The remainder of this report provides a comprehensive summary of the presentations and discussions that occurred during the workshop. Chapter 2 provides an overview of key issues in the use of biomarkers in drug development. Chapters 3, 4, and 5 present final versions of the white papers prepared for the workshop on cardiac, kidney, and liver safety biomarkers, respectively. In addition, the final section of each of those chapters summarizes the discussions that occurred during breakout sessions that followed the presentations in these areas. Chapter 6 summarizes future actions suggested by workshop participants to further the use of biomarkers in drug development.

It should be noted that while the IOM Forum on Drug Discovery, Development, and Translation introduced the idea for this workshop, its planning was the responsibility of an independently appointed committee. That committee’s role was limited to advance planning; this summary was prepared by an independent rapporteur, with the assistance of forum staff, as a factual summary of what occurred at the workshop.

Biomarkers Definitions Working Group. 2001. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics 69(3):89–95.

IOM (Institute of Medicine). 2007. The learning healthcare system: Workshop summary. Washington, DC: The National Academies Press.