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.
Application of engineering principles and equipment to biology and medicine. It includes the development and fabrication of life-support systems for underwater and space exploration, devices for medical treatment (seedialysis, prosthesis), and instruments for monitoring biological processes. Development has been particularly rapid in the area of artificial organs, which culminated in the implantation of an artificial heart into a human being in 1982. Bioengineers also develop equipment that enables humans to maintain body functions in hostile environments, such as the space suits worn by astronauts during extravehicular maneuvers.