Presenter

Vicki Seyfert-Margolis

Founder and CEO, My Own Med

Vicki Seyfert-Margolis, Ph.D. founded My Own Med in January 2013, based on over two years of self-financed development work on a database, web and mobile application platform technology for family based co-management of health and a strategy for community building and patient engagement for health care providers, payors and biotechnology/pharmaceutical companies.Prior to this, Dr. Seyfert-Margolis was the Senior Advisor Science Innovation and Policy in the Office of the Commissioner of the US Food and Drug Administration.  Dr. Seyfert-Margolis began her tenure at FDA during the transition of the Obama administration.  While at the FDA, she oversaw the development and execution of an agency wide strategic plan for regulatory science.  Dr. Seyfert-Margolis was also responsible for FDA’s  strategies and programs to drive innovation both within the agency and industry, with a particular focus on the science and policies to move personalized medicine and targeted therapeutic co-development pathways forward.  She also focused on agency wide big data initiatives, including the creation of a scientific computing/application development environment, establishment of multiple collaborations around analyses of large FDA datasets, and creation of a standardized repository for storage of all FDA clinical data, thus enabling electronic submission of applications to the agency.Dr. Seyfert-Margolis worked with President Obama’s Start Up America and the White House Jobs Council to help shape policies to promote growth within the biotechnology sector of the US economy.  She served as the lead FDA representative on the President’s Council of Advisors of Science and Technology (PCAST) study “Propelling Innovation in Drug Discovery, Development and Evaluation.  Dr. Seyfert-Margolis is continuing work on medical product innovation with the FDA and Obama Administration.Dr. Seyfert-Margolis also oversaw design and development of both scientific approaches and policies for issues surrounding food safety, including spearheading efforts to develop testing for dispersant and petro-hydrocarbons in seafood following the Deep Water Horizon, mercury in fish guidelines, arsenic in juices and rice, and radiation level detection in foods following the nuclear accident in Fukushima, Japan.Prior to FDA, she served as Chief Scientific Officer at Immune Tolerance Network (ITN), a non-profit consortium of researchers seeking new treatments for diseases of the immune system. At ITN, Dr. Seyfert-Margolis oversaw the development of over 20 leading edge assay development and centralized laboratory facilities, bringing them to GLP and CLIA compliance.  She designed and implemented biomarker discovery studies for over 25 Phase II clinical trials across a broad array of immunologically mediated diseases including autoimmune disorders, allergy, and solid organ transplantation.   As part of these biomarker discovery efforts she established biomarkers for monitoring effects of immune modulating therapeutics, primarily monoclonal antibodies; established a signature to predict subsets of kidney transplant patients amenable to immunosuppression minimization or withdrawal, and developed several methods for measurement of B and T cell activation and tolerance using a variety of in vitro assays and advanced multi-color flow cytometry.  She also was responsible for the integration and analyses of clinical and assay data to define signatures that correlated with clinical milestones, immune activation and immune tolerance.Dr. Seyfert-Margolis was also an Adjunct Associate Professor with the Department of Medicine at the University of California San Francisco. Prior to this, she served as Director of the Office of Innovative Scientific Research Technologies at the National Institute of Allergy and Infectious Diseases at NIH, where she worked to integrate emerging technologies into existing immunology and infectious disease programs.Dr. Seyfert-Margolis completed her PhD in immunology at the University of Pennsylvania’s School of Medicine, and her post-doctoral fellowship work at Harvard University and the National Cancer Institute. 

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