(1888PressRelease)
July 30, 2009 - Amy’s presentation highlights GSK's approach to immunotherapy for cancer (Antigen-Specific Cancer Immunotherapeutics), challenges of co-development - biologic & companion in vitro diagnostics (screening assays & biomarkers), development/regulatory challenges/considerations for the biologic component, and development/regulatory challenges/considerations for the in vitro diagnostic component.
Amy is the Vice President of Global Regulatory Strategy for Immunotherapeutics at GlaxoSmithKline Biologicals (GSK Bio) where she manages a global staff responsible for all regulatory activities relevant to the development and commercialization of immunotherapeutic products for cancer and chronic disorder indications. Amy is also responsible for the regulatory aspects of in-licensing opportunities and for partnerships with external parties for the global development of companion in vitro diagnostics.
Prior to joining regulatory affairs at GSK in 1998, Amy served in GSK’s World Wide Supply Operations as a Director of Quality Assurance & Compliance; supporting various business units including Research & Development, Biopharmaceuticals and Pharmaceuticals. Before joining GSK, Amy served for nearly 9 years at the Center for Biologics Evaluation and Research (CBER) at the US FDA in several capacities, including senior management, reviewer and inspector of biopharmaceutical manufacturing facilities. Amy received her B.S. in Microbiology from Pennsylvania State University and her M.S. in Biotechnology from Johns Hopkins University.
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