8:00am - 12:00pm • Morning (Workshops 1-3)

8:00 Registration and Morning Coffee Hosted by World Courier
8:30 Workshops Open
10:00 30-Minute Morning Break
12:00 Luncheon for Morning Workshop Delegates

Bridging the Gap to Make Higher Quality Outsourcing Decisions with a more Thorough Understanding of Technical Operations

This workshop is meant to assist outsourcing groups at pharmaceutical companies understand the science and operational impact of the outsourced decision as well as learn what questions to ask to be able to better differentiate among lab providers. It is not just pricing anymore, outsourcing is now more complicated with new assays and increasingly important biomarkers. Learn to incorporate process improvement strategies to decrease trial cost and improve efficiencies for large international trials. This workshop educates outsourcers of the nuances and differences in providers specifically:

• Strategic outsourcing with the science in mind
• Learn to present the financial implication of the science
• How make high-quality decisions and spend money wisely

Workshop Leaders:
Hal Mann, Senior Supplier Relationship Manager, Global Grants and Contracts, GLAXOSMITHKLINE

Nancy Widener, Global Head of Outsourcing Management, BRISTOL-MYERS SQUIBB

Raphaele Mary, Associate Director, BMS GSSM Central Labs

10:30-12:00 Practical Solutions to Tissue Based Testing

Dealing With:
• Centralized Diagnosis
• Biomarker Analysis
• Genomic Analysis
• Immunohistochemistry

In this interactive session we address the specific challenges encountered by sponsor clinical teams, regulatory groups, outsourcing groups and CROs when faced with providing efficacy and/or safety data involving tissue specimens. Typically, in protocols utilizing biopsy specimens, or cellular or tissue samples, there are a host of assays that may be needed to accomplish protocol objectives. These include biomarker and genomic analysis as well as centralized confirmation of local lab diagnoses.

Sample transportation and preparation for tissue based tests are typically different than with a blood or plasma sample. Pricing can be complicated and makes it difficult to determine if you're getting a fair deal or not. Reporting of tissue based tests by local labs is typically done in free text, a nightmare for data management and analysis; and don't forget the unique regulatory issues associated with tissue based testing.

In this workshop we work towards understanding these and many more issues that accompany tissue based testing in a regulated environment and provide solutions that prevent unsatisfactory study outcomes.

In this workshop the participant will:
• Understand the characteristics of tissue type samples and how these features impact clinical trial outcomes
• Understand the variables that impact specimen acceptability for a variety of downstream testing
• Identify parameters for handling tissue samples relative to fixative requirements and logistical considerations and create a specimen management algorithm that ensures specimen integrity for genomic and biomarker analyses
• Compare and contrast the pros and cons of using central or local labs to provide tissue based testing
• Understand the value of using codified diagnosis dictionaries for tissue based result reporting
• Discuss the components of test fees for tissue based assays

Michael D. Glant, MD, Chief Medical Officer, DCL MEDICAL LABORATORY

Douglas E. King, M.S., CT(ASCP), CFIAC Director, Business Development, Division of Pharmaceutical Studies, DCL MEDICAL LABORATORY

Royce Morris, NORTHWEST KINETICS

Outsourcers Field Guide to QT-Quality ECG Acquisition

The requisite ECG quality for QT Intensive Studies (Thorough QT and exploratory Phase 1 QT studies) is much higher than for standard clinical trials. Subtle refinement in technique is required to provide an ECGs acceptable for QT measurement. In this talk we will discuss:

• Some of the techniques and tools required to acquire QT-quality ECGs
• Tips on how outsourcing, clinical groups and Phase 1 units can work together to provide QT-quality ECGs.

Workshop Chairperson:
William Wheeler, MD, FACC, Chief Medical Officer, SPACELABS MEDICAL DATA

Conducting a QTc Trial in Japan, Adoption of ICH E14

Hiroshi Brook Koide, MD PhD, Director, Clinical Pharmacology, Clinical Research Pfizer Global R&D, Tokyo Laboratories, PFIZER JAPAN

Nenad Sarapa MD, Executive Director, DAIICHI SANKYO PHARMA DEVELOPMENT

Timothy Callahan, PhD, Chief Scientific Officer, BIOMEDICAL SYSTEMS

Wednesday, January 17, 2007 AFTERNOON PRECONFERENCE WORKSHOPS

1:30 - 5:00pm • Afternoon (Workshops 4-6)

1:00 Registration
1:30 Workshops Open
3:00 30-Minute Afternoon Break

5:00 Workshops Conclude
5:00-6:30 Welcome Reception in Exhibit Hall Hosted by ESOTERIX INC

Understanding the Operational and Regulatory Challenges in Operating In Emerging Markets

• Current clinical landscape in Asia
• Discuss advantages and disadvantages of establishing labs operations in emerging markets
• Determine the regional challenges and how they effect the operational complexity of the trial
• Implications in samples, sites and vendor inconsistencies
• Identify and overcoming data management challenges in emerging markets

Panel Debate:
Should we put ECGs in India or China, or other Emerging Markets?
a. Weigh the Financial Ramifications
b. Determine the Operational Challenges
c. Overcome the Quality challenges

Panelists:
C. Hyung Park, Director Lab Quality Management, WYETH

Jennifer Duff, Director Clinical Data Management, ACCENTURE AT WYETH

Michael Harvey, Quality Assurance and Medical Affairs, QUEST DIAGNOSTICS CLINICAL TRIALS

Karen Chu, Executive Director of International Clinical Operation, APEX

Please join us for an in-depth look at the Metrics Champion Consortium (MCC) organization and the Laboratory Performance Metrics being implemented throughout the industry. This two-part workshop will provide participants with the opportunity to learn about the metrics and their implementation to date as well as compare how the metrics are being used by sponsors and service providers. Specifically, the session will include:

Part One

Presentation:
An introduction to the MCC organization and the MCC Laboratory Performance Metrics

Discussion Groups:
Exploring ways to address challenges to implementing the MCC Laboratory Performance Metrics

Part Two
Case Study: Using the MCC Laboratory Performance Metrics to improve sponsor and service provider processes

Cynthia Lindemann Central Laboratory Coordinator ELI LILLY & COMPANY

Phyllis Haldimann, Associate Director, Business Support Services, QUINTILES LABORATORIES

Discussion Groups:
Comparing how the metrics are used by service providers and sponsors to manage internal processes.

Workshop Leaders
Sarah Martin-Munley, PhD, Senior Director, Clinical Programs, VERTEX PHARMACEUTICALS, Central Laboratory Steering Committee Member, MCC

Judy Klein, Manager, CSS&P, AMGEN, Central Laboratory Steering Committee Member, MCC

Richard Polgar, Manager, Clinical Operations Resource Management, SCHERING PLOUGH, Central Laboratory Steering Committee Member, MCC

Cynthia Lindemann, Central Laboratory Coordinator, ELI LILLY & COMPANY

Brian Schrock, Black Belt, Lilly Research Laboratories, ELI LILLY & COMPANY, Chairman of the Board, MCC

This compilation of case studies teaches strategies for using biomarkers in clinical studies, from the initial business case and outsourcing processes to overcoming the operational challenges.

Use of Biochemical and Imaging Biomarkers in the Clinical Development of Lipid-modifying Drugs

We will review biochemical and imaging biomarkers useful in the clinical development of lipid-modifying drugs and then focus on specific clinical trials. These case studies will highlight the strategy of biomarker usage and development all the way from phase II clinical trials to the ultimate commercial market. These examples will be discussed in light of recent FDA guidance documents and expectations. We will conclude by discussing the emerging business model of drug-diagnostic co-development and implications for co-marketing of future drugs with co-approved diagnostics.

Mario R. Ehlers, MD, PhD Chief Medical Officer, PACIFIC BIOMETRICS

David S. Lester, PhD, New York Site Head Pfizer Human Health Technologies, Global Clinical Technology, PFIZER GLOBAL RESEARCH AND DEVELOPMENT

From Development to Diagnostics: Transitioning Biomarkers from Clinical Trials into Clinical Practice

This session will focus on how to transition clinically validated biomarkers from clinical trials into the diagnostic market place to support therapies post-approval. Aspects related to assay validation and commercialization will be discussed, including regulatory issues, choice of a reference laboratory and IVD partner, and factors that affect test adoption in the reference laboratory setting. Case studies will be presented that illustrate various business models to ensure availability of a validated assay for drug commercialization.

David M. Johnston, MD Vice President, Chief Scientific Officer, ESOTERIX CLINICAL TRIALS SERVICES (A LabCorp Company)

Case Study: Overcoming Operational Challenges of Implementing Biomarkers into clinical Trials

Biomarkers have been an intensely discussed topic due to the fact that their use is being encouraged by regulatory authorities. The perspective of finding a significant change in the context of biological variation will be explored, the concept of reference change values discussed and the key elements for significant signal changes will be defined. The calculation of the probability Z using the reference change value definition permits the detection of a significant signal without the use of traditional reference range intervals. Historical data will be presented utilizing the Z-value signal detection method and will be compared against traditional signal detection methods to further provide validation to this concept.

Gordon Kapke, PhD, Vice President of Global Technical Affairs and Chief Scientific Officer, COVANCE CENTRAL LABORATORY SERVICES

David S. Lester, PhD, New York Site Head Pfizer Human Health Technologies, Global Clinical Technology, PFIZER GLOBAL RESEARCH AND DEVELOPMENT