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| 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, Biogen Idec |
| 10:30 | Morning Networking Break | | 11:00 | OPEN SESSION | | 11:45 | Going Global: Strategies for Success | | 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
Annette Chan, PhD , Manager-Medical Imaging Technical Services, AMGEN | | 3:15 | Afternoon Networking Break | | Panel Discussion | | 3:45 | How to Reduce the Burden on Smaller Sponsor Clinical Team-The Cross Functional Approach
Moderator:
Solomon Babani, Director, Celtic Pharma
DEVELOPMENT SERVICES
Panelists:
Karen H Turner, Senior Contract Analyst Global Resourcing, Grants & Contracts (GRGC), GLAXOSMITHKLINE
John Penman, Director, Clinical Trials and Medical Services, CRL, CLINICAL REFERENCE LABORATORY
Rhonda Benotti, Development Outsourcing & Contracts, GENENTECH
Chris Helton, Director of Data Management and Clinical Systems, ACM PIVOTAL
| | 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 | OPEN SESSION | | 12:30 | Networking Luncheon | | 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 | | 3:15 | Afternoon Networking Break | | 2:45 | Using Robust QT in Drug Development for Earlier Evaluation and Compound Advancement
William Wheeler, MD, FACC, Global Medical Director, Centralized Cardiac Services, MDS PHARMA SERVICES | | 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
Panelists:
Haren Rupani, Global Head, Oncology Clinical Imaging, NOVARTIS PHARMACEUTICALS CORPORATION
David Lester, Senior Vice President, Strategy and Corporate Development, GENE EXPRESS
David Johnston, PhD, Vice President, Companion Diagnostics, LABCORP; Chief Scientific Officer, ESOTERIX CLINICAL TRIALS SERVICES Ralph McDade, RULES BASED MEDICINE | | 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
William R. Shanahan, Jr. MD, JD, Vice President and Chief Medical Officer, 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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