Agenda
| Day One - 5/1/2012 : AM | PM |
| Day Two - 5/2/2012 : AM | PM |
| DAY ONE - Tuesday, May 1 | |
| 8:30-8:45 | Chairperson's Opening Remarks Richard Gliklich, MD, Harvard Medical School, President, Outcome, A Quintiles Company |
| A New World of Post-Approval Research | |
| 8:45-9:30 | Keynote: Impact of Real-World and Evidence-Based Medicine for Demonstrating the Safety and Effectiveness of New Therapeutics Michael Rosenblatt, MD, Executive Vice President and Chief Medical Officer, Merck |
| Meeting Safety Surveillance and Benefit Risk Management Requirements | |
| 9:30-10:15 | Emerging Regulatory Changes in Post-Approval Safety and Risk Management Gerald Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration |
| 10:15-10:30 | Break |
| 10:30-11:15 | Updates to European Pharmacovigilance Guidelines Stella Blackburn, MA, Msc, FRCP(ed), FFPM, Risk Management Development and Scientific Lead, European Medicines Agency |
| 11:15-12:00 | Role of Observational and Interventional Study Designs in Safety Research Brian Strom, MD, George S. Pepper, Professor of Public Health and Preventative Medicine in Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania |
| 12:00-1:00 | Lunch |
| 1:00-1:30 | Case Study: Using Retrospective Data to Evaluate Safety Signals and Assess Risk Jeanenne J. Nelson, MSPH, PhD, Director of Oncology Epidemiology, Worldwide Epidemiology, GlaxoSmithKline |
| 1:30-2:00 | The Role of the Big Database in Safety Paul Stang, PhD, Senior Director, Epidemiology, Johnson & Johnson Pharmaceutical Research and Development |
| 2:00-2:30 | ASTER-D and New Models in Device Safety Reporting and Surveillance Terrie L. Reed, MSIE, Senior Public Health Analyst and Associate Director Informatics, Center for Devices and Radiological Health, Food and Drug Administration |
| 2:30-3:00 | Panel: Perspectives in Safety |
| 3:00-3:15 | Break |
| Different Data Sources: Problems, Limitations, and Methods | |
| 3:15-3:45 | Case Study: Tale of Two Data Sources – A Uterine Fibroid Study Priscilla Velentgas, MS, PhD, Director of Epidemiology, Outcome, A Quintiles Company |
| 3:45-4:15 | Case Study: Novel Uses of Data Sources - Offlabel Use of Drugs in Cancer Amy Abernathy, MD, Associate Professor of Medicine, Division of Medical Oncology, Department of Medicine, Duke University School of Medicine, Director, Duke Cancer Care Research Program |
| Global and Local Considerations in Phase IV | |
| 4:15-5:00 | Challenges in Designing and Implementing Phase IV in Emerging Markets |
| 5:00-5:30 | Regulatory Considerations Barbara Isquith Arone, MS, Director of Professional Services, Outcome, A Quintiles Company |
| 6:00 |
Opening Night ReceptionAttendees are invited to attend the opening night reception at the Boston Skywalk Observatory, located at the top of the Prudential Center in Downtown Boston, on May 1 following the close of sessions. The reception offers attendees the opportunity see sweeping 360 degree views of Greater Boston and beyond, while networking with colleagues, speakers, and other attendees. Hors d'oeuvres and beverages will be provided. |
| DAY TWO - Wednesday, May 2 | |
| 8:30-8:45 | Chairperson's Opening Remarks Richard Gliklich, MD, Harvard Medical School, President, Outcome, A Quintiles Company |
| Comparative Effectiveness Research: Challenges, Best Practices and Methods, and Reimbursement | |
| 8:45-9:30 | Keynote: Early Stages and Direction of PCORI Joe V. Selby, MD, MPH, Executive Director of the Patient-Centered Outcomes Research Institute (PCORI) |
| 9:30-10:15 | Evolving Tools for Assessing the Effectiveness of Health Technologies for Reimbursement and Market Access Sun Hae Lee Robin, Head of Department of Medical and Surgical Procedures Assessment, French National Authority for Health (Invited) |
| 10:15-10:30 | Break |
| 10:30-11:15 | Re-emerging Role of the Randomized Trial in Post-Approval Robert J. Temple, MD, Deputy Center Director for Clinical Science, Center for Drug Evaluation and Research, Food and Drug Administration (Invited) |
| 11:15-12:00 | CER of Newly Marketed Medications Sebastian Schneeweiss, MD, ScD,Associate Professor of Epidemiology, Harvard School of Public Health, Associate Professor of Medicine, Harvard Medical School |
| 12:00-12:45 | Decision-Maker Preferences in Planning the Missing Evidence Link Robert Dubois, MD, PhD, Chief Science Officer, National Pharmaceutical Council |
| 12:45-1:45 | Lunch |
| 1:45-2:15 | Case Study: Using a Disease Registry to Evaluate Different Standards of Treatment and Treatment Patterns Samuel Wagner, PhD, RPh, Executive Director, Oncology, Global Health Economics and Outcomes Research, Bristol-Myers Squibb |
| 2:15-3:00 | Panel Discussion: Evidence Face-Off: Advantages and Disadvantages of Different Research Approaches |
| 3:00-3:15 | Break |
| 3:15-3:45 | Case Study: Understanding Treatment Patterns through Patient-Reported Data David Cooper, MD, Director Medical Affairs, Novo Nordisk (Invited) |
| 3:45-4:45 |
Putting the Patient into Patient-Centered Outcomes Research Note: An invitation only satellite workshop will continue on May 3. |