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41197 7/25/07 1:11 AM Page 8 • • • • ICPE Exhibitors and Sponsors • • • • ANNUAL MEETING SPONSORS (as of July 23, 2007) Platinum: 23rd International Conference on $12,000 LJohn Wiley & Sons Pharmacoepidemiology & Therapeutic LPfizer Risk Management Gold: $6,000 Silver: $3,000 LAmgen LAstra Zeneca Canada Sponsors LEli Lilly and Company LGenzyme LGenentech, Inc. LHealthCore LGlaxoSmithKline LPharmaNet & Li3 Drug Safety LSanofi Pasteur LKendle LMerck Research Bronze: $1,500 The International Society for Pharmacoepidemiology Laboratories LAllergan (ISPE) gratefully acknowledges the generous sup- LPharmaceutical LCephalon port of the following organizations and institutions. Research Associates LDrugLogic, Inc. Their contributions helped to enhance the scientific LProctor & Gamble LGPRD program content and increase attendance at the Pharmaceuticals LOutcome ICPE 2007. Thank you. LRoche LRisk Management LRTI Health Solutions Resources Academic Showcase/ LUnited Biosource Exhibitors Welcome Reception Sponsors Corporation LWyeth LCenter for Clinical Epidemiology & Biostatistics, University of Pennsylvania School of Medicine LCollege of Pharmacy, University of Texas LDrug Safety Research Unit, University of Portsmouth LPharmaceutical Health Services Research, University of Maryland, Baltimore LSlone Epidemiology Center, Boston University IN THIS PROGRAM LUniversity of North Carolina at Chapel Hill LDivision of Pharmacoepidemiology & Pharmacotherapy, 23rd ICPE Agenda L Utrecht Institute for Pharmaceutical Sciences Saturday.............................................................7 L Sunday ...............................................................8 L Monday ..............................................................9 (as of July 23, 2007) Exhibitors L Tuesday ............................................................17 LCerner LPharmIdeas Research L Wednesday.......................................................26 Corporation LRTI Health Solutions LDrugLogic, Inc. LThe Uppsala 23rd ICPE Posters L Poster Presentation Guidelines .......................30 LGPRD Monitoring Centre L Poster Session A ..............................................32 Li3 Drug Safety LThomson Healthcare L Poster Session B...............................................40 L LTrialStat Corporation IMS Health L Poster Session C...............................................49 LJohn Wiley & Sons LUnited BioSource LKendle Corporation 23rd Abstract Index LOutcome LUniform Data System L Abstract Index..................................................57 LPHARMO Institute LWolters Kluwer LPhase Forward Health 6 23rd ICPE August 19-22, 2007 Québec City Convention Centre 41197 7/25/07 1:11 AM Page 9 • • AGENDA Saturday, August 18 • • • • • 8:30am - 5:30pm / Hilton Courville/Montmorency / 2007 ISPE Board of Directors Meeting • ISPE’s Second Asian Meeting Noon - 5:00pm / Centre Foyer 4 / Convened in conjunction with the Japanese Society for Registration Pharmacoepidemiology October 26-27, 2007 PRE-CONFERENCE EDUCATIONAL SESSION Tokyo, Japan 1:00 - 5:00pm / Centre Room 205AB / 2008 Introduction to Pharmacoepidemiology ISPE Mid-Year Meeting [*Registration required; included as part of the full meeting registration] April 26-29, 2008 Chair: Andrew McAfee Radisson Hotel Boston • James Lewis, Case-Control Studies Boston, Massachusetts, USA • Andrew McAfee, Cohort Studies • Syed Rizwanuddin Ahmad, FISPE, Spontaneous Reporting 24th ICPE • Eileen Ming, Confounding by Indication August 17-20, 2008 Bella Centre 5:00 - 7:00pm / Centre Foyer 2 / Copenhagen, Denmark Student Meet and Greet 2009 (Meet at ISPE Registration Desk at 5:00 pm, then to Old Montreal Bar) • Open to all students. ISPE Mid-Year Meeting • Organized by the ISPE Student Council. April, TBD Stockholm, Sweden 7:00 - 10:00pm ISPE Board of Directors Dinner (By Invitation) 25th ICPE August 16-19, 2009 Rhode Island Convention Center Providence, Rhode Island, USA Visit the ISPE website, www.pharmacoepi.org, for meeting updates and information. • Future Meetings • • • BADGES • All attendees at ICPE 2007 must wear their name badges to ALL events. A badge will be needed for admission to meeting related functions such as the scien- tific sessions, the exhibit/poster hall, and social events. Badges will be included in the registration packet material. In some cases, tickets will be required. Badge Legend Student = Yellow New Member = Blue Québec City, One Day Attendee = Red Canada Room Legend Centre = Quebec City Convention Centre Québec,Québec, Canada Hilton = Quebec Hilton Hotel 23rd ICPE August 19-22, 2007 Québec City Convention Centre 7 41197 7/27/07 12:38 PM Page 10 • • • • AGENDA Sunday, August 19 • • • • 8:00am - 6:00pm / Centre Foyer 4 / Noon - 5:00pm / Centre 400A / Registration Exhibitor Move-In 8:00am - 5:00pm / Centre 201C / PRE-CONFERENCE Speakers’ Ready Room EDUCATIONAL SESSION PRE-CONFERENCE EDUCATIONAL SESSIONS 1:30 - 6:00pm / Centre 205AB / Sunday 8:30am - 12:00pm / Centre 205AB / Advanced Topics in Pharmacoepidemiology - Introduction to Therapeutic Risk Management [*Admission by ticket only. Tickets will be included in registration materials for those who registered for [*Admission by ticket only. Tickets will be included in registration materials for this session.] those who registered for this session.] Chair: Sebastian Schneeweiss, FISPE Co-Chairs: Elizabeth Andrews, FISPE & Carla van Bennekom • Alan Brookhart, Instrumental Variable • Elizabeth Andrews, FISPE, Introduction to Therapeutic Risk Methods in Pharmacoepidemiology Management • Tim Lash, Probabilistic Sensitivity • Carla van Bennekom, Examples of Risk Management Programs Analysis in Pharmacoepidemiology and Evaluations • Jean-François Boivin, Measuring Agenda • Judith Jones, FISPE, Developing Risk Minimization Action Plans Covariate Data in Subsets of Study Populations: A Review of Design and 8:30am - 12:00pm / Centre 302AB / Sampling Options Introduction to Drug Utilization/Health Services Research • Mary Sammel, Multi-level Modeling for [*Admission by ticket only. Tickets will be included in registration materials for Pharmacoepidemiology those who registered for this session.] 5:00 - 6:00pm / Centre Foyer 4 / Chair: Robert Vander Stichele Academic Showcase/Welcome Reception • Robert Vander Stichele, Methodological Framework and Tools for Cross-National Comparisons of Drug Utilization Data Set-up • Morten Anderson, Assessing Validity of Prescribing Quality Indicators 6:15 - 8pm / Centre Foyer 4 / Monique Elseviers, DUR and Pharmacoepidemiology: Academic Showcase/Welcome Reception Case Study —Analgesic Nephropathy Admission by badge or ticket. Cash Bar • Sebastian Schneeweiss, FISPE, Time Trend Analysis for Program Evaluation Welcome • Jean-Pierre Grégoire, Chair, 2007 8:30am - 12:00pm / Hilton Beaumont/Beauport/Belair / Scientific Program Committee • Allen A. Mitchell, FISPE, ISPE President Skills Workshop – Students Only* [*Registration required; included as part of full meeting registration.] Chair: Chris Delaney, Chair, Student Council • Toine Egberts, FISPE, Outcome Assessment: Databases vs.Clinical Data • Lucie Blais, Channeling and Confounding by Indication • Linda Levesque, Reverse Protapathic Bias • Tjeerd van Staa, Two Answers from the Same Data Source Noon - 1:30pm Lunch – on your own Noon - 1:30pm / Hilton Plaines/Citadelle / Luncheon for New Members/Student Prize Winners/ Scholarship Recipients (By Invitation) 8 23rd ICPE August 19-22, 2007 Québec City Convention Centre 41197 7/25/07 1:11 AM Page 11 • • AGENDA Monday, August 20 • • • • • 7:00 - 8:00am / Centre 400A / OPENING SESSION • Poster Session A Set-up 8:30 - 10:00am / Centre 200AB / 7:00 - 8:00am Welcome ISPE Committee Meetings • Jean-Pierre Grégoire, Chair, Scientific Open to all interested participants. Program Committee • Jocelyne Moisan, Chair, Local Host • Education / Hilton Montmorency / Committee • Finance / Hilton Courville / Presidential Address 7:30am - 6:00pm / Centre Foyer 4 / • Allen A. Mitchell, FISPE, ISPE President Registration Keynote Address 8:00am - 5:00pm / Centre 201C / • Norman Fost, Speakers’ Ready Room The Dysregulation of Research 10:00 - 10:30am / Centre 400A / 8:00am - 5:00pm / Centre 400A / Break/Posters/Exhibits Exhibits/Posters • • 23rd ICPE August 19-22, 2007 Québec City Convention Centre 9 41197 7/25/07 1:11 AM Page 12 • • • • AGENDA Monday, August 20 • • • 10:30am - Noon • CONCURRENT SESSIONS: CONTRIBUTED PAPERS Methods I / Centre 200AB / Risk Assessment in Commonly Used Drugs Moderators: Miriam Sturkenboom & Annie Hutchinsom / Centre 205AB / 10:30am Moderators: Joanna Haas & Maureen Cronin • The Use of the Overlapping Coefficient in Propensity Score 10:30am Monday Analysis [1] • Traffic Accident Risks Associated with Edwin P Martens, Wiebe R Pestman, Anthonius de Boer, Svetlana the Prescription of Medicinal Drugs: A - V Belitser, Olaf H Klungel. (Netherlands) Registry-Based Cohort Study [25] 10:45am Svetlana Skurtveit, Jorg Morland, Jorgen • Multilevel Confounding in Pharmacoepidemiologic Research: Bramness, Ineke Neutel, Ingebjorg An Application of Propensity Score Methods [2] Gustavsen, Liliana Bachs, Anders Andrea Gruneir, Kate L Lapane, Susan C Miller, Vincent Mor. Engeland. (Norway) (United States) 10:45am 11:00am • The Safety and Efficacy of Oral • Performance of Summary Risk Scores, Propensity Scores, and Contraceptives in Teenagers: Results from the EURAS-OC Study [26] Agenda Multivariable Regression in the Presence of Multiple Confounders [3] Juergen C Dinger, Anita Assmann, Lothar Patrick G Arbogast, Lisa Kaltenbach,
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    OVERVIEW Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks Toon van der Gronde1, Carin A. Uyl-de Groot2, Toine Pieters1* a1111111111 a1111111111 1 Department of Pharmaceutical Sciences, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands, 2 Institute for Medical Technology Assessment, Department of Health a1111111111 Policy & Management, Erasmus University, Rotterdam, the Netherlands a1111111111 a1111111111 * [email protected] Abstract OPEN ACCESS Citation: Gronde Tvd, Uyl-de Groot CA, Pieters T (2017) Addressing the challenge of high-priced Context prescription drugs in the era of precision medicine: Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in A systematic review of drug life cycles, therapeutic several disease areas outpaces other health care expenditures and results in a suboptimal drug markets and regulatory frameworks. PLoS ONE 12(8): e0182613. https://doi.org/10.1371/ global availability of essential medicines. journal.pone.0182613 Editor: Cathy Mihalopoulos, Deakin University, Method AUSTRALIA A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Published: August 16, 2017 Journal and the Guardian was performed to identify articles related to the pricing of Copyright: © 2017 Gronde et al. This is an open medicines. access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and Findings reproduction in any medium, provided the original author and source are credited. Changes in drug life cycles have dramatically affected patent medicine markets, which have Data Availability Statement: All relevant data are long been considered a self-evident and self-sustainable source of income for highly profit- within the paper and its supporting information able drug companies.