ELIZABETH GORDON

Vice President, Regulatory Affairs
Business
Amplyx Pharmaceuticals
Ireland

Business Expert Business and Management
Biography

Dr. Elizabeth Gordon brings 25 years of experience in the pharmaceutical industry and FDA. Dr. Gordon has an in-depth understanding of the requirements for successful new drug registration, along with a first-hand knowledge of facilitating regulatory interactions. Dr. Gordon was the president and founder of EG Consulting Inc., where she provided expert regulatory advice on requirements for biological and pharmaceutical product development. Her responsibilities included oversight of U.S. and non-U.S. regulatory operations; preparation of all regulatory submissions; project and strategic planning from candidate selection through completion of clinical studies; oversight of product development information management systems; and management of potential partners to support funding or other business transactions. Dr. Gordon also acted as head of regulatory affairs while consulting for Lumena Pharmaceuticals Inc., a position that transitioned into full-time employment as vice president of regulatory affairs in early 2014. Under her leadership, Lumena initiated 10 clinical trials in eight countries. Its drug candidate ultimately gained orphan product designation in the United States and the European Union for the treatment of four rare cholestatic liver diseases.  Dr. Elizabeth Gordon brings 25 years of experience in the pharmaceutical industry and FDA. Dr. Gordon has an in-depth understanding of the requirements for successful new drug registration, along with a first-hand knowledge of facilitating regulatory interactions. Dr. Gordon was the president and founder of EG Consulting Inc., where she provided expert regulatory advice on requirements for biological and pharmaceutical product development. Her responsibilities included oversight of U.S. and non-U.S. regulatory operations; preparation of all regulatory submissions; project and strategic planning from candidate selection through completion of clinical studies; oversight of product development information management systems; and management of potential partners to support funding or other business transactions. Dr. Gordon also acted as head of regulatory affairs while consulting for Lumena Pharmaceuticals Inc., a position that transitioned into full-time employment as vice president of regulatory affairs in early 2014. Under her leadership, Lumena initiated 10 clinical trials in eight countries. Its drug candidate ultimately gained orphan product designation in the United States and the European Union for the treatment of four rare cholestatic liver diseases. 

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