New opportunities for sharing data, including an update on the role of the FDA to build large public disease biology-based clinical and genomic datasets. Approaches will be presented to extend beyond the 2011 pilot project of accessing the “clinical trial comparator arms” of industry clinical trials (CTCAP) and will examine new joint opportunities in regulatory sciences."
Vicki L. Seyfert-Margolis
Vicki Seyfert-Margolis, Ph.D., serves as the Senior Science Advisor to the FDA's Chief Scientist in the mission of upgrading science, with a focus on bioinformatics and advancing regulatory science. She has most recently been Chief Scientific Officer at Immune Tolerance Network, a non-profit consortium of researchers seeking new treatments for diseases of the immune system; and an Adjunct Associate Professor with the Department of Medicine at the University of California - San Francisco.
Prior to that, Seyfert-Margolis was a program director in innovative scientific research at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. Dr. Seyfert-Margolis research interests are: Immunology, biomarker development, advancing scientific computing environment/high density data, health information technology, validation and standards development.