Dr. Urte Gayko

Chief Regulatory, Quality & Pharmacovigilance Officer

Dr. Urte Gayko

Urte Gayko, Ph.D., is our Chief Regulatory, Quality & Pharmacovigilance Officer. She provides strategic, scientific and operational leadership throughout the product development cycle.

Dr. Gayko brings over 20 years of experience leading extensive teams in regulatory affairs, as well as safety and program management. She joined us from Nektar, where she was the SVP of Drug Development and Regulatory Affairs.

Prior to Nektar, Dr. Gayko was the Global Head of Regulatory Affairs and Pharmacovigilance at Pharmacyclics, Inc., which was acquired by AbbVie Inc. She was a key member of the Pharmacyclics leadership team, which saw 13 approvals for ibrutinib over her 8 years there. She built out the regulatory team from 3 to approximately 35 team members (2012 to 2020) and lead the regulatory strategy and approvals for spanning 95 countries. The regulatory strategy for ibrutinib included three of the first Break Through Designations and adjusting the regulatory plans leading to first approval one year earlier than originally planned. Prior to joining Pharmacyclics, Dr. Gayko held roles of increasing responsibility at several companies, including Amgen, Inc.

Dr. Gayko performed her Ph.D. research in molecular and cellular biology at Harvard University. She has a Masters in Biochemistry from Freie University, Berlin, Germany.