Evidentiary Considerations for Integration of Biomarkers in Drug Development Symposium
Friday, August 21, 2015
9:00 a.m.-5:00 p.m.
University of Maryland, Pharmacy Hall at 20 North Pine Street in Baltimore
For More Information:
301 405 0285
About the Event:
On August 21, 2015, the University of Maryland School of Pharmacy will be hosting a special symposium on “Evidentiary Considerations for Integration of Biomarkers in Drug Development.” The symposium will be held in Pharmacy Hall at 20 North Pine Street in Baltimore from 9 a.m. to 5 p.m. This one-day symposium assembles leading scientists and researchers from industry, academia, and the Food and Drug Administration (FDA), and provides a unique opportunity to gain perspective on biomarker development and application of biomarkers in preclinical and clinical research. Topics to be covered include an overview of biomarkers in drug development, biomarker qualification, and evidentiary considerations for biomarker utilization in drug development. The symposium is open to public, and registration is required.
The symposium is jointly sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA. In a new FDA effort, the M-CERSI focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated. M-CERSI is a collaborative partnership between the University of Maryland, College Park, and the University of Maryland, Baltimore. Researchers from both campuses work with FDA staff to support the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.
A recording of the Symposium and presentations are available now: