Co-Chairpersons' Opening Remarks

Murray Stewart, Vice President, Clinical Europe Metabolic, GLAXOSMITHKLINE

Gerard Ranasinghe, Vice President Clinical Trials & International, QUEST DIAGNOSTICS

KEYNOTE

2007 Pharmaceutical Drivers of Change Update

Kenneth I Kaitin, PhD, Director, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

KEYNOTE
Critical Health Issues in the 21st Century

Susan J. Blumenthal, MD, MPA, Former U.S. Assistant Surgeon

General, Rear Admiral, Senior Medical and E-Health Advisor, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Expert Panel Discussion
Prepare your Organization for the Impact of Emerging Health Issues

Panelists:
Frances Grote, Director, Clinical Development Sourcing, Global Sourcing and Supplier Management BRISTOL-MYERS SQUIBB

Murray Stewart, MD, Vice President, Clinical Europe Metabolic, GLAXOSMITHKLINE

Oren Cohen, MD, Chief Medical and Scientific Officer, QUINTILES

The Challenges and Benefits Associated with the use of Biomarkers in Clinical Trials - A Case Study

Karolyn Jackson, Business Operations Manager, ASTRAZENECA

Tony Hughes, MS, Director, Business Development, QUINTILES LABORATORIES

TRACK A
Improving Project and Team Management

TRACK B
Data Management and Standardization

TRACK C
Strengthening
Clinical Lab Quality Management

TRACK D
Technical Aspects of
Working with ECG Labs

TRACK E
Best Practices in Outsourcing to
Imaging Labs

2:00

Track Chairs' Opening Remarks

Frances Grote, Director, Clinical Development Sourcing, Global Sourcing and Supplier Management, BRISTOL-MYERS SQUIBB

Annette Balog, Vice President, Global Product & Account Management, QUINTILES LABORATORY

Track Chair Opening Remarks

Karen Petrie, Manager, Clinical Data Management, GENENTECH

Track Chairs' Opening Remarks

Timothy Highman, Global Head Vendor Audits, PFIZER

Andrew Conrad, PhD, Global Head of ESOTERIX CLINICAL TRIALS SERVICES Chief Scientific Officer for NATIONAL GENETICS INSTITUTE

Track Chairs Opening Remarks

Daniel Bloomfield, MD, Director Clinical Pharmacology, Merck Research Laboratories, MERCK & CO

Jeffrey Litwin, MD, Chief Medical Officer, Senior VP International Operations, ERESEARCHTECHNOLOGY

Track Chairs Opening Remarks

Jeffrey Stewart, MBA, Associate Director of Clinical Operations, ADVENTRX PHARMACEUTICALS

Jay Zimmerman, Vice President Medical Imaging, PERCEPTIVE INFORMATICS

CASE STUDY
Reduce Study Set-up Time by Improving Process Efficiencies through Strategic Planning

Angela Baxter, Senior Clinical Diagnostic Services Associate, ELI LILLY & COMPANY

Cheryl Helton, Global Director, Project Management, COVANCE CENTRAL LABORATORY SERVICES

Improve Lab Relationships by Identifying Vendor and Sponsor Roles and Responsibilities in Data Management

Moderator:
Karen Petrie, Manager, Clinical Data Management,
GENENTECH

Joanna Mitchell, HUMAN GENOME SCIENCES

Jennifer Duff, Accenture at WYETH

Achieve Smoother Trials by Improving Quality Management and Sponsor Oversight

Kristin Spradlin, Clinical Quality Assurance and Regulatory Operations, P&GP

Scott Sawicki, MA, Associate Director, CRO Management, NOVARTIS PHARMACEUTICALS

How to Gain Valuable Cardiac Safety Data from Early Studies

Jane Gale, Associate Director, Global Development Informatics, BRISTOL-MYERS SQUIBB

Lawrence Satin, MD, Chief Medical Officer, CARDIOCORE

Money and Time Saving Strategies for Selecting and Qualifying Imaging Core Labs

Jeffrey Stewart, MBA, Associate Director of Clinical Operations, ADVENTRX PHARMACEUTICALS

Jay Zimmerman, Vice President Medical Imaging, PERCEPTIVE INFORMATICS

Ken Faulkner, PhD, Vice President Business Development, SYNARC

Facilitate Flexibility to Prepare for the Operational Impact of Adopting Adaptive Clinical Trial Design

Agostino L. Fede, PhD MBA, Senior Vice President and Head, Global Central Labs, PPD

Scott Sawicki, NOVARTIS PHARMACEUTICALS

Achieve Data Standardization through Lessons Learned in Adopting the CDISC Lab Data Format

Phil Pochon, Enterprise Information Architect for Data Standards, COVANCE CENTRAL LABORATORY SERVICE

Achieve Successful Audits by Identifying Compliance Expectations at Labs and Reading Facilities

Cynthia L Eckstein, Senior Compliance Associate, Corporate Compliance, GENENTECH

Rajani Prasad, PhD, Vice President CRL.MEDINET

Avoidable Pitfalls in Oncology Drug QT Assessment

William Wheeler, MD, Chief Medical Officer, SPACE LABS MEDICAL DATA

Steve Asbury, Clinical Diagnostic Services, ELI LILLY & COMPANY

Maximize Process Efficiencies with Imaging Labs

Deb Pano, PERCEPTIVE INFORMATICS

Yu Dong, Project Leader, Global Sourcing and Supplier Management, BRISTOL-MYERS SQUIBB

Extended Panel Money Saving Strategies:
Part 1

Best Practice to Seize Opportunities to Cut Costs and Pool Resources with Your Lab Partners

Moderators:
CEPHALON
Rajani Prasad, Vice President, CRL.MEDINET

Panelists
Bruno Gagnon, B. Pharm, MSc, Senior Consultant, BIOLOGICS CONSULTING GROUP

Hal Mann, Head, Global Central Laboratory Outsourcing, GLAXOSMITHKLINE

Scott Sawicki, MA, Associate Director, CRO Management, NOVARTIS

Craig Earl, CEPHALON

Meet Expectation for Standardizing, Processing, Editing and Handling of Laboratory Data

Jennifer Duff, Associate Director Clinical Data Management, ACCENTURE AT WYETH

Representative from Pharma Alliance in Clinical Trials (PACT) team

Implement Strategies to Achieve Greater Quality Management/ Sponsor Oversight Efficiencies

Brian O'Neill, Global Head Clinical Quality Assurance External Alliances, F. HOFFMANN-LA ROCHE Ltd, BASEL,
Switzerland

Integration of Cardiac Safety Assessments into Global Safety Surveillance and Pharmacovigilance

Christopher Cabell, MD, Chief Medical Officer, CORESEARCH

Jeff Green, CEO, DATATRAK INTERNATIONAL

Achieve Quality and Project Standardization by Implementation of the Monitoring Plan for Imaging Core labs

Moderator:
Craig H. Lipset, Associate Vice President, Program Management, ADNEXUS THERAPEUTICS

Panelists
David Rauh, Clinical Diagnostic Services Imaging Coordinator, ELI LILLY & COMPANY

Brian C Johnston, Project Manager Worldwide Clinical Operations, PROCTER & GAMBLE

Donald Rosen, MD, Founder, Chief Strategy Officer, RADPHARM

Money Saving Strategies Part 2:

Leveraging Partnerships: How to Achieve Shared Quality and Savings

Panelists
Scott Sawicki, MA, Associate Director, CRO Management, NOVARTIS

Craig H. Lipset,  PFIZER 

Agostino L. Fede, PhD MBA, Senior Vice President and Head, Global Central Labs, PPD

Collaborate For Defined Specifications to Reduce Cost of Queries and Electronic Data Errors

Jennifer Duff, Associate Director Clinical Data Management, ACCENTURE AT WYETH

Meryl Wiernik, Global Business Integrations, QUEST DIAGNOSTICS CLINICAL TRIALS

PANEL DISCUSSION
Ask the Experts!

Moderator
Timothy Highman, Global Head Vendor Audits, PFIZER

Panelists:
Erica Galbreath, MPH, Senior Compliance Specialist, Clinical Quality Assurance, NOVARTIS PHARMACEUTICALS

Jack W. Smith, Senior Clinical Quality Assurance Auditor, MERCK & CO

Brian O'Neill, Global Head Clinical Quality Assurance External Alliances, F. HOFFMANN-LA ROCHE Ltd, BASEL,
Switzerland

Diane Corby, Global Director, Quality Assurance, ESOTERIX CLINICAL TRIALS SERVICES (A LABCORP COMPANY)

ECG Metrics and the FDA ECG Warehouse

Nenad Sarapa MD, Executive Director, DAIICHI SANKYO PHARMA DEVELOPMENT

Justin L. Mortara, Ph.D., Vice President, MORTARA INSTRUMENT, INC.

PANEL DISCUSSION
Establish Superior Assessment Strategies for Outsourcing to Academic Labs or Commercial Core Labs

Terri Binder, PhD, Senior Scientist, AMGEN

Mark Punyanitya, MA, MS, Biomedical Engineer Director, Image Analysis Lab New York Obesity Research Center ST. LUKE'S-ROOSEVELT HOSPITAL, COLUMBIA UNIVERSITY

Manish Kothari, PhD, Vice President, Musculoskeletal Disorders, SYNARC

Lawrence Oliver, PhD, Chief Scientific Officer, MAYO CLINICAL TRIALS