Senior Policy Analyst at the FDA to Present at GTCbio's 2nd Annual Rediscovering Biomarkers on July 10-11
Elizabeth Mansfield, Senior Policy Analyst at the FDA to Present at GTCbio's 2nd Annual Rediscovering Biomarkers on July 10-11, 2008 in Boston, MA


/Biotechnology News Articles/ - MONROVIA, CA, April 20, 2008 - Dr. Elizabeth Mansfield, Senior Policy Analyst at the FDA will be speaking at GTCbio's 2nd Annual Rediscovering Biomarkers on July 10-11, 2008 in Boston, MA. Dr. Mansfield will present on the challenges and future opportunities of biomarkers.
Development and validation of novel biomarkers has the potential to advance clinical diagnostics, and to enable better, faster drug development. Ultimately, successful biomarker development will rely on careful analytical validation of the measurement platform(s), and on solid evidence that the biomarker has clinical meaning. Attention must be paid to all aspects of biomarker development, including assessment of preanalytical, analytical, and clinical variables, while robust study design is critical to establishing validity of the biomarker for its intended use. FDA has multiple processes for addressing biomarker validation, both in the context of drug development and in the context of use as diagnostic devices. This presentation will review the history of biomarkers, their validation as medical devices, and the importance of understanding the complete process.
The 2nd Annual Rediscovering Biomarkers Conference will expose attendees to the latest advancements and developments in biomarkers and predictive medicine. Attendees will gain insight into discovery and development processes, hear about new biomarkers and upcoming trends in the industry, as well as the status of those in clinical trials. Delegates will also receive highly valuable information on tools for improving reimbursement strategies and the efficacy and validation of biomarkers.

For more information including a detailed agenda, exhibitor opportunities and registration information visit http://gtcbio.com/conferenceDetails.aspx?id=124

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