Clinical Biomarker Summit

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Tony Rook
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Clinical Biomarker Summit

Register by December 16th and SAVE-up-to $400

Cambridige Healthtech Institute's Biomarker Series Presents:

CLINICAL BIOMARKER SUMMIT
March 29-31, 2006 | Hotel Del Coronado | Coronado, CA

Register Now

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Preliminary Agenda

Pre-Conference Events

Wednesday, March 29

Tutorial*

Biomarker Assay Development and Validation - Principles and Practices
Dr. Pauline Lau, President, Suntec Corporation

After biomarkers are identified, the development and validation of practical assays that are useful for clinical trials are often difficult tasks for pharmaceutical companies to handle without prior diagnostic development experience. This talk will present the critical requirements of assay development and validation, sample requirements, stability studies, and assay performance documentation. It will also address quality (e.g. GLP) requirements enabling the assays to be used for clinical trials and down-stream commercialization.

Executive ThinkTank**

Discussion I: Translational Medicine: Decision Making at the Preclinical/Clinical Interface
Discussion II: Pharmacogenomics: Impact of Genetic Polymorphisms on Drug Efficacy, Safety and Pharmacology
Discussion III: Role of Biomarkers in Clinical Pharmacology

* Separate registration is required.
** Qualified attendance only. Separate registration required. Access is limited to delegates who are Management-level or above at pharmaceutical, diagnostic or biotechnology companies. Every registration application is subject to approval by conference organizers. For additional information, please contact Julia Boguslavsky at eval(unescape('%64%6f%63%75%6d%65%6e%74%2e%77%72%69%74%65%28%27%3c%61%20%68%72%65%66%3d%22%6d%61%69%6c%74%6f%3a%6a%75%6c%69%61%62%40%68%65%61%6c%74%68%74%65%63%68%2e%63%6f%6d%22%3e%6a%75%6c%69%61%62%40%68%65%61%6c%74%68%74%65%63%68%2e%63%6f%6d%3c%2f%61%3e%27%29%3b')).

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Main Program (March 29-31)
Translational Medicine: Decision Making at the Preclinical/Clinical Interface

Translational Oncology: Hitting the Right Target in the Right Patient at the Right Dose
Dr. Dominic G. Spinella, Global Head of Oncology Translational Medicine, Pfizer Inc.

Organizational, Procedural and Scientific Changes to Incorporate Translational Medicine Concepts within R&D
Ms. Cynthia S. Cheesman, Assistant Vice President, Preclinical Project Management, Wyeth

Translational Medicine: The Quiet Revolution
Dr. Claudio Carini, Vice President, Global Head of Biomarkers, Global Development, F. Hoffman-La Roche Ltd.

Search for Biomarkers at Preclinical, Translational, and Clinical Level to Support Development of a Novel, First-in-Class Drug
Dr. Juan A. Leal, Senior Director, Translational Medicine, Exelixis, Inc.

Clinical Biomarkers Day

Clinical Validation of Biomarkers: Biological and Analytical

Clinical Validation of Cancer Biomarkers with Diagnostic Potentials
Prof. Daniel Chan, Director, Pathology, Johns Hopkins University

Biomarker Discovery and Validation with Rheumatoid Arthritis Registry
Dr. Danyi Wen, Scientist II, Inflammation, Millennium Pharmaceuticals, Inc.

Validation of the ELISpot Assay for Use in Monitoring Vaccine Trials
Dr. Janet Lathey, Director, Virology/Immunology, SeraCare BioServices

Biomarkers to Monitor and Predict Response to Therapy

Inflammatory Disease Biomarkers May be Useful Predictors of Clinical Efficacy of Infliximab Plus MTX Therapy in MTX-Nave Early Rheumatoid Arthritis Patients
Dr. Sudha Visvanathan, Principal Research Scientist, Clinical Pharmacology and Experimental Medicine, Centocor

EGFR Mutations and Response to Therapy
Dr. Somasekar Seshagiri, Scientist, Molecular Biology, Genentech Inc

The Functional Diffusion Map: A Noninvasive Imaging Biomarker for Early Prediction of Cancer Treatment Outcome
Dr. Brian Ross, Professor, Radiology & Biological Chemistry, University of Michigan

Biomarkers to Monitor and Predict Disease Progression

High PSA Nadir on Testosterone Inactivating Pharmaceuticals Accurately Predicts Early Progression to Bone Metastasis in Men with Prostate Cancer
Dr. Mark Scholz, Medical Director, Clinical Services, Prostate Oncology Specialists

Cell-Bound Complement Activation Products (CB-CAPs) for Monitoring Inflammatory Diseases
Dr. Joseph Ahearn, Director of Research, Medicine, University of Pittsburgh Arthritis Institute

Real-Time Molecular Diagnosis for Patient Stratification of Lymph Node Surgery
Dr. Dave Hoon, Director, Member, Molecular Onoclogy, John Wayne Cancer Institute

Quantitative End-Point LATE-PCR Assays for Monitoring Barretts Esophagus
Prof. Lawrence Wangh, Associate Professor, Biology, Brandeis University

Clinical Pharmacology Day

Effect of Genetic Polymorphisms on Clinical Pharmacology

Design Considerations for Pharmacogenomic Studies
Dr. Keith Johnson, Senior Director, Research and Development, Pfizer Inc.

Impact of Pharmacogenetics on Drug Interactions
Dr. Rene H. Levy, Professor & Chair, Pharmaceutics & Neurological Surgery, University of Washington

Pharmacogenomics of Drug Transporters
Prof. Wolfgang Sadee, Chair, Pharmacology, Ohio State University

Pharmacogenetics and the Prediction of Drug Interactions
Dr. Anne Nafziger, ORI Drug Development Center, Ordway Research Institute

Biomarkers for Safety Assessment and Predicting Adverse Effects

Identification of Susceptibility Marker for ACE Inhibitor-Induced Angioedema
Dr. David Chen, Clinical Research Director, Experimental Medicine, sanofi-aventis

Title to be Announced
Dr. Koustubh Ranade, Associate Director, Pharmacogenomics & Human Genetics, Pharmaceutical Research Institute, Bristol-Myers Squibb

Discovery of a Biomarker Profile of Drug-Induced Musculoskeletal Syndrome by Metabonomics and Proteomics
Dr. Tonny de Beer, Senior Scientist, Discovery Technologies, Procter & Gamble Pharmaceuticals, Inc.

New Emerging Predictive and Diagnostic Biomarkers of Renal and Hepatic Toxicity and Safety
Dr. Rakesh Dixit, Senior Director, Toxicology, Toxicology & Drug Evaluation, Johnson & Johnson Pharmaceutical R&D

PK/PD Biomarkers and Modeling

Integrating Novel PD Assays into Early Stage Clinical Trials
Dr. Dan Fitzpatrick, Associate Director, Molecular Sciences, Amgen Inc.

The Application of PKPD Modeling at the Preclinical/Clinical Interface to Improve Decision Making in Early Drug Development
Mr. Don Walker, Senior Director, Pharmacokinetics, Dynamics and Metabolism, Pfizer Global R & D, Pfizer Inc.

Biomarkers as Prerequisite for PK/PD Modeling and Model-Based Drug Development
Dr. Bernd Meibohm, Associate Professor of Pharmaceutical Sciences, College of Pharmacy, University of Tennessee Health Science Center

PK/PD Modeling of Early Biomarker Data: Impact on Study Design
Dr. Jean-Michel Gries, US Site Head, Clinical Pharmacology (PDMP), F. Hoffmann-La Roche Ltd.

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Sponsors/Exhibitors

SPONSORSHIP

Sponsorship packages are designed to achieve your lead generation, business development and networking goals and objectives. Through your sponsorship, CHI will help your company meet these goals plus maximize exclusive sponsorship branding opportunity pre, post and while at the Clinical Biomarker Summit.

The CHI managers will work closely with you to shape a package that suits your company's objectives and budget. Features include pre-conference, at-conference and post-conference benefits providing a well-rounded marketing campaign. Please call for details.

For more information, to reserve booth space, or discuss sponsorships
contact: Arnie Wolfson, Tel: 617-630-1331, Mobile Phone: (857)-636-8354
Email: eval(unescape('%64%6f%63%75%6d%65%6e%74%2e%77%72%69%74%65%28%27%3c%61%20%68%72%65%66%3d%22%6d%61%69%6c%74%6f%3a%61%77%6f%6c%66%73%6f%6e%40%68%65%61%6c%74%68%74%65%63%68%2e%63%6f%6d%22%3e%61%77%6f%6c%66%73%6f%6e%40%68%65%61%6c%74%68%74%65%63%68%2e%63%6f%6d%3c%2f%61%3e%27%29%3b'))

For program related information please contact:
Julia Boguslavsky, Conference Director, Cambridge Healthtech Institute
E-mail: eval(unescape('%64%6f%63%75%6d%65%6e%74%2e%77%72%69%74%65%28%27%3c%61%20%68%72%65%66%3d%22%6d%61%69%6c%74%6f%3a%6a%75%6c%69%61%62%40%68%65%61%6c%74%68%74%65%63%68%2e%63%6f%6d%22%3e%6a%75%6c%69%61%62%40%68%65%61%6c%74%68%74%65%63%68%2e%63%6f%6d%3c%2f%61%3e%27%29%3b'))

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