2008 Symposium Information

BUILDING A FRAMEWORK FOR BIOMARKER APPLICATION
September 10—12, 2008 Bethesda, MD

This meeting has been organized in collaboration with representatives from:

National Institutes of Health
US HHS Agency for Healthcare Research and Quality
US Food and Drug Administration
Centers for Disease Control and Prevention
Health Canada
European Medicines Agency
Public and private research institutions

Objectives:

• Examine surrogate endpoints and controversies regarding their use in cardiovascular and diabetes drug approvals
• Review the latest biomarker and imaging technology data from recently completed clinical trials
• Identify best practices for biomarker assessment and validation
• Build a framework for biomarker application in research, development and clinical practice

List of Topics:

Evaluating Biomarkers in Light of New Clinical Trial Data
Recent data on HbA1c, LDL-C, HDL-C, CRP, and BNP
Translating Science into Clinical Applications
Population Screening and Risk Stratification
Biomarker Guided Therapeutic Targets
Established and Emerging In-vitro Biomarkers and Diagnostics
Established and Emerging Imaging Technologies       
Proteomics and Genomics       
Lipoproteins, Inflammation, and Other Related Risk Factors
Biomarker Economics
Evidentiary Standards and Validation
Maximizing Biomarker Utility
Drug/Diagnostic Development Strategies
Biomarkers in Risk and Therapeutic Assessment
Biomarkers as Safety Surrogates
Atherothrombosis, Hypertension and Heart Failure
Use of Biomarkers and Surrogates for Regulatory Decision-Making
Cardiovascular Markers in Food Safety and Nutrition
Biomarkers in Model-Based Drug Development           
NIH/NHLBI Biomarker Initiatives
Statistical Considerations in Biomarker Evaluation     
Application of Systems Biology to Biomarkers
Diabetes, Obesity and Metabolic Syndrome
Molecular Imaging
Biomarker Qualification in Regulatory Science
Application of CV Markers to Clinical Practice and Public Health
Regulatory Considerations for Soluble and Imaging Biomarker Applications
Pathogenesis of Atherothrombotic Disease and Biomarker Identification

Welcome

Dear Colleague:
We are pleased to invite you to participate in the 6th Annual Cardiovascular Biomarkers and Surrogate Endpoints Symposium. This outstanding scientific program addresses current approaches for assessing and managing cardiovascular risk, as well as strategies for advancing the use of biomarkers and innovative technologies for cardiovascular disorders. We urgently require tools to address the residual burden of cardiovascular risk that represents a major challenge to human health worldwide. Future biomarker efforts are an integral part of this toolbox and we must continue to build on knowledge gained from basic research efforts and clinical evaluations, incorporating lessons from past successes and failures. The Cardiovascular Biomarkers and Surrogate Endpoints Symposium is designed to share knowledge and encourage the collaborative efforts needed to accelerate the development of improved cardiovascular diagnostics and therapeutic strategies.

Join us to learn how to translate the latest research findings to improve patient healthcare. Presentations from government, academic, industry, and healthcare thought-leaders will examine the issues surrounding the effective assessment and application of cardiovascular biomarkers and imaging technologies. Only with your support can we advance the field of cardiovascular biomarkers and find efficiencies toward improved healthcare.

Sincerely,

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