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 C. Geoffrey McDonough, Genzyme, Thomas Gross, FDA, Rosemarie Hakim, CMS, Richard Gliklich, Harvard, Panos Tsintis, EMEA, Peter Littlejohns, NICE (UK)
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| DAY ONE - Wednesday, May 14 |
| 8:15-8:30 |
Chairperson's Opening Remarks:
Richard Gliklich, MD, Harvard Medical School, and Outcome
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| Post-Approval Regulations and Expectations |
| 8:30-9:20 |
Keynote: PDUFA Reauthorization and Post-Approval Research: What Will it Mean?
Janet Woodcock, MD, Deputy Commissioner and Chief Medical Officer, The Food and Drug Administration (FDA)
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| 9:20-10:00 |
Retooling the Life Sciences Industry for a Post-Approval World
Joseph Camardo, MD, Senior Vice President Global Medical Affairs, Wyeth Pharmaceuticals
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| 10:00-10:15 |
Break |
| Risk Minimization, RiskMAPs, and Safety Surveillance |
| 10:15-11:00 |
Keynote: What Does the Future Hold for Safety Surveillance?
Mark McClellan, MD, PhD, Chairman, Reagan-Udall Foundation
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| 11:00 - 11:45 |
Case Study: Creating an Active Surveillance System
Richard Platt, MD, Professor of Ambulatory Care and Prevention, Professor of Medicine, Harvard Medical School
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| 11:45-12:45 |
Lunch |
| 12:45 - 1:30 |
What Are RiskMAPs and How Should They Be Evaluated?
Gerald Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration
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| 1:30 - 2:15 |
Building RiskMAPs
Jerome Premmereur, MD, Vice President Medical Risk Management, Sanofi-Aventis
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| 2:15 - 3:00 |
Tsyabri Case Study: Two Years Later
Carmen Bozic, MD, Vice President Drug Safety and Risk Management, Biogen
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| 3:00 - 3:15 |
Break |
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| 3:15 - 5:15 |
Panel: Safety, Phase IV Studies, and Global Trends
European Experiences with Risk Management Programs: Stella Blackburn, MD, Pharmacovigilance and Post-Authorisation Safety and Efficacy, European Agency for the Evaluation of Medicinal Products (EMEA)
Post-Approval Requirements and Risk Management in Canada: Marc Berthiaume, MD, Director, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada
The Future of Safety and Phase IV Studies in India: Dr. M. Venkateswarlu, Former, Drugs Controller General, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India
Q&A-All Panelists
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| 6:00 |
Opening Night Reception
Isabella Stewart Gardner Museum
Attendees are invited to attend the opening night reception at the Isabella Stewart Gardner Museum on May 14 following the close of sessions. The reception offers attendees the opportunity to see this beautiful, world-renowned museum while networking with colleagues, speakers, and other attendees. Hors d'oeuvres, beverages, and musical entertainment will be provided and all galleries will be open to view, with docents onsite to answer any questions on the art or history of the museum. |
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| DAY TWO - Thursday, May 15 |
| 8:15-8:30 |
Chairperson's Opening Remarks:
Richard Gliklich, MD, Harvard Medical School, and Outcome
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| Using Real-World Data & Decision Making |
| 8:30 - 9:15 |
Comparative Effectiveness Research: A Primer
Sebastian Schneeweiss, MD, ScD, Associate Professor of Medicine, Harvard Medical School, Director for Drug Evaluation and Outcomes Research, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
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| 9:15 - 10:00 |
Using Comparative Effectiveness Data for Product Commercialization
David Recker, MD, FACR, FACP, Senior Vice President, Clinical Science, Takeda Global Research and Development Center
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| 10:00 - 10:15 |
Break |
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| 10:15 - 11:00 |
Real-World Data and Decision-Making in the UK
Professor Michael Kelly, PhD, Public Health Excellence Centre Director, National Institute for Health and Clinical Excellence (NICE)
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| 11:00 - 12:10 |
Panel: Real-World Data from Measuring Effectiveness to Determining Reimbursement
Nancy Dreyer, PhD, MPH, Chief of Scientific Affairs, Outcome
Payer Perspective: Troyen Brennan, MD, MPH, Chief Medical Officer, Aetna
Industry Perspective: Lisa Griffin Vincent, PhD, Senior Director, Corporate Clinical Research and Development, Medtronic
Government Perspectives: Professor Michael Kelly, PhD, Public Health Excellence Center Director, National Institute for Health and Clinical Excellence (NICE); Marc Berthiaume, MD, Director, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada; Elise Berliner, PhD, Director, Technology Assessment Program Center for Outcomes and Evidence, Agency for Healthcare Research and Quality (AHRQ)
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| 12:10 - 1:15 |
Lunch |
| 1:15 - 2:00 |
Real-World Data, Quality and Value-Driven Healthcare
Meredith Rosenthal, PhD, Associate Professor Health Economics and Policy, Harvard School of Public Health
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| 2:00 - 2:25 |
Break |
| Workshop and Case Studies |
| 2:25 - 4:30 |
Practical Issues in Designing and Implementing Registries and Real-World Studies
Workshop Leader:
Nancy Dreyer, PhD, MPH, Chief of Scientific Affairs, Outcome
Case Presentation - Challenges of Understanding Treatment Effectiveness and PROs with a Rare Disease and New Product
Achim Obergfell, MD, Medical Manager Biopharm, Medical Affairs NNRE, Clinical Development Center Europe, Novo Nordisk A/S
Case Presentation - Strategies in Designing a Study to Meet a Post-Marketing Commitment Herb Neuman, MD, Chief Medical Officer, Covidien
Case Presentation - Benefits of Implementing a Quality Improvement Study and Techniques for Managing Publications
Barbara Arone, MS, Program Manager, Outcome
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