2010 Presentations
UBC scientists participate in scientific and clinical meetings around the world. To learn more about a presentation, please contact the UBC scientist directly or call 301-654-9729.
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52nd American Society of Hematology Meeting and Exposition
Dec 4 - Dec 7 2010
Orlando, FL, USA
www.hematology.org/Meetings/Annual-Meeting/
PRESENTATION
Variation in Health-Related Quality of Life (HRQOL) by ISS Stage and ECOG Status Among Multiple Myeloma Patients
Pashos CL, Durie BGM, Rifkin R, Shah J, Street T, Sullivan K, Khan ZM -
Late Phase Drug Development World 2010
Nov 30 - Dec 3 2010
London, UK
www.healthnetworkcommunications.com/2010/lpdd/
PRE-CONFERENCE WORKSHOP
Management of Differences (or Variations) within the EU Guidelines for Non-Interventional Studies
Hazel Wohlfahrt, Exec. Director, EU Clinical Operations, United BioSource Corp., Jess Sohal, Exec. Director, EU Clinical Operations, United BioSource Corp.PRESENTATION
The Right Evidence, Using the Right Decision, and the Right Tools
Krista Payne, MEd, Director and Research Scientist, Health Care Data Capture, United BioSource Corp. -
Gerontological Society of America's 63rd Annual Scientific Meeting
Nov 19 - Nov 23 2010
New Orleans, LA, USA
www.geron.org/Annual%20Meeting
POSTER PRESENTATION
The Prevalence and HRQL Impact of OAB in Older Adults: Results from EpiLUTS
Markland A, Sexton CC, Coyne KS, Thompson C, Bavendam T, Chen C-I -
7th Forum on Patient Reported Outcomes (PRO)
Nov 17 - Nov 18 2010
Philadelphia, PA, USA
www.cbinet.com/show_conference.cfm?confCode=PC10189
PRE-CONFERENCE WORKSHOP
Use Responder Analysis to Support Label Claims for Patient Reported Outcomes
Joseph C. Cappelleri, PhD, MPH, Sr. Dir., Biostatistics, Pfizer; Kathleen W. Wyrwich, PhD, Sr. Research Scientist, Center for Health Outcomes Research, United BioSource Corp.
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American Heart Association (AHA) Scientific Sessions 2010
Nov 13 - Nov 17 2010
Chicago, IL, USA
scientificsessions.americanheart.org/portal/scientificsessions/ss/
POSTER PRESENTATION
Is There an Association Between Aspirin Dosing and Cardiac and Bleeding Events in Acute Coronary Syndrome After Stent Placement? A Systematic Review of the Literature
Berger JS, Sallum RH, Katona B, Maya J, Ranganathan G, Mwamburi M -
The American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting 2010
Nov 11 - Nov 16 2010
Phoenix, AZ
www.acaai.org/
POSTER PRESENTATION
An Assessment of Change in Quality of Life Among Patients 12 Years and Older with Persistent Asthma in Mometasone Furoate/Formoterol Fumarate Clinical Trials
Wyrwich KAn Assessment of Change in Asthma Control Among Patients 12 Years and Older With Persistent Asthma in Mometasone Furoate/Formoterol Fumarate Clinical Trials
Wyrwich K -
ISPOR 13th Annual European Congress
Nov 6 - Nov 9 2010
Prague, Czech Republic
www.ispor.org/
EDUCATIONAL SYMPOSIUM
Sat., 6 Nov., 18:15 - 19:15
Orphan Drugs in Europe: Funding Challenges for Payers and Developers
Moderator: Adam Barak, MCIM, Head of International Pricing and Reimbursement, United BioSource Corp.
Speakers: Adam Barak, MCIM, Head of International Pricing and Reimbursement, United BioSource Corp., London, UK; Wills Hughes-Wilson, Senior Director, Health Policy Europe, Genzyme, Brussels, Belgium; Francis Pang, MSc, Phil, Senior Market Access & Public Affairs Director, Shire, Basingstoke, UK; Stefan Lange, PD Dr. Med., Deputy Director, German Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany
SHORT COURSE
Sat., 6 Nov., 9:00 - 18:00
Discrete Event Simulation for Economic Analyses
Faculty: J. Jaime Caro, MDCM, FCRPC, FACP, Adjunct Prof. of Medicine, Adjunct Prof. of Epidemiology and Biostatistics, McGill University, Montreal PQ, and SVP of Health Economics, United BioSource Corp.; Jorgen Moller, MSc Mech Eng, VP, Modeling, United BioSource Corp.
WORKSHOPS
Sun., 7 Nov., 16:00 - 17:00 SESSION I
W1: Conducting & Interpreting Indirect Treatment Comparison and Network Meta-Analysis: Learning the Basics
Discussion Leaders: Jeroen P. Jansen, PhD, MSc, Research Director, Mapi Values; Neil Hawkins, PhD, Director, Oxford Outcomes Ltd.; Joseph C. Cappelleri, PhD, MPH, Pfizer Inc.; Rachael Fleurence, PhD, Senior Research Scientist and Director, Practice for Evidence Review and Synthesis, United BioSource Corp.
W6: Innovative Methods for Electronically Capturing Patient-Reported Outcomes and Preference Data in Non-Interventional Studies
Discussion Leaders: Ingela Wiklund, PhD, Senior Research Leader, Center for Health Outcomes Research, United BioSource Corp.; Sonya Eremenco, MA, e-PRO Manager, United BioSource Corp.
Sun., 7 Nov., 17:15 - 18:15 SESSION II
W8: Understanding Mixed Treatment Comparisons (MTCS): What Do the Results Mean and How Should They be Used?
Discussion Leaders: Rachael Fleurence, PhD, Senior Reserach Scientist and Director, Practice for Evidence Review and Synthesis, United BioSource Corp.; Huseyin Naci, Research Associate II, United BioSource Corp.; David Vanness, PhD, Assistant Prof., Dept. of Population Health Sciences, Univ. of Wisconsin School of Medicine and Public Health
Tues., 9 Nov., 14:45 - 15:45 SESSION III
W16: Model Validation: Buyer Beware
Discussion Leaders: Ipek Ozer Stillman, MS, Research Scientist, United BioSource Corp.; Phil McEwan, PhD, Managing Director, Cardiff Research Consortium; Denis Getsios, Research Scientist, United BioSource Corp.
W18: Time-to-Progression Models: Rapidly Informing Indications in Oncology
Discussion Leaders: Georgia Mitsi, PhD, MBA, MSc, Manager, United BioSource Corp.; Zeba M. Khan, PhD, RPh, VP, Pricing & Market Access, Celgene Corp.; J. Jaime Caro, MDCM, FRCPC, SVP of Health Economics, United BioSource Corp.
ISSUE PANELS
Sun., 7 Nov., 14:45 - 15:45 SESSION I
IP2: Methods or Pragmatism: Who Should Have the Say in Health Economic Assessment?
Moderator: J. Jaime Caro, MD, SVP of Health Economics, United BioSource Corp.
Panelists: Andreas Gerber, MD, PhD, Head, Dept. of Health Economics, Insititue for Quality and Efficiency in Health Care (IQWiG); Lise Rochaix, PhD, Professor, Commission d'evaluation economique et de sante publique (CEESP); Gert Jan van der Wilt, PhD, Professor, Dept. of Epidemiology, Biostatistics and HTA, Radboud University Medical Centre
IP4: Rare (Orphan) Disease: Tension Between Government Support of Developing New Therapies and Reimbursement Processes? Perspectives From EU-5 (Germany, UK, France, Spain and Italy), Central & Eastern Europe, USA and Canada
Moderator: Vladimir Zah, PhD, Health Economics Consultant, Belgrade, Serbia
Panelists: Chris Pashos, PhD, VP, United BioSource Corp.; Mondher Toumi, PhD, MD, Prof. of Decision Sciences, UFR d'Odontologie, Univ. Claude Bernard Lyon 1; Zoltan Kalo, MD, MSc, PhD, Director, Health Economics Research Unit, Eotvos Lorand Univ.
IP5: Is Any Data Better Than No Data? The Use of Mixed Modalities for PRO Data Collection in Clinical Trials
Moderator: Sonya Eremenco, MA, e-PRO Manager, United BioSource Corp.
Panelists: Stephen Joel Coons, PhD, Director, Patient-Reported Outcomes (PRO) Consortium, Critical Path Institute; Ethan Basch, MD, MSc, Principal Investigator, Health Outcomes Group, Memorial Sloan-Kettering Cancer Center; Tara Symonds, PhD, Sr. Dir., PRO Centre of Excellence, Global Market Access, PCBU, Pfizer
Mon., 8 Nov., 10:15 - 11:15 SESSION II
IP9: Greece's National Drug Budget Cut: What Will Be Its Impact on Europe?
Moderator: Chris Pashos, PhD, VP, United BioSource Corp.
Panelists: John Yfantopoulos, PhD, Prof., Faculty of Political Science and Public Administration, National and Kapodistrian Univ. of Athens; Mary Geitona, PhD, Asst. Prof., Dept. of Economics, Univ. of Thessaly; Adam Barak, Head, International Pricing & Reimbursement
Mon., 8 Nov., 14:00 - 15:00 SESSION III
IP13: EBM, HTA, CER: Clearing the Confusion Or Are We Now Confused at a Higher Level?
Moderator: Bryan R. Luce, PhD, MBA, SVP, Science Policy, United BioSource Corp.
Panelists: Marc L. Berger, MD, VP, Global Health Outcomes, Eli Lilly and Co.; Penny Mohr, MA, VP, Center for Medical Technology Policy; Finn Borlum Kristensen, MD, PhD, Dir. and Coordinating Secretariat, European Network for Health Technology Assessment (EUnetHTA) and Chairman of the EUnetHTA Executive Committee
IP14: QALY or the Need for a New Approach?
Moderator: Peter Kolominsky-Rabas, MD, PhD, MBA, Director, Centre for Health Technology Assessment (HTA) and Public Health (IZPH), University of Erlangen-Nurnberg
Panelists: J. Jaime Caro, MD, SVP of Health Economics, United BioSource Corp.; Mark J. Sculpher, PhD, Prof. of Health Economics, Centre for Health Economics, The University of York
Tues., 9 Nov., 10:00 - 11:00 SESSION IV
IP18: What Opportunities are Emerging Today to Harmonise Efforts to Generate Evidence Needed by Regulators, Payers and Drug Developers?
Moderator: Lisbet Coulton, Director, International Pricing and Reimbursement, United BioSource Corp.
Panelists: Hans-Georg Eichler, Sr. Medical Officer, European Medicines Agency; Carole Longson, PhD, Director, Centre for Health Technology Evaluation, National Institute for Health and Clinical Excellence; Lise Rochaix, PhD, Prof., Commission d'evaluation economique et de sante publique (CEESP), Haute Autorite de Sante; Ansgar Hebborn, PhD, Head - Global Payer & HTA Program Policy, F. Hoffmann-LaRoche AG
IP20: Identifying and Characterizing Heterogeneity in Treatment Response: Interesting Intellectual Exercise or Valuable For Drug Development, Reimbursement, and Personalized Medicine?
Moderator: Kerstin Uhl-Hochgraeber, MD, Head, GHEOR Women's Health and Diagnostic Imaging, Bayer Schering Pharma AG
Panelists: Donald E. Stull, PhD, Sr. Research Scientist, United BioSource Corp.; Kathleen W. Wyrwich, PhD, Sr. Research Leader, Center for Health Outcomes Research, United BioSource Corp.
PODIUM PRESENTATION
Mon., 8 Nov., 15:15 - 16:15 SESSION II
MT3: Comparative Effectiveness of Anti-Depressants (AD) in the Treatment of the Elderly with Major Depressive Disorder (MDD): A Mixed Treatment Comparison and Meta-Regression Analysis
Benedict A, Naci H, Fahrbach K, Bozkaya D, Happich M, Deberdt W, Raskin J
POSTER PRESENTATIONS
Sun., 7 Nov., 12:00 - 20:00 SESSION I
PDB12: Time to Opioid Use Among Commercially-Insured Patients with Diabetic Peripheral Neuropathic Pain Who Initiated Duloxetine Versus Other Treatments - a Propensity Score Approach
Zhao Y, Wu N, Chen SY, Fraser K, Boulanger L
PRS50: Employing Multi-Attribute Utility Theory to Develop the EXACT-U: A Preference-Based Measure for COPD Exacerbation Utilities
Petrillo J, Cairns J, Revicki DA
Mon., 8 Nov., 8:00 - 19:00 SESSION II
PMC7: Tariff Lists From Spanish Autonomous Communities: An Assessment of Its Structure, Contents, and Tariff Levels
DeCock E, Raluy M, Rovira J
PMC18: Multi-National Chart Review Studies in Europe: Opportunities and Challenges
Payne KA, Wasiak R, Stein D, Chancellor J
PCV32: Budget Impact Analysis of Paclitaxel Drug Eluting Stent (DES) for the Treatment of Lower Limb Peripheral Arterial Disease (PAD) in France
Lopes S, DeCock E
PCV73: Economic Evaluation of Combination Therapy for Hypertension in High Risk Patients in Sweden
Brown R, Brede Y, Getsios D, Tambour M, Falvey H
PCV107: Valuation of Health State Utilities Related to Cardiovascular Prevention with Aspirin
Manson SC, van Hanswijck de Jonge P, Palsgrove A, Gorelick PB
PIH10: Treatment and Cost for Patients with Endometriosis in the United Kingdom
Wasiak R, Manson S, Ryan J, Petri JC
PIH35: Demonstrating Conceptual Equivalence Across Multiple Cultures: Translation and Linguistic Validation of the IPAQ
Arnold BJ, Kimel M, Goddard A, McCormack J, Parks-Vernizzi E, Dhar J, Pleil A
PIH40: Methodological Considerations When Assessing Work Productivity (WP) and Activities of Daily Living (ADL) Outcomes in Multinational Clinical Trials in Women with Heavy and/or Prolonged Menstrual Bleeding (HPMB) Treated with Estradiol Valerate/Dienogest (E2V/DNG)
Wasiak R, Filonenko A, Stull DE, Kreif N, Raluy M, Ryan J, Jeddi M, Uhl-Hochgraber K, Vanness D
PIH61: Calibration of a Discrete Event Simulation Model of Natural History of HPV-Related Diseases
Quon P, Vanness DJ, Kansal A, Hillemanns P, Remy V, Quilici S
PND5: Budget-Impact Model to Test Effects of Changing Rufinamide Tier Status From a Payer Perspective
Powers A, Faria C, Buchner D, Shaul A, Cragin L
PND16: Modeling the Clinical and Economic Implications of Galantamine in the Treatment of Mild to Moderate Alzheimer's Disease in Germany
Guo S, Hernandez L, Wasiak R, Gaudig M
Tues., 9 Nov., 11:00 - 12:00 SESSION III
PIN10: Cost Versus DRG Revenue Implications of Treating a Patient with Ventilator-Associated Pneumonia (VAP) with Doripenem Versus Imipenem in Germany
DeCock E, Gast C, Berndt K, Kubitz N
PIN67: Modelling G-DRG Revenue When Hospitalisation Duration From Clinical Trials is Available: The Case of Doripenem Versus Imipenem in Treating Ventilator-Associated Pneumonia (VAP) in Germany
DeCock E, Gast C, Berndt K, Kubitz N
PSY4: Biological Agents for the Treatment of Nail Psoriasis: A Systematic Review of the Literature
Naci H, Green J, Prasad M, Fleurence R
PSY38: Cost-Effectiveness of Golimumab in Ankylosing Spondylitis from the UK Payer Perspective
Muszbek N, Punekar Y, Buchanan J, Prasad M, Vioix H, Brown R
PSY52: Development and Content Validation of a Multicentric Castlemans Disease Symptom Scale
Teschendorf B, Vernon M, O'Quinn S, van Rhee F
PUK27: Time Savings with Q4W (Once-Monthly) C.E.R.A.: A Time and Motion Study Conducted in Haemodialysis Centres in Five European Countries
Raluy M, Irgl H, DeCock E
PUK32: Content Validity of a Patient-Reported Urinary Urgency Rating Scale: Results of a Cognitive Interview Study
Chen WH, Notte S, Marshall TS, Lee M, Hakimi Z, Revicki DA
PUK33: Test-Retest Reliability and Acclimation Effect of Patient Perception of Intensity of Urgency Scale (PPIUS) for Overactive Bladder
Chen WH, Notte S, Marshall TS, Lee M, Hakimi Z, Revicki DA -
ISOQOL 17th Annual Conference
Oct 27 - Oct 30 2010
London, England
www.isoqol.org/
SYMPOSIA
Thurs., Oct. 28, 2:00 p.m. - 3:30 p.m.
Symposium Title: Development and Comparisons of Alternative Preference-Based Measures of Health
Steven B. Clauser, National Cancer Institute; John Brazier, Sheffield School of Health and Related Research; David Feeny, Kaiser Permanente Northwest; Dennis A. Revicki, United BioSource Corp.; Paul Kind, University of York
Health Preference Assessment in the PROMIS Project: Estimation and Variation in Preference Scores by Demographic and Disease Groups
Revicki DA
Fri., Oct. 29, 2:00 p.m. - 3:30 p.m.
Symposium Title: Current Methods for Measuring and Valuing Health States: Methodological Issues and Policy Implications
William Lenderking, United BioSource Corp.; Rick Berzon; Dominique Dubois; John Brazier, Sheffield School of Health and Related Research; Alan Haycox
Methodology Regarding Valuing and Measuring Health States
Lenderking W
EDUCATIONAL WORKSHOPS
Wed., Oct. 27, 9:00 a.m. - 12:00 p.m.
W5: Interpretation of PRO Data Within Clinical Trials
Instructors: Josephine Norquist, MS, Merck, Sharpe & Dohme; Kathleen Wyrwich, PhD, United BioSource Corp.
W7: Advanced Psychometric Methods, Part 1: Use of Exploratory and Confirmatory Factor Analyses in PRO Instrument Development and Evaluation
Instructors: Donald Stull, PhD, United BioSource Corp.; Margaret Vernon, PhD, United BioSource Corp.
Wed., Oct. 27, 1:00 p.m. - 4:00 p.m.
W13: Advanced Psychometric Methods, Part 2: Executing and Interpreting Exploratory and Confirmatory
Instructors: Donald Stull, PhD, United BioSource Corp.; Margaret Vernon, PhD, United BioSource Corp.
W15: Innovative Methods for Electronically Capturing Patient-Reported Outcomes and Preference Data in Non-Interventional Studies
Instructors: Ingela Wiklund, PhD, United BioSource Corp.; Karin Coyne, PhD, United BioSource Corp.; Shae Wilkins, Arrowhead Electronic Healthcare
ORAL PRESENTATIONS
Thurs., Oct. 28, 11:30 a.m.
Item Identification for the EXACT-U: A Preference-Based Measure to Report Utilities for COPD Exacerbations.
Petrillo J, Cairns J, Lamping D, Jones P
Fri., Oct. 29, 11:30 a.m.
Copyright of Translations of PRO Measures: Rules and Applications
Anfray C, Conway K, Acquadro C, Eremenco S
POSTER PRESENTATIONS
Assessment of Unidimensionality for the Visual Function Questionnaire-Utility Index (VFQ-UI) Items in Patients with Central Vision Loss
Revicki DA, Rentz AM, Kowalski JW, Chen WH
Development of an Excessive Daytime Sleepiness Diary
Norquist JM, Vernon MK, O'Quinn S, McQuarrie K, Dinges D, Roth T, Herring W, Brodovicz GH
Development of the U.S. National Frequent Heartburn Index (FHBI) and Associated Composite Score
Stull D, Houghton K, van Hanswijck de Jonge P, Kocun C, Sandor DA
Patient-Reported Outcome Instruments Used to Assess Pain and Functioning in Studies of Treatment for Bone Metastases
Matza LS, Fallowfield L, Chung K, Currie BM, Van Brunt K, Patrick DL
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2010 RAPS Annual Conference & Exhibition
Oct 24 - Oct 27 2010
San Jose, CA
www.raps.org/
PRESENTATION
REMS: Theory, Practice, Evolution
Kelly Davis, MD, Vice President, Safety Epidemiology and Risk Management, United BioSource Corporation; David Feigal, Jr., MD, MPH, Principal, NDA Partners LLP; Florence Houn, MPH, MD, Vice President, Regulatory Policy and Strategy, Celgene Corporation; Raj Kishore, PhD, Principal, Regulatory Strategy, Quintiles Consulting -
American Society for Reproductive Medicine (ASRM) 66th Annual Meeting
Oct 23 - Oct 27 2010
Denver, CO, USA
www.asrm.org/annualmeeting.aspx
POSTER PRESENTATION
Impact of Estradiol Valerate / Dienogest (E2V / DNG) on Work Productivity (WP) and Activities of Daily Living (ADL) Impairment in North American Women with Heavy and / or Prolonged Menstrual Bleeding (HPMP)
Wasiak R, Filonenko A, Jensen JT, Law AW, Jeddi M, Stull DE
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48th Annual Meeting of the Infectious Disease Society of America (IDSA)
Oct 21 - Oct 24 2010
Vancouver, Canada
www.idsociety.org/
PRESENTATION
Complicated Skin and Soft Tissue Infections (cSSTI) in Hospitalized Patients - a Prospective Multi-Center Observational Study of Clinical Characteristics and Medical Treatment
Lipsky BA, Napolitano L, Moran GJ, Vo L, Nicholson S, Freier K, Boulanger L, Kim M -
AdvaMed 2010
Oct 18 - Oct 20 2010
Washington, DC, USA
www.advamed2010.com/
EDUCATIONAL PANEL DISCUSSION
Wed., Oct. 20, 9:00 a.m. - 10:15 a.m.
Panel Location: 207A Medical Affairs: Adding Value in Today's Global Medical Devices Industry
Moderator: Ross Segan, MD, FACS, VP, Global Medical Affairs, Deputy Chief Medical Officer, Covidien
Panelists: Peter Heeckt, MD, Chief Medical Officer, Smith & Nephew Orthopaedics; Greg de Lissovoy, PhD, MPH, Vice President for Health Technology, United BioSource Corp. -
Third Annual Risk Management and Drug Safety Summit
Oct 18 - Oct 19 2010
Washington, DC, USA
www.fdanews.com/conference/detail?eventId=2920
CONFERENCE CO-CHAIR
Annette Stemhagen, DrPH, FISPE, SVP Safety, Epidemiology, Registries & Risk Management, United BioSource Corp.
SPEAKER
REMS Evaluations: What Have We Learned?
Kelly Davis, MD, VP Safety, Epidemiology & Risk Management, United BioSource Corp.
PANEL DISCUSSIONS
Reading the Drug Safety Tea Leaves - Top Legal and Compliance Challenges That Lie Ahead
Panel Moderator: Mark Ammann, PharmD, VP, Regulatory Affairs, United BioSource Corp.
Panelists: Gordon Johnston, VP Regulatory Sciences, Generic Pharmaceutical Association; Edward Fotsch, MD, CEO, PDR Network; Josephine Torrente, JD, Director, Hyman, Phelps & McNamara; Peter Pitts, Co-Founder, President, Center for Medicine in the Public Interest; Gerald Faich, MD, MPH, FISPE, SVP, Safety, Epidemiology, Registries & Risk Management, United BioSource Corp.
REMS "Veterans" Share Their Battlefront Tales
Panel Moderator: Patricia Fritz, VP, Govt. Affairs and Policy, UCB Inc.
Panelists: Gerald Faich, MD, MPH, FISPE, SVP, Safety, Epidemiology, Registries & Risk Management, United BioSource Corp.; Carmen Bozic, MD, VP, Drug Safety & Risk Management, Biogen Idec; Gary Friedman, MD, Medical Director, Novartis Pharmaceuticals; Bob Anders, PharmD, VP, U.S. Processes & Systems, Lundbeck; Christopher Pitcherella, External Provider Management Team Leader, AstraZeneca -
AMCP's 2010 Educational Conference
Oct 13 - Oct 15 2010
St. Louis, MO, USA
www.amcp.org/conferences/2010/stlouis/index.cfm
POSTER PRESENTATIONS
Healthcare Resource Use and Costs Among Chronic and Episodic Migraine in the United States
Stokes M, Varon SF, Sullivan S, Blumenfeld A, Lipton RB, Goadsby PJ, Wilcox TK
Acute Medication Use Among Americans with Chronic and Episodic Migraine
Lipton RB, Varon SF, Goadsby PJ, Buse DC, Kawata AK, Wilcox TK, Blumenfeld A
Preventive Medication Use Among Americans with Chronic and Episodic Migraine
Blumenfeld A, Kawata AK, Goadsby PJ, Buse DC, Wilcox TK, Varon SF, Lipton RB -
35th Annual European Society of Medical Oncology (ESMO) Congress
Oct 8 - Oct 12 2010
Milan, Italy
www.esmo.org/
POSTER PRESENTATION
Health-Related Quality of Life (HRQL) Outcomes of Ipilimumab Treatment in Patients with Previously Treated Unresectable Stage III or IV Melanoma (USIII/IV Mel)
Revicki D, Kotapati S, van den Eertwegh A, Lorigan Paul, Linette G, Ottensmeier CH, Lebbe C, Messina M, Abdallah K, Wagner S -
AUGS 31st Annual Scientific Meeting
Sep 29 - Oct 2 2010
Long Beach, CA
/www.augs.org/
POSTER PRESENTATION
Responsiveness and Discriminant Validity of the PISQ-12 Questionnaire in Vaginal Prolapse Repair Using a Lightweight Mesh System
Sikirica V, Gelhorn H, Coyne K, Gauld J, Robinson D -
Visiongain 9th Annual Pricing and Reimbursement Conference
Sep 28 - Sep 29 2010
London, UK
www.visiongain.com/Conference/272/9th-Annual-Pricing-and-Reimbursement
ORAL PRESENTATION
Wed., 29 Sept., 15:10
Pricing, Reimbursement and Market Access Strategies for Orphan Medicines
Speaker: Adam Barak, Head, International Pricing and Reimbursement, United BioSource Corp. -
CBI's 13th Registries and Post-Approval Studies Congress
Sep 28 - Sep 30 2010
Princeton, NJ, USA
www.cbinet.com/show_conference.cfm?confCode=PC10155
ORAL PRESENTATIONS
Strategic Considerations
Chris Pashos, PhD, Vice President, United BioSource Corp.
Methodological Considerations
Krista Payne, MEd, Director and Research Scientist, Health Care Data Capture, United BioSource Corp.
Ensuring Post-Approval Studies are Operationalized to Fulfill Their Multiple Purposes
David C. Hufner, Clinical Program Director, United BioSource Corp. -
EFNS Geneva 2010, 14th Congress of the European Federation of Neurological Societies
Sep 25 - Sep 28 2010
Geneva, Switzerland
efns2010.efns.org/
ORAL PRESENTATION
Health-Related Quality of Life (HRQoL) Among Subjects with Chronic Migraine (CM) and Episodic Migraine (EM) in Five European Countries
Kawata A, Varon S, Blumenfeld A, Lipton R, Wilcox T, Goadsby P
POSTER PRESENTATION
Comparing EuroQol-5 Dimensions (EQ-5D) Index Scores Between Subjects with Chronic Migraine (CM) and Episodic Migraine (EM) in Five European Countries and with Other Chronic Diseases
Kawata A, Maglinte G, Doan Q, Lipton R, Wilcox T, Blumenfeld A, Goadsby P -
2010 FDA / Industry Statistics Workshop
Sep 20 - Sep 22 2010
Washington, DC, USA
www.amstat.org/meetings/fdaworkshop/index.cfm?fuseaction=main
SHORT COURSE
Mon., Sept. 20, 8:30 a.m. - 12:00 p.m., Room C
SC3: Interpreting Change and Responder Analyses for Patient-reported Outcomes
Instructors: Joe Cappelleri, Pfizer; Lisa A. Kammerman, FDA; Kathleen W. Wyrwich, United BioSource Corp.
PANEL DISCUSSIONS
Wed., Sept. 22, 10:00 a.m. - 11:15 a.m., Room C
PS5c: Heterogeneity in Treatment Response: What It Is, Why It's Important and How to Find It
Presenters: Heterogeneity Issue in Clinical Trial, Chul Ahn, FDA/CDRH; Examining Heterogeneity in Treatement Response in Clinical Trials: The Poor Man's Mixture Model Analysis, Kathleen Wyrwich, United BioSource Corp.; Examining Heterogeneity in Treatment Response in Clinical Trials: Use of Factor Mixture Models, Donald E. Stull, United BioSource Corp.
Wed., Sept 22, 12:45 p.m. - 2:00 p.m., Room C
PS6c: Quantitative Assessments of Patient Reported Outcomes: Questionnaire Design and Analysis
Discussants: Rima Izem, FDA/CDER/OB/DB4; Margaret Rothman, Johnson & Johnson; Kathleen Wyrwich, United BioSource Corp.
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ERS Barcelona 2010
Sep 18 - Sep 22 2010
Barcelona, Spain
www.erscongress2010.org/
POSTER
Evaluation of COPD Exacerbations Using the EXACT-U.
Petrillo J, Cairns J -
Congres International D'Epidemiologie
Sep 15 - Sep 17 2010
Marseille, France
etudes.isped.u-bordeaux2.fr/ADELF2010_MARSEILLE/
PRESENTATION
Disability, HRQOL, HRU in France
Lanteri-Minet M, Lipton R, Kawata AK, Velard ME, Varon SF, Goadsby P -
JSCNP (Japan Society for Neuropsychopharmacology)
Sep 15 - Sep 17 2010
Sendai, Japan
www.jscnp.org/en/annualmeeting/index.html
POSTER PRESENTATION
Improving Data Quality Throughout the Course of Alzheimer's Trials
D Miller, C McNamara, S Podolin -
ISPOR 4th Asia-Pacific Conference
Sep 5 - Sep 7 2010
Phuket, Thailand
www.ispor.org/
ISSUE PANEL AND WORKSHOPS
Tues., Sept. 7, 11 a.m. - 12 p.m. - Session II
IP4: Risk-Sharing Schemes in the Asian Marketplace: What are the Steps for Success?
Moderator: Lisbet Coulton, Director, International Pricing and Reimbursement, United BioSource Corporation
Panelists: Abdulkadir Keskinaslan, MD, MBA, MPH, Market Pricing Director Asia, Novartis Pharma AG; Nathorn Chaiyakunapruk, PharmD, PhD, Associate Professor, Center of Pharmaceutical Outcomes Research, Naresuan Univ.; Wen Chen, PhD, Professor, Center for Pharmacoeconomic Research and Evaluation, Fudan Univ.
W8: The New German Methods for Economic Evaluation and Their Applicability in Asia
Discussion Leaders: J. Jaime Caro, MD, Senior Vice President of Health Economics, United BioSource Corporation; Charalabos-Markos Dintsios, MPH, MA, Scientific Staff Department of Health Economics, Institute for Quality and Efficiency in Health Care (IQWiG); Anja Schwalm, MSc, Health Economist, Institute for Quality and Efficiency in Health Care (IQWiG); Isao Kamae, MD, DrPH, Professor of Pharmacoeconomics, JPMA Research and Education Project, Keio Univ.
POSTER PRESENTATIONS
Mon. and Tues., Sept. 6 and 7, 8 a.m. - 9 p.m. and 8 a.m. - 6:00 p.m.
PCV18: Economic Evaluation of Using High-Dose Atorvastatin for the Prevention of Recurrent Stroke: Evidence from Thailand
Suwanwela N, Kongnakorn T, Leartsakulpanitch J
PHP15: Risk-Sharing Schemes Worldwide: A Landscape Analysis of Health Outcomes-Based Reimbursement Agreements
Coulton L, Annemans L, Javier J, Brown R, Keskinaslan A -
7th International Conference on Prevention of Work-Related Musculoskeletal Disorders
Aug 29 - Sep 3 2010
Angers, France
www.premus2010.org/index.html
POSTER PRESENTATION
Recurrence of Low Back Pain: Injured Workers' Perspectives
Young AE, Wasiak R, Phillips LA, Gross DP -
ECNP (European Collegium of Neuropsychopharmacology)
Aug 28 - Sep 1 2010
Amsterdam, The Netherlands
www.ecnp.eu/emc.asp?pageId=1516
POSTER PRESENTATIONS
Issues and Opportunities in Cognitive Psychopharmacology Trials in Children
K Wesnes, H Brooker
The Profile of Attentional Deficits in Schizophrenia: Implications for Pharmacotherapy
K Wesnes, H Brooker, C Edgar -
ICS/IUGA 2010
Aug 23 - Aug 27 2010
Toronto, Canada
www.icsoffice.org/
Poster
Validation of the Patient Global Impression of Change (PGIC) in a Patient Population Following Vaginal Prolapse Repair with Mesh
Coyne K, Sikirica V, Gelhorn H, Robinson D, Hinoul P, Gauld J -
26th International Conference on Pharmacoepidemiology and Therapeutic Risk Management
Aug 19 - Aug 22 2010
Brighton, UK
www.pharmacoepi.org/meetings/26thconf/
Workshop
Guidance Regarding the Identification, Development, Validation and Translation of Coding Algorithms in Electronic Healthcare (EH) Databases
Mehta V, Locasale RJ, Reynolds MW, Bohn RL, Trifiro G, Mark TL
Oral Presentation
Liver Function Test Abnormalities in Patients Treated with Small Molecule Tyrosine Kinase Inhibitors
Nordstrom B
Poster Presentations
Characteristics of Patients Receiving Varenicline Treatment for Smoking Cessation in UK Primary Care: A THIN Database Study
Blak BT, Wilson K, Metcalfe M, Maguire A, Hards M
Global Prevalence of Pregnancy Outcomes
Neibauer MW, Reynolds MW, Michels SL, Collins J
Impact of Comorbidites on the Burden for Patients with Parkinson's Disease
Ward A, Michels SL, Lanes S, O'Neill NG, Papapetropoulos S
Parameterizing Risk-Benefit Models from Primary Care Data: Recurrence and Exacerbation
Maguire A, Blak B, Haynes K
Systematic Literature Review and Meta-Analysis of Apolipoprotein E e4 Prevalence in Alzheimer's Disease Patients
Crean SM, Ward A, Mercaldi CJ, Collins JM, Cook MC, Baker NL, Arrighi HM
Validation of ICD-9-CM codes to Identify Gastrointestinal Perforation Cases in Administrative Claims Data in Rheumatoid Arthritis Patients
Curtis JR, Chen SY, Werther W, John A, Johnson D -
ICAD (International Conference on Alzheimer's Disease) 2010
Jul 10 - Jul 15 2010
Honolulu, HI, USA
www.alz.org/icad/overview.asp
Workshop
Advancing Measurement of Cognition in Clinical Trials
Frank L, Miller D, Tractenberg R, Hobart J, Gauthier S, Black R, Landen J, Iwatsubo T
Poster Presentations
Systematic Literature Review and Meta-Analysis of Apolipoprotein E e4 Prevalence in Alzheimer's Disease Patients
Arrighi HA, Crean SM, Ward A, Mercaldi CJ, Collins JM, Cook MN, Baker NLAttentional Deficits in the Dementias: Behavioural and Treatment Implications
Wesnes K, Edgar C, Brooker H
Training and Surveillance Considerations When Utilizing Expanded Versions of the ADAS-Cog
Miller D, McClellan R, Siemers E -
8th European Conference on Health Economics
Jul 7 - Jul 10 2010
Helsinki, Finland
www.eche2010.fi/
Presentation
Comparison of the Statistical Inference and Multi-Attribute Utility Theory Models to Develop a Preference-Based Instrument: The EXACT-U as a Case Study
Petrillo J -
26th International Papillomavirus Conference
Jul 3 - Jul 8 2010
Montreal, Canada
hpv2010.org/main/
Poster
A Discrete Event Simulation Approach in Modeling the Impact of HPV Vaccination and Cervical Cancer Screening
Quon P, Vanness D, Hillemanns P, Largeron N, Remy V -
Spanish Health Association (AES) XXX Conference on Health Economics
Jun 22 - Jun 25 2010
Valencia, Spain
www.portalferias.com/jornadas-de-economia-de-la-salud-2010-valencia-espana_3282.htm
Poster Presentation
Use of Tariff Lists from Spanish Autonomous Communities for Economic Evaluations in Spain
Raluy Callado M, De Cock E, Rovira J -
NCDEU (New Clinical Drug Evaluation Unit) 2010
Jun 14 - Jun 17 2010
Boca Raton, FL, USA
www.ncdeumeeting.org/NCDEU%202010.htm
Panel
Novel and Emerging Endpoints in Child Psychopharmacology Research
Busner J, Vitiello B, Greenhill, Wesnes K, Kotagal SWorkshop
Methodological Issues for Studying Negative Symptoms of Schizophrenia
Daniel D, Marder SPoster
Doctorate Level US PANSS Raters Score Higher on a Measure of Interview Quality than Non-doctorate Level Raters
Daniel DPoster
Improvements to Cognitive and Visuo-Perceptual Task Performance in Dementia with Lewy Bodies Galantamine
Edgar C, Wesnes K, Zangar A, Edwards KPoster
The Implications of the Cognitive Deficit Profile in Schizophrenia for Therapeutic Strategies
Wesnes K, Brooker H, Hassman H, Edgar C, Daniel D -
MDS (Movement Disorders Society) International Congress
Jun 13 - Jun 17 2010
Buenos Aires, Argentina
www.movementdisorders.org/congress/congress10/
Poster
Does the Addition of New Raters to a Parkinson's Disease Clinical Trial Result in Increased Noise?
Kott A, Miller D, McClellan R -
DIA 46th Annual Meeting
Jun 13 - Jun 17 2010
Washington, DC, USA
www.diahome.org
Panel Sessions
Can a Risk Management Program Save a Product from Withdrawal?
Session Chairperson: Gerald A. Faich, MD, MPH, Senior Vice President, SERRM, United BioSource Corporation
Panel Speakers: The Tysabri Experience - Representative Invited, Vice President, Global Head, Drug Safety and Risk Management, Biogen; Inhaled Insulin - Anders H. Boss, MD, FFPM, Chief Medical Officer, MannKind Corporation; FDA Point of View - Gerald J. Dal Pan, MD, MPH, Director, Office of Surveillance and Epidemiology, CDER, FDA
Document Preparation When You're Short on Time
Session Chairperson: Laura Webb, BSN, RN, President, WebbWrites
Panel Speakers: Key Performance Indicators for Medical Writing: Fact or Fantasy? - Michael D. Hoffman, MS, Senior Director, Medical Writing and Regulatory Operations, United BioSource Corporation; Statisticians and Writers: Effective Ways to Work Together to Save Time - Rebecca Drummond, PhD, Principal Biostatistician, Lundbeck; So Many Documents, So Little Time, So Little Time - Laura Webb, BSN, RN, President, WebbWrites
Incorporating Risk Management Strategies Into Premarketing Clinical Trials
Session Chairperson: Annette Stemhagen, DrPH, FISPE, Senior Vice President, Safety, Epidemiology, Registries and Risk Management, United BioSource Corporation
Panel Speaker: Translating Premarket Risk Assessments into Postmarketing Risk Management Programs - Mwango Kashoki, MD, MPH, Associate Director, Safety, Office of New Drugs, CDER, FDA
Innovations in Combining Patient-reported Outcomes with Physiologic Measurements to Leverage Real-time Access to Data
Session Chairperson: Christina Curry, MSc
Panel Speakers: Innovations in Physiologic and Patient-reported Data Capture: Implications for Streamlining Data Collection and Leveraging Access to Real-time Data - Sonya L. Eremenco, MA, ePRO Manager, United BioSource Corporation; Innovations in Oncology Symptom Data Capture: PROs versus ClinROs - Ethan M. Basch, MD, Medical Oncologist; Memorial Sloan-Kettering Cancer Center; Innovations in Cognitive Testing: Using ePRO to Assess Drug Effect - Christina Curry, MSc, Marketing Specialist, PHT Corporation
Patient Recruitment in a Technological Era
Session Chairperson: Richard J. Mayewski, Global Trial Optimization Specialist, Merck & Co.
Panel Speakers: Patient Recruitment 2.0: Making the Case for Technological Adoption - Joseph Kim, MBA, MEd, Director, Site Feasibility and Patient Recruitment, ePharmaSolutions; Is TV Advertising Old School? Leveraging the Digital Age for Effective Clinical Trial Patient Recruitment and Retention - Abbe Steel, Executive Director, United BioSource Corporation; Determining the Best Way to Reach and Support Patients in a Technological Era - Tim Davis, CEO and Co-founder, Exco InTouch
Payer Perspectives of Evidence-based Medicine and Comparative Effectiveness: Making Evidence Matter in the Marketplace
Session Chairperson: Craig A. Hunter, MPP, PGDP, Senior Science Policy Analyst & Senior Manager, Science Policy, United BioSource Corporation
Personalized Medicine: Are We There Yet?
Session Chairperson: Georgia Mitsi, PhD, MBA, MSc, Senior Research Associate, United BioSource Corporation
Panel Speakers: Personalized Medicine: FDA Perspective - Francis Kalush, PhD, Network Leader, Diagnostics and Personalized Medicine, FDA
Qualification of Patient-Reported Outcome (PRO) Tools to Support Labeling Claims: Development, Evaluation, and a Consortium Approach
Session Chairperson: Laurie Burke, MPH, RPh, Assistant Director, Study Endpoints and Label Development, CDER, FDA
Panel Speakers: FDA Evaluation of PRO Measures for Regulatory Qualification to Support Claims - Elektra J. Papadopoulos, DrMed, Medical Officer, FDA; Development and Documentation of PRO Tools for Regulatory Review - Nancy Kline Leidy, PhD, Senior Vice President, Scientific Affairs, United BioSource Corporation; The Patient-reported Outcomes (PRO) Consortium: A Public-private Partnership Approach - Stephen Joel Coons, PhD, MEd, MSc, Director, PRO Consortium, Critical Path Institute
REMS Evalutions: What Have We Learned?
Session Chairperson: Kelly D. Davis, MD, Vice President, Safety, Epidemiology and Risk Management, United BioSource Corporation
Panel Speakers: Development of the REMS Assessment Plan - Kelly D. Davis, MD, Vice President, Safety, Epidemiology and Risk Managment, United BioSource Corporation; REMS KAB Survey Design: Did the Patients and HCPs Get the Message? - Kala L. Paul, MD, MS, President, The Corvallis Group; FDA's Perspective on the First Round of REMS Evaluation Results - Mary Willy, PhD, Senior Risk Management Analyst, Team Leader, CDER, FDA
What Deliverable? Importance of Close Collaboration Between Data Management and Other Functions
Session Chairperson: Teresa Ancukiewicz, MA
Panel Speakers: Statistical Programmers: What They Do and How They Can Help - Carol Matthews, Senior Director, Clinical Programming, United BioSource Corporation; What Deliverable? Importance of Close Collaboration Between Data Management and Biostatistics Teams - Zia Haque, MA, Associate Director, Data Management, Pharmanet Development Group -
15th Congress of the European Hematology Association (EHA)
Jun 10 - Jun 13 2010
Barcelona, Spain
www.ehaweb.org/
Poster
Impact of Lenalidomide on Health-Related Quality of Life in Patients with RBC Transfusion-Dependent Low- or Int-1-Risk Myelodysplastic Syndromes with del(5q): A Randomized Phase 3 Study (MDS-004)
Brandenburg N, Fu T, Revicki D, Knight R, Muus P, Fenaux P -
Canadian Neurological Sciences Foundation (CNSF) 45th Annual Congress
Jun 8 - Jun 11 2010
Quebec City, Quebec, Canada
www.ccns.org/congress_program.html
Poster
Migraine-Related Disability, Work Impact and Quality of Life (QOL) Among Canadians with Chronic and Episodic Migraine
Becker W, Wilcox T, Wells L, Blumenfeld A, Kawata A, Varon S, Lipton R
Podium Presentation
Headache Severity, Comorbidities, and Healthcare Resource Utilization Among Chronic Migraine and Episodic Migraine in Canada
Becker W, Kawata A, Yeomans K, Varon S, Lipton R, Wells L, Blumenfeld A -
CINP (Collegium Internationale Neuro-Psychopharmacologicum) 2010 World Congress
Jun 6 - Jun 10 2010
Hong Kong, China
Symposium
Conducting Clinical Trials in Asia
Daniel D, Hua J, et al. -
HTAi 7th Annual Meeting Dublin 2010
Jun 6 - Jun 9 2010
Dublin, Ireland
www.htai2010.org
Oral Presentations
Finding Ways to Make Outcomes Assessments Effective in Risk-sharing Agreements
Coulton L, Keskinaslan A, Annemans L, Javier J
HTA When There are No Direct Comparative Effectiveness Data: PARTS
Caro JJ, Khan Z -
ASCO 2010 Annual Meeting
Jun 4 - Jun 8 2010
Chicago, IL, USA
www.asco.org/
Presentation
Burden of Illness Estimates of Metastatic Breast Cancer (MBC) in the United States
Sorensen S, Benedict A, Yardley D, Martin M, Knopf K, Pan F, Goh J, Giorgetti C, Chen C
Economic Analysis of DecitabineVersus Best Supportive Care in the Treatment of Intermediate and High Risk Myelodysplastic Syndromes (MDS).
Kim E, Pan F, Peng S, Fleurence R -
World Ophthalmology Congress 2010 (WOC 2010)
Jun 3 - Jun 9 2010
Berlin, Germany
www.woc2010.org
Oral Presentations
Effect of Dexamethasone Intravitreal Implant on Patient-Reported Visual Functioning for the Treatment of Macular Edema Following Retinal Vein Occlusion
Kowalski J, Rentz A, Revicki D, Bandello F, Gillies M, Yoon Y, Liu C, Whitcup SM
Normative Comparison of Generic- and Vision-Targeted Health-Related Quality of Life (HRQL) Outcomes in Patients with Vision Loss Due to Macular Edema Following Retinal Vein Occlusion
Rentz A, Kowalski J, Revicki D, Lowenstein A, Whitcup SM
Poster Presentation
Efficacy of Dexamethasone Intravitreal Implant for the Treatment of Uveitis Based on Patient-Reported Vision Function Outcome Measures
Kowalski J, Gelhorn H, Naik R, Cui H, Revicki D, Lowder CY, Belfort Jr R, Foster CS, Lightman S, Whitcup SM -
Statisticians in the Pharmaceutical Industry (PSI) Meeting on Patient Reported Outcomes
Jun 2 - Jun 2 2010
London, UK
www.psiweb.org/
Oral Presentation
Interpreting Change Over Time in Patient-Reported Outcomes
Kathy Wyrwich, PhD, Senior Research Leader, Center for Health Outcomes, United BioSource Corporation -
XI Congreso Nacional AEEM
Jun 1 - Jun 4 2010
Malaga, Spain
www.meetandforum.net/aeem2010malaga/
Presentation
Evaluacion de la Calidad de Vida Relacionada con la Salud (HRQOL) en Mujeres Postmenopausicas que Participaron en el Estudio FREEDOM
Palacios S, Siris E, Silverman S, Viswanathan H, Wang A, Qian Y, Ragi-Eis S, Fardellone P, Gilchrist N, Lips P, Nevitt M, Pavelka K, Revicki D, Simon J, Macarios D -
13th Biennial European Conference of the Society for Medical Decision Making (SMDM Europe 2010)
May 30 - Jun 2 2010
Hall in Tyrol, Austria
www.smdm.org/index.shtml
Poster
A Discrete Event Simulation Approach in Modeling the Health and Economic Impact of HPV Vaccination and Cervical Cancer Screening
Quon P, Vanness D, Hillemanns P, Largeron N, Remy V -
CBI and ISOQOL's Forum on Patient Reported Outcomes
May 25 - May 26 2010
Philadelphia, PA, USA
www.cbinet.com/
Joint Forum Co-Chairs
William Lenderking, PhD, Senior Research Scientist, United BioSource Corporation and Jeff Sloan, PhD, Lead Statistician, Mayo Clinic
Tues. May 25
3:30 p.m.
Panel Discussion
Influencing Commercial Market Research to Reflect Necessary PRO Concepts
Moderator: Robert DiGregorio, DO, FACOOG, Director II, Regulatory Affairs, Pfizer
Panelists: Jeff Sloan, PhD, Senior Statistician, Mayo Clinic; William Lenderking, PhD, Senior Research Scientist, United BioSource Corporation
Wed. May 26
11:00 a.m.
Oral Presentation
A Significant Change in FDA's Final Guidance on Patient Reported Outcomes -- Interpretation
Kathleen W. Wyrwich, PhD, Senior Research Leader, Center for Health Outcomes Research, United BioSource Corporation
-
APA (American Psychiatric Association) Annual
May 22 - May 26 2010
New Orleans, LA
psych.org/MainMenu/EducationCareerDevelopment/Meetings/AnnualMeeting.aspx
Workshop
The Use of Research Instruments in Clinical Practice
Busner J, Greco N, Kaplan SPoster
Educational Quality of the Rater Predicts Quality of Symptom Assessment Interviews in Schizophrenia Trials
Daniel D, Sartorius N, Bartko JPoster
The Application of a Comparative Effectiveness Trial Criteria to a Commercially insured Population of Children with ADHD
Busner J, Abousaid S, Durkin M, Schneider G -
ISPOR 15th Annual International Meeting
May 15 - May 19 2010
Atlanta, GA, USA
www.ispor.org
EDUCATIONAL SYMPOSIUM
Tues. May 18
1:30 - 2:30 p.m.
Comparative Effectiveness & Standards of Evidence: The Intersection of Science, Policy, Regulation and Business
Moderator: Bryan R. Luce, PhD, MBA, Senior Vice President, United BioSource, Corporation
Speakers: Scott Gottlieb, MD, Resident Fellow, American Enterprise Institute; FDA Representative (invited), Director, Study Endpoints and Label Development, Center for Drug Evaluation and Research, Food and Drug Administration; Les Paul, MD, Vice President, Clinical & Scientific Affairs, National Pharmaceutical Council; Brian Sweet, RPh, MBA, Chief Pharmacy Officer, Wellpoint Inc.
SHORT COURSES
Sat. May 15
8:00 a.m. - 5:00 p.m.
Bayesian Analysis: Overview and Applications
Faculty: David Vanness, PhD, Visiting Scientist, Center for Health Economics and Science Policy, United BioSource Corporation and Assistant Professor, University of Wisconsin School of Medicine and Public Health; Christopher S. Hollenbeak, PhD, Associate Professor, Surgery and Public Health Sciences, Penn State College of Medicine
Sun. May 16
8:00 a.m. - 5:00 p.m.
Discrete Event Simulation for Economic Analyses
Faculty: J. Jaime Caro, MDCM, FRCPC, FACP, Adjunct Professor of Medicine, Adjunct Professor of Epidemiology and Biostatistics, McGill University & Senior Vice-President of Health Economics, United BioSource Corporation; Jörgen Möller, MSc Mech Eng, Vice President, Modeling, United BioSource Corporation
Sun. May 16
8:00 a.m. - 12:00 p.m.
Bayesian Analysis - Advanced
Faculty: Keith R. Abrams, PhD, Professor of Medical Statistics, Department of Health Sciences, University of Leicester; David Vanness, PhD, Visiting Scientist, Center for Health Economics and Science Policy, United BioSource Corporation and Assistant Professor, University of Wisconsin School of Medicine and Public Health; Christopher S. Hollenbeak, PhD, Associate Professor, Surgery and Public Health Sciences, Penn State College of Medicine
PLENARY SESSIONS
Tues. May 18, Session II
11:15 a.m. - 12:45 p.m.
Is Health Outcomes Research Valuable to Real Decision Makers: A Candid Discussion with Medical and Pharmacy Directors
Moderator: J. Jaime Caro, MDCM, FRCPC, FACP, Senior Vice President of Health Economics, United BioSource Corporation
Wed. May 19, Session III
10:00 - 11:30 a.m.
Bayesian and Adaptive Trial Methods Meets the Pragmatic Clinical Trial and Comparative Effectiveness Research
Moderator: Bryan R. Luce, PhD, MBA, Senior Vice President, Science Policy, United BioSource Corporation
ISSUE PANEL
Tues. May 18, Session II
2:45 - 3:45 p.m.
Cost-Effectiveness Analysis in the Southwest Quadrant: Adopting Medical Technology That Costs Less and Does Less
Moderator: Greg de Lissovoy, PhD, MPH, Senior Research Scientist and Vice President, Health Technology, Center for Health Economics, Epidemiology and Science Policy, United BioSource Corporation
Panelists: 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; John F.P. Bridges, PhD, Assistant Professor, Department of Health Policy and Management, Johns Hopkins University; David W. Lee, PhD, Senior Director, Health Economics - Americas, GE Healthcare
WORKSHOPS
Mon. May 17, Session II
4:15 - 5:15 p.m.
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; Laurie B. Burke, RPh, MPH, Director, Study Endpoints and Label Development, Center for Drug Evaluation and Research, Food and Drug Administration; Ann Marie Trentacosti, MD, Endpoints Reviewer, Study Endpoints and Label Development, Center for Drug Evaluation and Research, Food and Drug Administration
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; Kyle Fahrbach, PhD, Senior Biostatistician, United BioSource Corporation; David Vanness, PhD, Assistant Professor, Population Health Sciences, University of Wisconsin School of Medicine and Public Health
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; Georgia Mitsi, PhD, MBA, MSc, Manager, United BioSource Corporation; J. Jaime Caro, MD, Senior Vice President of Health Economics, United BioSource Corporation
Tues. May 18, Session III
4:00 - 5:00 p.m.
Identifying and Projecting Product Value Through Early-Phase Clinical-Economic Modeling
Discussion Leaders: Ipek Ozer-Stillman, MS, Research Scientist, United BioSource Corporation; J. Jaime Caro, MDCM, FRCPC, FACP, Senior Vice President, United BioSource Corporation; Bjorn Bolinder, MBA, Head, Primary Care, Global Health Outcomes, Merck & Co.
Strategies and Methods for Optimizing the Use of Outcomes Reported by Patients Along the Health Care Decision Making Continuum - From Regulators, to Health Technology Assessors, to Payers
Discussion Leaders: Asha Hareendran, PhD, Senior Research Scientist, United BioSource Corporation; William Lenderking, PhD, Senior Research Leader, United BioSource Corporation; Lou Garrison, PhD, Professor, Pharmaceutical Outcomes Research & Policy Program, Department of Pharmacy, University of Washington
Tues. May 18, Session IV
5:15 - 6:15 p.m.
When There is No Head-To-Head Trial: Using a PARTS Approach
Discussion Leaders: Zeba Khan, PhD, Vice President, Pricing and Market Access, Celgene; J. Jaime Caro, MD, Senior Vice President of Health Economics, United BioSource Corporation
Wed. May 19, Session V
1:45 - 2:45 p.m.
Enriching Budget Impact Models for U.S. Payers with Relevant Clincal Outcomes
Discussion Leaders: Ipek Ozer-Stillman, MS, Research Scientist, United BioSource Corporation; John D. Whalen, Research Associate II, United BioSource Corporation; Bjorn Bolinder, MBA, Head, Primary Care, Global Health Outcomes, Merck & Co.
Wed. May 19, Session VI
3:00 - 4:00 p.m.
Failure at the Mean: The Importance of Reflecting Heterogeneity in Economic Evaluations
Discussion Leaders: Denis Getsios, Research Scientist, United BioSource Corporation; Phil McEwan, PhD, Managing Director, CRC
The Use of Observational Evidence for Comparative Effectiveness Research: Is It Fit-For-Purpose?
Discussion Leaders: Rachael Fleurence, PhD, Senior Research Scientist, Center for Health Economics and Science Policy, United BioSource Corporation; Kyle Fahrbach, PhD, Senior Biostatistician, United BioSource Corporation; David Vanness, PhD, Assistant Professor, Population Health Sciences, University of Wisconsin School of Medicine and Public Health
PODIUM PRESENTATIONS
Mon. May 17, Session I
1:45 - 2:45 p.m.
Accounting for the Relationship Between Per Diem Cost and LOS When Estimating Hospitalization Costs
Stolar M, Hu MY, Ishak K, Wang Y, Williams GC, Ferguson J, Getsios D, Alvarez P
Tues. May 18, Session III
9:45 - 10:45 p.m.
Perioperative Blood Pressure Control During Cardiac Surgery Reduces Hospitalization Costs
Ishak K, Stolar M, Wang Y, Alvarez P, Hu MY, Williams GC, Ferguson J, Aronson S, Multz AS, Dyke CM, Getsios D
POSTER PRESENTATIONS
Mon. May 17, Session I
8:00 a.m. - 8:30 p.m.
A Systematic Review of Adherence, Quality of Life and Medical Costs in Fixed-Dose Combination Regimens in Diabetes
Hutchins V, Krishnarajah G, Fleurence R
Budget Impact Analysis of an Organized Breast Cancer Screening Program Based on Annual Mamography for Colombian Women
Hernandez L, Castillo M
Cost-Effectiveness Analysis of Bendamustine Compared to Alemtuzumab and Chlorambucil for Chronic Lymphocytic Leukemia in a Treatment-Naive Population
Malin J, Kongnakorn T, Sterchele J, Salvador C, Getsios D, Mwamburi M
Cost-Effectiveness Analysis of Sorafenib Versus Best Supportive Care (BSC) in Advanced Hepatocellular Carcinoma (AHCC): The Public Health Care System Perspective in Brazil
Muszbek N, Munir U, Vioix H, Schiola A, Valderrama A, Teich V
Methodologic Issues of Identifying Febrile Neutropenia Patients Using Medical Claims Data
Michels SL, Barron R
Methods for Identifying Case Reports of Suspected Adverse Drug Reactions: An Evaluation of the Efficiency of Alternative Search Strategies in Medline and EMBASE
Michels SL, Ward A, Jones N
Tues. May 18, Session II
8:00 a.m. - 8:00 p.m.
The Comparative Efficacy of Injectable and Oral Atypical Antipsychotics in Reducing Relapses in Adult Schizophrenia Patients: A Systematic Review and Mixed Treatment Comparison Analysis
Blume S, Naci H, Green J, Fleischmann J, Gaudig M
Differences in Clinician Reported Ease of Use Between 2 Hemostasis Treatment Methods: Results From a Randomized Controlled Study
Rupnow MF, McCormack J, Vernon M, Batiller J, Hammond J
Effect of Equivalent and Non-Equivalent Substitution of Prescribed Drugs for Depression and Anxiety Disorders on Patients Treatment Adherence and Perception
LaPensee K, Carson R, Werner P, Sexton CC, Gelhorn H, Stankus A, Erder H
Impact of Bleeding-Related Complications and Blood Product Transfusions on Hospital Length of Stay and Costs in Inpatient Surgical Patients
Stokes M, Ye X, Mercaldi K, Reynolds MW, Rupnow MF, Hammond J
The Utilization of Parenteral Nutrition in the United States
Liu FX, Mercaldi K, Turpin R
Web-Surveys: Real World Evidence Gathering and Minimizing Uncertainty in Economic Models
Mitsi G, Cragin L, Payne K, Yu R, Goh J
Wed. May 19, Session III
8:00 a.m. - 3:00 p.m.
Cost-Analysis of Levofloxacin IV Compared to Other Guideline-Endorsed Therapies for Patients Hospitalized with Community-Acquired Pneumonia
Kongnakorn T, Mody S, Li Q, Frei C, Raut M, Schein J
Discrete Event Simulation of Cardiac Hospitals Performing Percutaneous Coronary Interventions
Pei P, Kongnakorn T, Hernandez L, Bae JP, Ramaswamy K, Moller J
Economic Evaluation of Ceftobiprole for the Treatment of Complicated Skin and Skin Structure Infections in the United States
Kongnakorn T, Baker TM, Akhras K, Merchant S, Mwamburi M, Caro JJ
Methods to Identify and Compare Bloodstream Infection Rates Among Patients Administered Parenteral Nutrition via Hospital Compounded vs. Premixed Multi-Chamber Bags
Liu FX, Mercaldi K, Reynolds MW, Turpin R
Systematic Review of the Economic Burden of Venous Thromboembolism Treatment
Woodward TC, Kachroo S, Bookhart B, Chen J, Reynolds MW
Translating the EXACT: Ensuring Conceptual Equivalence Across Multiple Cultures
Arnold BJ, Murray L, Herzberg T, Roberts L, Leidy N
Using Different Measures to Determine Time in Therapeutic INR Range Among Warfarin-Treated Patients Following Total Hip or Knee Replacement
Nordstrom B, Kachroo S, Nutescu E, Schein J, Fisher A, Bookhart BClinical-Economic Evaluation of Azacitidine Versus Decitabine For Treating Patients with Myelodysplastic Syndromes (MDS)
Miller J, Fenaux P, Beach C.L., Gidwani R, Khan, Zeba -
2010 American Thoracic Society (ATS) International Conference
May 14 - May 19 2010
New Orleans, LA, USA
www.thoracic.org
Oral Presentations
Session Title: Celebrating the 25th Anniversary of the National Institute of Nursing Research (NINR)
Sunday, May 16, 8:45 a.m.
Intramural Research at NIH: Improving Functional Outcomes in COPD
Nancy K. Leidy, PhD, Senior Vice President, Scientific Affairs, United BioSource Corporation
Session Title: Meet the Professor
Sunday, May 16, 12 p.m.
Objective Measurement of Subjective Phenomena: Patient-Reported Outcome Measurement in Clinical Studies
Nancy K. Leidy, PhD, Senior Vice President, Scientific Affairs, United BioSource Corporation
Poster Presentations
The CAT Can Detect Improvements in Overall COPD Health Status Associated with Recovery from Acute Exacerbations
Jones P, Harding G, Wiklund I, Yu R, Leidy NK
The CAT Can Detect COPD Health Status Gains Resulting from Rehabilitation Programmes
Jones P, Harding G, Wiklund I, Berry P, Tabberer M, Yu R, Leidy NK
Patient Willingness to Pay for Specific Attributes of Maintenance Medication for COPD
Kleinman L, Kawata AK, Harding G, Ramachandran S
Reliability and Validity of the Shortness of Breath with Daily Activity (SOBDA) Questionnaire: A New Outcome Measure for Evaluating Dyspnea in COPD
Wilcox T, Chen WH, Howard KA, Cates CE, Wiklund I, Watkins ML, Brooks J, Tabberer M, Crim C
Smoking, Smoking Cessation, and Smoking Relapse Patterns in the US: A Web-Based Survey of Current and Former Smokers
Yeomans K, Marton JP, Merikle E, Ishak KJ, Proskorovsky I, Zou KH, Willke RJ, Payne KA -
The Canadian Pain Society Annual Conference
May 12 - May 15 2010
Calgary, Alberta, Canada
www.canadianpainsociety.ca/congres/calgary2010/index.htm
Presentation
Methodology of a Web-based Observational Study to Evaluate the Impact of Opioid Tolerability Issues on Chronic Pain Management
Rod K, Kozak J, Payne K, Prinzo R -
ABN (Association of British Neurologists) Annual Meeting 2010
May 11 - May 14 2010
Bournemouth, UK
www.theabn.org/Home.aspx
Poster Presentation
Impact of Chronic versus Episodic Migraine on Disability, HRQOL and Healthcare Resource Utilisation in the UK
Goadsby P, Lipton R, Varon S, Buse D, Kawata A, Wilcox T, Girod I, Blumenfeld A -
ARVO 2010 Annual Meeting
May 2 - May 6 2010
Fort Lauderdale, FL, USA
www.arvo.org/eweb/startpage.aspx?site=AM2010
Poster Presentations
Effect of Dexamethasone Intravitreal Implant on Patient-Reported Visual Functioning for the Treatment of Macular Edema Following Retinal Vein Occlusion
Kowalski JW, Rentz A, Revicki D, Heier J, Belfort R, Haller J, Liu C-C, Whitcup SM
Efficacy of Dexamethasone Intravitreal Implant for the Treatment of Uveitis Based on Patient-Reported Vision Function Outcome Measures
Naik RK, Gelhorn H, Kowalski JW, Cui H, Revicki D, Lowder CY, Belfort Jr R, Foster S, Lightman S, Whitcup SM
Normative Comparison of Generic and Vision-Targeted Health-Related Quality of Life (HRQL) Outcomes in Patients with Vision Loss Due to Macular Edema Following Retinal Vein Occlusion
Rentz A, Kowalski JW, Revicki D, Loewenstein A, Blumenkranz M, Yoon Y, Whitcup SM -
Digestive Disease Week 2010
May 1 - May 5 2010
New Orleans, LA, USA
www.ddw.org/wmspage.cfm?parm1=679
Poster Presentation
Prevalence of Constipation and Fecal Incontinence in Men and Women with Overactive Bladder and Lower Urinary Tract Symptoms
Cash BD, Coyne KS, Kopp ZS, Gelhorn H, Berriman S, Khullar V -
Society of Cardiovascular Anesthesiologists 32 Annual Meeting & Workshops
Apr 24 - Apr 28 2010
New Orleans, LA, USA
www.scahq.org/
Poster Presentation
The Impact of Perioperative Blood Pressure Control on Hospitalization Costs in Patients Undergoing Cardiac Surgery: Results from ECLIPSE
Multz AS, Dyke CM, Hu M, Wang Y, Williams GC, Ferguson J, Getsios D, Ishak J, Alvarez P, Stolar M, Aronson S -
19th Annual Partnerships in Clinical Trials
Apr 12 - Apr 14 2010
Orlando, FL, USA
www.iirusa.com/cropartners/welcome-to-CROs.xml
Panel Discussion
RiskMaps, Registries and REMS: Next Generation Post Marketing Research (PMR) and Obligations to Meet Regulatory Standards and Enhance Patient Safety
Moderator: John Balian, MD, Senior Vice President, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb
Panelists: Maria Harrison, Vice President, Late Phase Services, PRA International; Thomas More, Technical Manager, NYCLIX; Amrit Ray, MD, MBA, FCMI, Chief Safety Officer, Head, Global Medical Safety, Johnson & Johnson Pharmaceuticals Group; Annette Stemhagen, DrPH, FISPE, Senior Vice President, Epidemiology, Registries and Risk Management, United BioSource Corporation; Philippe Van der Auwere, MD, PhD, Global Head of Safety Risk Management (PDS) & EU-QPPV, Pharma Development, F. Hoffmann-La Roche Ltd.
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2010 American Academy of Neurology (AAN) Annual Meeting
Apr 10 - Apr 17 2010
Toronto, ON, Canada
www.aan.com/go/am10
Poster Presentations
Determinants of Migraine-Related Disability
Lipton RB, Blumenfeld A, Ishak KJ, Varon SF, Kawata AK, Manack A, Buse DC, Goadsby PJ
Effectiveness of Memantine in Patient with Moderate to Severe Alzheimer's Disease as Measured by Caregiver Perceived Burden Questionnaire (CPBQ)
Wilcox T, Chen W-H, OQuinn S, Setyawan J, Saxton J, Erder MH
Relationship Between Headache Frequency and Migraine-Related Disability in the International Burden of Migraine Study (IBMS)
Wilcox TK, Blumenfeld A, Varon SF, Payne KA, Manack A, Buse DC, Goadsby PJ, Lipton RB -
DIA Evidence-Based Medicine and Health Technology Assessment: Moving from Separate Appraisals to Synergistic Communications
Mar 23 - Mar 24 2010
Washington, DC, USA
www.diahome.org
Tuesday, Mar. 23, 3:30 - 5:00 p.m.
SESSION 2 - Evidence Hierarchies and Methodological Best Practices
Speaker
Designing Studies for Better Evidence
Bryan Luce, PhD, Senior Vice President, Science Policy, United BioSource Corporation
Tuesday, Mar. 23, 5:30 - 6:30 p.m.
Poster Presentation
Do Comparative Effectiveness Reviews Make an Impact? A Case Study of AHRQ Effective Health Care Program Reports
Singer Cohen R, Hunter C -
Pharmaceutical Education & Research Institute (PERI) - Asthma and COPD: Clinical Drug Development Course
Mar 22 - Mar 23 2010
Arlington, VA, USA
www.peri.org/course_details.cfm?course=1972
Course Presentation
Patient-Reported Outcomes for Asthma and COPD
Instructor: Nancy Kline Leidy, PhD, Senior Vice President, Scientific Affairs, United BioSource Corporation -
European Pharmaceutical Reimbursement & Market Access Conference
Mar 8 - Mar 9 2010
London, UK
www.q1productions.com/eventPages/event_LSCONF-2016.php
Session Presentation
Pricing, Reimbursement and Market Access Strategies for Orphan Medicines
Adam Barak, Head, International Pricing and Reimbursement, United BioSource Corporation -
The International Society for CNS Clinical Trials and Methodology (ISCTM) 2010 Mental Health Research-To-Policy Forum
Feb 23 - Feb 23 2010
Washington, DC, USA
www.isctm.org/
8:30 - 11:30 a.m.
Session: The Role of CER in Future Mental Health Policy Decision Making
Presenter
CER 2010: Critical Review of the Current Science and the Politics of CER
Bryan R. Luce, PhD, MBA, Senior Vice President, Science Policy, United BioSource Corporation -
International Society for the Study of Women’s Sexual Health 2010 Annual Meeting
Feb 18 - Feb 21 2010
St. Petersburg, FL, USA
www.isswsh.org/
Presentation
The Impact of Hypoactive Sexual Desire Disorder (HSDD) on Women and Their Relationships: Qualitative Data from Patient Focus Groups
Revicki D, Fisher W, Rosen R, Kuppermann M, Margolis MK, Hanes V
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Preventive Medicine 2010
Feb 17 - Feb 20 2010
Washington, DC, USA
www.preventivemedicine2010.org/
Poster Presentation
Psychosocial Effects of Frequent Heartburn: A Nationally Representative Survey of Frequent Heartburn Sufferers in America
Stull DE, van Hanswijck de Jonge P, Winnette R, Fennerty MB, Farber M, Ferguson D, Fourcroy J, Sandor DW -
Joint DIA / IFAPP Pharmaceutical Policy Forum
Feb 4 - Feb 5 2010
London, UK
www.diahome.org
Presentation
Economic and Reimbursement Drivers for Pharma / Healthcare Collaboration
Robert M.A. Thwaites, MA, Senior Executive Director - Europe, United BioSource Corporation -
Adaptive Designs in Clinical Drug Development
Feb 3 - Feb 4 2010
London, UK
www.smi-online.co.uk/events/overview.asp?is=4&ref=3182
Presentation
Implementing Adaptive Design: A Technology Perspective
Scott Hamilton, Senior Director, Biometrics and Randomisation Technologies, United BioSource Corporation -
COPD Biomarkers Qualification Workshop
Jan 27 - Jan 28 2010
Bethesda, MD, USA
www.copdfoundation.org
Presentation
The Exacerbations of Chronic Pulmonary Disease Tool - Patient-Reported Outcomes (EXACT-PRO)
Nancy K. Leidy, PhD, Senior Vice President, Scientific Affairs, United BioSource Corporation