Kevin Bugin

Head of Global Regulatory Policy and Intelligence at Amgen

Speaker

Kevin Bugin is the Associate Vice President of Global Regulatory Policy and Intelligence at Amgen, Inc, where he leads a diverse team of professionals engaged in promoting innovative, efficient and effective approaches to developing and providing access to safe and effective new therapies to patients. Prior to his current role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he led the establishment of the CDER Center for Clinical Trial Innovation (C3TI) which aimed to promote the implementation of innovative clinical trial approaches in drug development. From May 2020 through May 2021, Dr. Bugin served as the Chief of Staff for the Therapeutics Response Efforts as part of the US Government’s HHS and DOD operation formerly known as Operation Warp Speed. He is also an adjunct faculty at the George Washington University in the Clinical Leadership Program, focusing on areas of clinical research, regulatory affairs, and medicines development.