EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION I
8:30AM - 10:30AM
WELCOME & FIRST PLENARY SESSION
MEETING PROGRAM OVERVIEW Daniel C. Malone RPh, PhD Professor, College of Pharmacy, University of Arizona, Tucson, AZ, USA
PRESIDENTIAL ADDRESS Michael Barry PhD 2009-2010 ISPOR President & Clinical Director, National Centre for Pharmacoeconomics, St. James’s Hospital and Senior Lecturer in Clinical Pharmacology, Trinity College Dublin, Dublin, Ireland
Personalized Medicine: The Value of Targeted Therapy
The mapping of the human genome has opened the gate for developing therapies that benefit select subsets of the population. This plenary session will provide an introduction to pharmacogenomics and pharmacogenetics, debate the role of genotyping, present case studies where therapies are being tailored to specific genetic disposition, and discuss the role of pharmacoeconomics and outcomes research in defining the value of personalized medicine.
9:00 – 9:20 AM
Moderator/Speaker: Scott D. Ramsey MD, PhD, Full Member and Professor, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, USA
9:20 – 9:40 AM
Speaker: Lawrence J. Lesko PhD, FCP, Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
9:40 – 10:00 AM
Speaker:Ralph J. Coates PhD, Associate Director for Science, Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, GA, USA
10:00 – 10:20 AM
Speaker: Robert S. Epstein MD, MS, Chief Medical Officer and President, Medco Research Institute, Medco Health Solutions Inc., Franklin Lakes, NJ, USA
10:20 – 10:30 AM
DISCUSSION
10:30AM-11:00AM
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION I
11:00AM-12:00PM
ISSUE PANELS – SESSION I
Clinical Outcomes Research Issues
11:00AM-12:00PM
IP1: HETEROGENEITY OF TREATMENT EFFECTS: A REASSESSMENT IN THE ERA OF COMPARATIVE EFFECTIVENESS RESEARCH Moderator: David Thompson PhD, Vice President, Global Health Economics, i3 Innovus, Medford, MA, USA Panelists: John Cook PhD, Senior Director, Scientific Staff, Health Economics Statistics, Merck & Co., Inc., North Wales, PA, USA; Sheldon Greenfield MD, Professor of Medicine and Executive Director, Center for Health Policy Research, School of Medicine, University of California, Irvine, Irvine, CA, USA
Health Policy Development Using Outcomes Research Issues
11:00AM-12:00PM
IP2: MEDICARE, HEALTH REFORM AND THE FUTURE OF EVIDENCE REQUIREMENTS Moderator: Peter J. Neumann ScD, Professor, Tufts University School of Medicine and Director, The Center for the Evaluation of Value and Risk in Health, The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA Panelists: Steve E. Phurrough MD, MPA, (Formerly at CMS), Chief Operating Officer and Senior Clinical Director, Center for Medical Technology Policy, Baltimore, MD, USA; Penny Mohr MA, (Formerly at CMS), Vice President, Programs, Center for Medical Technology Policy, Baltimore, MD, USA; James Chambers MPharm, MSc, Project Director, The Center for the Evaluation of Value and Risk in Health, The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA
11:00AM-12:00PM
IP3: PERSPECTIVES ON COMPARATIVE EFFECTIVENESS RESEARCH (CER): VIEWS FROM DIVERSE CONSTITUENCIES Moderator: Howard Birnbaum PhD, Principal, Analysis Group, Inc., Boston, MA, USA Panelists: Marc L. Berger MD, Vice President, Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; Jean Slutsky PA, MSPH, Director, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality, Rockville, MD, USA; Robert S. Epstein MD, MS, Chief Medical Officer and President, Medco Research Institute, Medco Health Solutions Inc., Franklin Lakes, NJ, USA
Patient-Reported Outcomes Research Issues
11:00AM-12:00PM
IP4: PATIENT-REPORTED OUTCOMES FOR ADVERSE EVENT MONITORING Moderator: Ethan Basch MD, MSc, Principal Investigator, Health Outcomes Group, Memorial Sloan-Kettering Cancer Center, New York, NY, USA Panelists: Laurie B. Burke RPh, MPH, Director, Study Endpoint and Label Development, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA; Bryce Reeve PhD, Program Director, National Cancer Institute, Bethesda, MD, USA; Stephen Joel Coons PhD, Director, Patient-Reported Outcomes (PRO) Consortium, Critical Path Institute, Tucson, AZ, USA
12:00PM-1:45PM
LUNCH, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION I
Juday T1, Jing Y1, Chang E2, Broder M2 1Bristol-Myers Squibb, Plainsboro, NJ, USA, 2Partnership for Health Analytic Research, LLC, Beverly Hills, CA, USA
Hoverman JR1, Pohl G2, Gruschkus SK3, Marciniak M2, Forsyth M3, Peltz G2 1Texas Oncology, Dallas, TX, USA, 2Eli Lilly and Company, Indianapolis, IN, USA, 3Healthcare Informatics, The Woodlands, TX, USA
Parthan A1, Kulakodlu M2, Deflin M1, Taylor D3, Barber B4, Zhao Z4 1i3 Innovus, San Francisco, CA, USA, 2i3 Innovus, Eden Prairie, MN, USA, 3i3 Innovus, Medford, MA, USA, 4Amgen Inc., Thousand Oaks, CA, USA
Toumi M1, Misset JL2, Cristeau O1, Krukowski L3, Aballea S4, Lamure M5 1University Claude Bernard Lyon 1, Lyon, France, 2Hopital Saint Louis, Paris, France, 3Synovate, London, UK, 4CREATIV-CEUTICAL, Paris, France, 5University Claude Bernard Lyon 1, Paris, France
Mohr P1, Sonnad S2, Mullins CD3, Whicher D1, Goldsack J2, Tunis SR1 1Center for Medical Technology Policy, Baltimore, MD, USA, 2University of Pennsylvania, Philadelphia, PA, USA, 3University of Maryland School of Pharmacy, Baltimore, MD, USA
Gu NY1, Bond TG2, Craig BM3 1Pharmerit North America, LLC, Bethesda, MD, USA, 2James Cook University, Townsville, QLD, Australia, 3Moffitt Cancer Center, Tampa, FL, USA
Yu S1, Shaw JW1, Crawford SY1, Groo V2 1University of Illinois at Chicago, Chicago, IL, USA, 2University of Illinois at Chicago, Chicago , IL, USA
3:00PM-4:00PM
WORKSHOPS – SESSION I
Clinical Outcomes Research Issues
3:00PM-4:00PM
W1: COMPARATIVE EFFECTIVENESS RESEARCH FOR PERSONALIZED MEDICINE Discussion Leaders: James Signorovitch PhD, Manager, Analysis Group, Inc., Boston, MA, USA; Eric Q. Wu PhD, Vice President, Analysis Group, Inc., Boston, MA, USA; Lee-Jen Wei PhD, Professor, Biostatistics, Harvard University, Boston, MA, USA
Economic Outcomes Research
3:00PM-4:00PM
W2: CHALLENGES IN DESIGNING, CONDUCTING AND ANALYSING MULTINATIONAL ECONOMIC CLINICAL TRIALS Discussion Leaders: Michael Drummond PhD, Professor of Health Economics, Centre for Health Economics, University of York, York, UK; Andrea Manca PhD, MSc, Senior Research Fellow, Centre for Health Economics, University of York, York, UK; Arie Barlev PhD, Senior Manager, Global Health Economics, Amgen, Thousand Oaks, CA, USA
Health Care Policy Development Using Outcomes Research
3:00PM-4:00PM
W4: THE 2009 UPDATE OF THE AMCP FORMAT FOR FORMULARY COVERAGE AND REIMBURSEMENT DECISIONS IN THE US Discussion Leaders: Richard Fry RPh, Director of Programs, Foundation for Managed Care Pharmacy, Alexandria, VA, USA; Sean Sullivan PhD, RPh, MS, Professor and Director, Pharmaceutical Outcomes Research & Policy Program, Department of Pharmacy, University of Washington, Seattle, WA, USA; Pete Penna PharmD, President, Formulary Resources, LLC, Mercer Island, WA, USA; Iris Tam PharmD, Director, Institutional Medical Communications, Genentech, South San Francisco, CA, USA
Patient-Reported Outcomes/PREFERENCE-BASED Research
3:00PM-4:00PM
W5: REGULATORY EVALUATION OF PATIENT-REPORTED OUTCOME MEASURES (PROS) USED IN CLINICAL TRIALS Discussion Leaders: Laurie B. Burke RPh, MPH, Director, Study Endpoints and Label Development, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA; June Cai MD, Endpoints Reviewer, Study Endpoints and Label Development, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA; Ann Marie Trentacosti MD, Endpoints Reviewer, Study Endpoints and Label Development, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA; Donald Patrick PhD, Professor, Seattle Quality of Life Group, University of Washington, Seattle, WA, USA
3:00PM-4:00PM
W6: DEFINING A RESPONDER: IMPLEMENTING THE PATIENT-REPORTED OUTCOME (PRO) GUIDANCE RECOMMENDATIONS Discussion Leaders: Lori McLeod PhD, Head, Psychometrics, Patient-Reported Outcomes, RTI Health Solutions, Research Triangle Park, NC, USA; Ron D. Hays PhD, Professor of Medicine, Division of General Internal Medicine and Health Services Research, University of California at Los Angeles, Los Angeles, CA, USA; Susan Martin MSPH, Senior Director, Patient-Reported Outcomes, RTI Health Solutions, Ann Arbor, MI, USA; Sheri Fehnel PhD, Vice President, Patient-Reported Outcomes, RTI Health Solutions, Research Triangle Park, NC, USA
BREAK, EXHIBITS & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION I
4:15PM-5:15PM
WORKSHOPS – SESSION II
Clinical Outcomes Research Issues
4:15PM-5:15PM
W8: MODEL ASSUMPTIONS IN MIXED TREATMENT COMPARISONS (MTCS): WHY THEY MATTER AND WHY YOU SHOULD CARE Discussion Leaders: Rachael Fleurence PhD, Senior Research Scientist, Center for Health Economics and Science Policy, United BioSource Corporation, Bethesda, MD, USA; Kyle Fahrbach PhD, Senior Biostatistician, United BioSource Corporation, Lexington, MA, USA; David Vanness PhD, Assistant Professor, Population Health Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
W10: WHAT CAN RESOURCE ALLOCATION IN SITUATIONS OF EXTREME SCARCITY TELL US ABOUT THE ROLE OF THE QALY IN PRIORITY SETTING? Discussion Leaders: Peter Kolominsky-Rabas PhD, MBA, Scientific Director, Interdisziplinäres Zentrum für Public Health (IZPH) der Universität Erlangen-Nürnberg, Erlangen, Germany; Georgia Mitsi PhD, MBA, MSc, Manager, United BioSource Corporation, Lexington, MA, USA; J. Jaime Caro MD, Senior Vice President of Health Economics, United BioSource Corporation, Lexington, MA, USA
Health Care Policy Development Using Outcomes Research
4:15PM-5:15PM
W11: YOUR ROLE IN INTERPRETING AND APPROPRIATELY COMMUNICATING CER RESULTS IN A HIGHLY CHARGED ENVIRONMENT Discussion Leaders: Robert Dubois PhD, MD, Chief Medical Officer, Cerner LifeSciences, Beverly Hills, CA, USA; Jean Slutsky PA, MSPH, Director, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality, Rockville, MD, USA; Lester Paul MD, MS, Vice President, Clinical & Scientific Affairs, National Pharmaceutical Council, Reston, VA, USA; Brian Sweet RPh, MBA, Chief Pharmacy Officer, WellPoint, Grand Island, NY, USA
Patient-Reported Outcomes/PREFERENCE-BASED Research
4:15PM-5:15PM
W12: INTERPRETATION OF PRO TRIAL RESULTS TO SUPPORT FDA LABELING CLAIMS Discussion Leaders: Kathleen W. Wyrwich PhD, Senior Research Leader, Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD, USA; Laurie B. Burke RPh, MPH, Director, Study Endpoints and Label Development, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA; Ann Marie Trentacosti MD, Endpoints Reviewer, Study Endpoints and Label Development, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
USE OF REAL WORLD DATA
4:15PM-5:15PM
W13: PROJECTING DISEASE PREVALENCE: THE IMPACT OF METHODOLOGY– EXAMPLES IN ATRIAL FIBRILLATION Discussion Leaders: Kathy L. Schulman MA, Principal, Outcomes Research Solutions, Inc., Bolton, MA, USA; Stephen S. Johnston MA, Research Leader, Outcomes Research, Thomson Reuters, Washington, DC, USA; Jay Lin PhD, MBA, Director, Evidence Based Medicine, sanofi-aventis U.S., Bridgewater, NJ, USA; Dan Huse MA, Vice President, Outcomes Research, Thomson Reuters, Cambridge, MA, USA
4:15PM-5:15PM
W14: POST-APPROVAL RESEARCH: ALTERNATIVE STUDY DESIGNS AND OPERATIONAL CONSIDERATIONS Discussion Leaders: Cynthia Verst PharmD, MS, Senior Vice President, Late Phase Research, i3 Innovus, Cold Spring, KY, USA; Michael Drummond PhD, Professor of Health Economics, Centre for Health Economics, University of York, York, UK; Myoung Kim PhD, MA, MBA, Director, Health Economics & Outcomes Research, Ortho-McNeil Janssen Scientific Affairs, Raritan, NJ, USA; Frank Lobeck PharmD, Vice President, Americas, Late Phase Research, i3 Innovus, Dexter, MI, USA
5:30PM-6:30PM
ISPOR FORUMS
5:30PM-6:30PM
ISPOR RECOMMENDATIONS ON THE FDA’S GUIDANCE FOR INDUSTRY PATIENT REPORTED OUTCOME MEASURES: USE IN MEDICAL PRODUCT DEVELOPMENT TO SUPPORT LABELING CLAIMS
The ISPORGood Research Practices for the Assessment of Patient-Reported Outcomes in Children and Adolescents Task Force will present their findings. The Good Research Practices for Establishing and Reporting Evidence of the Content Validity is presenting their manuscript on addressing content validity for newly developed PROs. Presented by the ISPOR Patient Reported Outcomes Good Research Practices Task Forces.
5:30PM-6:30PM
ISSUES AND CHALLENGES IN THE DEVELOPMENT AND REIMBURSEMENT OF PERSONALIZED MEDICINE
The applications of health outcomes and economic research for addressing issues and challenges in the development and reimbursement of Personalized Medicine will be discussed. Presented by the ISPOR Personalized Medicine Special Interest Group
5:30PM-6:30PM
THE ISPOR GLOBAL HEALTH CARE SYSTEMS ROAD MAP – MOVING FORWARD WITH HTA FOR MEDICAL DEVICES & DIAGNOSTIC PRODUCTS!
ISPOR Global Health Care Systems Road Map will be used as a tool to discuss and compare the similarities and differences between the decision-making bodies and reimbursement and pricing approval process for products being assessed – pharmaceuticals, medical devices or diagnostics. Road maps for medical devices & diagnostics will be discussed together with some pragmatic solutions to the current issues associated with assessing their value.Presented by the ISPOR HTA Special Interest Group
5:30PM-6:30PM
INDIRECT TREATMENT COMPARISONS GOOD RESEARCH PRACTICES
The mission of this ISPOR Task Force is to develop and present a good research practice on indirect treatment comparisons that addresses key issues from the outcomes researcher’s perspective as well as key issues from the health care decision-maker’s perspective, the Task Force draft report will be discussed. Presented by the ISPOR Indirect Treatment Comparison Task Force
5:30PM-6:30PM
COMPLIANCE ISSUES AND WHY MEASUREMENT AND ANALYSIS ARE IMPORTANT
Compliance research requires an understanding about the best methodology to conduct studies including: randomized controlled clinical trials, observational, and quasi- experimental studies. Key considerations for researchers regarding the design, analysis and reporting of results of such studies will be reviewed. Presented by the ISPOR Medication Compliance & Persistence Special Interest Group
5:30PM-6:30PM
ISPOR STUDENT FORUM: DEFINING YOUR CAREER PATH - FROM STRATEGIC JOB SEARCH SKILLS TO DECISION MAKING
A panel of experts will address how students should strategize a job search. What are the important points a student should consider during a job search? How should a CurriculumVitae be modified to appeal to employers in various sectors? What are the pros and cons of jobs in industry versus academia and what might help a graduate decide to take one position over another? Organized by the ISPOR Student Council
6:30PM-7:30PM
ISPOR FORUMS
6:30PM-7:30PM
HEALTH CARE IN RUSSIA: ISSUES, CHALLENGES, SOLUTIONS
The forum will focus on a discussion of the most current health care issues in Russia. Presented by the ISPOR Russia Chapter
6:30PM-7:00PM
ISPOR ANNUAL BUSINESS MEETING
6:30PM-7:30PM
POSTER AUTHOR DISCUSSION HOUR – SESSION I
6:30PM-8:30PM
EXHIBITORS’ OPEN HOUSE RECEPTION & RESEARCH POSTER PRESENTATIONS VIEWING – SESSION I