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Agenda at a Glance
Agenda at a Glance
Monday, September 20, 2010 | Workshops |
| 8:15 | Registration and Morning Coffee | 1:15 | Sessions Continue |
| 9:00 | Sessions Begin | 3:00 | 30-Minute Afternoon Networking Break |
| 10:30 | 30-Minute Morning Networking Break | 5:00 | Session Concludes |
| 12:00 | Luncheon | ||
A | RFI University: Building a Clinical Core Lab RFI Request for Information | B | Logistics Task Force: Best Practices in Transportation Logistics |
The RFI University curriculum is filled with hands on information for developing an industry standard Request for Information (RFI) for clinical outsourcing and data managers. The lessons of the one day university are designed to make outsourcing to core labs a more standardized process. Discuss tips, tools and lessons learned to make your job easier during planning, execution and analysis of Core Lab Outsourcing. University Professors: | The Logistics Task Force is dedicated to open and inclusive discussion of logistics issues which affect clinical research and define best practices to address those issues. Each issue will be followed by a discussion on best practices which will include opportunities for the audience to contribute. The Logistics Task Force is an open forum. Our discussions can be found on the Clinical Trial Logistics forum on LinkedIn. Your contributions would be welcome. Case study: “Reducing the Use of Specialty Couriers in Clinical Trials”
B: Specialty Courier Cost Drivers: Understanding the cost issues and quality issues Moderator: Panelists: Alejandro Serricchio, Vice President, OCASA Logistics Solutions | ||
Tuesday, September 21, 2010 | Morning Plenary |
| 8:00 | Registration and Morning Coffee |
| 8:45 | Chairperson’s Welcome Craig H. Lipset, Director, Molecular Medicine, PFIZER |
| 9:00 | Prediction, Prevention and Detection – How the Patient will be the Game Changer in Personalized Medicine, Diagnostics and Clinical Drug Development Thomas Goetz, MPH, Executive Editor, WIRED MAGAZINE Author, The Decision Tree |
| 9:45 | Future of Central Labs – Autumn Update Breaking News: Solutions to R&D Challenges – Tufts CSDD’s Annual Report on Drug Development Kenneth I Kaitin, PhD, Director and Professor of Medicine, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, TUFTS UNIVERSITY |
| 10:30 | 45-Minute Morning Networking Break in the Exhibit Hall |
| 11:15 | Technology in Action Spirometry OverRead Process – Gain Access to Investigator Site Pulmonary Function Data Jim Sowash, Director, OverRead Department, ERT |
| 11:30 | Keynote Presentation The Language of Life: DNA and the Revolution in Human Genomics Stephan Schuster, Professor of Biochemistry and Molecular Biology, PENN STATE UNIVERSITY CENTER FOR COMPARATIVE GENOMICS AND BIOINFORMATICS |
| 12:00 | Case Study Siteless Trials and the ePatient: Learn to Use New Technologies to Change the Clinical Trial as We Know It Craig H. Lipset, Director, Molecular Medicine, PFIZER |
| 12:30 | Networking Luncheon |
Tuesday, September 21, 2010 | Afternoon Tracks |
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| 1:30 | Track Chair: Sarah Martin-Munley, PhD, Biotech and Pharmaceutical Consultant | Track Chair: Jennifer Duff, Associate Director, Clinical Data Management, ACCENTURE AT PFIZER | ||||
| 1:35 | Cost, Quality and Time Management Strategies When Outsourcing to Central Labs, ECG and Imaging Labs Panelists: George Tiger, eRT | Adopt Process Efficiencies to Reduce Internal Overhead and Improve Biomarker Data Management Daru Sharp, BA, MS, DMCP Team Lead, External Data Operations, BRISTOL-MYERS SQUIBB | ||||
| 2:15 | Case Study Relationship Governance to Ensure Optimal Partnerships Beverly Armstrong, Outsourcing Manager, BRISTOL-MYERS SQUIBB | Real-Time Data Transfer Between Sponsors and Vendors to Improve First-Time Data Quality Jennifer Duff, Associate Director, Clinical Data Management, ACCENTURE AT PFIZER | ||||
| 2:45 | New Pharma Business Models: Effect on Budgets, Timelines and Relationships Analysis Bernadette Donohue, Head of Clinical Outsourcing, COVIDIEN Solomon Babani, Director, Celtic Pharma Development Rajani Prasad, Vice President, CLINICAL REFERENCE LABORATORY GLOBAL SERVICES | Standardization of Lab and Imaging Data Transfers Specifications Greg Burgess, External Data Acquisition Operations, SCHERING PLOUGH | ||||
| 3:15 | 30-minute Afternoon Networking Break | |||||
| 3:45 | Optimal Lab Selection for Oncology Studies to Improve Patient Care and Data Quality Panelists: Ken J. Pennline, PhD, Vice President Scientific Affairs and Global LAb Operations, ESOTERIX CLINICAL TRIAL SERVICES | Technical Data Management: Local Lab Data Harmonization, Collection of Repeat PK Data and Strategies for Faster Data Loading Collection of Repeat PK Data Strategies for Faster Data Loading and Faster Database Lock Panelists: | ||||
| 4:30 | TEAM APPROACH! How to Ensure that Lab Partnering Doesn’t Stop at the Outsourcing Transaction Dr. Marietta Henry, Vice President, Medical Affairs and Global Laboratory Medical Director, COVANCE CENTRAL LABORATORY | Local Lab Data Solutions Jim Wagner, Vice President of Technical Services, ICON CENTRAL LABORATORIES | ||||
| 5:00 -6:15 | Networking Reception in the Exhibit Hall | |||||
Wednesday, September 22, 2010 | Morning Plenary |
| 8:00 | Morning Coffee |
| 8:30 | Chairperson’s Recap of Day One Craig H. Lipset, Director, Molecular Medicine, PFIZER |
| 8:45 | Pharmacogenomics in Clinical Trials Michael Luther, President, David H Murdock Research Institute |
| 9:30 | Virtual Site Tour-Central Lab Kevin Smith, MBA, Director Clinical Operations, EUROFINS MEDINET |
| 9:45 | Panel Discussion Do Emerging Markets Still Exist? Discover Where the Value is and Learn about New Choices for Quality Global Central Lab Services Norman Mustafa, Global Outsourcing & Supplier Governance, Center for Clinical Study Excellence, GSK |
| 10:30 | 30 Minute Networking Break in Exhibit Hall |
| 11:00 | Virtual Site Tour- ECG Acquisition and Site training Jim Sowash, Director, OverRead Department, ERT |
| 11:15 | Performance Metrics Adoption and Integration Lessons from MCC Members to Improve Trial Operations Guy Mascaro, President, METRICS CHAMPION CONSORTIUM (MCC) Debbie Walton, MS, MBA, CPM, Relationship Manager, CENTRAL LABS AND DIAGNOSTICS, MERCK |
| 12:00 | Technology in Action Use of Ambulatory Blood Pressure Monitoring in Clinical Trials for Better Quality Measurements Lawrence Satin, MD, FACC, Chief Medical Officer, CARDIOCORE |
| 12:15 | Networking Luncheon |
Wednesday, September 22, 2010 | Afternoon Tracks |
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| 1:35 | Track Chair:
| Track Chair: Lawrence Satin, MD, FACC, Chief Medical Officer, CARDIOCORE | ||||
| 1:35 | Is the Decentralized Central Lab the New Model? Rajani Prasad, Vice President, CLINICAL REFERENCE LABORATORY GLOBAL SERVICES | Standardization and Process Efficiencies for Studies that Incorporate Clinical Endpoint Committees (CECs) or Data Safety Monitoring Boards (DSMBs) Rafael Escandon, Vice President, Clinical Outcomes, ICON MEDICAL IMAGING | ||||
| 2:15 | Identify Process Bottlenecks and Solutions to Save Everyone Time and Money Moderator: Panelists: | Standardization of Imaging Lab Processes in Oncology Studies Neeta Fahey, Associate Director, Clinical Imaging and Technologies, PFIZER | ||||
| 3:00 | Spotlight on Quality: Improve Vendor Quality Standardization for Global Regulatory Compliance
| Strategies to Efficiently Integrate Accurate ECG and Lab Data Jay W. Mason, MD, Chief Medical Officer, SPAULDING CLINICAL RESEARCH | ||||
| 3:45 | Conference Concludes | |||||
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