Summit Agenda 2013
| Day One - 5/7/2013: Morning » Afternoon » Day Two - 5/8/2013: Morning » Afternoon » |
| { Day One - Tuesday, May 7 } | |
| 8:30-8:45 | Chairperson's Opening Remarks Richard Gliklich, MD, Professor, Harvard Medical School and President, Quintiles Outcome |
| Comprehensive Approaches to Evidence Development for Safety and Effectiveness | |
| 8:45-9:30 | Keynote: Evolving Role of Different Approaches to Meeting Safety and Effectiveness Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, Food and Drug Administration |
| 9:30-10:15 | Changing the Drug Development and Commercialization Paradigm for Meeting Stakeholder Requirements Jens Grueger, PhD, Vice President, Head of Global Pricing & Market Access, Roche Pharmaceuticals |
| 10:15-10:30 | Break |
| 10:30-11:15 | Best Practices and Considerations in Designing and Implementing Cardiovascular Outcome Trials Steven Nissen, MD, Chairman, Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Cleveland Clinic |
| 11:15-12:00 | Shifting Role of Pragmatic Clinical Trials in Effectiveness Research Sean Tunis, MD, MSc, President and Chief Executive Officer, Center for Medical Technology Policy |
| 12:00-1:15 | Lunch |
| 1:15-2:00 | Growth of Prospective Observational Research, New Methods and Initiatives Elise Berliner, PhD, Director of Technology Assessment Program, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality |
| 2:00-2:30 | Case Study: Using a Registry for Evaluating Outcomes from Different Treatments Flora Lum, MD, Executive Director, The H. Dunbar Hoskins Jr., M.D. Center for Quality Eye Care, American Academy of Ophthalmology |
| 2:30-3:15 | Big Data: Leveraging EHR and Health System Data Sebastian Schneeweiss, MD, Sc.D, SM, Professor of Medicine and Epidemiology, Department of Medicine, Harvard Medical School |
| 3:15-3:45 | Case Study: Integrating EHR Data into Research Robert Cuddihy, MD, Vice President, Medical Diabetes Head, Sanofi US |
| 3:45-4:00 | Break |
| 4:00-6:00 |
Panel Presentations: The Need for New and Comprehensive Models for Evidence Development Evolving Models for Partnering in Evidence Development |
| 6:30 | Opening Night Reception Attendees are invited to attend the opening night reception at the Isabella Stewart Gardner Museum, on May 7 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 and beverages will be provided. |
| { DAY TWO - Wednesday, May 8 } | |
| 8:15-8:30 | Chairperson's Opening Remarks Richard Gliklich, MD, Professor, Harvard Medical School and President, Quintiles Outcome |
| Monitoring and Managing Safety: Updates on Changing Requirements | |
| 8:30-9:15 | European Updates to Pharmacovigilance Guidelines Stella Blackburn, MA, MSc, FRCP(ed), FFPM, Risk Management Development and Scientific Lead, European Medicines Agency |
| 9:15-10:00 | Using Sentinel for Safety and Comparative Effectiveness Richard Platt, MD, Professor and Chair of the Department of Population Medicine, Harvard Medical School and Executive Director, Harvard Pilgrim Health Care Institute |
| 10:00-10:15 | Break |
| 10:15-10:45 | Case Study: Evidence Generation for Oncology Veronique Kugener, MD, MSc, MBA, Vice President, Pharmacovigilance and Risk Management, Millennium: The Takeda Oncology Company |
| 10:45-11:30 | Device Safety: Developing a Sustainable Infrastructure for Post-Approval Research Danica Marinac-Dabic, PhD, MD, Office of Surveillance and Biometrics, Division of Epidemiology, Center for Devices and Radiological Health, Food and Drug Administration |
| 11:30-12:30 | Lunch |
| 12:30-1:15 | Exploring Comprehensive Evidence for Supporting Coverage Decisions for Devices Louis Jacques, MD, Director, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare and Medicaid Services |
| 1:15-1:30 | Device Discussions |
| Evolving Models and Methods for Evidence Development | |
| 1:30-2:15 | Making Research Better: Methods, Guides and Checklists Robert Dubois, MD, PhD, Chief Science Officer, National Pharmaceutical Council Nancy Dreyer, Chief of Scientific Affairs and Senior Vice President, Quintiles Outcome |
| 2:15-3:00 | NICE International and Evolving Reimbursement Models in Emerging Markets Professor Peter Littlejohns, Division of Health and Social Research, School of Medicine, King's College London |
| 3:00-3:45 | Alternative Models to Researching Safety and Effectiveness in Underserved Populations David Reddy, PhD, Chief Executive Officer, Medicines for Malaria Venture |
| 3:45-4:00 | Closing Remarks |
The listed program and speakers are subject to change without notice.