The drive towards realizing the promise of personalized/stratified medicine is dependent on the use of valid biomarkers to develop companion diagnostic tests. Numerous complexities and barriers exist to this process. Experts in the field will lead a discussion on the key scientific, clinical, statistical and regulatory risks which must be overcome to accelerate this important process and improve the outcomes for patients with cancer.
Special Session: CBC Special Session: Towards a More Efficient Biomarker Development Process-- Right on the Path of the Critical Path

Overview of the AACR-FDA-NCI Cancer Biomarkers Collaborative; William N. Hait. Johnson & Johnson Pharmaceuticals, R&D, L.L.C., Raritan, NJ

Update on the Collaborative's Activities Addressing the Critical Path; Samir N. Khleif. National Cancer Institute, Bethesda, MD

Key Issues for Consideration in the Co-development of Drugs and Diagnostics; Lois M. Hinman. Novartis Pharmaceuticals Corporation, East Hanover, PA

A Critical Examination of the Use of Archived Specimens for Evaluating the Medical Utility of Prognostic and Predictive Biomarkers; Richard M. Simon. National Cancer Institute, Bethesda, MD

The Role of Cooperative Groups in Clinical Validation of Biomarkers; Richard L. Schilsky. Univ. of Chicago, Chicago, IL,