Agenda

Day One - 5/11/2010 : AM | PM
Day Two - 5/12/2010 : AM | PM
DAY ONE - Tuesday, May 11
8:00-8:15 Chairperson's Opening Remarks
Richard Gliklich, MD, Harvard Medical School, Outcome
State of the Industry - Safety, Quality, and Effectiveness
8:15-9:00 Keynote: Envisioning the Future of Safety and Effectiveness
To Be Announced
9:00-9:45 Keynote: Adjusting for Success: The Impact of the Evolving Post-Approval Landscape
Michael Rosenblatt, MD, Executive Vice President and Chief Medical Officer, Merck & Co., Inc.
9:45-10:00 Break
Safety and Risk Management
10:00-10:45 Evolving Role and Expectations for REMS and Safety Programs
Gerald Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration (FDA)
10:45-11:30 European Updates to Risk Management
Stella Blackburn, MA, MSc, FRCP(Ed), FFPM, Risk Management Development and Scientific Lead, European Medicines Agency
11:30-12:00 Case Study: Using a Registry for REMS and PASS Requirements
Eleanor Segal, MD, Vice President and Head Global Drug Safety, Actelion Pharmaceuticals
12:00-1:15 Lunch
1:15-2:00 Designing Safety Studies: Interventional vs Observational
Sharon-Lise Normand, PhD, Professor of Health Care Policy, Harvard Medical School and Harvard School of Public Health
2:00-2:45 Challenges of Device Tracking and Adverse Event Reporting
Richard E. Kuntz, MD, Senior Vice President, Chief Scientific, Clinical and Regulatory Officer, Medtronic
2:45-3:30 Integrating Risk Management Planning into the Regulatory Decision-Making Process
Marc Berthiaume, MD, Director, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada
3:30-3:45 Break
3:45-5:00 New Innovations in Safety
Stella Blackburn, MA, MSc, FRCP(Ed), FFPM, Risk Management Development and Scientific Lead, European Medicines Agency

Nancy Dreyer, MPH, PhD, Chief of Scientific Affairs and Senior Vice President, Outcome

Michael Ibara, PharmD, Head of Pharmacovigilance Information Management, Pfizer, Inc.
5:00-5:30 Case Study
5:30-6:15 Molecular Networks: The New Grammar of Medicine
Mark Fishman, MD, President, Novartis Institute for Biomedical Research
6:15

Opening Night Reception
Isabella Stewart Gardner Museum
Attendees are invited to attend the opening night reception at the Isabella Stewart Gardner Museum on May 11 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.

Back to Top

DAY TWO - Wednesday, May 12
8:00-8:15 Chairperson's Opening Remarks
Richard Gliklich, MD, Harvard Medical School, Outcome
Comparative Effectiveness and Evidence Development
8:15-9:00 Keynote: ARRA and Comparative Effectiveness Research in the New U.S. Healthcare System
Patrick Conway, MD, MSc, Chief Medical Officer, Office of the Secretary, U.S. Department of Health and Human Services
9:00-9:45 Planning Across the Product Lifecycle: Addressing New Challenges for Post-Approval Data Requirements
Freda Lewis-Hall, MD, FAPA, Chief Medical Officer and Senior Vice President, Pfizer
9:45-10:00 Break
10:00-10:45   
Evolving Role of Effectiveness and Quality Performance Data
Barry M. Straube, MD, Director and Chief Clinical Officer, Office of Clinical Standards and Quality, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services
10:45-11:15 Challenges and Benefits of New CE Initiatives to Industry
Marc Berger, MD, Vice President, Global Health Outcomes, Eli Lilly and Company
11:15-11:45     Role of CER, Coverage Determinations, and Value-Based Reimbursement 
Fadia Shaya, PhD, MPH, Associate Director, Center on Drugs and Public Policy, Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy
11:45-12:15 Comparative Effectiveness and Evidence-Based Decision-Making in the UK
Sarah Garner, BPharm, MRPharmS, PhD, Associate Director Research and Development, National Institute for Health and Clinical Excellence (NICE)
12:15-1:15 Lunch
Multi-Stakeholder Collaboration in Evidence Development
1:15-2:00 Collaborative Models for Priority Setting and Program Support
Sean Tunis, MD, MSc, Founder and Director, Center for Medical Technology Policy
2:00-2:45 Case Study: Using a Registry for Multi-Stakeholder Needs
Bruce Marshall, MD, Vice President of Clinical Affairs, Cystic Fibrosis Foundation
Registries Workshop: Planning, Operational, and Analytical Challenges
2:45-3:45 Designing and Operating Registries
Workshop Leaders:
Nancy Dreyer, PhD, MPH, Senior Vice President and Chief of Scientific Affairs, Outcome

Leanne Larson, MHA, Senior Vice President, Strategic Development, Outcome

Michelle Bulliard, Director Clinical Operations, Outcome Europe Sàrl
3:45-4:15 Case Study: Maximizing Communications 
David Cooper, MD, Director, Medical Affairs, Novo Nordisk

 

Back to Top