Biotech China 2014
7th Annual Partnering with Central Labs
Red Rock Casino Resort Spa
11011 West Charleston Boulevard
Las Vegas, NV
http://www.iirusa.com/centrallab/day-one.xml

Schedule of Presentations:

Monday, January 26, 2009
08:00:00 B2 : Registration and Morning Coffee hosted by WORLD COURIER
08:00:00 B3 Morning Half Day Workshop - Cardiac Safety
08:00:00 B1 Overcome Outsourcing & Operational Challenges for Smaller Companies
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 B2 Getting the Most Technical Expertise from Your Labs: Biomarkers, Personalized Medicine, Diagnostics, and Assay Development
09:00:00 B1 : Workshop Begins
09:00:00 B3 : Workshop Begins
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 B1 : Best Practices in Outsourcing to Central Labs to Improve Efficiencies Gary Albert
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 B1 : Morning Networking Break
10:30:00 B2 : Morning Networking Break
10:30:00 B3 : 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 Joseph Schappert, Carol W Johnson
11:45:00 B1 : Going Global: Strategies for Success
12:00:00 B2 : OPEN SESSION
12:30:00 Networking Luncheon
12:30:00 B3 : Networking Luncheon
12:30:00 B1 : Networking Luncheon
13:00:00 B4 Afternoon Half Day Workshop - Echocardiography in Clinical Trials
13:00:00 Registration hosted by WORLD COURIER
13:00:00 B3 : Cardiac Safety: Premarketing Assessment for Noncardiac Drugs Todd Durham, J. Rick Turner
13:45:00 B1 : Navigating ECG RFPs and Maximizing the Continuum of Service Kristian Hubbard
13:45:00 B2 : The Use of Imaging Biomarkers in Phase I/II trials Haren Rupani
13:45:00 B4 : The Value & Increasing Importance of Echocardiography in Clinical Trials Nelson Schiller, Polina Voloshko
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 B4 : Afternoon Networking Break
15:15:00 B2 : Afternoon Networking Break
15:15:00 B1 : Afternoon Networking Break
15:45:00 B1 : How to Reduce the Burden on Smaller Sponsor Clinical Team-The Cross Functional Approach Solomon Babani, Rhonda Benotti, John Penmann, Karen Turner
15:45:00 B2 : Kidney Injury Molecule-1: Biology and Analytical Validation Shalini Chaturvedi
15:45:00 B4 : Centralizing Echocardiography in Clinical Trials William R Shanahan, Tim Callahan, Julio Perez
16:30:00 B1 : Working with a Central Laboratory to Help Control your Clinical Trial Costs Millie Marsh, Maria Taboada, Susan Martin, Marietta M Henry
16:30:00 Technical Hot Topics Ralph McDade, David Johnston, David Lester, Haren Rupani
17:15:00 B1 : Networking Reception
17:15:00 B2 : Networking Reception
17:15:00 B4 : Networking Reception
Tuesday, January 27, 2009
07:30:00 Registration and Morning Coffee hosted by World Courier
08:15:00 Chairperson’s Welcome Cynthia Lindemann, Robert Edwards Scott
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 John Penmann, Marie Ulrich, Solomon Babani
11:45:00 Risk Assessment : Current and Future Metrics Champion Consortium Metrics Initiatives Julia Amo, Sue Hwang, David Rauh, Guy Mascaro
12:15:00 Risk Assessment : Strolling Networking Luncheon in Exhibit Hall
13:30:00 Track C : Chairperson’s Opening Remarks
13:30:00 Track B : Chairperson’s Opening Remarks David Rauh
13:30:00 Chairperson’s Opening Remarks Denise Legenzoff
13:35:00 Track B : Current Standardization Initiatives for Use of Imaging in Clinical Trials Mark Tengowski
13:35:00 Track C : Update on FDA Guidance for ECG Related Studies Jeffrey Litwin
13:35:00 Track A : Improve Patient Care, Transparency and Process Efficiency in Global Studies Patrick Lindsay, Stephanie Talbott, Scott Sawicki, Solomon Babani
14:00:00 Track B : Metrics Champion Consortium Imaging Performance Metrics Announcement Craig Lipset, David Rauh
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 David Mooney, Rajani Prasad, Scott Sawicki, John Monetti
14:30:00 Track A : Support of Local Laboratories by a Central Laboratory in Global Phase III Oncology Trials Jaap H.M Dijkman
14:30:00 Track C : New Equipment and Software Technology Landscape Tosja K Zywietz, Tim Callahan
14:30:00 Track B : Utility of Imaging in Clinical Trials- Strategies for Success P David Mozley, Craig Lipset
15:00:00 Track C : Networking Break in Exhibit Hall
15:00:00 Track B : Networking Break in Exhibit Hall
15:00:00 Track A : Networking Break in Exhibit Hall
15:45:00 Track A : OPEN SESSION
15:45:00 Track B : Bridging Small Imaging Studies to Large Imaging Studies for Smoother Transitions James Paskavitz
15:45:00 Track A : Best Practices for Collecting and Integrating Data in International Clinical Trials Elena Gogoleva, Jennifer Duff
16:15:00 Track B : Standardizing Intra/Inter Observer Variability and Adjudication Rates in Imaging Studies Ed Ashton, Ted Gastineau
16:15:00 Track A : Risk Management for Global Studies Raphaële Mary
16:15:00 Track C : Using the MCC ECG Metrics Steve Asbury, Jeffrey Litwin
16:45:00 Track A : Development of Central Laboratory in China- Challenges and Opportunities James J Ho
16:45:00 Track C : Hot Topics and Trends in Cardiac Safety Studies Matthew Spear, Tim Callahan
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 Cynthia Lindemann, Robert Edwards Scott
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 Denise Legenzoff, Gary Albert
10:00:00 INSPIRATIONAL KEYNOTE : Incredible Change: Overcome your Partnering Obstacles with the “Hulk”
10:45:00 NETWORKING BREAK KEYNOTE MEET AND GREET
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? Roberto Vaccaro, Jim Meringolo, Diane Stinson
12:30:00 Networking Luncheon in Exhibit Hall
13:30:00 Track B : Chairperson’s Opening Remarks David Rauh
13:30:00 Track A : Chairperson’s Opening Remarks Stephanie Talbott
13:30:00 Track C : Chairperson’s Opening Remarks
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 Cynthia Lindemann, Sue Hwang
13:35:00 Track C : Working Together to Develop Biomarkers for Safety Monitoring and Surrogate Endpoints Bill Wheeler, Samir Khleif, Patrice Hugo, Wendy Sanhai
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 Jonathan Koch, Jennifer Christie
15:00:00 Track B : Imaging Regulatory Environment Shift Strategies Beth Sabatino, George Mills
15:00:00 Track C : Methods to Mitigate the Potentially Distorting Effect of Heart Rate in QT Analyses Lawrence Satin
15:00:00 Track A : OPEN SESSION
15:30:00 Conference Concludes
4th Annual Pharma R&D Asia Congress
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