovationrdquo
Daniel presented innovation as the ability to anticipate and solve a problem before you actually have it ldquoKeeping up is a foolrsquos gamerdquo he said ldquoWho wants to keep up I want to jump aheadrdquo
ldquoWe say wersquore collaborating but are werdquo he asked ldquoAre you using your 4G phone to advance innovation or to watch Netflix Yoursquove already got amazing tools Are you underutilizing them Hint Yesrdquo
ldquoThe world needs yourdquo he said to close the Opening Plenary ldquoYoursquore the enablers of innovationrdquo
Annual Meeting Co-Chairs Dr Michael Rosenblatt (left) and Dr Christopher Austin (right) welcome attendees to the Opening Plenary
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
Global DevelopmentGlobal Launch
We Know How
Global IMPACT
6 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
(continued from page 5)
Parties amp Events
Giveaway Guide
Food amp Drink
Sights
TransportationBrought to you by BioClinica
KAI Research Inc 2740KCR 2722KCRN MampC 1945KellyOCG 1035Klein Hersh International 2034KlinEra Global Services 2110KoNECT 1651Korea Clinical Trials Global Initiative (KCGI) 1651Kuantum CRO and Logistics 1019LabAnswer 2155LabConnect LLC 911LabCorp 1835Lambda Therapeutic Research Inc 2105Langland 2046Launchpad 543Life Science Leader 2623Linical USA 2720Lionbridge Technologies 1246LMK Clinical Research Consulting 645Longboat Clinical Ltd 612LORENZ Life Sciences Group 1427Lovelace Scientific Resources 923Luto Research Limited 1213
M-N-O MakroCare 2618Mapi 754MASIMO 1340Massachusetts College of Pharmacy and Health Sciences 2153MasterControl 1809MaxisIT Inc 2535McGuire Research Institute 2107
MDCPartners 2449Med Fusion 1140MedDATA Foundation 755MedDRA MSSO 1009Medical Research Network Ltd 854Medical Vigilance Solutions Cincinnati Childrenrsquos 1039Medicines Evaluation Unit 1210Medidata Solutions Worldwide 2641Medidata Solutions Inc 2201MEDIX 1846MedNet Solutions Inc 1838Medpace Inc 1801MedPoint Digital Inc 2517Medrio Inc 1202MedSource 1935MedTrials 1346Merge eClinical 2209MESM Ltd 2042META Solutions Inc 2021MMG 2534MNX Global Logistics 1914MonitorForHirecom 1421Montrium Inc 2106Morningside Translations 1953Mortara Instrument Inc 729National Death Index 518NCGS Incorporated 2611NeoGenomics Laboratories 1251Neuroscience Trials Australia 2627New Orleans Center for Clinical Research 728Next Phase Research 2637NextDocs 2038Nextrials Inc 2717NIPER Hyderabad 1127
Green Key Resources 1947Greenphire 613Greens LTD 2156Guangzhou KingMed Center for Clinical Laboratory Co Ltd 2538HampJ CRO International Inc 2646Hangzhou Tigermed Consulting Co Ltd 746HCL America Inc 1635Health Decisions Inc 821HealthCarePoint 1757Hurley Consulting Associates Ltd 955Hurley Write Inc 2727Hydrogen International Ltd 1955iCardiac Technologies 2102ICON plc 503IDT Australia 1746ImageIQ Imaging CRO 1227IMS Health 1317Inamed GmbH 529INC Research 2303Industry Standard Research 725Informa Business Information 2354Information Builders Inc 1853Infotehna Inc 1444Innovative Print amp Media Group 1354InnovoCommerce LLC 1747Integrated Clinical Systems Inc 901Integrated Development Associates Co Ltd 1047IntegReview IRB 2420INTERLAB GmbH central lab services worldwide 1425International Dermatology Research Inc 1538Interspond LLC 2547Intertek Scientific amp Regulatory Consultancy 2516Intralinks Inc 1822inVentiv Health 1517Investigational Cancer Therapeutics - MD Anderson 1546IPHARMA ChemDiv 521
NNIT 2254Norav Medical 514Nova Language Services Ltd 1209Novella Clinical 1439November Research Group 2218Novotech 1134NSF Health Sciences 1847Nuventra Pharma Sciences 824Ocasa Logistics Solutions 2036Ohio Clinical Trials Collaborative 2442OmniComm Systems Inc 2135Online Business Applications 1314OpenClinica 635Optum 1826Oracle Health Sciences 1819Orlando Clinical Research Center 2208Otto Trading Inc 1018
P-Q-RPacific Bridge Medical 2446Palm Beach CRO 1804Paragon International Inc 1403Paragon Solutions 2204
Parallel6 1957PAREXEL International 1535PCM TRIALS 2733Pennside Partners Ltd 2518PerkinElmer Inc 513Personify 1756Pharma Start 1148Pharmaceutical eConsulting 1650Pharmaceutical Outsourcing Hall A EntrancePharmaceutical Packaging Professionals Pty Ltd 2120Pharmaceuticals and Medical Devices Agency (PMDA) 1520Pharmaceuticals Export Promotion Council of India 1127PharmApprove 2054PharmaQuest Ltd 1348PharmaSeek Companies 822PharmaSys Inc 2438PharmaVOICE 1001Pharm-Olam International Ltd 919Phlexglobal Inc 2007Pilgrim Quality Solutions 2044Planet Pharma 1149PleaseTech Ltd 1114Polar Leasing Company Inc 546Popsi Cube 539Porzio Life Sciences 1055PPD 2227PQE 1054PRA Health Sciences 1501Praxis Communications LLC 629Precision for Medicine 1351Premier Research 1711Pretium 1010
PrimeVigilance 2347PRL Central Laboratory Services 1423Proforma Giraffe Graphics Inc 2549Projecis Inc 1645PROSAR 2206Proteus Digital Health Inc 2255ProTrials Research Inc 1108PSKW LLC 1053Pyxant Labs Inc 1950Q2 Business Intelligence 1449QPS LLC 1307Quality and Compliance Consulting Inc 2417Quality Associates Inc 1607Quanticate Inc 1334QuantifiCare 527Queensland Clinical Trials Network 1000Quest Diagnostics 2628Quintiles 601Quorum Review IRB 1219Radiant Research Clinical Research Advantage 2112Randstad Pharma 2715Real Staffing Group 2620RegCheck 955Regeneron Pharmaceuticals 638Regxia Inc 1949Research Across America 2728ReSolution Latin America 2421Rho Inc 724RR Donnelley 2626RWS Group - Medical Translation Division 1350Rx Trials Inc 1400RxLogix Corporation 2521
S-TSan Diego State University - Regulatory Science Programs 1524SanaClis sro 541SAS Institute Inc 2127SAS Institute Inc JMP Division 1744Scarritt Group Inc 1844Schlafender Hase Inc 2012Schulman Associates IRB 1020SeaView Research 1944Sharp Clinical Services 1305Sidus Biodata 1745Signix Inc 2739SNBL Clinical Pharmacology Center 2448Society for Clinical Research Sites - SCRS 1548Sonic Clinical Trials 1010SOUSEIKAI Global Clinical Research Center 1946Southern California Research 2721Southern Star Research 1702Sparta Systems 826Spaulding Clinical Research 2217Speaking Books 1605SPRI Clinical Trials - Global 1021Springer 526Statistics amp Data Corporation (SDC) 1704Stefanini 2723Sterling IRB 2010Stiris Research Inc 1707Symbio LLC 1700Symogen 1856Symphony Clinical Research 2422Synchrogenix Information Strategies Inc 1105Syngene International Ltd 1127Synowledge 1540Syntel Inc 1157SynteractHCR 1335Target Health Inc 2527Tarius AS 1103Tata Consultancy Services 1909Technical Resources International Inc 1913Technology Catalysts International 2447Techorizon 1347TechSol Corporation 2642Telerx 735Teuteberg Incorporated 1948TFDA Center for Drug Evaluation Taiwan 1522
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
8 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Thatrsquos Nice LLC 1240The Clinical Resource Network 1318The Geneva Foundation 2548The Patient Recruiting Agency 2119Theorem Clinical Research 511Theorem Clinical Research Business Suite 1Therapak Corporation 1005Therapeias Health Management 641Therapeutics Inc 1341Thomson Reuters 1440ThreeWire Inc 1939TKL Research Inc 2202Total Clinical Trial Management 2725Total Root Concepts Inc 523TrakCel Limited 2747TransPerfect 1025Trial Runners 2742Trievr Inc 2103Trifecta 1921
U-V-WUBC 2401Unanet 1152University of Florida 1551University of Maryland Online MS in Regulatory Science 1147University of the Sciences 852University of Utah Clinical Trials Office 1725Uppsala Monitoring Centre 2426UTMB Sealy Center for Vaccine Development 1657Valesta Clinical Research Solutions 2629Validated Cloud 2056Veeva Systems Inc 1203Verified Clinical Trials 1109Veristat Inc 1941
(continued from page 7)
Vigilare International 1141Vince amp Associates Clinical Research 748Viracor-IBT Laboratories 2546Viroclinics Biosciences 547VirtualScopics 2320Vitalograph Inc 1406Voluntis 1447WCCT Global 2121WebbWrites LLC 953Whitsell Innovations Inc 626Wincere Inc 1144Wingspan Technology Inc 1445WIRB-Copernicus Group 701Women in Life Sciences - WILS 1356Woodley Equipment Company 1215Worldwide Clinical Trials 1311
TKL Research is an international CRO offering expertise in a full spectrum of indications as well as clinical trial management services from Phase 1 to multicenter international studies TKL serves the pharmaceutical biotech generic drug medi-cal device OTC and consumer health care indus-tries The leader in dermatological research TKL has performed over 200 dermatological clinical trials and is unrivaled in the number of dermato-logical safety studies TKL also has significant ex-perience in Phase 1-4 multinational clinical trials and differentiates itself from the competition with a strong Phase 1 safety capability and full service CRO combined into one cohesive organization
QuintilesBooth 601wwwquintilescomcareers
Quintiles CareersQuintiles is the worldrsquos largest provider of
biopharmaceutical development and commercial outsourcing services and wersquod like to meet you Please stop by the Marriott Marquis Hotel to hellip
ATTEND OUR COCKTAIL RECEPTION in the Chinatown Meeting Room
bull Monday June 15th from 6pm - 8pm
MEET OUR RECRUITING TEAM from Immunol-ogy and Internal Medicine in the Judiciary Square Meeting Room
bull Monday June 15th from 2pm - 5pmbull Tuesday June 16th from 9am - 7pmbull Wednesday June 17th from 9am - 7pm
Improve your probability of successtrade
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Your Opinion MattersComplete an evaluation for each offering
you attend for a chance to win great prizes
Access online evaluations at DIAGlobalorgDIA2015evals or stop by Evaluation Stations in the Registration
Area beginning Tuesday
Free registration to the DIA 2016 52nd Annual Meeting
$100 American Express Gift Card
Discover Safety around the World
ldquoGlobal production of FDA-regulated goods has exploded over the past ten years In addi-tion to an increase in imported finished prod-ucts manufacturers increasingly use imported materials and ingredients in their US produc-tion facilities making the distinction between domestic and imported products obsoleterdquo said FDA Commissioner Dr Margaret A Ham-burg upon the release of the FDA 2011 report Pathway to Global Product Safety and Quality ldquoThe FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face The FDA must further collaborate and leverage in order to close the gap between our import levels and our regula-tory resourcesrdquo she concluded
At 1030AM today staff from FDArsquos interna-tional posts in China Europe and India will provide exclusive updates from their respec-tive posts in Session 245 FDArsquos International Posts International Efforts Regulatory System Strengthening and Inspections presented in Room 152A Their updates will include out-reach to foreign regulators facility inspections risk-based global surveillance to protect supply chains and related topics
Chair Leslie Ball MD Assistant Commis-sioner and Deputy Director OIP OC FDA
Update from the FDA China Office S Leigh Verbois PhD Incoming Director China Office Office of International Programs OC FDA
Update from the FDA India Office Mathew T Thomas MD Acting Country Director India Of-fice Office of International Programs OC FDA
Update from the FDA European Office Donald Prater DVM Acting Regional Director Europe Office OIP OC FDA
9ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Route 1 Red Hotel Pickup LocationJW Marriott E Street EntranceGrand Hyatt 11th Street EntranceMarriott Metro Center At Hyatt 11th Street Entrance
Route 2 Yellow Hotel Pickup LocationHamilton Crown Plaza Lobby EntranceDonovan House Lobby EntranceWashington Plaza Curbside Vermont mdash Near DrivewayComfort Inn Convention Center At Washington Plaza Curbside Vermont
Route 3 Blue Hotel Pickup LocationLoews Madison Lobby EntranceWestin Washington At Loews Madison Lobby EntranceDoubletree Washington Lobby EntranceHotel Helix At Doubletree Lobby EntranceMayflower Renaissance Desales Street Entrance
Hotels within walking distance of the Walter E Washington Convention Center are Embassy Suites Convention Center Hampton
Inn Henley Park Hotel Morrison-Clark Inn Renaissance Washington DC Downtown Hotel and Marriott Marquis
Tuesday June 16 through Wednesday June 17Hours Frequency 645-930AM 15 Minutes930AM-330PM No Service330-630PM 15 MinutesLast Bus Departs Hotels 530PM
Thursday June 18 Hours Frequency 730-900AM 15 Minutes900AM-1230pm 30 MinutesLast Bus Departs Hotels 1130AM
For Shuttle Information or to Pre-Schedule ADA Pick-up call 877-865-3437 during convention shuttle hours
Complimentary Shuttle InformationPlease allow up to 20 minutes (including waiting and riding time under nor-mal peak traffic conditions) to travel from your hotel to the Walter E Wash-ington Convention Center located on Mount Vernon Place Delays may occur due to circumstances beyond our control
Discover tomorrowrsquos solutions to to-dayrsquos challenges through the products and services showcased in todayrsquos Innovation Theater sessions presented near Exhibit Hall Entrance B
945AM 225 Covance Innovation Theater Advances in Risk-Based Mon-itoring Transforming Drug Develop-ment Through Efficient Workflows Big Data and Elegant Software Discover Covancersquos risk-based monitoring (RBM) platform which provides clients with best-in-class implementation of the RBM principles put forth by FDA EMA and TransCelerate and facilitates RBM through timely secure and inte-grated access to all relevant trial data
1200PM 249 Quintiles Innova-tion Theater Transform Clinical De-velopment ndash Modernizing for Smarter Trials Because of our imperative to ldquomodernizerdquo clinical trials to de-liver medicines faster at less cost to patients who need them learn how you can gauge global capabilities to model and predict better outcomes identify appropriate investigator sites and deliver faster ldquoanalysis-readyrdquo data to identify trends and issues in near real time
100PM 250 Veeva Innovation Theater 2015 Paperless Trial Master File (TMF) Survey Trends and Insights Results from the follow-up to Veevarsquos benchmark 2014 Paperless TMF Sur-vey which analyzed the observations of TMF owners to identify the barriers business drivers and benefits of mov-ing to fully paperless TMFs How does your organization compare and why do some organizations benefit more than others
300PM 267 BBK Worldwide Innovation Theater mHealth A New Era in Patient Engagement BBK Worldwide and mHealth experts from the Landon Pediatric Foundation and CareThings discuss opportunities for patient engagement in clinical trials within mHealth and how advance-ments in apps wearables and per-sonalized content delivery are shaping a new patient engagement model and impacting the entire clinical research enterprise
See Innovation in Action Innovation Theater
We ask all Annual Meeting speak-ers to please check in at the Speaker Registration Desk when you arrive at the Convention Center to pick up your name badge Speaker registration will be open today from 700AMndash500PM The Speaker Preparation Room will also be open from 700AMndash500PM to-day this is where you will confirm that your presentation has been properly uploaded
A Speaker Training Room is also available for you to practice your pre-sentation alone or with your fellow pre-senters Please schedule your practice time when you check in at the Registra-tion Desk This Training Room will host a special Speaker Training Session coaching on podium presentation best practices from 945-1015AM today
The Speaker Registration Desk Speaker Preparation Room and Speaker Training Room are all located in the East Registration area
We ask all speakers to arrive at their assigned room 20 minutes before
Speaker Registration amp Preparationyour session scheduled start time to confirm that the proper visual presen-tation is loaded on the session room computer You cannot upload or edit your presentations in the session room you may do so however in the Speaker Preparation Room We also recommend that you carry an elec-tronic copy (via USB) of your presen-tation for backup purposes
Exhibitor PassportVisit our Exhibitors to hear about their products and services You must have 50 Exhibitors sign your card found in your attendee bag to be eligible to win bull First Prize Apple Watch Sport bull Second Prize $250 VISA Gift Card (Two)
bull Third Prize Fitbit Charge HR (Three)
Passports must be dropped off to the DIA Booth 1523 by 400pm on Wednesday June 17
The Medical Heroes Appreciation Walk organized by CISCRP (Center for Information and Study on Clinical Research Participation) on Monday morning brought over 250 people together in celebration of study volunteers and their gift of participation in clinical research
10 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
The DIA 2015 51st Annual Meeting offers a variety of over 250 education opportunities to help strengthen your understanding of the value of cross-discipline integration and to foster innovation for better health outcomes
Participants may receive up to 18 AMA PRA Category 1 Creditstrade 18 pharmacy contact hours or 18 con-tinuing education units (CEUs) 18 nursing contact hours 10 Project Man-agement Institute (PMI) professional development units or 24 International Association for Continuing Education and Training CEUs There are multiple program offering formats at the meet-ing including sessions forums work-shops symposia and one hour TURBO offerings Program offerings desig-nated for credit are clearly identified in the final program with the pertinent CME Pharmacy Nursing or PMI PDUs statements IACET CEUs are offered for all program offerings except that no continuing education credits are avail-able for the following offerings
bull Plenary Session and Keynote Addressbull Session 226 How Pharmaceutical Companies Can Engage Responsibly with Patients Online bull Session 246 Using Registries to Support Recruitment in Alzheimers Disease (AD) Prevention or Delay-of-Onset Studies bull Session 345 Power Up Give Your Brain a Breakbull Track 20 Innovation Theaterbull Track 21 Poster Presentations
Participants who would like to
Continuing Education at DIA 2015 51st Annual Meetingreceive continuing education credits for the Annual Meeting must scan their DIA name badge at each program offering to record hisher attendance Participants must scan their name badges within 45 minutes after the start time of each 15 hour program offering and within 30 minutes after the start time for the one hour TURBO offerings If a participant attends multiple offerings within the same time frame only the last scanned entry will be recorded Participants who do not scan their badge within the allotted time will not be eligible to request the available continuing education credits for that program offering
Evaluation Station ndash Your Opinion Counts
DIA will again utilize an online evaluation portal to obtain your feed-back on our program offerings You can access this portal at DIAglobalorgDIA2015evals Each evening dur-ing the Annual Meeting we will send an email to participants requesting their feedback on the offerings they attended that day
Beginning Tuesday June 16 there will also be an onsite Evaluation Sta-tion in the Attendee Registration Area (West Wing) for you to complete your evaluations while onsite Your feed-back is valued and we would really appreciate hearing from you
DIA will conduct a drawing with a chance for one participant to win a free registration to the DIA 2016 52nd Annual Meeting in Philadelphia PA Eligible participants must complete all
program offering evaluations from each educational offering they attended dur-ing the Annual Meeting time frame
DIA will also offer one winner a $100 American Express gift card from a ran-dom drawing of the participants who complete the Overall Evaluation form During the week of July 20 the winners will be announced and notified Dead-line for submitting evaluation feedback is Wednesday July 15 2015
All DIA 2015 51st Annual Meeting continuing education credit requests are processed through DIArsquos My Transcript DIArsquos My Transcript OPENS on Tuesday June 23 My Transcript allow you to request an Attendance Certificate or request CE credit(s) and download a statement of credit To ac-cess My Transcript
bull Login to My DIA at DIAglobalorgbull Enter your User ID and Passwordbull Select My Transcript from the
left side barbull Select DIA 2015 51st Annual Meeting Credit Requestbull Proceed to request an Attendance Certificate or CE credit for each offering and for each daybull Select the Credit Type or Attendance Certificate for each
offeringbull Select Continue after your credit request is completed for all requested offeringsbull Submitbull Print statement(s) of credit or Attendance Certificate All ACPE credit requests must be
submitted by Wednesday July 29 2015 so your request can be sub-mitted to the CPE Monitor Please have your NABP eProfile ID and DOB (MMDD) readily available when requesting ACPE credit If you need to obtain your NABP eProfile ID visit wwwcpemonitornet
MOBILIZE YOUR TRIAL WITH IN-HOME CLINICAL TRIAL VISITSbull Subject Conveniencebull Improves Recruitment Retention amp Compliancebull Access to Certified Mobile Research Nursesbull US amp Global Services
For RFPs or to request a capabilities presentation please contact infopcmtrialscom or call
888-628-9707 | DIA booth 2733
Our Certified Mobile Research Nurses
Set Us Apart
PCM Trials DIA Ad Half Page2015_v3indd 1 31015 518 PM
of New Drugs CDER
In Room 146C 291 CDRH Town Hall continues the Annual Meeting tra-dition of providing you with a unique opportunity to hear directly from the Director of the Center for Devices and Radiological Health (CDRH) on the state of CDRH and its vision for the future Specific topics include FDA-SIA accomplishments and activities 2017 MDUFA Reauthorization and the impact of the House Energy and Com-merce 21st Century Cures initiatives
the regulatory framework for labora-tory developed tests expedited path-ways development the future of next gen sequencing and innovative ap-proaches for companion diagnostics and personalized medicine human factors studies combination products regulation of mobile and web software applications and the impact of other new technologies on patient care
Chair Janet Jenkins-Showalter Senior Regulatory Group Director Regulatory Policy amp Intelligence Genentech A Member of the Roche Group
Panelists Jeffrey Shuren JD MD Director CDRH FDA Alberto Gutier-rez PhD Director Office of In Vitro Diagnostics amp Radiological Health CDRH and Jonette R Foy PhD Deputy Director for Engineering amp Sci-ence Review ODE CDRH
InnovationsContinued from Page 3
28th Annual EuroMeeting 6-8 April 2016 Hamburg GermanyDIAGlobalorgEuroMeeting
Save the date
DIA Europe Middle East amp AfricaKuumlchengasse 164051 Basel Switzerland
Flanked by DIA Globlal Chief Executive Barbara Lopez Kunz and Dr Per Spindler (DIA President and Chair Board of Directors) DIA welcomes our 2015 DIA Fellows Minnie Baylor-Henry RPh JD (Incoming Chair) Jennifer L Riggins PharmD Kenneth A Getz MBA and Noriaki Murao MS 2015 DIA Fellow Gaby Danan MD PhD was unable to attend
ldquoMy commitment to you at this meeting is to provide the environment that will help you seize the opportuni-ties that present themselves both here in Washington as we meet and moving forward as you return to your places of workrdquo she concluded ldquoSo I invite you to seize the opportunity that we have this week to take advantage of this lsquoone shotrsquordquo
Annual Meeting Co-Chair Christo-pher P Austin MD (Director National Center for Advancing Translational Sci-ences US National Institutes of Health) followed Barbara to the podium ldquoOur focus at NCATS is not on spe-cific diseases but on what is common among all diseasesrdquo he explained ldquoOur chosen field is remarkably if not painfully empirical because we donrsquot understand the general principles and thatrsquos what NCATS is all aboutrdquo
ldquoWe are fond of saying that transla-tional science is a team sportrdquo he said to introduce one such ldquoteamrdquo project The Tissue Chip for Drug Screening program a collaboration between the FDA and the Defense Advanced Research Projects Agency (DARPA) that has developed organ and organ systems on microchips for drug toxic-ity testing that doesnrsquot require animals or humans In the future these chips could include hormones for example to identify the difference between male and female response to drugs ldquoI really thought this was just science fiction ndash and I was wrongrdquo he confessed
ldquoOne of my favorite proverbs
comes from Japanese literature lsquoNone of us is as smart as all of usrsquo Solving the systemic and highly complex problems of translation will require that adage as a guiding principle and the DIA meeting this year promises to provide the perfect setting to establish and strengthen the connections that will help us all collectively develop innovate and advance to new solutionsrdquo he con-cluded
ldquoLike many of you this organization and its expanding influence have been essential to my lifersquos work in the phar-maceutical and biotechnology arenardquo said Per Spindler DVM MBA MSc (DIA President and Chair Board of Directors Director Biopeople Univer-sity of Copenhagen Denmark ldquoI was born in 1963 in Copenhagen the year before DIA was foundedrdquo
ldquoIn 2003 I was invited to become a member of the DIA Advisory Council of Europe and I was elected to the Board of Directors in 2007 In the recent past as member of the Board I have been instrumental in establishing our journal within therapeutic innova-tion and regulatory science ndash pro-fessional fields where DIA takes the global leadership You might say DIA and I have grown up togetherrdquo Per continued
ldquoBy the time DIA celebrates its 100th Anniversary our world will be a very different place shaped in part by the innovations that we will ad-vance here in Washington Review the program for this 51st meeting of DIA with its rich and diverse offerings and you will have no doubt that a trans-formational agenda for our industry is evolving You will also be convinced that DIA will be at the forefront of that transformationrdquo
ldquoLike Per I have greatly benefited from my association with DIA and this organization has been essential to my career and to the proficiencies I have developed in the regulatory science arenardquo began President-Elect San-dra A Milligan JD MD (Senior Vice President Global Regulatory Affairs amp Clinical Safety Merck Research Laboratories) ldquoIn 2013 I chaired the Annual Meeting in Boston and now I find myself grateful to you the mem-bership to be the next president of DIA starting July 1strdquo
ldquoOur organization brings people to-gether creating a rich mix of ideas of service to our professions and service to our patients DIA as an organization truly proves that the whole is greater than the sum of its partsrdquo Sandra concluded
Co-Chair Michael Rosenblatt MD
(Executive Vice President amp Chief Medical Officer Merck amp Co Inc) concluded the welcoming remarks ldquoDIA is the only place i know of where professionals from every aspect of RampD ndash from the laboratory to the patient ndash gather to learn and to share best practicesrdquo he began ldquoI see great value in the lively and massive ex-change of information and ideas that takes place here It illustrates some-thing i deeply believe all of us ndash and the patients we serve ndash are interde-pendentrdquo
ldquoThe patient has always been ndash and should always be ndash at the core of what we dordquo he continued ldquoBut todayrsquos patients are different They are better informed more independent more ac-tive and more engaged than ever They are interested in taking charge of their own care Many have organized them-selves into learning communitiesrdquo
ldquoLike any big social trend this renewed emphasis on the patient has created a new mindset that in turn has helped spawn exciting innova-tionsrdquo he concluded ldquoWe need only look at this conference agenda to see evidence of new and previously unlikely collaborations ndash all with re-newed focus on in the patient These are partnerships between academia industry practitioners payers and regulators aimed at speeding the ar-rival of urgently needed vaccines and cures targeting the right therapies to the right people and improving patient accessrdquo
Daniel Burrus (President amp CEO Burrus Research Associates Inc) opened his Keynote Address by refer-ring to DIA Annual Meeting attendees as ldquothe great enablersrdquo His energetic remarks encompassed the themes of collaboration and innovation through real-world and theoretical examples ldquoWe live in a world of amazing inno-vation right nowrdquo he began ldquoIn fact wersquore standing at the base of a moun-tain of innovationrdquo
Daniel presented innovation as the ability to anticipate and solve a problem before you actually have it ldquoKeeping up is a foolrsquos gamerdquo he said ldquoWho wants to keep up I want to jump aheadrdquo
ldquoWe say wersquore collaborating but are werdquo he asked ldquoAre you using your 4G phone to advance innovation or to watch Netflix Yoursquove already got amazing tools Are you underutilizing them Hint Yesrdquo
ldquoThe world needs yourdquo he said to close the Opening Plenary ldquoYoursquore the enablers of innovationrdquo
Annual Meeting Co-Chairs Dr Michael Rosenblatt (left) and Dr Christopher Austin (right) welcome attendees to the Opening Plenary
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
Global DevelopmentGlobal Launch
We Know How
Global IMPACT
7ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
(continued on page 8)
NNIT 2254Norav Medical 514Nova Language Services Ltd 1209Novella Clinical 1439November Research Group 2218Novotech 1134NSF Health Sciences 1847Nuventra Pharma Sciences 824Ocasa Logistics Solutions 2036Ohio Clinical Trials Collaborative 2442OmniComm Systems Inc 2135Online Business Applications 1314OpenClinica 635Optum 1826Oracle Health Sciences 1819Orlando Clinical Research Center 2208Otto Trading Inc 1018
P-Q-RPacific Bridge Medical 2446Palm Beach CRO 1804Paragon International Inc 1403Paragon Solutions 2204
Parallel6 1957PAREXEL International 1535PCM TRIALS 2733Pennside Partners Ltd 2518PerkinElmer Inc 513Personify 1756Pharma Start 1148Pharmaceutical eConsulting 1650Pharmaceutical Outsourcing Hall A EntrancePharmaceutical Packaging Professionals Pty Ltd 2120Pharmaceuticals and Medical Devices Agency (PMDA) 1520Pharmaceuticals Export Promotion Council of India 1127PharmApprove 2054PharmaQuest Ltd 1348PharmaSeek Companies 822PharmaSys Inc 2438PharmaVOICE 1001Pharm-Olam International Ltd 919Phlexglobal Inc 2007Pilgrim Quality Solutions 2044Planet Pharma 1149PleaseTech Ltd 1114Polar Leasing Company Inc 546Popsi Cube 539Porzio Life Sciences 1055PPD 2227PQE 1054PRA Health Sciences 1501Praxis Communications LLC 629Precision for Medicine 1351Premier Research 1711Pretium 1010
PrimeVigilance 2347PRL Central Laboratory Services 1423Proforma Giraffe Graphics Inc 2549Projecis Inc 1645PROSAR 2206Proteus Digital Health Inc 2255ProTrials Research Inc 1108PSKW LLC 1053Pyxant Labs Inc 1950Q2 Business Intelligence 1449QPS LLC 1307Quality and Compliance Consulting Inc 2417Quality Associates Inc 1607Quanticate Inc 1334QuantifiCare 527Queensland Clinical Trials Network 1000Quest Diagnostics 2628Quintiles 601Quorum Review IRB 1219Radiant Research Clinical Research Advantage 2112Randstad Pharma 2715Real Staffing Group 2620RegCheck 955Regeneron Pharmaceuticals 638Regxia Inc 1949Research Across America 2728ReSolution Latin America 2421Rho Inc 724RR Donnelley 2626RWS Group - Medical Translation Division 1350Rx Trials Inc 1400RxLogix Corporation 2521
S-TSan Diego State University - Regulatory Science Programs 1524SanaClis sro 541SAS Institute Inc 2127SAS Institute Inc JMP Division 1744Scarritt Group Inc 1844Schlafender Hase Inc 2012Schulman Associates IRB 1020SeaView Research 1944Sharp Clinical Services 1305Sidus Biodata 1745Signix Inc 2739SNBL Clinical Pharmacology Center 2448Society for Clinical Research Sites - SCRS 1548Sonic Clinical Trials 1010SOUSEIKAI Global Clinical Research Center 1946Southern California Research 2721Southern Star Research 1702Sparta Systems 826Spaulding Clinical Research 2217Speaking Books 1605SPRI Clinical Trials - Global 1021Springer 526Statistics amp Data Corporation (SDC) 1704Stefanini 2723Sterling IRB 2010Stiris Research Inc 1707Symbio LLC 1700Symogen 1856Symphony Clinical Research 2422Synchrogenix Information Strategies Inc 1105Syngene International Ltd 1127Synowledge 1540Syntel Inc 1157SynteractHCR 1335Target Health Inc 2527Tarius AS 1103Tata Consultancy Services 1909Technical Resources International Inc 1913Technology Catalysts International 2447Techorizon 1347TechSol Corporation 2642Telerx 735Teuteberg Incorporated 1948TFDA Center for Drug Evaluation Taiwan 1522
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
8 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Thatrsquos Nice LLC 1240The Clinical Resource Network 1318The Geneva Foundation 2548The Patient Recruiting Agency 2119Theorem Clinical Research 511Theorem Clinical Research Business Suite 1Therapak Corporation 1005Therapeias Health Management 641Therapeutics Inc 1341Thomson Reuters 1440ThreeWire Inc 1939TKL Research Inc 2202Total Clinical Trial Management 2725Total Root Concepts Inc 523TrakCel Limited 2747TransPerfect 1025Trial Runners 2742Trievr Inc 2103Trifecta 1921
U-V-WUBC 2401Unanet 1152University of Florida 1551University of Maryland Online MS in Regulatory Science 1147University of the Sciences 852University of Utah Clinical Trials Office 1725Uppsala Monitoring Centre 2426UTMB Sealy Center for Vaccine Development 1657Valesta Clinical Research Solutions 2629Validated Cloud 2056Veeva Systems Inc 1203Verified Clinical Trials 1109Veristat Inc 1941
(continued from page 7)
Vigilare International 1141Vince amp Associates Clinical Research 748Viracor-IBT Laboratories 2546Viroclinics Biosciences 547VirtualScopics 2320Vitalograph Inc 1406Voluntis 1447WCCT Global 2121WebbWrites LLC 953Whitsell Innovations Inc 626Wincere Inc 1144Wingspan Technology Inc 1445WIRB-Copernicus Group 701Women in Life Sciences - WILS 1356Woodley Equipment Company 1215Worldwide Clinical Trials 1311
TKL Research is an international CRO offering expertise in a full spectrum of indications as well as clinical trial management services from Phase 1 to multicenter international studies TKL serves the pharmaceutical biotech generic drug medi-cal device OTC and consumer health care indus-tries The leader in dermatological research TKL has performed over 200 dermatological clinical trials and is unrivaled in the number of dermato-logical safety studies TKL also has significant ex-perience in Phase 1-4 multinational clinical trials and differentiates itself from the competition with a strong Phase 1 safety capability and full service CRO combined into one cohesive organization
QuintilesBooth 601wwwquintilescomcareers
Quintiles CareersQuintiles is the worldrsquos largest provider of
biopharmaceutical development and commercial outsourcing services and wersquod like to meet you Please stop by the Marriott Marquis Hotel to hellip
ATTEND OUR COCKTAIL RECEPTION in the Chinatown Meeting Room
bull Monday June 15th from 6pm - 8pm
MEET OUR RECRUITING TEAM from Immunol-ogy and Internal Medicine in the Judiciary Square Meeting Room
bull Monday June 15th from 2pm - 5pmbull Tuesday June 16th from 9am - 7pmbull Wednesday June 17th from 9am - 7pm
Improve your probability of successtrade
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Your Opinion MattersComplete an evaluation for each offering
you attend for a chance to win great prizes
Access online evaluations at DIAGlobalorgDIA2015evals or stop by Evaluation Stations in the Registration
Area beginning Tuesday
Free registration to the DIA 2016 52nd Annual Meeting
$100 American Express Gift Card
Discover Safety around the World
ldquoGlobal production of FDA-regulated goods has exploded over the past ten years In addi-tion to an increase in imported finished prod-ucts manufacturers increasingly use imported materials and ingredients in their US produc-tion facilities making the distinction between domestic and imported products obsoleterdquo said FDA Commissioner Dr Margaret A Ham-burg upon the release of the FDA 2011 report Pathway to Global Product Safety and Quality ldquoThe FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face The FDA must further collaborate and leverage in order to close the gap between our import levels and our regula-tory resourcesrdquo she concluded
At 1030AM today staff from FDArsquos interna-tional posts in China Europe and India will provide exclusive updates from their respec-tive posts in Session 245 FDArsquos International Posts International Efforts Regulatory System Strengthening and Inspections presented in Room 152A Their updates will include out-reach to foreign regulators facility inspections risk-based global surveillance to protect supply chains and related topics
Chair Leslie Ball MD Assistant Commis-sioner and Deputy Director OIP OC FDA
Update from the FDA China Office S Leigh Verbois PhD Incoming Director China Office Office of International Programs OC FDA
Update from the FDA India Office Mathew T Thomas MD Acting Country Director India Of-fice Office of International Programs OC FDA
Update from the FDA European Office Donald Prater DVM Acting Regional Director Europe Office OIP OC FDA
9ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Route 1 Red Hotel Pickup LocationJW Marriott E Street EntranceGrand Hyatt 11th Street EntranceMarriott Metro Center At Hyatt 11th Street Entrance
Route 2 Yellow Hotel Pickup LocationHamilton Crown Plaza Lobby EntranceDonovan House Lobby EntranceWashington Plaza Curbside Vermont mdash Near DrivewayComfort Inn Convention Center At Washington Plaza Curbside Vermont
Route 3 Blue Hotel Pickup LocationLoews Madison Lobby EntranceWestin Washington At Loews Madison Lobby EntranceDoubletree Washington Lobby EntranceHotel Helix At Doubletree Lobby EntranceMayflower Renaissance Desales Street Entrance
Hotels within walking distance of the Walter E Washington Convention Center are Embassy Suites Convention Center Hampton
Inn Henley Park Hotel Morrison-Clark Inn Renaissance Washington DC Downtown Hotel and Marriott Marquis
Tuesday June 16 through Wednesday June 17Hours Frequency 645-930AM 15 Minutes930AM-330PM No Service330-630PM 15 MinutesLast Bus Departs Hotels 530PM
Thursday June 18 Hours Frequency 730-900AM 15 Minutes900AM-1230pm 30 MinutesLast Bus Departs Hotels 1130AM
For Shuttle Information or to Pre-Schedule ADA Pick-up call 877-865-3437 during convention shuttle hours
Complimentary Shuttle InformationPlease allow up to 20 minutes (including waiting and riding time under nor-mal peak traffic conditions) to travel from your hotel to the Walter E Wash-ington Convention Center located on Mount Vernon Place Delays may occur due to circumstances beyond our control
Discover tomorrowrsquos solutions to to-dayrsquos challenges through the products and services showcased in todayrsquos Innovation Theater sessions presented near Exhibit Hall Entrance B
945AM 225 Covance Innovation Theater Advances in Risk-Based Mon-itoring Transforming Drug Develop-ment Through Efficient Workflows Big Data and Elegant Software Discover Covancersquos risk-based monitoring (RBM) platform which provides clients with best-in-class implementation of the RBM principles put forth by FDA EMA and TransCelerate and facilitates RBM through timely secure and inte-grated access to all relevant trial data
1200PM 249 Quintiles Innova-tion Theater Transform Clinical De-velopment ndash Modernizing for Smarter Trials Because of our imperative to ldquomodernizerdquo clinical trials to de-liver medicines faster at less cost to patients who need them learn how you can gauge global capabilities to model and predict better outcomes identify appropriate investigator sites and deliver faster ldquoanalysis-readyrdquo data to identify trends and issues in near real time
100PM 250 Veeva Innovation Theater 2015 Paperless Trial Master File (TMF) Survey Trends and Insights Results from the follow-up to Veevarsquos benchmark 2014 Paperless TMF Sur-vey which analyzed the observations of TMF owners to identify the barriers business drivers and benefits of mov-ing to fully paperless TMFs How does your organization compare and why do some organizations benefit more than others
300PM 267 BBK Worldwide Innovation Theater mHealth A New Era in Patient Engagement BBK Worldwide and mHealth experts from the Landon Pediatric Foundation and CareThings discuss opportunities for patient engagement in clinical trials within mHealth and how advance-ments in apps wearables and per-sonalized content delivery are shaping a new patient engagement model and impacting the entire clinical research enterprise
See Innovation in Action Innovation Theater
We ask all Annual Meeting speak-ers to please check in at the Speaker Registration Desk when you arrive at the Convention Center to pick up your name badge Speaker registration will be open today from 700AMndash500PM The Speaker Preparation Room will also be open from 700AMndash500PM to-day this is where you will confirm that your presentation has been properly uploaded
A Speaker Training Room is also available for you to practice your pre-sentation alone or with your fellow pre-senters Please schedule your practice time when you check in at the Registra-tion Desk This Training Room will host a special Speaker Training Session coaching on podium presentation best practices from 945-1015AM today
The Speaker Registration Desk Speaker Preparation Room and Speaker Training Room are all located in the East Registration area
We ask all speakers to arrive at their assigned room 20 minutes before
Speaker Registration amp Preparationyour session scheduled start time to confirm that the proper visual presen-tation is loaded on the session room computer You cannot upload or edit your presentations in the session room you may do so however in the Speaker Preparation Room We also recommend that you carry an elec-tronic copy (via USB) of your presen-tation for backup purposes
Exhibitor PassportVisit our Exhibitors to hear about their products and services You must have 50 Exhibitors sign your card found in your attendee bag to be eligible to win bull First Prize Apple Watch Sport bull Second Prize $250 VISA Gift Card (Two)
bull Third Prize Fitbit Charge HR (Three)
Passports must be dropped off to the DIA Booth 1523 by 400pm on Wednesday June 17
The Medical Heroes Appreciation Walk organized by CISCRP (Center for Information and Study on Clinical Research Participation) on Monday morning brought over 250 people together in celebration of study volunteers and their gift of participation in clinical research
10 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
The DIA 2015 51st Annual Meeting offers a variety of over 250 education opportunities to help strengthen your understanding of the value of cross-discipline integration and to foster innovation for better health outcomes
Participants may receive up to 18 AMA PRA Category 1 Creditstrade 18 pharmacy contact hours or 18 con-tinuing education units (CEUs) 18 nursing contact hours 10 Project Man-agement Institute (PMI) professional development units or 24 International Association for Continuing Education and Training CEUs There are multiple program offering formats at the meet-ing including sessions forums work-shops symposia and one hour TURBO offerings Program offerings desig-nated for credit are clearly identified in the final program with the pertinent CME Pharmacy Nursing or PMI PDUs statements IACET CEUs are offered for all program offerings except that no continuing education credits are avail-able for the following offerings
bull Plenary Session and Keynote Addressbull Session 226 How Pharmaceutical Companies Can Engage Responsibly with Patients Online bull Session 246 Using Registries to Support Recruitment in Alzheimers Disease (AD) Prevention or Delay-of-Onset Studies bull Session 345 Power Up Give Your Brain a Breakbull Track 20 Innovation Theaterbull Track 21 Poster Presentations
Participants who would like to
Continuing Education at DIA 2015 51st Annual Meetingreceive continuing education credits for the Annual Meeting must scan their DIA name badge at each program offering to record hisher attendance Participants must scan their name badges within 45 minutes after the start time of each 15 hour program offering and within 30 minutes after the start time for the one hour TURBO offerings If a participant attends multiple offerings within the same time frame only the last scanned entry will be recorded Participants who do not scan their badge within the allotted time will not be eligible to request the available continuing education credits for that program offering
Evaluation Station ndash Your Opinion Counts
DIA will again utilize an online evaluation portal to obtain your feed-back on our program offerings You can access this portal at DIAglobalorgDIA2015evals Each evening dur-ing the Annual Meeting we will send an email to participants requesting their feedback on the offerings they attended that day
Beginning Tuesday June 16 there will also be an onsite Evaluation Sta-tion in the Attendee Registration Area (West Wing) for you to complete your evaluations while onsite Your feed-back is valued and we would really appreciate hearing from you
DIA will conduct a drawing with a chance for one participant to win a free registration to the DIA 2016 52nd Annual Meeting in Philadelphia PA Eligible participants must complete all
program offering evaluations from each educational offering they attended dur-ing the Annual Meeting time frame
DIA will also offer one winner a $100 American Express gift card from a ran-dom drawing of the participants who complete the Overall Evaluation form During the week of July 20 the winners will be announced and notified Dead-line for submitting evaluation feedback is Wednesday July 15 2015
All DIA 2015 51st Annual Meeting continuing education credit requests are processed through DIArsquos My Transcript DIArsquos My Transcript OPENS on Tuesday June 23 My Transcript allow you to request an Attendance Certificate or request CE credit(s) and download a statement of credit To ac-cess My Transcript
bull Login to My DIA at DIAglobalorgbull Enter your User ID and Passwordbull Select My Transcript from the
left side barbull Select DIA 2015 51st Annual Meeting Credit Requestbull Proceed to request an Attendance Certificate or CE credit for each offering and for each daybull Select the Credit Type or Attendance Certificate for each
offeringbull Select Continue after your credit request is completed for all requested offeringsbull Submitbull Print statement(s) of credit or Attendance Certificate All ACPE credit requests must be
submitted by Wednesday July 29 2015 so your request can be sub-mitted to the CPE Monitor Please have your NABP eProfile ID and DOB (MMDD) readily available when requesting ACPE credit If you need to obtain your NABP eProfile ID visit wwwcpemonitornet
MOBILIZE YOUR TRIAL WITH IN-HOME CLINICAL TRIAL VISITSbull Subject Conveniencebull Improves Recruitment Retention amp Compliancebull Access to Certified Mobile Research Nursesbull US amp Global Services
For RFPs or to request a capabilities presentation please contact infopcmtrialscom or call
888-628-9707 | DIA booth 2733
Our Certified Mobile Research Nurses
Set Us Apart
PCM Trials DIA Ad Half Page2015_v3indd 1 31015 518 PM
of New Drugs CDER
In Room 146C 291 CDRH Town Hall continues the Annual Meeting tra-dition of providing you with a unique opportunity to hear directly from the Director of the Center for Devices and Radiological Health (CDRH) on the state of CDRH and its vision for the future Specific topics include FDA-SIA accomplishments and activities 2017 MDUFA Reauthorization and the impact of the House Energy and Com-merce 21st Century Cures initiatives
the regulatory framework for labora-tory developed tests expedited path-ways development the future of next gen sequencing and innovative ap-proaches for companion diagnostics and personalized medicine human factors studies combination products regulation of mobile and web software applications and the impact of other new technologies on patient care
Chair Janet Jenkins-Showalter Senior Regulatory Group Director Regulatory Policy amp Intelligence Genentech A Member of the Roche Group
Panelists Jeffrey Shuren JD MD Director CDRH FDA Alberto Gutier-rez PhD Director Office of In Vitro Diagnostics amp Radiological Health CDRH and Jonette R Foy PhD Deputy Director for Engineering amp Sci-ence Review ODE CDRH
InnovationsContinued from Page 3
28th Annual EuroMeeting 6-8 April 2016 Hamburg GermanyDIAGlobalorgEuroMeeting
Save the date
DIA Europe Middle East amp AfricaKuumlchengasse 164051 Basel Switzerland
Flanked by DIA Globlal Chief Executive Barbara Lopez Kunz and Dr Per Spindler (DIA President and Chair Board of Directors) DIA welcomes our 2015 DIA Fellows Minnie Baylor-Henry RPh JD (Incoming Chair) Jennifer L Riggins PharmD Kenneth A Getz MBA and Noriaki Murao MS 2015 DIA Fellow Gaby Danan MD PhD was unable to attend
ldquoMy commitment to you at this meeting is to provide the environment that will help you seize the opportuni-ties that present themselves both here in Washington as we meet and moving forward as you return to your places of workrdquo she concluded ldquoSo I invite you to seize the opportunity that we have this week to take advantage of this lsquoone shotrsquordquo
Annual Meeting Co-Chair Christo-pher P Austin MD (Director National Center for Advancing Translational Sci-ences US National Institutes of Health) followed Barbara to the podium ldquoOur focus at NCATS is not on spe-cific diseases but on what is common among all diseasesrdquo he explained ldquoOur chosen field is remarkably if not painfully empirical because we donrsquot understand the general principles and thatrsquos what NCATS is all aboutrdquo
ldquoWe are fond of saying that transla-tional science is a team sportrdquo he said to introduce one such ldquoteamrdquo project The Tissue Chip for Drug Screening program a collaboration between the FDA and the Defense Advanced Research Projects Agency (DARPA) that has developed organ and organ systems on microchips for drug toxic-ity testing that doesnrsquot require animals or humans In the future these chips could include hormones for example to identify the difference between male and female response to drugs ldquoI really thought this was just science fiction ndash and I was wrongrdquo he confessed
ldquoOne of my favorite proverbs
comes from Japanese literature lsquoNone of us is as smart as all of usrsquo Solving the systemic and highly complex problems of translation will require that adage as a guiding principle and the DIA meeting this year promises to provide the perfect setting to establish and strengthen the connections that will help us all collectively develop innovate and advance to new solutionsrdquo he con-cluded
ldquoLike many of you this organization and its expanding influence have been essential to my lifersquos work in the phar-maceutical and biotechnology arenardquo said Per Spindler DVM MBA MSc (DIA President and Chair Board of Directors Director Biopeople Univer-sity of Copenhagen Denmark ldquoI was born in 1963 in Copenhagen the year before DIA was foundedrdquo
ldquoIn 2003 I was invited to become a member of the DIA Advisory Council of Europe and I was elected to the Board of Directors in 2007 In the recent past as member of the Board I have been instrumental in establishing our journal within therapeutic innova-tion and regulatory science ndash pro-fessional fields where DIA takes the global leadership You might say DIA and I have grown up togetherrdquo Per continued
ldquoBy the time DIA celebrates its 100th Anniversary our world will be a very different place shaped in part by the innovations that we will ad-vance here in Washington Review the program for this 51st meeting of DIA with its rich and diverse offerings and you will have no doubt that a trans-formational agenda for our industry is evolving You will also be convinced that DIA will be at the forefront of that transformationrdquo
ldquoLike Per I have greatly benefited from my association with DIA and this organization has been essential to my career and to the proficiencies I have developed in the regulatory science arenardquo began President-Elect San-dra A Milligan JD MD (Senior Vice President Global Regulatory Affairs amp Clinical Safety Merck Research Laboratories) ldquoIn 2013 I chaired the Annual Meeting in Boston and now I find myself grateful to you the mem-bership to be the next president of DIA starting July 1strdquo
ldquoOur organization brings people to-gether creating a rich mix of ideas of service to our professions and service to our patients DIA as an organization truly proves that the whole is greater than the sum of its partsrdquo Sandra concluded
Co-Chair Michael Rosenblatt MD
(Executive Vice President amp Chief Medical Officer Merck amp Co Inc) concluded the welcoming remarks ldquoDIA is the only place i know of where professionals from every aspect of RampD ndash from the laboratory to the patient ndash gather to learn and to share best practicesrdquo he began ldquoI see great value in the lively and massive ex-change of information and ideas that takes place here It illustrates some-thing i deeply believe all of us ndash and the patients we serve ndash are interde-pendentrdquo
ldquoThe patient has always been ndash and should always be ndash at the core of what we dordquo he continued ldquoBut todayrsquos patients are different They are better informed more independent more ac-tive and more engaged than ever They are interested in taking charge of their own care Many have organized them-selves into learning communitiesrdquo
ldquoLike any big social trend this renewed emphasis on the patient has created a new mindset that in turn has helped spawn exciting innova-tionsrdquo he concluded ldquoWe need only look at this conference agenda to see evidence of new and previously unlikely collaborations ndash all with re-newed focus on in the patient These are partnerships between academia industry practitioners payers and regulators aimed at speeding the ar-rival of urgently needed vaccines and cures targeting the right therapies to the right people and improving patient accessrdquo
Daniel Burrus (President amp CEO Burrus Research Associates Inc) opened his Keynote Address by refer-ring to DIA Annual Meeting attendees as ldquothe great enablersrdquo His energetic remarks encompassed the themes of collaboration and innovation through real-world and theoretical examples ldquoWe live in a world of amazing inno-vation right nowrdquo he began ldquoIn fact wersquore standing at the base of a moun-tain of innovationrdquo
Daniel presented innovation as the ability to anticipate and solve a problem before you actually have it ldquoKeeping up is a foolrsquos gamerdquo he said ldquoWho wants to keep up I want to jump aheadrdquo
ldquoWe say wersquore collaborating but are werdquo he asked ldquoAre you using your 4G phone to advance innovation or to watch Netflix Yoursquove already got amazing tools Are you underutilizing them Hint Yesrdquo
ldquoThe world needs yourdquo he said to close the Opening Plenary ldquoYoursquore the enablers of innovationrdquo
Annual Meeting Co-Chairs Dr Michael Rosenblatt (left) and Dr Christopher Austin (right) welcome attendees to the Opening Plenary
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
Global DevelopmentGlobal Launch
We Know How
Global IMPACT
8 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
Thatrsquos Nice LLC 1240The Clinical Resource Network 1318The Geneva Foundation 2548The Patient Recruiting Agency 2119Theorem Clinical Research 511Theorem Clinical Research Business Suite 1Therapak Corporation 1005Therapeias Health Management 641Therapeutics Inc 1341Thomson Reuters 1440ThreeWire Inc 1939TKL Research Inc 2202Total Clinical Trial Management 2725Total Root Concepts Inc 523TrakCel Limited 2747TransPerfect 1025Trial Runners 2742Trievr Inc 2103Trifecta 1921
U-V-WUBC 2401Unanet 1152University of Florida 1551University of Maryland Online MS in Regulatory Science 1147University of the Sciences 852University of Utah Clinical Trials Office 1725Uppsala Monitoring Centre 2426UTMB Sealy Center for Vaccine Development 1657Valesta Clinical Research Solutions 2629Validated Cloud 2056Veeva Systems Inc 1203Verified Clinical Trials 1109Veristat Inc 1941
(continued from page 7)
Vigilare International 1141Vince amp Associates Clinical Research 748Viracor-IBT Laboratories 2546Viroclinics Biosciences 547VirtualScopics 2320Vitalograph Inc 1406Voluntis 1447WCCT Global 2121WebbWrites LLC 953Whitsell Innovations Inc 626Wincere Inc 1144Wingspan Technology Inc 1445WIRB-Copernicus Group 701Women in Life Sciences - WILS 1356Woodley Equipment Company 1215Worldwide Clinical Trials 1311
TKL Research is an international CRO offering expertise in a full spectrum of indications as well as clinical trial management services from Phase 1 to multicenter international studies TKL serves the pharmaceutical biotech generic drug medi-cal device OTC and consumer health care indus-tries The leader in dermatological research TKL has performed over 200 dermatological clinical trials and is unrivaled in the number of dermato-logical safety studies TKL also has significant ex-perience in Phase 1-4 multinational clinical trials and differentiates itself from the competition with a strong Phase 1 safety capability and full service CRO combined into one cohesive organization
QuintilesBooth 601wwwquintilescomcareers
Quintiles CareersQuintiles is the worldrsquos largest provider of
biopharmaceutical development and commercial outsourcing services and wersquod like to meet you Please stop by the Marriott Marquis Hotel to hellip
ATTEND OUR COCKTAIL RECEPTION in the Chinatown Meeting Room
bull Monday June 15th from 6pm - 8pm
MEET OUR RECRUITING TEAM from Immunol-ogy and Internal Medicine in the Judiciary Square Meeting Room
bull Monday June 15th from 2pm - 5pmbull Tuesday June 16th from 9am - 7pmbull Wednesday June 17th from 9am - 7pm
Improve your probability of successtrade
Exhibit Hall Hours
Tuesday June 16900AM ndash 500PM
Wednesday June 17900AM ndash 400PM
Your Opinion MattersComplete an evaluation for each offering
you attend for a chance to win great prizes
Access online evaluations at DIAGlobalorgDIA2015evals or stop by Evaluation Stations in the Registration
Area beginning Tuesday
Free registration to the DIA 2016 52nd Annual Meeting
$100 American Express Gift Card
Discover Safety around the World
ldquoGlobal production of FDA-regulated goods has exploded over the past ten years In addi-tion to an increase in imported finished prod-ucts manufacturers increasingly use imported materials and ingredients in their US produc-tion facilities making the distinction between domestic and imported products obsoleterdquo said FDA Commissioner Dr Margaret A Ham-burg upon the release of the FDA 2011 report Pathway to Global Product Safety and Quality ldquoThe FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face The FDA must further collaborate and leverage in order to close the gap between our import levels and our regula-tory resourcesrdquo she concluded
At 1030AM today staff from FDArsquos interna-tional posts in China Europe and India will provide exclusive updates from their respec-tive posts in Session 245 FDArsquos International Posts International Efforts Regulatory System Strengthening and Inspections presented in Room 152A Their updates will include out-reach to foreign regulators facility inspections risk-based global surveillance to protect supply chains and related topics
Chair Leslie Ball MD Assistant Commis-sioner and Deputy Director OIP OC FDA
Update from the FDA China Office S Leigh Verbois PhD Incoming Director China Office Office of International Programs OC FDA
Update from the FDA India Office Mathew T Thomas MD Acting Country Director India Of-fice Office of International Programs OC FDA
Update from the FDA European Office Donald Prater DVM Acting Regional Director Europe Office OIP OC FDA
9ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Route 1 Red Hotel Pickup LocationJW Marriott E Street EntranceGrand Hyatt 11th Street EntranceMarriott Metro Center At Hyatt 11th Street Entrance
Route 2 Yellow Hotel Pickup LocationHamilton Crown Plaza Lobby EntranceDonovan House Lobby EntranceWashington Plaza Curbside Vermont mdash Near DrivewayComfort Inn Convention Center At Washington Plaza Curbside Vermont
Route 3 Blue Hotel Pickup LocationLoews Madison Lobby EntranceWestin Washington At Loews Madison Lobby EntranceDoubletree Washington Lobby EntranceHotel Helix At Doubletree Lobby EntranceMayflower Renaissance Desales Street Entrance
Hotels within walking distance of the Walter E Washington Convention Center are Embassy Suites Convention Center Hampton
Inn Henley Park Hotel Morrison-Clark Inn Renaissance Washington DC Downtown Hotel and Marriott Marquis
Tuesday June 16 through Wednesday June 17Hours Frequency 645-930AM 15 Minutes930AM-330PM No Service330-630PM 15 MinutesLast Bus Departs Hotels 530PM
Thursday June 18 Hours Frequency 730-900AM 15 Minutes900AM-1230pm 30 MinutesLast Bus Departs Hotels 1130AM
For Shuttle Information or to Pre-Schedule ADA Pick-up call 877-865-3437 during convention shuttle hours
Complimentary Shuttle InformationPlease allow up to 20 minutes (including waiting and riding time under nor-mal peak traffic conditions) to travel from your hotel to the Walter E Wash-ington Convention Center located on Mount Vernon Place Delays may occur due to circumstances beyond our control
Discover tomorrowrsquos solutions to to-dayrsquos challenges through the products and services showcased in todayrsquos Innovation Theater sessions presented near Exhibit Hall Entrance B
945AM 225 Covance Innovation Theater Advances in Risk-Based Mon-itoring Transforming Drug Develop-ment Through Efficient Workflows Big Data and Elegant Software Discover Covancersquos risk-based monitoring (RBM) platform which provides clients with best-in-class implementation of the RBM principles put forth by FDA EMA and TransCelerate and facilitates RBM through timely secure and inte-grated access to all relevant trial data
1200PM 249 Quintiles Innova-tion Theater Transform Clinical De-velopment ndash Modernizing for Smarter Trials Because of our imperative to ldquomodernizerdquo clinical trials to de-liver medicines faster at less cost to patients who need them learn how you can gauge global capabilities to model and predict better outcomes identify appropriate investigator sites and deliver faster ldquoanalysis-readyrdquo data to identify trends and issues in near real time
100PM 250 Veeva Innovation Theater 2015 Paperless Trial Master File (TMF) Survey Trends and Insights Results from the follow-up to Veevarsquos benchmark 2014 Paperless TMF Sur-vey which analyzed the observations of TMF owners to identify the barriers business drivers and benefits of mov-ing to fully paperless TMFs How does your organization compare and why do some organizations benefit more than others
300PM 267 BBK Worldwide Innovation Theater mHealth A New Era in Patient Engagement BBK Worldwide and mHealth experts from the Landon Pediatric Foundation and CareThings discuss opportunities for patient engagement in clinical trials within mHealth and how advance-ments in apps wearables and per-sonalized content delivery are shaping a new patient engagement model and impacting the entire clinical research enterprise
See Innovation in Action Innovation Theater
We ask all Annual Meeting speak-ers to please check in at the Speaker Registration Desk when you arrive at the Convention Center to pick up your name badge Speaker registration will be open today from 700AMndash500PM The Speaker Preparation Room will also be open from 700AMndash500PM to-day this is where you will confirm that your presentation has been properly uploaded
A Speaker Training Room is also available for you to practice your pre-sentation alone or with your fellow pre-senters Please schedule your practice time when you check in at the Registra-tion Desk This Training Room will host a special Speaker Training Session coaching on podium presentation best practices from 945-1015AM today
The Speaker Registration Desk Speaker Preparation Room and Speaker Training Room are all located in the East Registration area
We ask all speakers to arrive at their assigned room 20 minutes before
Speaker Registration amp Preparationyour session scheduled start time to confirm that the proper visual presen-tation is loaded on the session room computer You cannot upload or edit your presentations in the session room you may do so however in the Speaker Preparation Room We also recommend that you carry an elec-tronic copy (via USB) of your presen-tation for backup purposes
Exhibitor PassportVisit our Exhibitors to hear about their products and services You must have 50 Exhibitors sign your card found in your attendee bag to be eligible to win bull First Prize Apple Watch Sport bull Second Prize $250 VISA Gift Card (Two)
bull Third Prize Fitbit Charge HR (Three)
Passports must be dropped off to the DIA Booth 1523 by 400pm on Wednesday June 17
The Medical Heroes Appreciation Walk organized by CISCRP (Center for Information and Study on Clinical Research Participation) on Monday morning brought over 250 people together in celebration of study volunteers and their gift of participation in clinical research
10 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
The DIA 2015 51st Annual Meeting offers a variety of over 250 education opportunities to help strengthen your understanding of the value of cross-discipline integration and to foster innovation for better health outcomes
Participants may receive up to 18 AMA PRA Category 1 Creditstrade 18 pharmacy contact hours or 18 con-tinuing education units (CEUs) 18 nursing contact hours 10 Project Man-agement Institute (PMI) professional development units or 24 International Association for Continuing Education and Training CEUs There are multiple program offering formats at the meet-ing including sessions forums work-shops symposia and one hour TURBO offerings Program offerings desig-nated for credit are clearly identified in the final program with the pertinent CME Pharmacy Nursing or PMI PDUs statements IACET CEUs are offered for all program offerings except that no continuing education credits are avail-able for the following offerings
bull Plenary Session and Keynote Addressbull Session 226 How Pharmaceutical Companies Can Engage Responsibly with Patients Online bull Session 246 Using Registries to Support Recruitment in Alzheimers Disease (AD) Prevention or Delay-of-Onset Studies bull Session 345 Power Up Give Your Brain a Breakbull Track 20 Innovation Theaterbull Track 21 Poster Presentations
Participants who would like to
Continuing Education at DIA 2015 51st Annual Meetingreceive continuing education credits for the Annual Meeting must scan their DIA name badge at each program offering to record hisher attendance Participants must scan their name badges within 45 minutes after the start time of each 15 hour program offering and within 30 minutes after the start time for the one hour TURBO offerings If a participant attends multiple offerings within the same time frame only the last scanned entry will be recorded Participants who do not scan their badge within the allotted time will not be eligible to request the available continuing education credits for that program offering
Evaluation Station ndash Your Opinion Counts
DIA will again utilize an online evaluation portal to obtain your feed-back on our program offerings You can access this portal at DIAglobalorgDIA2015evals Each evening dur-ing the Annual Meeting we will send an email to participants requesting their feedback on the offerings they attended that day
Beginning Tuesday June 16 there will also be an onsite Evaluation Sta-tion in the Attendee Registration Area (West Wing) for you to complete your evaluations while onsite Your feed-back is valued and we would really appreciate hearing from you
DIA will conduct a drawing with a chance for one participant to win a free registration to the DIA 2016 52nd Annual Meeting in Philadelphia PA Eligible participants must complete all
program offering evaluations from each educational offering they attended dur-ing the Annual Meeting time frame
DIA will also offer one winner a $100 American Express gift card from a ran-dom drawing of the participants who complete the Overall Evaluation form During the week of July 20 the winners will be announced and notified Dead-line for submitting evaluation feedback is Wednesday July 15 2015
All DIA 2015 51st Annual Meeting continuing education credit requests are processed through DIArsquos My Transcript DIArsquos My Transcript OPENS on Tuesday June 23 My Transcript allow you to request an Attendance Certificate or request CE credit(s) and download a statement of credit To ac-cess My Transcript
bull Login to My DIA at DIAglobalorgbull Enter your User ID and Passwordbull Select My Transcript from the
left side barbull Select DIA 2015 51st Annual Meeting Credit Requestbull Proceed to request an Attendance Certificate or CE credit for each offering and for each daybull Select the Credit Type or Attendance Certificate for each
offeringbull Select Continue after your credit request is completed for all requested offeringsbull Submitbull Print statement(s) of credit or Attendance Certificate All ACPE credit requests must be
submitted by Wednesday July 29 2015 so your request can be sub-mitted to the CPE Monitor Please have your NABP eProfile ID and DOB (MMDD) readily available when requesting ACPE credit If you need to obtain your NABP eProfile ID visit wwwcpemonitornet
MOBILIZE YOUR TRIAL WITH IN-HOME CLINICAL TRIAL VISITSbull Subject Conveniencebull Improves Recruitment Retention amp Compliancebull Access to Certified Mobile Research Nursesbull US amp Global Services
For RFPs or to request a capabilities presentation please contact infopcmtrialscom or call
888-628-9707 | DIA booth 2733
Our Certified Mobile Research Nurses
Set Us Apart
PCM Trials DIA Ad Half Page2015_v3indd 1 31015 518 PM
of New Drugs CDER
In Room 146C 291 CDRH Town Hall continues the Annual Meeting tra-dition of providing you with a unique opportunity to hear directly from the Director of the Center for Devices and Radiological Health (CDRH) on the state of CDRH and its vision for the future Specific topics include FDA-SIA accomplishments and activities 2017 MDUFA Reauthorization and the impact of the House Energy and Com-merce 21st Century Cures initiatives
the regulatory framework for labora-tory developed tests expedited path-ways development the future of next gen sequencing and innovative ap-proaches for companion diagnostics and personalized medicine human factors studies combination products regulation of mobile and web software applications and the impact of other new technologies on patient care
Chair Janet Jenkins-Showalter Senior Regulatory Group Director Regulatory Policy amp Intelligence Genentech A Member of the Roche Group
Panelists Jeffrey Shuren JD MD Director CDRH FDA Alberto Gutier-rez PhD Director Office of In Vitro Diagnostics amp Radiological Health CDRH and Jonette R Foy PhD Deputy Director for Engineering amp Sci-ence Review ODE CDRH
InnovationsContinued from Page 3
28th Annual EuroMeeting 6-8 April 2016 Hamburg GermanyDIAGlobalorgEuroMeeting
Save the date
DIA Europe Middle East amp AfricaKuumlchengasse 164051 Basel Switzerland
Flanked by DIA Globlal Chief Executive Barbara Lopez Kunz and Dr Per Spindler (DIA President and Chair Board of Directors) DIA welcomes our 2015 DIA Fellows Minnie Baylor-Henry RPh JD (Incoming Chair) Jennifer L Riggins PharmD Kenneth A Getz MBA and Noriaki Murao MS 2015 DIA Fellow Gaby Danan MD PhD was unable to attend
ldquoMy commitment to you at this meeting is to provide the environment that will help you seize the opportuni-ties that present themselves both here in Washington as we meet and moving forward as you return to your places of workrdquo she concluded ldquoSo I invite you to seize the opportunity that we have this week to take advantage of this lsquoone shotrsquordquo
Annual Meeting Co-Chair Christo-pher P Austin MD (Director National Center for Advancing Translational Sci-ences US National Institutes of Health) followed Barbara to the podium ldquoOur focus at NCATS is not on spe-cific diseases but on what is common among all diseasesrdquo he explained ldquoOur chosen field is remarkably if not painfully empirical because we donrsquot understand the general principles and thatrsquos what NCATS is all aboutrdquo
ldquoWe are fond of saying that transla-tional science is a team sportrdquo he said to introduce one such ldquoteamrdquo project The Tissue Chip for Drug Screening program a collaboration between the FDA and the Defense Advanced Research Projects Agency (DARPA) that has developed organ and organ systems on microchips for drug toxic-ity testing that doesnrsquot require animals or humans In the future these chips could include hormones for example to identify the difference between male and female response to drugs ldquoI really thought this was just science fiction ndash and I was wrongrdquo he confessed
ldquoOne of my favorite proverbs
comes from Japanese literature lsquoNone of us is as smart as all of usrsquo Solving the systemic and highly complex problems of translation will require that adage as a guiding principle and the DIA meeting this year promises to provide the perfect setting to establish and strengthen the connections that will help us all collectively develop innovate and advance to new solutionsrdquo he con-cluded
ldquoLike many of you this organization and its expanding influence have been essential to my lifersquos work in the phar-maceutical and biotechnology arenardquo said Per Spindler DVM MBA MSc (DIA President and Chair Board of Directors Director Biopeople Univer-sity of Copenhagen Denmark ldquoI was born in 1963 in Copenhagen the year before DIA was foundedrdquo
ldquoIn 2003 I was invited to become a member of the DIA Advisory Council of Europe and I was elected to the Board of Directors in 2007 In the recent past as member of the Board I have been instrumental in establishing our journal within therapeutic innova-tion and regulatory science ndash pro-fessional fields where DIA takes the global leadership You might say DIA and I have grown up togetherrdquo Per continued
ldquoBy the time DIA celebrates its 100th Anniversary our world will be a very different place shaped in part by the innovations that we will ad-vance here in Washington Review the program for this 51st meeting of DIA with its rich and diverse offerings and you will have no doubt that a trans-formational agenda for our industry is evolving You will also be convinced that DIA will be at the forefront of that transformationrdquo
ldquoLike Per I have greatly benefited from my association with DIA and this organization has been essential to my career and to the proficiencies I have developed in the regulatory science arenardquo began President-Elect San-dra A Milligan JD MD (Senior Vice President Global Regulatory Affairs amp Clinical Safety Merck Research Laboratories) ldquoIn 2013 I chaired the Annual Meeting in Boston and now I find myself grateful to you the mem-bership to be the next president of DIA starting July 1strdquo
ldquoOur organization brings people to-gether creating a rich mix of ideas of service to our professions and service to our patients DIA as an organization truly proves that the whole is greater than the sum of its partsrdquo Sandra concluded
Co-Chair Michael Rosenblatt MD
(Executive Vice President amp Chief Medical Officer Merck amp Co Inc) concluded the welcoming remarks ldquoDIA is the only place i know of where professionals from every aspect of RampD ndash from the laboratory to the patient ndash gather to learn and to share best practicesrdquo he began ldquoI see great value in the lively and massive ex-change of information and ideas that takes place here It illustrates some-thing i deeply believe all of us ndash and the patients we serve ndash are interde-pendentrdquo
ldquoThe patient has always been ndash and should always be ndash at the core of what we dordquo he continued ldquoBut todayrsquos patients are different They are better informed more independent more ac-tive and more engaged than ever They are interested in taking charge of their own care Many have organized them-selves into learning communitiesrdquo
ldquoLike any big social trend this renewed emphasis on the patient has created a new mindset that in turn has helped spawn exciting innova-tionsrdquo he concluded ldquoWe need only look at this conference agenda to see evidence of new and previously unlikely collaborations ndash all with re-newed focus on in the patient These are partnerships between academia industry practitioners payers and regulators aimed at speeding the ar-rival of urgently needed vaccines and cures targeting the right therapies to the right people and improving patient accessrdquo
Daniel Burrus (President amp CEO Burrus Research Associates Inc) opened his Keynote Address by refer-ring to DIA Annual Meeting attendees as ldquothe great enablersrdquo His energetic remarks encompassed the themes of collaboration and innovation through real-world and theoretical examples ldquoWe live in a world of amazing inno-vation right nowrdquo he began ldquoIn fact wersquore standing at the base of a moun-tain of innovationrdquo
Daniel presented innovation as the ability to anticipate and solve a problem before you actually have it ldquoKeeping up is a foolrsquos gamerdquo he said ldquoWho wants to keep up I want to jump aheadrdquo
ldquoWe say wersquore collaborating but are werdquo he asked ldquoAre you using your 4G phone to advance innovation or to watch Netflix Yoursquove already got amazing tools Are you underutilizing them Hint Yesrdquo
ldquoThe world needs yourdquo he said to close the Opening Plenary ldquoYoursquore the enablers of innovationrdquo
Annual Meeting Co-Chairs Dr Michael Rosenblatt (left) and Dr Christopher Austin (right) welcome attendees to the Opening Plenary
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
Global DevelopmentGlobal Launch
We Know How
Global IMPACT
9ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
Route 1 Red Hotel Pickup LocationJW Marriott E Street EntranceGrand Hyatt 11th Street EntranceMarriott Metro Center At Hyatt 11th Street Entrance
Route 2 Yellow Hotel Pickup LocationHamilton Crown Plaza Lobby EntranceDonovan House Lobby EntranceWashington Plaza Curbside Vermont mdash Near DrivewayComfort Inn Convention Center At Washington Plaza Curbside Vermont
Route 3 Blue Hotel Pickup LocationLoews Madison Lobby EntranceWestin Washington At Loews Madison Lobby EntranceDoubletree Washington Lobby EntranceHotel Helix At Doubletree Lobby EntranceMayflower Renaissance Desales Street Entrance
Hotels within walking distance of the Walter E Washington Convention Center are Embassy Suites Convention Center Hampton
Inn Henley Park Hotel Morrison-Clark Inn Renaissance Washington DC Downtown Hotel and Marriott Marquis
Tuesday June 16 through Wednesday June 17Hours Frequency 645-930AM 15 Minutes930AM-330PM No Service330-630PM 15 MinutesLast Bus Departs Hotels 530PM
Thursday June 18 Hours Frequency 730-900AM 15 Minutes900AM-1230pm 30 MinutesLast Bus Departs Hotels 1130AM
For Shuttle Information or to Pre-Schedule ADA Pick-up call 877-865-3437 during convention shuttle hours
Complimentary Shuttle InformationPlease allow up to 20 minutes (including waiting and riding time under nor-mal peak traffic conditions) to travel from your hotel to the Walter E Wash-ington Convention Center located on Mount Vernon Place Delays may occur due to circumstances beyond our control
Discover tomorrowrsquos solutions to to-dayrsquos challenges through the products and services showcased in todayrsquos Innovation Theater sessions presented near Exhibit Hall Entrance B
945AM 225 Covance Innovation Theater Advances in Risk-Based Mon-itoring Transforming Drug Develop-ment Through Efficient Workflows Big Data and Elegant Software Discover Covancersquos risk-based monitoring (RBM) platform which provides clients with best-in-class implementation of the RBM principles put forth by FDA EMA and TransCelerate and facilitates RBM through timely secure and inte-grated access to all relevant trial data
1200PM 249 Quintiles Innova-tion Theater Transform Clinical De-velopment ndash Modernizing for Smarter Trials Because of our imperative to ldquomodernizerdquo clinical trials to de-liver medicines faster at less cost to patients who need them learn how you can gauge global capabilities to model and predict better outcomes identify appropriate investigator sites and deliver faster ldquoanalysis-readyrdquo data to identify trends and issues in near real time
100PM 250 Veeva Innovation Theater 2015 Paperless Trial Master File (TMF) Survey Trends and Insights Results from the follow-up to Veevarsquos benchmark 2014 Paperless TMF Sur-vey which analyzed the observations of TMF owners to identify the barriers business drivers and benefits of mov-ing to fully paperless TMFs How does your organization compare and why do some organizations benefit more than others
300PM 267 BBK Worldwide Innovation Theater mHealth A New Era in Patient Engagement BBK Worldwide and mHealth experts from the Landon Pediatric Foundation and CareThings discuss opportunities for patient engagement in clinical trials within mHealth and how advance-ments in apps wearables and per-sonalized content delivery are shaping a new patient engagement model and impacting the entire clinical research enterprise
See Innovation in Action Innovation Theater
We ask all Annual Meeting speak-ers to please check in at the Speaker Registration Desk when you arrive at the Convention Center to pick up your name badge Speaker registration will be open today from 700AMndash500PM The Speaker Preparation Room will also be open from 700AMndash500PM to-day this is where you will confirm that your presentation has been properly uploaded
A Speaker Training Room is also available for you to practice your pre-sentation alone or with your fellow pre-senters Please schedule your practice time when you check in at the Registra-tion Desk This Training Room will host a special Speaker Training Session coaching on podium presentation best practices from 945-1015AM today
The Speaker Registration Desk Speaker Preparation Room and Speaker Training Room are all located in the East Registration area
We ask all speakers to arrive at their assigned room 20 minutes before
Speaker Registration amp Preparationyour session scheduled start time to confirm that the proper visual presen-tation is loaded on the session room computer You cannot upload or edit your presentations in the session room you may do so however in the Speaker Preparation Room We also recommend that you carry an elec-tronic copy (via USB) of your presen-tation for backup purposes
Exhibitor PassportVisit our Exhibitors to hear about their products and services You must have 50 Exhibitors sign your card found in your attendee bag to be eligible to win bull First Prize Apple Watch Sport bull Second Prize $250 VISA Gift Card (Two)
bull Third Prize Fitbit Charge HR (Three)
Passports must be dropped off to the DIA Booth 1523 by 400pm on Wednesday June 17
The Medical Heroes Appreciation Walk organized by CISCRP (Center for Information and Study on Clinical Research Participation) on Monday morning brought over 250 people together in celebration of study volunteers and their gift of participation in clinical research
10 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
The DIA 2015 51st Annual Meeting offers a variety of over 250 education opportunities to help strengthen your understanding of the value of cross-discipline integration and to foster innovation for better health outcomes
Participants may receive up to 18 AMA PRA Category 1 Creditstrade 18 pharmacy contact hours or 18 con-tinuing education units (CEUs) 18 nursing contact hours 10 Project Man-agement Institute (PMI) professional development units or 24 International Association for Continuing Education and Training CEUs There are multiple program offering formats at the meet-ing including sessions forums work-shops symposia and one hour TURBO offerings Program offerings desig-nated for credit are clearly identified in the final program with the pertinent CME Pharmacy Nursing or PMI PDUs statements IACET CEUs are offered for all program offerings except that no continuing education credits are avail-able for the following offerings
bull Plenary Session and Keynote Addressbull Session 226 How Pharmaceutical Companies Can Engage Responsibly with Patients Online bull Session 246 Using Registries to Support Recruitment in Alzheimers Disease (AD) Prevention or Delay-of-Onset Studies bull Session 345 Power Up Give Your Brain a Breakbull Track 20 Innovation Theaterbull Track 21 Poster Presentations
Participants who would like to
Continuing Education at DIA 2015 51st Annual Meetingreceive continuing education credits for the Annual Meeting must scan their DIA name badge at each program offering to record hisher attendance Participants must scan their name badges within 45 minutes after the start time of each 15 hour program offering and within 30 minutes after the start time for the one hour TURBO offerings If a participant attends multiple offerings within the same time frame only the last scanned entry will be recorded Participants who do not scan their badge within the allotted time will not be eligible to request the available continuing education credits for that program offering
Evaluation Station ndash Your Opinion Counts
DIA will again utilize an online evaluation portal to obtain your feed-back on our program offerings You can access this portal at DIAglobalorgDIA2015evals Each evening dur-ing the Annual Meeting we will send an email to participants requesting their feedback on the offerings they attended that day
Beginning Tuesday June 16 there will also be an onsite Evaluation Sta-tion in the Attendee Registration Area (West Wing) for you to complete your evaluations while onsite Your feed-back is valued and we would really appreciate hearing from you
DIA will conduct a drawing with a chance for one participant to win a free registration to the DIA 2016 52nd Annual Meeting in Philadelphia PA Eligible participants must complete all
program offering evaluations from each educational offering they attended dur-ing the Annual Meeting time frame
DIA will also offer one winner a $100 American Express gift card from a ran-dom drawing of the participants who complete the Overall Evaluation form During the week of July 20 the winners will be announced and notified Dead-line for submitting evaluation feedback is Wednesday July 15 2015
All DIA 2015 51st Annual Meeting continuing education credit requests are processed through DIArsquos My Transcript DIArsquos My Transcript OPENS on Tuesday June 23 My Transcript allow you to request an Attendance Certificate or request CE credit(s) and download a statement of credit To ac-cess My Transcript
bull Login to My DIA at DIAglobalorgbull Enter your User ID and Passwordbull Select My Transcript from the
left side barbull Select DIA 2015 51st Annual Meeting Credit Requestbull Proceed to request an Attendance Certificate or CE credit for each offering and for each daybull Select the Credit Type or Attendance Certificate for each
offeringbull Select Continue after your credit request is completed for all requested offeringsbull Submitbull Print statement(s) of credit or Attendance Certificate All ACPE credit requests must be
submitted by Wednesday July 29 2015 so your request can be sub-mitted to the CPE Monitor Please have your NABP eProfile ID and DOB (MMDD) readily available when requesting ACPE credit If you need to obtain your NABP eProfile ID visit wwwcpemonitornet
MOBILIZE YOUR TRIAL WITH IN-HOME CLINICAL TRIAL VISITSbull Subject Conveniencebull Improves Recruitment Retention amp Compliancebull Access to Certified Mobile Research Nursesbull US amp Global Services
For RFPs or to request a capabilities presentation please contact infopcmtrialscom or call
888-628-9707 | DIA booth 2733
Our Certified Mobile Research Nurses
Set Us Apart
PCM Trials DIA Ad Half Page2015_v3indd 1 31015 518 PM
of New Drugs CDER
In Room 146C 291 CDRH Town Hall continues the Annual Meeting tra-dition of providing you with a unique opportunity to hear directly from the Director of the Center for Devices and Radiological Health (CDRH) on the state of CDRH and its vision for the future Specific topics include FDA-SIA accomplishments and activities 2017 MDUFA Reauthorization and the impact of the House Energy and Com-merce 21st Century Cures initiatives
the regulatory framework for labora-tory developed tests expedited path-ways development the future of next gen sequencing and innovative ap-proaches for companion diagnostics and personalized medicine human factors studies combination products regulation of mobile and web software applications and the impact of other new technologies on patient care
Chair Janet Jenkins-Showalter Senior Regulatory Group Director Regulatory Policy amp Intelligence Genentech A Member of the Roche Group
Panelists Jeffrey Shuren JD MD Director CDRH FDA Alberto Gutier-rez PhD Director Office of In Vitro Diagnostics amp Radiological Health CDRH and Jonette R Foy PhD Deputy Director for Engineering amp Sci-ence Review ODE CDRH
InnovationsContinued from Page 3
28th Annual EuroMeeting 6-8 April 2016 Hamburg GermanyDIAGlobalorgEuroMeeting
Save the date
DIA Europe Middle East amp AfricaKuumlchengasse 164051 Basel Switzerland
Flanked by DIA Globlal Chief Executive Barbara Lopez Kunz and Dr Per Spindler (DIA President and Chair Board of Directors) DIA welcomes our 2015 DIA Fellows Minnie Baylor-Henry RPh JD (Incoming Chair) Jennifer L Riggins PharmD Kenneth A Getz MBA and Noriaki Murao MS 2015 DIA Fellow Gaby Danan MD PhD was unable to attend
ldquoMy commitment to you at this meeting is to provide the environment that will help you seize the opportuni-ties that present themselves both here in Washington as we meet and moving forward as you return to your places of workrdquo she concluded ldquoSo I invite you to seize the opportunity that we have this week to take advantage of this lsquoone shotrsquordquo
Annual Meeting Co-Chair Christo-pher P Austin MD (Director National Center for Advancing Translational Sci-ences US National Institutes of Health) followed Barbara to the podium ldquoOur focus at NCATS is not on spe-cific diseases but on what is common among all diseasesrdquo he explained ldquoOur chosen field is remarkably if not painfully empirical because we donrsquot understand the general principles and thatrsquos what NCATS is all aboutrdquo
ldquoWe are fond of saying that transla-tional science is a team sportrdquo he said to introduce one such ldquoteamrdquo project The Tissue Chip for Drug Screening program a collaboration between the FDA and the Defense Advanced Research Projects Agency (DARPA) that has developed organ and organ systems on microchips for drug toxic-ity testing that doesnrsquot require animals or humans In the future these chips could include hormones for example to identify the difference between male and female response to drugs ldquoI really thought this was just science fiction ndash and I was wrongrdquo he confessed
ldquoOne of my favorite proverbs
comes from Japanese literature lsquoNone of us is as smart as all of usrsquo Solving the systemic and highly complex problems of translation will require that adage as a guiding principle and the DIA meeting this year promises to provide the perfect setting to establish and strengthen the connections that will help us all collectively develop innovate and advance to new solutionsrdquo he con-cluded
ldquoLike many of you this organization and its expanding influence have been essential to my lifersquos work in the phar-maceutical and biotechnology arenardquo said Per Spindler DVM MBA MSc (DIA President and Chair Board of Directors Director Biopeople Univer-sity of Copenhagen Denmark ldquoI was born in 1963 in Copenhagen the year before DIA was foundedrdquo
ldquoIn 2003 I was invited to become a member of the DIA Advisory Council of Europe and I was elected to the Board of Directors in 2007 In the recent past as member of the Board I have been instrumental in establishing our journal within therapeutic innova-tion and regulatory science ndash pro-fessional fields where DIA takes the global leadership You might say DIA and I have grown up togetherrdquo Per continued
ldquoBy the time DIA celebrates its 100th Anniversary our world will be a very different place shaped in part by the innovations that we will ad-vance here in Washington Review the program for this 51st meeting of DIA with its rich and diverse offerings and you will have no doubt that a trans-formational agenda for our industry is evolving You will also be convinced that DIA will be at the forefront of that transformationrdquo
ldquoLike Per I have greatly benefited from my association with DIA and this organization has been essential to my career and to the proficiencies I have developed in the regulatory science arenardquo began President-Elect San-dra A Milligan JD MD (Senior Vice President Global Regulatory Affairs amp Clinical Safety Merck Research Laboratories) ldquoIn 2013 I chaired the Annual Meeting in Boston and now I find myself grateful to you the mem-bership to be the next president of DIA starting July 1strdquo
ldquoOur organization brings people to-gether creating a rich mix of ideas of service to our professions and service to our patients DIA as an organization truly proves that the whole is greater than the sum of its partsrdquo Sandra concluded
Co-Chair Michael Rosenblatt MD
(Executive Vice President amp Chief Medical Officer Merck amp Co Inc) concluded the welcoming remarks ldquoDIA is the only place i know of where professionals from every aspect of RampD ndash from the laboratory to the patient ndash gather to learn and to share best practicesrdquo he began ldquoI see great value in the lively and massive ex-change of information and ideas that takes place here It illustrates some-thing i deeply believe all of us ndash and the patients we serve ndash are interde-pendentrdquo
ldquoThe patient has always been ndash and should always be ndash at the core of what we dordquo he continued ldquoBut todayrsquos patients are different They are better informed more independent more ac-tive and more engaged than ever They are interested in taking charge of their own care Many have organized them-selves into learning communitiesrdquo
ldquoLike any big social trend this renewed emphasis on the patient has created a new mindset that in turn has helped spawn exciting innova-tionsrdquo he concluded ldquoWe need only look at this conference agenda to see evidence of new and previously unlikely collaborations ndash all with re-newed focus on in the patient These are partnerships between academia industry practitioners payers and regulators aimed at speeding the ar-rival of urgently needed vaccines and cures targeting the right therapies to the right people and improving patient accessrdquo
Daniel Burrus (President amp CEO Burrus Research Associates Inc) opened his Keynote Address by refer-ring to DIA Annual Meeting attendees as ldquothe great enablersrdquo His energetic remarks encompassed the themes of collaboration and innovation through real-world and theoretical examples ldquoWe live in a world of amazing inno-vation right nowrdquo he began ldquoIn fact wersquore standing at the base of a moun-tain of innovationrdquo
Daniel presented innovation as the ability to anticipate and solve a problem before you actually have it ldquoKeeping up is a foolrsquos gamerdquo he said ldquoWho wants to keep up I want to jump aheadrdquo
ldquoWe say wersquore collaborating but are werdquo he asked ldquoAre you using your 4G phone to advance innovation or to watch Netflix Yoursquove already got amazing tools Are you underutilizing them Hint Yesrdquo
ldquoThe world needs yourdquo he said to close the Opening Plenary ldquoYoursquore the enablers of innovationrdquo
Annual Meeting Co-Chairs Dr Michael Rosenblatt (left) and Dr Christopher Austin (right) welcome attendees to the Opening Plenary
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
Global DevelopmentGlobal Launch
We Know How
Global IMPACT
10 JUNE 16 2015 WASHINGTON DCANNUAL MEETING DAILY
The DIA 2015 51st Annual Meeting offers a variety of over 250 education opportunities to help strengthen your understanding of the value of cross-discipline integration and to foster innovation for better health outcomes
Participants may receive up to 18 AMA PRA Category 1 Creditstrade 18 pharmacy contact hours or 18 con-tinuing education units (CEUs) 18 nursing contact hours 10 Project Man-agement Institute (PMI) professional development units or 24 International Association for Continuing Education and Training CEUs There are multiple program offering formats at the meet-ing including sessions forums work-shops symposia and one hour TURBO offerings Program offerings desig-nated for credit are clearly identified in the final program with the pertinent CME Pharmacy Nursing or PMI PDUs statements IACET CEUs are offered for all program offerings except that no continuing education credits are avail-able for the following offerings
bull Plenary Session and Keynote Addressbull Session 226 How Pharmaceutical Companies Can Engage Responsibly with Patients Online bull Session 246 Using Registries to Support Recruitment in Alzheimers Disease (AD) Prevention or Delay-of-Onset Studies bull Session 345 Power Up Give Your Brain a Breakbull Track 20 Innovation Theaterbull Track 21 Poster Presentations
Participants who would like to
Continuing Education at DIA 2015 51st Annual Meetingreceive continuing education credits for the Annual Meeting must scan their DIA name badge at each program offering to record hisher attendance Participants must scan their name badges within 45 minutes after the start time of each 15 hour program offering and within 30 minutes after the start time for the one hour TURBO offerings If a participant attends multiple offerings within the same time frame only the last scanned entry will be recorded Participants who do not scan their badge within the allotted time will not be eligible to request the available continuing education credits for that program offering
Evaluation Station ndash Your Opinion Counts
DIA will again utilize an online evaluation portal to obtain your feed-back on our program offerings You can access this portal at DIAglobalorgDIA2015evals Each evening dur-ing the Annual Meeting we will send an email to participants requesting their feedback on the offerings they attended that day
Beginning Tuesday June 16 there will also be an onsite Evaluation Sta-tion in the Attendee Registration Area (West Wing) for you to complete your evaluations while onsite Your feed-back is valued and we would really appreciate hearing from you
DIA will conduct a drawing with a chance for one participant to win a free registration to the DIA 2016 52nd Annual Meeting in Philadelphia PA Eligible participants must complete all
program offering evaluations from each educational offering they attended dur-ing the Annual Meeting time frame
DIA will also offer one winner a $100 American Express gift card from a ran-dom drawing of the participants who complete the Overall Evaluation form During the week of July 20 the winners will be announced and notified Dead-line for submitting evaluation feedback is Wednesday July 15 2015
All DIA 2015 51st Annual Meeting continuing education credit requests are processed through DIArsquos My Transcript DIArsquos My Transcript OPENS on Tuesday June 23 My Transcript allow you to request an Attendance Certificate or request CE credit(s) and download a statement of credit To ac-cess My Transcript
bull Login to My DIA at DIAglobalorgbull Enter your User ID and Passwordbull Select My Transcript from the
left side barbull Select DIA 2015 51st Annual Meeting Credit Requestbull Proceed to request an Attendance Certificate or CE credit for each offering and for each daybull Select the Credit Type or Attendance Certificate for each
offeringbull Select Continue after your credit request is completed for all requested offeringsbull Submitbull Print statement(s) of credit or Attendance Certificate All ACPE credit requests must be
submitted by Wednesday July 29 2015 so your request can be sub-mitted to the CPE Monitor Please have your NABP eProfile ID and DOB (MMDD) readily available when requesting ACPE credit If you need to obtain your NABP eProfile ID visit wwwcpemonitornet
MOBILIZE YOUR TRIAL WITH IN-HOME CLINICAL TRIAL VISITSbull Subject Conveniencebull Improves Recruitment Retention amp Compliancebull Access to Certified Mobile Research Nursesbull US amp Global Services
For RFPs or to request a capabilities presentation please contact infopcmtrialscom or call
888-628-9707 | DIA booth 2733
Our Certified Mobile Research Nurses
Set Us Apart
PCM Trials DIA Ad Half Page2015_v3indd 1 31015 518 PM
of New Drugs CDER
In Room 146C 291 CDRH Town Hall continues the Annual Meeting tra-dition of providing you with a unique opportunity to hear directly from the Director of the Center for Devices and Radiological Health (CDRH) on the state of CDRH and its vision for the future Specific topics include FDA-SIA accomplishments and activities 2017 MDUFA Reauthorization and the impact of the House Energy and Com-merce 21st Century Cures initiatives
the regulatory framework for labora-tory developed tests expedited path-ways development the future of next gen sequencing and innovative ap-proaches for companion diagnostics and personalized medicine human factors studies combination products regulation of mobile and web software applications and the impact of other new technologies on patient care
Chair Janet Jenkins-Showalter Senior Regulatory Group Director Regulatory Policy amp Intelligence Genentech A Member of the Roche Group
Panelists Jeffrey Shuren JD MD Director CDRH FDA Alberto Gutier-rez PhD Director Office of In Vitro Diagnostics amp Radiological Health CDRH and Jonette R Foy PhD Deputy Director for Engineering amp Sci-ence Review ODE CDRH
InnovationsContinued from Page 3
28th Annual EuroMeeting 6-8 April 2016 Hamburg GermanyDIAGlobalorgEuroMeeting
Save the date
DIA Europe Middle East amp AfricaKuumlchengasse 164051 Basel Switzerland
Flanked by DIA Globlal Chief Executive Barbara Lopez Kunz and Dr Per Spindler (DIA President and Chair Board of Directors) DIA welcomes our 2015 DIA Fellows Minnie Baylor-Henry RPh JD (Incoming Chair) Jennifer L Riggins PharmD Kenneth A Getz MBA and Noriaki Murao MS 2015 DIA Fellow Gaby Danan MD PhD was unable to attend
ldquoMy commitment to you at this meeting is to provide the environment that will help you seize the opportuni-ties that present themselves both here in Washington as we meet and moving forward as you return to your places of workrdquo she concluded ldquoSo I invite you to seize the opportunity that we have this week to take advantage of this lsquoone shotrsquordquo
Annual Meeting Co-Chair Christo-pher P Austin MD (Director National Center for Advancing Translational Sci-ences US National Institutes of Health) followed Barbara to the podium ldquoOur focus at NCATS is not on spe-cific diseases but on what is common among all diseasesrdquo he explained ldquoOur chosen field is remarkably if not painfully empirical because we donrsquot understand the general principles and thatrsquos what NCATS is all aboutrdquo
ldquoWe are fond of saying that transla-tional science is a team sportrdquo he said to introduce one such ldquoteamrdquo project The Tissue Chip for Drug Screening program a collaboration between the FDA and the Defense Advanced Research Projects Agency (DARPA) that has developed organ and organ systems on microchips for drug toxic-ity testing that doesnrsquot require animals or humans In the future these chips could include hormones for example to identify the difference between male and female response to drugs ldquoI really thought this was just science fiction ndash and I was wrongrdquo he confessed
ldquoOne of my favorite proverbs
comes from Japanese literature lsquoNone of us is as smart as all of usrsquo Solving the systemic and highly complex problems of translation will require that adage as a guiding principle and the DIA meeting this year promises to provide the perfect setting to establish and strengthen the connections that will help us all collectively develop innovate and advance to new solutionsrdquo he con-cluded
ldquoLike many of you this organization and its expanding influence have been essential to my lifersquos work in the phar-maceutical and biotechnology arenardquo said Per Spindler DVM MBA MSc (DIA President and Chair Board of Directors Director Biopeople Univer-sity of Copenhagen Denmark ldquoI was born in 1963 in Copenhagen the year before DIA was foundedrdquo
ldquoIn 2003 I was invited to become a member of the DIA Advisory Council of Europe and I was elected to the Board of Directors in 2007 In the recent past as member of the Board I have been instrumental in establishing our journal within therapeutic innova-tion and regulatory science ndash pro-fessional fields where DIA takes the global leadership You might say DIA and I have grown up togetherrdquo Per continued
ldquoBy the time DIA celebrates its 100th Anniversary our world will be a very different place shaped in part by the innovations that we will ad-vance here in Washington Review the program for this 51st meeting of DIA with its rich and diverse offerings and you will have no doubt that a trans-formational agenda for our industry is evolving You will also be convinced that DIA will be at the forefront of that transformationrdquo
ldquoLike Per I have greatly benefited from my association with DIA and this organization has been essential to my career and to the proficiencies I have developed in the regulatory science arenardquo began President-Elect San-dra A Milligan JD MD (Senior Vice President Global Regulatory Affairs amp Clinical Safety Merck Research Laboratories) ldquoIn 2013 I chaired the Annual Meeting in Boston and now I find myself grateful to you the mem-bership to be the next president of DIA starting July 1strdquo
ldquoOur organization brings people to-gether creating a rich mix of ideas of service to our professions and service to our patients DIA as an organization truly proves that the whole is greater than the sum of its partsrdquo Sandra concluded
Co-Chair Michael Rosenblatt MD
(Executive Vice President amp Chief Medical Officer Merck amp Co Inc) concluded the welcoming remarks ldquoDIA is the only place i know of where professionals from every aspect of RampD ndash from the laboratory to the patient ndash gather to learn and to share best practicesrdquo he began ldquoI see great value in the lively and massive ex-change of information and ideas that takes place here It illustrates some-thing i deeply believe all of us ndash and the patients we serve ndash are interde-pendentrdquo
ldquoThe patient has always been ndash and should always be ndash at the core of what we dordquo he continued ldquoBut todayrsquos patients are different They are better informed more independent more ac-tive and more engaged than ever They are interested in taking charge of their own care Many have organized them-selves into learning communitiesrdquo
ldquoLike any big social trend this renewed emphasis on the patient has created a new mindset that in turn has helped spawn exciting innova-tionsrdquo he concluded ldquoWe need only look at this conference agenda to see evidence of new and previously unlikely collaborations ndash all with re-newed focus on in the patient These are partnerships between academia industry practitioners payers and regulators aimed at speeding the ar-rival of urgently needed vaccines and cures targeting the right therapies to the right people and improving patient accessrdquo
Daniel Burrus (President amp CEO Burrus Research Associates Inc) opened his Keynote Address by refer-ring to DIA Annual Meeting attendees as ldquothe great enablersrdquo His energetic remarks encompassed the themes of collaboration and innovation through real-world and theoretical examples ldquoWe live in a world of amazing inno-vation right nowrdquo he began ldquoIn fact wersquore standing at the base of a moun-tain of innovationrdquo
Daniel presented innovation as the ability to anticipate and solve a problem before you actually have it ldquoKeeping up is a foolrsquos gamerdquo he said ldquoWho wants to keep up I want to jump aheadrdquo
ldquoWe say wersquore collaborating but are werdquo he asked ldquoAre you using your 4G phone to advance innovation or to watch Netflix Yoursquove already got amazing tools Are you underutilizing them Hint Yesrdquo
ldquoThe world needs yourdquo he said to close the Opening Plenary ldquoYoursquore the enablers of innovationrdquo
Annual Meeting Co-Chairs Dr Michael Rosenblatt (left) and Dr Christopher Austin (right) welcome attendees to the Opening Plenary
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
Global DevelopmentGlobal Launch
We Know How
Global IMPACT
11ANNUAL MEETING DAILYJUNE 16 2015 WASHINGTON DC
PlenaryContinued from Page 1
Flanked by DIA Globlal Chief Executive Barbara Lopez Kunz and Dr Per Spindler (DIA President and Chair Board of Directors) DIA welcomes our 2015 DIA Fellows Minnie Baylor-Henry RPh JD (Incoming Chair) Jennifer L Riggins PharmD Kenneth A Getz MBA and Noriaki Murao MS 2015 DIA Fellow Gaby Danan MD PhD was unable to attend
ldquoMy commitment to you at this meeting is to provide the environment that will help you seize the opportuni-ties that present themselves both here in Washington as we meet and moving forward as you return to your places of workrdquo she concluded ldquoSo I invite you to seize the opportunity that we have this week to take advantage of this lsquoone shotrsquordquo
Annual Meeting Co-Chair Christo-pher P Austin MD (Director National Center for Advancing Translational Sci-ences US National Institutes of Health) followed Barbara to the podium ldquoOur focus at NCATS is not on spe-cific diseases but on what is common among all diseasesrdquo he explained ldquoOur chosen field is remarkably if not painfully empirical because we donrsquot understand the general principles and thatrsquos what NCATS is all aboutrdquo
ldquoWe are fond of saying that transla-tional science is a team sportrdquo he said to introduce one such ldquoteamrdquo project The Tissue Chip for Drug Screening program a collaboration between the FDA and the Defense Advanced Research Projects Agency (DARPA) that has developed organ and organ systems on microchips for drug toxic-ity testing that doesnrsquot require animals or humans In the future these chips could include hormones for example to identify the difference between male and female response to drugs ldquoI really thought this was just science fiction ndash and I was wrongrdquo he confessed
ldquoOne of my favorite proverbs
comes from Japanese literature lsquoNone of us is as smart as all of usrsquo Solving the systemic and highly complex problems of translation will require that adage as a guiding principle and the DIA meeting this year promises to provide the perfect setting to establish and strengthen the connections that will help us all collectively develop innovate and advance to new solutionsrdquo he con-cluded
ldquoLike many of you this organization and its expanding influence have been essential to my lifersquos work in the phar-maceutical and biotechnology arenardquo said Per Spindler DVM MBA MSc (DIA President and Chair Board of Directors Director Biopeople Univer-sity of Copenhagen Denmark ldquoI was born in 1963 in Copenhagen the year before DIA was foundedrdquo
ldquoIn 2003 I was invited to become a member of the DIA Advisory Council of Europe and I was elected to the Board of Directors in 2007 In the recent past as member of the Board I have been instrumental in establishing our journal within therapeutic innova-tion and regulatory science ndash pro-fessional fields where DIA takes the global leadership You might say DIA and I have grown up togetherrdquo Per continued
ldquoBy the time DIA celebrates its 100th Anniversary our world will be a very different place shaped in part by the innovations that we will ad-vance here in Washington Review the program for this 51st meeting of DIA with its rich and diverse offerings and you will have no doubt that a trans-formational agenda for our industry is evolving You will also be convinced that DIA will be at the forefront of that transformationrdquo
ldquoLike Per I have greatly benefited from my association with DIA and this organization has been essential to my career and to the proficiencies I have developed in the regulatory science arenardquo began President-Elect San-dra A Milligan JD MD (Senior Vice President Global Regulatory Affairs amp Clinical Safety Merck Research Laboratories) ldquoIn 2013 I chaired the Annual Meeting in Boston and now I find myself grateful to you the mem-bership to be the next president of DIA starting July 1strdquo
ldquoOur organization brings people to-gether creating a rich mix of ideas of service to our professions and service to our patients DIA as an organization truly proves that the whole is greater than the sum of its partsrdquo Sandra concluded
Co-Chair Michael Rosenblatt MD
(Executive Vice President amp Chief Medical Officer Merck amp Co Inc) concluded the welcoming remarks ldquoDIA is the only place i know of where professionals from every aspect of RampD ndash from the laboratory to the patient ndash gather to learn and to share best practicesrdquo he began ldquoI see great value in the lively and massive ex-change of information and ideas that takes place here It illustrates some-thing i deeply believe all of us ndash and the patients we serve ndash are interde-pendentrdquo
ldquoThe patient has always been ndash and should always be ndash at the core of what we dordquo he continued ldquoBut todayrsquos patients are different They are better informed more independent more ac-tive and more engaged than ever They are interested in taking charge of their own care Many have organized them-selves into learning communitiesrdquo
ldquoLike any big social trend this renewed emphasis on the patient has created a new mindset that in turn has helped spawn exciting innova-tionsrdquo he concluded ldquoWe need only look at this conference agenda to see evidence of new and previously unlikely collaborations ndash all with re-newed focus on in the patient These are partnerships between academia industry practitioners payers and regulators aimed at speeding the ar-rival of urgently needed vaccines and cures targeting the right therapies to the right people and improving patient accessrdquo
Daniel Burrus (President amp CEO Burrus Research Associates Inc) opened his Keynote Address by refer-ring to DIA Annual Meeting attendees as ldquothe great enablersrdquo His energetic remarks encompassed the themes of collaboration and innovation through real-world and theoretical examples ldquoWe live in a world of amazing inno-vation right nowrdquo he began ldquoIn fact wersquore standing at the base of a moun-tain of innovationrdquo
Daniel presented innovation as the ability to anticipate and solve a problem before you actually have it ldquoKeeping up is a foolrsquos gamerdquo he said ldquoWho wants to keep up I want to jump aheadrdquo
ldquoWe say wersquore collaborating but are werdquo he asked ldquoAre you using your 4G phone to advance innovation or to watch Netflix Yoursquove already got amazing tools Are you underutilizing them Hint Yesrdquo
ldquoThe world needs yourdquo he said to close the Opening Plenary ldquoYoursquore the enablers of innovationrdquo
Annual Meeting Co-Chairs Dr Michael Rosenblatt (left) and Dr Christopher Austin (right) welcome attendees to the Opening Plenary
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
Global DevelopmentGlobal Launch
We Know How
Global IMPACT
l i fesciencestransperfectcom
BOOTH 1025
bull eTMF and eClinical Technologiesbull Paper TMF Migrationbull Pharmacovigilance and Safety Solutions
bull Translation and Language Servicesbull Call Center Supportbull Global Product Launch
