Conference: Breakout Sessions

Track: Biomarkers

Date: Monday May 3, 2010

Time: 4:00 PM - 5:30 PM

Location: McCormick Place, Chicago

Room: N426B

Description: Medical research is evolving toward identifying biological variations that determine individual disease susceptibility, prognosis and treatment outcomes. The dramatic increase in discovery of biomarkers, as measured by biomarker-related patent filings and publications, continues to outpace their clinical validation and market introduction. Clinical validation of biomarkers is a resource-intensive process involving assay development, validation of analytical methods, development of protocols for tissue acquisition, storage and processing, and retrospective and prospective clinical studies to determine sensitivity and specificity. To make the substantial investment required to bring a novel biomarker to market, test developers require that candidate markers to meet a range of technical, clinical, regulatory and commercial criteria.

Objectives:
1. Understand the differences between the United States and European patent laws (including recent cases) for biomarkers, including practical issues in enforcement of such protection.

2. Understand reimbursement models for diagnostics and whether they are suited to biomarker development, particularly in light of the potential cost savings to the public health system.

3. Understand challenges to existing diagnostic business models from direct-to-consumer marketing and the personal genome, and explore ways these challenges may be managed.