VP, Global Regulatory Policy and Intelligence
Janssen Pharmaceuticals
Ginny is Vice President, Global Regulatory Policy and Intelligence at Janssen Pharmaceuticals. She leads Janssen’s Global Regulatory Policy efforts, working to shape the regulatory environment to support innovative drug development and patient access to new therapies. She works with colleagues in Regulatory and other departments on a wide variety of regulatory and policy matters. Previously Ginny led the Global Regulatory and R&D Policy group at Amgen, working on issues related to trial design, real world data, companion diagnostics, combination products, patient centricity, and other topics. Ginny joined Amgen from Eisai, where she led the Global Regulatory Policy team for 8 years. During her last 2 years at Eisai, Ginny was the Executive Director/Special Counsel, Regulatory Strategy and Law, and was a member of the Global Regulatory Affairs and Legal Departments. Ginny previously worked at Genentech as Director, Regulatory Policy and Strategy.
Prior to her work at Genentech, Ginny was at the Center for Drug Evaluation and Research (CDER) at FDA where she was the Director, Division of Regulatory Policy II, Office of Regulatory Policy, for 8 years. She was responsible for the development of all regulations affecting CDER, and involved with crafting policy positions in areas such as follow-on biologics. Before her tenure at FDA, Ginny was a US Army JAG, working as a prosecutor and appellate attorney. Ginny is also an RN and started her career as an intensive care nurse in the US Air Force. Ginny holds B.S.N. and J.D. degrees from the University of Virginia.
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Thursday, October 5, 2023
9:30 AM – 10:30 AM EDT