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Day Two

Day Two

Wednesday January 28th, 2009
8:15Morning fCoffee Hosted by:
9:00Chairperson’s Welcome
Robert Scott-Edwards, President, ICON CENTRAL LABORATORIES

Cynthia Lindemann, Associate CDS Consultant/Central Laboratory Coordinator, Clinical Diagnostic Services, ELI LILLY & COMPANY

9:15Strengthening the Sponsor / Vendor / Site Relationship. What Do Sites Really Think? Site Survey- Sites’ Perspective to Improve Efficiency and Quality in Clinical Trials

Gary Albert, Manager Clinical Operations, ALNYLAM PHARMACEUTICALS
William Smith, President, Clinical Research, NEW ORLEANS CENTER FOR CLINICAL RESEARCH INVITED invited
Clare O'Sullivan, General Manager, ICON CENTRAL LABORATORIES, Dublin
10:00INSPIRATIONAL KEYNOTE
 Lou FerrignoIncredible Change: Overcome your Partnering Obstacles with the “Hulk”
Overcome fear and maximizing your own personal power! Hear how he has dealt with adversity and how he came from nothing to overcome every obstacle he has encountered! Lou Ferrigno, “THE INCREDIBLE HULK
10:45NETWORKING BREAK KEYNOTE MEET AND GREET
11:30 Sample Management: Tracking Global Lab Samples to Ensure you Get the Data

Adam Ruskin, Director, MAXYGEN PHARMACEUTICALS
PANEL DISCUSSION
12:00Comparing Approaches: Preferred Providers vs Competitive Bidding, What is your Best Choice?

Panelists:
Diane Stinson, External Services Group, MERCK & COMPANY
Jim Meringolo, Vice President, ICON CENTRAL LABORATORIES
Roberto Vaccaro, Senior Manager, Electronic Data Services
R&D Strategic Sourcing & Procurement, AMGEN
12:30 Networking Luncheon in Exhibit Hall
Track A: Central Lab Relationship Development
1:30Chairperson’s Opening Remarks Stephanie Talbott, Vice President, Global Business Development, ICON CENTRAL LABORATORIES
MCC CENTRAL LABORATORY METRICS VERSION 1.1 CASE STUDY AND PANEL
1:35

Overview of Metrics: Definition Refinement & Update from the Central Lab MCC Initiative

Sue Hwang, Senior Manager, R&D Global Strategic Sourcing, AMGEN
Cynthia Lindemann, CDS Consultant, Central Laboratory ,Coordinator, Clinical Diagnostic Services, ELI LILLY & COMPANY

Alissa Kerry, Sr. Manager, Business Process Measurements Covance Central Laboratory

2:15

PANEL DISCUSSION

Reducing Costs at Investigator Sites through Process Improvement

Jennifer Christie, Master Black Belt, COVANCE CENTRAL LABORATORIES SERVICES
Jonathan Koch, Vice President, Global Clinical Trial Management & Operations, COVANCE CENTRAL LABORATORIES SERVICES

TBA JOHNSON & JOHNSON

3:00OPEN SESSION
3:30Conference Concludes
Track B: Standardization in Imaging Studies
1:30Chairperson’s Opening Remarks
David Rauh, Clinical Diagnostic Services Imaging Management, ELI LILLY & COMPANY
1:35 Charter Development and Industry Standardization with FDA/ PhRMA

Vahe Ghahraman, PhD, Associate Director, RAC, DYAX CORPORATION
2:15Building the Imaging Lexicon for Rate Cards to Improve Industry Consistency

P. David Mozley, MD, Senior Director, MERCK & COMPANY
3:00Imaging Regulatory Environment Shift Strategies

George Mills, PhD, Vice President, Medical Imaging Consulting, Perceptive Informatics, PAREXEL INTERNATIONAL
Beth Sabatino, Outsourcing Manager, BRISTOL MYERS SQUIB
3:30 Conference Concludes
Track C: Improving and Standardizing ECG and Cardiac Safety Studies
1:30Chairperson’s Opening Remarks
EXTENDED SESSION
1:35

Working Together to Develop Biomarkers for Safety Monitoring and Surrogate Endpoints

Samir Khleif, Head, Cancer Vaccine Section Investigator, NATIONAL CANCER INSTITUTE, NIH

Wendy R. Sanhai, PhD, Senior Scientific Advisor, Office of the Commissioner, FDA *FDA Session*

Dr. Bill Wheeler, MD, FACC,  Global Medical Director, Centralized Cardiac Sevices, MDS PHARMA SERVICES
Dr. Patrice Hugo Vice-President of Scientific Affairs, MDS PHARMA SERVICES

3:00Methods to Mitigate the Potentially Distorting Effect of Heart Rate in QT Analyses

Lawrence Z. Satin, MD, FACC, Chief Medical Officer, CARDIOCORE TBA SHIRE PHARMACEUTICALS
3:30Conference Concludes
  
             
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