Speaker

Ginny Beakes-Read

EXECUTIVE DIRECTOR AND LEAD, GLOBAL REGULATORY AND R&D POLICY, AMGEN
Ginny Beakes-Read is Executive Director, Global Regulatory and R&D Policy at Amgen. She leads the GRR&D policy group, which works to shape the regulatory environment in ways that support innovative drug development and patient access to new therapies. The team works with Regulatory, Development, Commercial, Health Policy, Government Affairs, and other departments on a variety of regulatory and policy matters. Ginny joined Amgen from Eisai, where she led the Global Regulatory Policy team for 8 years. For her last 2 years at Eisai, Ginny was the Executive Director/Special Counsel, Regulatory Strategy and Law, where she was a member of the Global Regulatory Affairs and Legal Departments.

Ginny previously worked at Genentech, Inc., as Director, Regulatory Policy and Strategy, in the Washington, D.C. Office. Prior to her work at Genentech, Ginny was at FDA where she was the Director, Division of Regulatory Policy II, Office of Regulatory Policy in CDER for 8 years. In that position she was responsible for the development of regulations affecting CDER, and was 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.
Speaking In
1:45 PM - 2:45 PM
Wednesday, June 7
This session will review exciting developments in cloud-based submissions which are now a reality…