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Day One
Day One
| Tuesday January 27th, 2009 | |
| 7:30 | Registration and Morning Coffee hosted by  |
| 8:15 | Chairperson’s Welcome Cynthia Lindemann, Associate CDS Consultant/Central Laboratory Coordinator, Clinical Diagnostic Services, ELI LILLY & COMPANY |
| 8:30 | Featured Session The Changing Face of R&D: Trends in New Drug Development How are economic, regulatory, and competitive forces changing the  pharmaceutical landscape? What are researchbased companies doing to meet the growing demand for improved R&D efficiency and output? In what ways can outsourcing and offshoring stem the rising time, cost, and risk of drug development? Reporting on recent Tufts CSDD analyses, we will explore the current environment for pharmaceutical R&D and examine the impact of efforts to boost R&D performance. Kenneth I. Kaitin, PhD, Director and Professor of Medicine, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT |
| Risk Assessment | |
| 9:30 | Drug Safety Evaluation: Benefit-Risk Assessments throughout Development and Therapy J. Rick Turner, PhD, Chairman, Department of Clinical Research, CAMPBELL UNIVERSITY SCHOOL OF PHARMACY |
| 10:15 | Networking Break in Exhibit Hall |
| 11:00 | Improve Operational Success by Developing Vendor Quality Management Plans Martie Griffin, VP of QA, CELTIC PHARMA Marie V. Ulrich, Vendor Quality Manager, GLOBAL VENDOR QUALITY MANAGEMENT a division of Global Clinical Trial Logistics, WYETH RESEARCH John Penman, Director, Clinical Trials and Medical Services, CRL, CLINICAL REFERENCE LABORATORY |
| 11:45 | Current and Future Metrics Champion Consortium Metrics Initiatives Guy Mascaro, President, Metrics Champion Consortium, MCC David Rauh, Clinical Diagnostic Services Imaging Management, ELI LILLY & COMPANY Sue Hwang, Senior Manager, R&D Global Strategic Sourcing, AMGEN Steve Asbury, Global ECG Coordinator, ELI LILLY & COMPANY |
| 12:15 | Strolling Networking Luncheon in Exhibit Hall |
| Track A: Central Lab Relationship Development | |
| 1:30 | Chairperson’s Opening Remarks Clare O’Sullivan, General Manager, ICON Central Laboratories, Dublin |
| 1:35 | Improve Patient Care, Transparency and Process Efficiency in Global Studies Solomon Babani, Director, CELTIC PHARMA DEVELOPMENT SERVICES Scott Sawicki, MA, Section Head, Central Laboratory & Diagnostic Services, CRO Management, NOVARTIS PHARMACEUTICALS CORPORATION Stephanie Talbott, Vice President, Global Business Development, ICON CENTRAL LABORATORIES Patrick Lindsay, Senior Vice President, Strategy and Business Development, UNITED BIOSOURCE CORPORATION - Invited |
| 2:00 | Central Lab Cost Drivers and Logistics Discussion Forum David Mooney, Director, Global Supply Chain, QUEST DIAGNOSTICS |
| 2:30 | Support of Local Laboratories by a Central Laboratory in Global Phase III Oncology Trials Dr. Marc-Ulrich Häusler, Senior Clinical Data Manager, Global Data Management, Merck Serono Development/Global Clinical Operations |
| 3:00 -3:45 | Networking Break in Exhibit Hall Hosted by: |
| 3:45 | Best Practices for Collecting and Integrating Data in International Clinical Trials Jennifer Duff, Associate Director, ACCENTURE AT WYETH Elena Gogoleva, Laboratory Data Manager, GENENTECH - Invited |
| 3:45 | OPEN SESSION |
| 4:15 | Risk Management for Global Studies Beth Sabatino, Outsourcing Manager, BRISTOL-MYERS SQUIBB |
| PANEL DISCUSSION | |
| 4:45 | Development of Central Laboratory in China- Challenges and Opportunities Dr. James J Ho, MD, PhD, DABCC, Chief Executive Officer, PEKING UNION LAWKE BIOMEDICAL DEVELOPMENT LIMITED |
| 5:15 | Tuesday Concludes |
| 5:15-6:45 | Reception in Exhibit Hall Hosted by  |
| Track B: Standardization in Imaging Studies | |
| 1:30 | Chairperson’s Opening Remarks David Rauh, Clinical Diagnostic Services Imaging Management, ELI LILLY & COMPANY |
| 1:35 | Current Standardization Initiatives for Use of Imaging in Clinical Trials Mark Tengowski, DVM, PhD, Director Clinical Affairs, VIRTUALSCOPICS |
| 2:00 | MCC METRICS Metrics Champion Consortium Imaging Performance Metrics Announcement David Rauh, Clinical Diagnostic Services Imaging Management, ELI LILLY & COMPANY Craig Lipset, Director, Molecular Medicine, PFIZER |
| 2:30 | Utility of Imaging in Clinical Trials- Strategies for Success Craig Lipset, Director, Molecular Medicine, PFIZER P David Mozley, MD, Senior Director, MERCK & COMPANY |
| 3:00 -3:45 | Networking Break in Exhibit Hall Hosted by: |
| PANEL DISCUSSION | |
| 3:45 | Bridging Small Imaging Studies to Large Imaging Studies for Smoother Transitions James Paskavitz, MD, Medical Director, PERCEPTIVE INFORMATICS TBA, BIOMEDICAL SYSTEMS |
| PANEL DISCUSSION & EXTENDED SESSION | |
| 4:15 | Standardizing Intra/Inter Observer Variability and Adjudication Rates in Imaging Studies David L. Raunig, PhD, Associate Director, Imaging Translational Technologies Statistics, Pfizer Global Research and Development (TBC) Ted Gastineau, Chief Executive Officer, ICON MEDICAL IMAGING Ed Ashton, Chief Scientific Officer, VIRTUAL SCOPICS Dr. Derek Hill, Co-founder and CEO, IXICO |
| 5:15 | Tuesday Concludes |
| 5:15-6:45 | Reception in Exhibit Hall Hosted by |
| Track C: Improving and Standardizing ECG and Cardiac Safety Studies | |
| 1:30 | Chairperson’s Opening Remarks |
| 1:35 | Update on FDA Guidance for ECG Related Studies Jeffrey Litwin, MD, Chief Medical Officer & Executive Vice President, eRESEARCHTECHNOLOGY |
| 2:00 | ECG Data Integration and Standardization with CDM/ EDC Systems Jennifer Cotteleer, Chief Executive Officer, CARDIOCORE |
| PANEL DISCUSSION | |
| 2:30 | New Equipment and Software Technology Landscape Moderator: Tim Callahan, PhD, Chief Scientific Officer, BIOMEDICAL SYSTEMS Panelists: Dr. Tosja K. Zywietz, CARDINAL HEALTH RESEARCH SERVICES |
| 3:00 -3:45 | Networking Break in Exhibit Hall Hosted by: |
| MCC METRICS | |
| 4:15 | Using the MCC ECG Metrics Jeffrey Litwin, MD, Chief Medical Officer & Executive Vice President, eRESEARCHTECHNOLOGY Steve Asbury, Global ECG Coordinator, ELI LILLY & COMPANY |
| PANEL DISCUSSION | |
| 4:45 | Hot Topics and Trends in Cardiac Safety Studies Moderator: Tim Callahan, PhD, Chief Scientific Officer, BIOMEDICAL SYSTEMS Panelists: Matthew Spear, MD, Chief Medical Officer, Vice President, NEREUS PHARMACEUTICALS Invited Jay W. Mason, MD, Cardiac Safety Consultant CMO, OBS MEDICAL |
| 5:15 | Tuesday Concludes |
| 5:15-6:45 | Reception in Exhibit Hall Hosted by |
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