Biomarkers are biological measures of a biological state and may be defined as:

\’A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacological responses to a therapeutic intervention. A biomarker is any biological molecule found in blood, other body fluids, or tissues that may be a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition.\’

In this first Forum of our 2 part Biomarker series, we will present the history of biomarker discovery and why biomarkers are important to clinical research. We will explore the basic concepts of biomarkers including:

• what they are, with specific illustrations
• how are they discovered
• how are they linked to therapeutic products and personalized medicine and who is developing them
• how is biomarker data quality maintained
• what distinguishes biomarkers from companion diagnostics

This Forum will provide an in-depth look into the discovery process and illustrate the many classes of biomarkers.  We will show how biomarker R&D is a modular, highly interdependent process that requires a systems-based approach.  Our panel of industry experts will discuss the transfer of candidate markers from early discovery to clinical validation, and set the stage for Biomarkers Forum, Part II, which will explore how biomarkers are used in clinical development and in regulatory submissions.