Integrating predictive biomarkers in the development of targeted cancer therapies

6^th International Conference on Biomarkers & Clinical Research

August 31-September 02, 2015 Toronto, Canada

Baolin Zhang

U.S. Food and Drug Administration, USA

Posters-Accepted Abstracts: J Mol Biomark Diagn

Abstract :

The regulatory approval of new drugs for marketing requires a demonstration that the drug is safe and effective in the intended patient population that is specified in the drug label. In evaluating potential anticancer agents, there is a continued interest in using predictive biomarkers to select patients likely to respond or be resistant to a particular treatment. The ability to identify the subsets of patients with molecularly defined cancers could significantly improve patient outcome. Several clinically validated biomarkers such as HER2 and K-Rasmutation status has become an essential part of the clinical use of the HER2/EGFR targeted therapies. However, the identification of clinically useful predictive biomarkers for solid tumours has proven challenging with many initially promising biomarkers failing to translate into clinical useful applications. The problem mainly lies in the inherent heterogeneity of tumor cells as being found between tumor types, individuals with the same type of tumor, and within one tumor of a patient at any given time. The complex matter also poses challenges to the regulatory review of submissions for biomarker development and drug and biomarker co-development. This presentation will introduce the recent efforts of the US Food and Drug Administration in facilitating the development of biomarkers as well as case studies to highlight the major challenges in the discovery, qualification and regulatory review of predictive cancer biomarkers.

Biography :

Email: baolin.zhang@fda.hhs.gov