SCIENTIFIC ADVISORY BOARD
Kenneth Evans, Ph.D., President and CEO, Ontario Cancer Biomarker Network
Charles Jaffe, M.D., Ph.D., Senior Global Strategist, Digital Health Group, Intel Americas, Inc.
David S. Lester, Ph.D., New York Site Head, WorldWide Clinical Technology, Pfizer Inc.
Robert Phillips, Ph.D., President and CEO, Ontario Cancer Research Network

DISTINGUISHED SPEAKERS
Peter Liu, M.Sc., M.D., FRCPC, Scientific Director, Institute of Circulatory and Respiratory Health, Canadian Institutes of Health Research (CIHR) and Professor in Medicine and Physiology, Toronto General Hospital
Ralph Meyer, M.D., Director, National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
Todd Georgieff, BScPhm, M.B.A., Senior Manager, Clinical Research Operations, Abbott Laboratories Ltd.
Robert G. Bristow, M.D., Ph.D., F.R.C.P.C., Head, Prostate Clinical Research Program and Clinician-Scientist, Applied Molecular Oncology and Radiation Medicine, Ontario Cancer Institute-Princess Margaret Hospital, University of Toronto
Peter A. Covitz, Ph.D., Chief Operating Officer, National Cancer Institute Center for Bioinformatics
Douglas B. Fridsma, M.D., Ph.D., FACP, University of Pittsburgh Cancer Institute
Charles Jaffe, M.D., Ph.D., Senior Global Strategist, Digital Health Group, Intel Americas, Inc.
Rebecca Kush, Ph.D., President, Clinical Data Interchange Standards Consortium (CDISC)
Ellen Feigal, M.D., Director, Medical Devices and Imaging, Critical Path Institute
Peter Ho, M.D., Ph.D., Vice-President, Oncology Clinical Pharmacology & Discovery Medicine, GlaxoSmithKline 
Donald Berry, Ph.D., Professor and Chair of the Department of Biostatistics and Applied Mathematics, University of Texas M. D. Anderson Cancer Center
Douglas L. Arnold, M.D., Professor, Neurology and Neurosurgery, Montreal Neurological Institute, McGill University, and NeuroRx
Vish Viswanathan, Ph.D., Director, Decision Analysis, Johnson & Johnson Pharmaceutical R&D

KEYNOTE PRESENTATIONS
Alan Breier, M.D., Vice President for Medical and Chief Medical Officer, Eli Lilly and Company
Lionel Edwards, MBBS, FFPM, Director, Medical Affairs, Novartis Pharmaceuticals
Gary K. Mallow, Ph.D., Director, Research Informa-tion Services, Merck & Co., Inc.
Eleftherios P. Diamandis, M.D., Ph.D., FRCPC, Head, Clinical Biochem-istry & Pathology, Mt. Sinai Hospital

This special, two-day executive forum will show you how to optimize clinical trials through strategy, technology, process, and policy.

Z Implement Biomarkers in Clinical Trials to Reduce Costs and Duration
Z Select Patients Most Likely to Respond to Therapy with Biomarkers
Z Meet Regulatory Requirements for Imaging Submissions
Z Optimize Trial Design with Advanced Statistical Tools, Pharmacogenetics and Imaging Technologies
Z Realize the Impact of FDA Critical Path Initiative on Clinical Trial Design 
Z Reduce the Exposure of Patients in Trials to Ineffective Therapy Using the Bayesian Approach
Z Building an Effective and Compliant Network for Data Sharing

Pre-Conference Tutorial
Strategies for Improving Critical Drug Development Decision Making through Clinical Trial Simulation and Modeling

Chairperson’s Opening Remarks
Christian Burks, Ph.D., President & Chief Executive Officer, Ontario Genomics Institute

KEYNOTE PRESENTATIONS
Changing the Late Stage Development Paradigm: Enhancing Benefit/Risk and Data Transparency
Alan Breier, M.D., Vice President for Medical and Chief Medical Officer, Eli Lilly and Company 

Strategies for New Cancer Biomarker Identification
Eleftherios P. Diamandis, M.D., Ph.D., F.R.C.P.C., Head of Clinical Biochemistry, Mount Sinai Hospital, University Health Network and Toronto Medical Laboratories, Professor and Head, Division of Clinical Biochemistry, Department of Laboratory Medicine and Pathobiology, University of Toronto

Generating and Managing Biomarker Data 

Chairpersons: Kenneth Evans, Ph.D., President and CEO, Ontario Cancer Biomarker Network and Robert Phillips, President and CEO, Ontario Cancer Research Network

Identifying Molecular Biomarkers in Blood to Identify Patients with Early-Stage Heart Failure, or Who Are at Risk
Peter P. Liu, M.Sc., M.D., FRCPC, Scientific Director, Institute of Circulatory and Respiratory Health, Canadian Institutes of 
Health Research (CIHR) and Professor in Medicine and Physiology, Toronto General Hospital 

Opportunities for Generating Biomarker Data to Impact Clinical Trials
Ralph Meyer, M.D., Director Designate, NCIC Clinical Trials Group

Biomarkers for Tracking DNA Repair within Radiotherapy Clinical Trials
Robert G. Bristow, M.D., Ph.D., F.R.C.P.C., Head, Prostate Clinical Research Program and Clinician-Scientist, Applied Molecular Oncology and Radiation Medicine, Ontario Cancer Institute-Princess Margaret Hospital, University of Toronto

How Biomarkers are Changing the Landscape of Drug Development 
Todd Georgieff, BScPhm, M.B.A., Senior Manager, Clinical Research Operations, Abbott Laboratories Ltd. 

INTERACTIVE PANEL

• What does validation mean?
• How do you design clinical trials using surrogate endpoints?
• How do you analyze subsets of patients?
• How do you use biomarkers in pivotal studies?
• Who is going to do pharmacogenomic studies?
• How do you separate biomarkers in development from validation?

KEYNOTE PRESENTATIONS
Clinical Sciences Integration: The Impact Ten Years from Now
Lionel Edwards, M.B.B.S., F.F.P.M., Director, Medical Affairs, Novartis Pharmaceuticals

IT Frameworks for Biomarker Discovery Data Management and Integration
Gary K. Mallow, Ph.D., Director, Research Information Services, Merck & Co., Inc.

Building an Effective and Compliant Network for Data Sharing 

Chairperson: Charles Jaffe, M.D., Ph.D., Senior Global Strategist, Digital Health Group, Intel Americas, Inc.

Interoperability of Clinical Trials Systems in the Cancer Biomedical Informatics Grid (caBIG)
Peter A. Covitz, Ph.D., Chief Operating Officer, National Cancer Institute Center for Bioinformatics

The BRIDG Project: A Shared Modeled of the Semantics of Clinical Trials Research
Douglas B. Fridsma, M.D., Ph.D., FACP, Center for Biomedical Informatics University of Pittsburgh Cancer Institute

Global Trial Bank Initiative
Charles Jaffe, M.D., Ph.D., Senior Global Strategist, Digital Health Group, Intel Americas, Inc.

CDISC: A Case for Standards in Research and Healthcare
Rebecca Kush, Ph.D., Founder and President, Clinical Data Interchange Standards Consortium (CDISC)

Integration and Management of Diverse Clinical Trials and Mechanistic Data, Through an Ontology-Driven Knowledge Management Approach 
Dave Parrish, Executive Director of Informatics, Immune Tolerance Network

Designing Trials of the Future

Chairperson: David S. Lester, Ph.D., New York Site Head, WorldWide Clinical Technology, Pfizer Inc.

Accelerating Medical Product Development: FDA Critical Path Initiative and the Impact of Enhanced Clinical Trial Design on Patient Outcomes
Ellen Feigal, M.D., Director, Medical Devices and Imaging, The Critical Path Institute

Adapting to Adaptive Trial Designs: Responding to the Call in Oncology 
Peter Ho, M.D., Ph.D., Vice-President, Oncology Clinical Pharmacology & Discovery Medicine, GlaxoSmithKline 

Reducing the Exposure of Patients in Trials to Ineffective Therapy Using the Bayesian Approach
Donald Berry, Ph.D., Professor and Chair of the Department of Biostatistics and Applied Mathematics, University of Texas M. D. Anderson Cancer Center

Imaging CRO Services for Drug Development: Get the Picture!
Douglas L. Arnold, M.D., Professor, Neurology and Neurosurgery, Montreal Neurological Institute, McGill University, and NeuroRx

Drug Development Decisions and Value of Information
Vish Viswanathan, Ph.D., Director, Decision Analysis, Johnson & Johnson Pharmaceutical R&D