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Pre-Conference Workshops
Pre-Conference Workshops
| Monday January 26, 2009 | |
B1 Overcome Outsourcing & Operational Challenges for Smaller Companies | |
| 8:00 | Registration and Morning Coffee hosted by  |
| 9:00 | Workshop Begins |
| 9:00 | Best Practices in Outsourcing to Central Labs to Improve Efficiencies Gary Albert, Manager Clinical Operations, ALNYLAM PHARMACEUTICALS |
| 10:00 | Building the Checklists-Qualification, Selection, and Operating Tools to Save You Time Donna Saligan, MBA, MT (ASCP), Contracts and Outsourcing Manager, RH Bouchard & Associates, INC. |
| 10:30 | Morning Networking Break |
| 11:00 | Building the Checklists-Qualification, Selection, and Operating Tools to Save You Time Donna Saligan, MBA, MT (ASCP), Contracts and Outsourcing Manager, RH Bouchard & Associates, INC. |
| 11:45 | Going Global: Strategies for Success Guy Dewil, PhD, Chief Operating Officer, ICON CENTRAL LABORATORIES |
| 12:30 | Networking Luncheon |
| 1:45 | Navigating ECG RFPs and Maximizing the Continuum of Service Kristian B. Hubbard, Research, Grants and Contracts, Clinical Pharmacology, Translational Medicine, Biostatistics and Anti Infective, EISAI MEDICAL RESEARCH |
| 2:30 | How Continuous Improvement and Targeted Metrics Yield Dramatic Gains for Sponsors And Imaging Core Labs Jeff Markin, President and CEO, VIRTUALSCOPICS |
| 3:15 | Afternoon Networking Break |
| Panel Discussion | |
| 3:45 | How to Reduce the Burden on Smaller Sponsor Clinical Team-The Cross Functional Approach |
| Panel Discussion | |
| 4:30 | Working with a Central Laboratory to Help Control your Clinical Trial Costs Panelists: Marietta M. Henry, MD, Vice President, Medical Affairs and Global Laboratory Medical Director, COVANCE CENTRAL LABORATORY SERVICES Susan Martin, MD, Director, Medical Affairs, COVANCE CENTRAL LABORATORY SERVICES Maria Taboada, Associate Director, Global Logistics, COVANCE CENTRAL LABORATORY SERVICES Millie Marsh, Global Director, Site Support, COVANCE CENTRAL LABORATORY SERVICES |
| 5:15-6:45 | Networking Reception |
 Networking, Networking and More Networking!Please join us for the Partnering with Central Labs Welcome Reception Monday, January 26th, 5:15-6:45 Mingle with your colleagues and clients and have a drink on us! Join us as we welcome everyone and kick off our 7th Annual Conference. | |
B2 Getting the Most Technical Expertise from Your Labs: Biomarkers, Personalized Medicine, Diagnostics, and Assay Development | |
| 8:00 | Registration and Morning Coffee hosted by |
| 9:00 | Workshop Begins |
| 9:00 | Personalized Medicine and Its Impact on Drug development and Commercialization David Lester, Senior Vice President, Strategy and Corporate Development, GENE EXPRESS |
| Case Study | |
| 9:30 | Companion Diagnostics: Implementation models for Rx/Dx Co development Concept David Johnston, PhD, Vice President, Companion Diagnostics, LABCORP; Chief Scientific Officer, ESOTERIX CLINICAL TRIALS SERVICES |
| 10:00 | Biomarkers in Oncology |
| 10:30 | Morning Networking Break |
| Case Study | |
| 11:00 | Biomarkers as Potential Companion Diagnostics: A New Paradigm for Central Laboratories Services Maribeth Raines, PhD, Director, Scientific Affairs, QUEST DIAGNOSTICS CLLINICAL TRIALS |
| 11:30 | Archival Surgical Pathology Specimens: A New Exercise in Clinical Trials Carol W Johnson, DVM, PhD, DACVP, Pathology Director, AMGEN - Invited Joseph Schappert, MD, Global Medical Director, ICON CENTRAL LABORATORIES |
| 12:00 | Bridging the Gaps in Biomaker Development and Testing for Global Clinical Trials Biomarkers, Digital Patheology & the Central Lab Christopher Ung, M.S., MBA, Vice President, Global Central Laboratories, TMD, A QUINTILES CENTRAL LABORATORY |
| 12:30 | Networking Luncheon |
1:15 | Case Studies using Biomarkers for Dosage in Phase I, Early Detection of Nephrotoxicity and Diagnosis of Schizophrenia: The Rule-Based Medicine Approach Ralph McDade, Ph.D. Strategic Development Officer, Rules Based Medicine |
| 1:45 | The Use of Imaging Biomarkers in Phase I/II trials Haren Rupani, Global Head, Oncology Clinical Imaging, NOVARTIS PHARMACEUTICALS CORPORATION |
| 2:15 | Using Technical Consulting Services to Avoid Pitfalls in Biomarker Data Collection Rajani Prasad, PhD, Vice President, Clinical Research, CRL CLINICAL REFERENCNE LABORATORY |
| 2:45 | Using Robust QT in Drug Development for Earlier Evaluation and Compound Advancement |
| 3:15 | Afternoon Networking Break |
| 3:45 | Kidney Injury Molecule-1: Biology and Analytical Validation Tom Turi, VP Biomarkers, COVANCE CENTRAL LABORATORY SERVICES |
| Panel Discussion | |
| 4:30 | Technical Hot Topics |
| 5:15-6:45 | Networking Reception |
| Networking, Networking and More Networking! Please join us for the Partnering with Central Labs Welcome Reception Monday, January 26th, 5:15-6:45 Mingle with your colleagues and clients and have a drink on us! Join us as we welcome everyone and kick off our 7th Annual Conference. | |
B3 Morning Half Day Workshop - Cardiac Safety | |
| 8:00 | Registration and Morning Coffee hosted by |
| 9:00 | Workshop Begins |
| 10:30 | Networking Break |
| 12:30 | Networking Luncheon |
| Cardiac Safety: Premarketing Assessment for Noncardiac Drugs Workshop Leaders J. Rick Turner, PhD, Chairman, Department of Clinical Research, CAMPBELL UNIVERSITY SCHOOL OF PHARMACY Todd A. Durham, MS, Senior Director of Biostatistics and Data Management, INSPIRE PHARMACEUTICALS | |
B4 Afternoon Half Day Workshop - Echocardiography in Clinical Trials | |
| 1:00 | Registration hosted by |
| 1:45 | The Value & Increasing Importance of Echocardiography in Clinical Trials Polina Voloshko, Vice President, Medical Operations. CARDIOCORE Nelson Schiller, MD, FACC, Chair of Cardiology, University of California San Francisco, and Director of Echocardiography, SAN FRANCISCO VA HOSPITAL |
| 3:15 | Afternoon Networking Break |
| 3:45 | Centralizing Echocardiography in Clinical Trials Dave Donahue, ARENA PHARMACEUTICALS Julio E. Pérez, MD, Professor of Medicine, Director of Echocardiography, WASHING TON UNIVERSITYSCHOOL OF MEDICINE Tim Callahan, PhD, Chief Scientific Officer, BIOMEDICAL SYSTEMS |
| 5:15-6:45 | Networking Reception |
| Networking, Networking and More Networking! Please join us for the Partnering with Central Labs Welcome Reception Monday, January 26th, 5:15-6:45 Mingle with your colleagues and clients and have a drink on us! Join us as we welcome everyone and kick off our 7th Annual Conference. | |
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