7th Annual Partnering with Central Labs
Red Rock Casino Resort Spa
11011 West Charleston Boulevard
Las Vegas, NV

Schedule of Presentations:

Monday, January 26, 2009
08:00:00 B2 : Registration and Morning Coffee hosted by WORLD COURIER
08:00:00 B1 : Registration and Morning Coffee hosted by WORLD COURIER
08:00:00 B3 : Registration and Morning Coffee hosted by World Courier
08:00:00 B1 Overcome Outsourcing & Operational Challenges for Smaller Companies
08:00:00 B3 Morning Half Day Workshop - Cardiac Safety
08:00:00 B2 Getting the Most Technical Expertise from Your Labs: Biomarkers, Personalized Medicine, Diagnostics, and Assay Development
09:00:00 B2 : Workshop Begins
09:00:00 B2 : Personalized Medicine and Its Impact on Drug development and Commercialization David Lester
09:00:00 B3 : Workshop Begins
09:00:00 B1 : Best Practices in Outsourcing to Central Labs to Improve Efficiencies Gary Albert
09:00:00 B1 : Workshop Begins
09:30:00 B2 : Companion Diagnostics: Implementation models for Rx/Dx Co development Concept David Johnston
10:00:00 B1 : Building the Checklists-Qualification, Selection, and Operating Tools to Save You Time Suzanne Fosburgh
10:00:00 B2 : Biomarkers in Oncology
10:30:00 B2 : Morning Networking Break
10:30:00 B3 : Networking Break
10:30:00 B1 : Morning Networking Break
11:00:00 B1 : OPEN SESSION
11:00:00 B2 : Biomarkers as Potential Companion Diagnostics: A New Paradigm for Central Laboratories Services Maribeth Raines
11:30:00 B2 : Archival Surgical Pathology Specimens: A New Exercise in Clinical Trials Carol W Johnson, Joseph Schappert
11:45:00 B1 : Going Global: Strategies for Success
12:00:00 B2 : OPEN SESSION
12:30:00 B1 : Networking Luncheon
12:30:00 Networking Luncheon
12:30:00 B3 : Networking Luncheon
13:00:00 B4 Afternoon Half Day Workshop - Echocardiography in Clinical Trials
13:00:00 B3 : Cardiac Safety: Premarketing Assessment for Noncardiac Drugs J. Rick Turner, Todd Durham
13:00:00 Registration hosted by WORLD COURIER
13:45:00 B1 : Navigating ECG RFPs and Maximizing the Continuum of Service Kristian Hubbard
13:45:00 B4 : The Value & Increasing Importance of Echocardiography in Clinical Trials Polina Voloshko, Nelson Schiller
13:45:00 B2 : The Use of Imaging Biomarkers in Phase I/II trials Haren Rupani
14:15:00 B2 : Using Technical Consulting Services to Avoid Pitfalls in Biomarker Data Collection Rajani Prasad
14:30:00 B1 : How Continuous Improvement and Targeted Metrics Yield Dramatic Gains for Sponsors And Imaging Core Labs
14:45:00 B2 : Using Robust QT in Drug Development for Earlier Evaluation and Compound Advancement
15:15:00 B1 : Afternoon Networking Break
15:15:00 B4 : Afternoon Networking Break
15:15:00 B2 : Afternoon Networking Break
15:45:00 B4 : Centralizing Echocardiography in Clinical Trials Julio Perez, Tim Callahan, William R Shanahan
15:45:00 B1 : How to Reduce the Burden on Smaller Sponsor Clinical Team-The Cross Functional Approach Karen Turner, John Penmann, Rhonda Benotti, Solomon Babani
15:45:00 B2 : Kidney Injury Molecule-1: Biology and Analytical Validation Shalini Chaturvedi
16:30:00 Technical Hot Topics Haren Rupani, David Lester, David Johnston, Ralph McDade
16:30:00 B1 : Working with a Central Laboratory to Help Control your Clinical Trial Costs Marietta M Henry, Susan Martin, Maria Taboada, Millie Marsh
17:15:00 B4 : Networking Reception
17:15:00 B1 : Networking Reception
17:15:00 B2 : Networking Reception
Tuesday, January 27, 2009
07:30:00 Registration and Morning Coffee hosted by World Courier
08:15:00 Chairperson’s Welcome Robert Edwards Scott, Cynthia Lindemann
08:30:00 Featured Session : The Changing Face of R&D: Trends in New Drug Development Kenneth I Kaitin
09:30:00 Risk Assessment : Drug Safety Evaluation: Benefit-Risk Assessments throughout Development and Therapy J. Rick Turner
10:15:00 Risk Assessment : Networking Break in Exhibit Hall
11:00:00 Risk Assessment : Improve Operational Success by Developing Vendor Quality Management Plans Solomon Babani, Marie Ulrich, John Penmann
11:45:00 Risk Assessment : Current and Future Metrics Champion Consortium Metrics Initiatives Guy Mascaro, David Rauh, Sue Hwang, Julia Amo
12:15:00 Risk Assessment : Strolling Networking Luncheon in Exhibit Hall
13:30:00 Chairperson’s Opening Remarks Denise Legenzoff
13:30:00 Track B : Chairperson’s Opening Remarks David Rauh
13:30:00 Track C : Chairperson’s Opening Remarks
13:35:00 Track B : Current Standardization Initiatives for Use of Imaging in Clinical Trials Mark Tengowski
13:35:00 Track A : Improve Patient Care, Transparency and Process Efficiency in Global Studies Solomon Babani, Scott Sawicki, Stephanie Talbott, Patrick Lindsay
13:35:00 Track C : Update on FDA Guidance for ECG Related Studies Jeffrey Litwin
14:00:00 Track B : Metrics Champion Consortium Imaging Performance Metrics Announcement David Rauh, Craig Lipset
14:00:00 Track C : ECG Data Integration and Standardization with CDM/ EDC Systems Jennifer Cotteleer
14:00:00 Track A : Central Lab Cost Drivers and Logistics Discussion Forum John Monetti, Scott Sawicki, Rajani Prasad, David Mooney
14:30:00 Track B : Utility of Imaging in Clinical Trials- Strategies for Success Craig Lipset, P David Mozley
14:30:00 Track C : New Equipment and Software Technology Landscape Tim Callahan, Tosja K Zywietz
14:30:00 Track A : Support of Local Laboratories by a Central Laboratory in Global Phase III Oncology Trials Jaap H.M Dijkman
15:00:00 Track B : Networking Break in Exhibit Hall
15:00:00 Track C : Networking Break in Exhibit Hall
15:00:00 Track A : Networking Break in Exhibit Hall
15:45:00 Track A : Best Practices for Collecting and Integrating Data in International Clinical Trials Jennifer Duff, Elena Gogoleva
15:45:00 Track B : Bridging Small Imaging Studies to Large Imaging Studies for Smoother Transitions James Paskavitz
15:45:00 Track A : OPEN SESSION
16:15:00 Track C : Using the MCC ECG Metrics Jeffrey Litwin, Steve Asbury
16:15:00 Track A : Risk Management for Global Studies Raphaële Mary
16:15:00 Track B : Standardizing Intra/Inter Observer Variability and Adjudication Rates in Imaging Studies Ted Gastineau, Ed Ashton
16:45:00 Track C : Hot Topics and Trends in Cardiac Safety Studies Tim Callahan, Matthew Spear
16:45:00 Track A : Development of Central Laboratory in China- Challenges and Opportunities James J Ho
17:15:00 Track C : Reception in Exhibit Hall
17:15:00 Track B : Reception in Exhibit Hall
17:15:00 Reception in Exhibit Hall Hosted by ESOTERIX
Wednesday, January 28, 2009
08:15:00 Morning Coffee Hosted by : World Courier
09:00:00 Chairperson’s Welcome Robert Edwards Scott, Cynthia Lindemann
09:15:00 Strengthening the Sponsor / Vendor / Site Relationship. What Do Sites Really Think? Site Survey- Sites’ Perspective to Improve Efficiency and Quality in Clinical Trials Gary Albert, Denise Legenzoff
10:00:00 INSPIRATIONAL KEYNOTE : Incredible Change: Overcome your Partnering Obstacles with the “Hulk”
11:30:00 Sample Management: Tracking Global Lab Samples to Ensure you Get the Data Adam Ruskin
12:00:00 PANEL DISCUSSION : Comparing Approaches: Preferred Providers vs Competitive Bidding, What is your Best Choice? Diane Stinson, Jim Meringolo, Roberto Vaccaro
12:30:00 Networking Luncheon in Exhibit Hall
13:30:00 Track A : Chairperson’s Opening Remarks Stephanie Talbott
13:30:00 Track B : Chairperson’s Opening Remarks David Rauh
13:30:00 Track C : Chairperson’s Opening Remarks
13:35:00 Track C : Working Together to Develop Biomarkers for Safety Monitoring and Surrogate Endpoints Wendy Sanhai, Patrice Hugo, Samir Khleif, Bill Wheeler
13:35:00 Track B : Charter Development and Industry Standardization with FDA/ PhRMA Vahe Ghahraman
13:35:00 Track A : Overview of Metrics: Definition Refinement & Update from the Central Lab MCC Initiative Sue Hwang, Cynthia Lindemann
14:15:00 Track B : Building the Imaging Lexicon for Rate Cards to Improve Industry Consistency P David Mozley
14:15:00 Track A : Reducing Costs at Investigator Sites through Process Improvement Jennifer Christie, Jonathan Koch
15:00:00 Track C : Methods to Mitigate the Potentially Distorting Effect of Heart Rate in QT Analyses Lawrence Satin
15:00:00 Track B : Imaging Regulatory Environment Shift Strategies George Mills, Beth Sabatino
15:00:00 Track A : OPEN SESSION
15:30:00 Conference Concludes
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