Oncology Clinical Trials 2007

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April 10 - 12, 2007 | Rosen Shingle Creek, Orlando, FL

Wednesday, April 11, 2007

7:00	Registration & Morning Coffee
8:15	Keynote – General Session Room Business Management Guru Address: The Evolution and Art of Outsourcing C. K. Prahalad, Paul and Ruth McCracken Distinguished University Professor of Corporate Strategy, UNIVERSITY OF MICHIGAN
9:15	Transition time to oncology trial conference room
9:30	Chair's Welcome - Oncology trial conference room
9:45	Drug Development Strategies in Oncology with GlaxoSmithKline Part I- Drug Development Perspective Debasish Roychowdhury, MD, Vice President, Clinical Drug Development, GLAXOSMITHKLINE Part II-Translational Oncology Maria Koehler MD, Clinical Development, Oncology MDC, GLAXOSMITHKLINE Part III- Accelerated Drug Approval Grant Williams, MD, Clinical Development, Oncology MDC, GLAXOSMITHKLINE Part IV- Q&A
11:15	15 Minute Break
11:30	Adaptive Designs for Clinical Trials Philip Banks, MS, Senior Director of Biostatistics and IT, PROLOGUE RESEARCH
12:30	Luncheon
2:00	Case Study Cardiac Concerns in Oncology Clinical Trials Howard Fingert, MD, Senior Director, Clinical Lead, Signal Transduction Development Program, PFIZER ONCOLOGY PFIZER GLOBAL R&D Christopher H. Cabell, MD MHS FACC, Director, Cardiac Safety, DUKE CLINICAL RESEACH INSTITUTE; Chief Executive Officer, CORESEARCH
3:30	Networking Break – Exhibit Hall Open
	Choose From

Conducting Trials in Asia	Targeted Therapies / Partnerships with Cooperative Groups
Conducting Trials in India & China Patient Recruitment in India and China is seriously being considered by many drug development companies. There are many questions to ask when conducting trials in Asia and our afternoon is dedicated to getting you answers.
4:15	4:15
Regulations and Intellectual Property Concerns in India and China Andrew C. Chang, PhD, Senior Director, PHARMANET CONSULTING Dr. M. Venkateswarlu, DRUG CONTROLLER GENERAL OF INDIA	Case Study Circulating Oncoproteins as Cancer Biomarkers for Targeted Therapies Walter P. Carney, MD, Head of Oncogene Science, BAYER HEALTHCARE
5:00	4:45
Balancing Harmonization of Lab Testing Data and Costs of Sample Transportation in Asia: Selecting Central Labs Debbie Kerr-Leathem, Director, Clinical Logistics, Data Generation Division, ORTHO-MCNEIL JANSSEN SCIENTIFIC AFFAIRS, LLC, JOHNSON & JOHNSON Alan Ong, Vice President and General Manager, Asia, Africa, Australia Lab Operations, QUINTILES	"Nuts and Bolts" of QT Assessment in Oncology Programs William Wheeler, MD, FAAC, Chief Medical Officer, Clinical Trial Services Division, SPACELABS HEALTHCARE
5:30 Day One Concludes