Institute for International Research

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Workshops October 11, 2006

AM Workshop:(B1)
Patience in Patient Recruitment: Examining Current Challenges with Humans in Clinical Trials
Bryan McIntyre, Senior Vice President, INCLINIX

PM Workshop (B2):
Cardiac Concerns-Examining the Use of Thorough QT/QTc Studies
Charles M. Beasley, Jr., MD, FRCPP, Distinguished Lilly Scholar; Chief Scientific Officer, Global Product Safety, ELI LILLY & COMPANY

Cardiac Concerns-Examining the Use of Thorough QT/QTc Studies
Polina Voloshko, MD, Vice President, Cardiovascular Clinical Services, GENTIAE CLINICAL SERVICES

Cardiac Concerns-Examining the Use of Thorough QT/QTc Studies
Pierre Wicker, Executive Director, Clinical Group Head, PFIZER GROUP RESEARCH AND DEVELOPMENT

Agenda Day One, October 12, 2006

Collaboration in the Industry: Taking a Closer Look at Wyeth's Translational Medicine Research Collaboration (TMRC)
Giora Feuerstein, MD, MSC, FAHA Assistant Vice President, Head of Discovery and Translational Medicine WYETH RESEARCH

Breaking Free From the Mold-Examining Challenges and Innovation in Early Phase I Study Designs
Stephen Freestone, MD Medical Director CHARLES RIVER LABORATORIES CLINICAL SERVICES

Breaking Free From the Mold-Examining Challenges and Innovation in Early Phase I Study Designs
Steve Matheson, Pharmaceutical Profiles

Understanding How the Critical Path Initiative (CPI) Will Impact Phase I Trials
Christopher-Paul Milne, DVM, MPH, JD Assistant Director, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

Breaking Free From the Mold-Examining Challenges and Innovation in Early Phase I Study Designs
Sandra F. Reilley, MD., Director of Clinical Operations NORTHWEST KINETICS

Regulatory Framework for Conducting Phase I Studies: a Comparison Between U.S., European Union and Canada
Mario Tanguay, PhD, B Pharm. Vice President, Scientific and Regulatory Affairs ANAPHARM

Predictive Computer Simulation in Early-Stage Clinical Research
Sam Holtzman, PhD CEO ROSA PHARMACEUTICALS

Agenda Day Two, October 13, 2006

Dealing with IRBs to Promote Timely, Efficient and Compliant Review
Lynn A. Myer President CIP, CIM, INTEGREVIEW- ETHICAL REVIEW BOARD

Steady Enrollment and Optimal Trial Metrics Can Become Reality: The Use of Key Enrollment Optimization Processes, Clinical Investigative Networks and eClinical Processes to Facilitate Cost Effective Clinical Trials
Michael Pozsgai Global Optimization Consultant ELI LILLY
Lee Scheible, RPh Senior Medical Consultant ELI LILLY

Part I-Process, Approach and Standards - Learning from the TeGenero & Parexel TGN1412 London Phase I Study
Part II - Overseas Phase I Trials: Examining the Status and Future of Partnerships Abroad
Francis P. Crawley Director General GOOD CLINICAL PRACTICE ALLIANCE