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PROGRAM - WEDNESDAY, MAY 20, 2009 |
| 8:00AM-8:30AM |
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BREAKFAST, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION III |
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| 8:30AM-9:30AM |
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WORKSHOPS – SESSION III |
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Clinical Outcomes Research |
| 8:30AM-9:30AM |
W15: UPDATING SYSTEMATIC REVIEWS - THEIR IMPORTANCE AND TECHNIQUES FOR UPDATING
Discussion Leaders: Alexander Tsertsvadze MD, MSc, Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa, ON, Canada; Samuel Stoddart PhD, Systematic Review Technical Lead, Heron Evidence Development Ltd, Luton, UK; Melanie Plested BSc, Senior Health Outcomes Analyst, Heron Evidence Development Ltd, Luton, UK |
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ECONOMIC OUTCOMES RESEARCH |
| 8:30AM-9:30AM |
W16: EARLY PHASE MODELING TO SUPPORT GO/NO GO DECISIONS: INCORPORATING TARGET PRODUCT PROFILES, PRICING VARIABILITY AND DIAGNOSTICS TO FACILITATE INTERNAL DECISION MAKING
Discussion Leaders: Louis P. Garrison PhD, Professor, Pharmaceutical Outcomes Research & Policy Program Department of Pharmacy Health Sciences, University of Washington, Seattle, WA, USA; Jonathan D. Campbell PhD, Senior Fellow, University of Washington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA; Josh J. Carlson PhD, MPH, Senior Fellow, University of Washington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA; Tripthi Kamath PhD, Senior Health Economist, Genentech, Inc, South San Francisco, CA, USA |
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PATIENT-REPORTED OUTCOMES/PREFERENCE-BASED RESEARCH |
| 8:30AM-9:30AM |
W17: COPING WITH THE VALIDATION REQUIREMENTS OF THE FDA PRO GUIDANCE: THE INTERSECTION OF SCIENCE AND PRACTICE
Discussion Leaders: William Lenderking PhD, Senior Research Leader, United BioSource Corporation, Bethesda, MD, USA; Elizabeth Merikle PhD, Research Scientist, United BioSource Corporation, Montreal, QC, Canada; Michelle Stewart PhD, Director, Pfizer, Inc, New London, CT, USA |
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USE OF REAL WORLD DATA |
| 8:30AM-9:30AM |
W18: HOW TO IMPROVE THE QUALITY OF MEDICATION ADHERENCE ESTIMATES DERIVED FROM HEALTHCARE CLAIMS OR ELECTRONIC MEDICAL RECORDS DATABASES
Discussion Leaders: Peter Sun MD, PhD, Chief Health Economist, Kailo Research Group, Indianapolis, IN, USA; Yang Zhao PhD, Sr. Health Outcomes Scientist, Eli Lilly and Company, Indianapolis, IN, USA; Saurabh Ray PhD, Associate Director, Abbott Laboratories, Global Health Economics & Outcomes Research, Abbott Park, IL, USA |
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| 8:30AM-9:30AM |
W19: THE UTILIZATION OF OUTPATIENT ELECTRONIC HEALTH RECORD SYSTEMS DATA FOR OUTCOMES AND QUALITY RESEARCH: STRENGTHS, WEAKNESSES AND LESSONS LEARNED: A CASE STUDY USING THE GE CENTRICITY EHR
Discussion Leaders: Joseph Couto PharmD, MBA, Outcomes Research Fellow, Jefferson School of Population Health, Thomas Jefferson University, Philadelphia, PA, USA; Albert G. Crawford PhD, MBA, MSIS, Assistant Professor, Thomas Jefferson University, School of Population Health, Philadelphia, PA, USA; Candace Gunnarsson EdD, President CEO, S2 Statistical Solutions, Inc, Cincinnati, OH, USA; Somesh Nigam PhD, Vice President, Healthcare IT, Johnson & Johnson, Office of Evidence Based Medicine, Medical Device and Diagnostics, New Brunswick, NJ, USA |
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HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH |
| 8:30AM-9:30AM |
W20: UTILIZING RECEIVER OPERATOR CHARACTERISTIC CURVES TO ESTABLISH A MODEL FOR CLINICAL INTERVENTION: A CASE STUDY IN THE PREVENTION OF PROSTATE CANCER
Discussion Leaders: Michael Eaddy PharmD, PhD, Senior Director, Xcenda, Palm Harbor, FL, USA; Michael Goodman PhD, Assistant Professor, University of Utah, College of Pharmacy, Salt Lake City, UT, USA |
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| 8:30AM-9:30AM |
W21: CURE, CARE, PREVENT - HOW TO SUPPORT DECISIONS ON HEALTH-CARE BUDGETS?
Discussion Leaders: Maarten J. Postma PhD, Professor Pharmacoeconomics, University of Groningen, Department of Pharmacy, Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), Groningen, The Netherlands; Lieven Annemans PhD, MSc, Professor of Health Economics, University of Ghent, Brussels University, Ghent, Belgium; Keith H. Tolley MPhil, Director, Tolley Health Economics Limited, Buxton, Derbyshire, UK; Cornelis Boersma MSc, PhD Student, and Director, University of Groningen, Department of Pharmacy, Unit of PharmaEpidemiology & PharmacoEconomics (PE2)/HECTA B.V, Groningen, The Netherlands |
| 9:30AM-10:30AM |
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POSTER AUTHOR DISCUSSION HOUR – SESSION III |
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| 10:30AM-12:00PM |
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THIRD PLENARY SESSION |
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Building a Bridge Over Troubled QALYs: Developing Consensus
Thought leaders have been debating the QALY’s methodology, assumptions, and ultimate user value over the past several years. Stimulated by this debate, ISPOR convened an ISPOR invitational QALY Consensus Development Workshop, November 2007, funded by AHRQ, where participants debated alternative paradigms and measures, assumptions underlying the QALY, potential value of current systems, and decision-maker needs. A summary of the arguments presented and consensus statements and recommendation developed at the workshop will be presented.
For more information on this QALY invitational workshop,
see: http://www.ispor.org/meetings/Invitational/WorkshopPhila1107.asp
| 10:30 - 10:40AM |

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Moderator: Michael Drummond DPhil, Professor of Health Economics, Centre for Health Economics, University of York, York, UK |
| 10:40 - 10:50AM |
QALYs: The Basics |
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Speaker: Milton Weinstein PhD, Professor Health Policy and Management, Harvard School of Public Health, Boston, MA, USA |
10:50 - 11:00AM |
QALYs: Some Challenges |
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Speaker: Mark Scott Kamlet PhD, Provost and Senior Vice President Professor of Economics and Public Policy Carnegie Mellon University, Pittsburgh, PA, USA |
11:00 - 11:10AM |
Retaining & Enhancing the QALY
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Speaker: Joseph Lipscomb PhD, Professor of Public Health, Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, GA, USA |
11:10 - 11:20AM |
Use of QALYs in Decision-making |
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Speaker: Karl Matuszewski MS, PharmD, Vice President, Editor-in-Chief, Elsevier/Gold Standard, Tampa, FL, USA |
11:20 - 11:30AM |
Toward a Consensus on the QALY |
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Speaker: Marthe R. Gold MD, MPH, Logan Professor and Chair, Department of Community Health and Social Medicine, City University of New York Medical School, New York, NY, USA |
11:30 - 12:00PM |
Where Do We Go From Here? |
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Speaker: Michael Drummond DPhil, Professor of Health Economics, Centre for Health Economics, University of York, York, UK |
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| 12:00PM-12:15PM |
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ISPOR RESEARCH PRESENTATION AWARDS |
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| 12:15PM-12:45PM |
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LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION III |
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| 12:45PM-1:45PM |
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WORKSHOPS - SESSION IV |
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Clinical Outcomes Research |
| 12:45PM-1:45PM |
W22: VALUE MESSAGES: DEVELOPING, INCORPORATING, AND MAKING USE OF A CORE STRATEGIC TOOL
Discussion Leaders: Kati Copley-Merriman MBA, MS, Global Head, Regulatory and Health Outcomes Strategy, RTI Health Solutions, Ann Arbor, MI, USA; Amy Barrett MSPH, MA, Director, Regulatory and Health Outcomes Strategy, RTI Health Solutions, Research Triangle Park, NC, USA; Stephanie Barrows MA, MPH, Associate Director, Regulatory and Health Outcomes Strategy, RTI Health Solutions, Ann Arbor, MI, USA; Jennifer Whiteley EdD, MSc, MA, Associate Director, Global Health Outcomes and Strategic Pricing, Genzyme, Cambridge, MA, USA |
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ECONOMIC OUTCOMES RESEARCH |
| 12:45PM-1:45PM |
W23: UNCERTAINTY IN COST EFFECTIVENESS STUDIES: WHEN PICTURE IS WORTH A THOUSAND WORDS
Discussion Leaders: Katia Noyes PhD, MPH, Associate Professor, University of Rochester School of Medicine, Community and Preventive Medicine, Rochester, NY, USA; Elisabeth Fenwick PhD, Lecturer, University of Glasgow, Section of Public Health and Health Policy, Glasgow, UK |
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| 12:45PM-1:45PM |
W24: MODELING APPROACHES FOR ASSESSING THE VALUE OF VACCINATION AGAINST INFECTIOUS DISEASES: WHAT ARE THE NEEDS AND WHAT IS THE BEST ANSWER?
Discussion Leaders: Laurent Coudeville PhD, Health Economics Deputy Director, Sanofi Pasteur, Lyon, France; Pascal Crépey PhD, Health Economics Manager, Sanofi Pasteur, Lyon, France; Andrew J. Dunning PhD, Biostatistics Manager, Sanofi Pasteur, Swiftwater, PA, USA; Vicky Ng BSc(Hon), PhD Candidate, The Hospital for Sick Children, Toronto, ON, Canada |
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PATIENT-REPORTED OUTCOMES/PREFERENCE-BASED RESEARCH |
| 12:45PM-1:45PM |
W25: CONDUCTING QUALITATIVE RESEARCH TO ASSESS CONTENT VALIDITY: SHARING BEST PRACTICES
Discussion Leaders: Meryl Brod PhD, President, The BROD GROUP, Mill Valley, CA, USA; Torsten Christensen MSc, Senior Health Economist, Novo Nordisk A/S, Bagsværd, Denmark |
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| 12:45PM-1:45PM |
W26: HEALTHY YEARS EQUIVALENTS: A PRACTICAL ALTERNATIVE TO QALYS?
Discussion Leaders*: A. Brett Hauber PhD, Senior Economist and Head, RTI Health Solutions, Health Preference Assessment, Research Triangle Park, NC, USA; F. Reed Johnson PhD, Principal Economist, RTI International, Research Triangle Park, NC, USA; John FP Bridges PhD, Assistant Professor, Johns Hopkins University, Bloomberg School of Public Health, Health Policy and Management,
Baltimore, MD, USA |
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USE OF REAL WORLD DATA |
| 12:45PM-1:45PM |
W27: CONSIDERATIONS IN THE USE OF SECONDARY DATA SOURCES FOR ONCOLOGY RESEARCH
Discussion Leaders: Kathy L. Schulman MA, Lead Researcher, Thomson Reuters, Healthcare, Cambridge, MA, USA; Kathleen A. Foley PhD, Project Director, Thomas Jefferson University, School of Population Health, Philadelphia, PA, USA; Mark S. Walker PhD, Director of Scientific Management, Accelerated Community Oncology Research Network, Inc, Memphis, TN, USA |
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HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH |
| 12:45PM-1:45PM |
W28: DECISION-MAKING PROCESS BY PAYERS IN EUROPE: A MULTIPLE CRITERIA PROCESS
Discussion Leaders: Eline Kogels MSc, Consultant, Danone Medical Nutrition, Health Economic & Market Access Manager, Amsterdam, The Netherlands; Mark JC Nuijten MD, PhD, MBA, Consultant, Ars Accessus Medica/Erasmus University Rotterdam, Amsterdam, The Netherlands |
| 1:45PM-2:00PM |
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BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION III |
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| 2:00PM-3:00PM |
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WORKSHOPS - SESSION V |
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Clinical Outcomes Research |
| 2:00PM-3:00PM |
W29: A REVIEW OF CURRENT RISK-BENEFIT ASSESSMENTS FOR DRUG SAFETY
Discussion Leaders: Jeff Jianfei Guo PhD, Associate Professor, University of Cincinnati, College of Pharmacy, Cincinnati, OH, USA; Swapnil Pandey MS, Project Lead of Risk Management, Kendle International, Cincinnati, OH, USA; John J. Doyle DrPH, MPH, Managing Director & Practice Leader, Quintiles Global Consulting, Global Market Access, Hawthorne, NY, USA; Dennis W. Raisch PhD, Professor, College of Pharmacy, University of New Mexico and Associate Center Director, Scientific Affairs, VA Cooperative Studies Program Clinical Research Pharmacy, Albuquerque, NM, USA |
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ECONOMIC OUTCOMES RESEARCH |
| 2:00PM-3:00PM |
W30: THE WILLINGNESS TO PAY FOR THE WELLBEING OF PETS – OR HOW TO APPLY COST-EFFECTIVENESS CRITERIA FOR PHARMACEUTICALS FOR COMPANION ANIMALS
Discussion Leaders: Mark JC Nuijten MD, PhD, MBA, Consultant, Ars Accessus Medica/Erasmus University Rotterdam, Amsterdam, The Netherlands; Ilse Van Vlaenderen DVM, MSc, Consultant, Deloitte, Diegem, Belgium; Barbara Poulsen Nautrup DVM, PhD, Consultant, EAH Consulting, Juelich, Northrhine Westf, Germany |
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| 2:00PM-3:00PM |
W31: ESTABLISHING THE CONTENT VALIDITY OF PRO INSTRUMENTS
Discussion Leaders: Chad Gwaltney PhD, Scientific Consultant, PRO Consulting, Westerly, RI, USA; Mona Martin MPA, Director, Health Research Associates, Seattle, WA, USA |
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PATIENT-REPORTED OUTCOMES/PREFERENCE-BASED RESEARCH |
| 2:00PM-3:00PM |
W32: IMPLEMENTING E-PRO MEASURES IN CLINICAL TRIALS: WHAT SPONSORS NEED TO KNOW
Discussion Leaders: Sonya Eremenco MA, ePRO Manager, United BioSource Corporation, Health Care Analytics, Bethesda, MD, USA; Stephen Joel Coons PhD, Professor, University of Arizona, Pharmaceutical Sciences, Tucson, AZ, USA; Ari Gnanasakthy MSc, Director, Novartis Pharmaceuticals, Health Economics and Outcomes Research, East Hanover, NJ, USA |
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USE OF REAL WORLD DATA |
| 2:00PM-3:00PM |
W33: REAL WORLD DATA BEFORE MARKET ACCESS
Discussion Leaders: Martin Nottmeier MSc, Pharm, International Pricing & Market Access Manager, Nycomed, International Pricing & Market Access, Taastrup, Denmark; David Becedas MSc, Pharm, Team Leader Observational Research, Scandinavian Outcomes, Observational Research, Solna, Sweden |
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| 2:00PM-3:00PM |
W34: EVALUATION OF CONTINUITY OF CARE BETWEEN INPATIENT AND OUTPATIENT SETTINGS VIA ADMINISTRATIVE CLAIMS DATABASES USING THE EXAMPLE OF VTE PROPHYLAXIS IN TOTAL HIP AND TOTAL KNEE REPLACEMENT
Discussion Leaders: Henry Joe Henk PhD, Director, i3 Innovus, Health Economics & Outcomes, Eden Prairie, MN, USA; Heather P. McDonald MSc, Senior Manager, Health Economics and Outcomes Research, Bayer Inc, Toronto, ON, Canada; Bijan Borah PhD, Senior Researcher, i3 Innovus, Eden Prairie, MN, USA; Michael Nelson, Vice President, Health Economics and Outcomes, i3 Innovus, Eden Prairie, MN, USA |
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HEALTH CARE POLICY DEVELOPMENT USING OUTCOMES RESEARCH |
| 2:00PM-3:00PM |
W35: A REVISED FRAMEWORK FOR APPRAISING NOVEL MOLECULAR CLASSIFIERS
Discussion Leaders: John Hornberger MD, MS, Principal, CEDAR Associates LLC and Adjunct Clinical Professor of Medicine, Stanford University School of Medicine, Menlo Park, CA, USA; Gary Lyman MD, MPH, Professor of Medicine, Duke University and the Duke Comprehensive Cancer Center, Oncology, Durham, NC, USA |
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