Dr. Kevin Bugin, Ph.D. - Deputy Director of Operations, Office of New Drugs, CDER, U.S. FDA - Clinical Trial Innovation To Improve The Efficiency And Effectiveness Of Drug Development

Progress, Potential, and Possibilities

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Dr. Kevin Bugin, Ph.D. is Deputy Director of Operations in the Office of New Drugs ( OND - https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-new-drugs ) in FDA’s Center for Drug Evaluation and Research ( CDER - https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder ), where among his many responsibilities he serves as lead for the Center for Clinical Trial Innovation ( C3TI - https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-clinical-trial-innovation-c3ti ), a central hub within CDER to support the implementation of innovative approaches to clinical trial design and conduct.
Prior to his current role, 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.
Dr. Bugin is adjunct faculty at the George Washington University in the Clinical Leadership Program, focusing on areas of clinical research and medicines development.
Dr. Bugin joined the FDA in 2008 in the Office of Business Process Support, then joined the Division of Gastroenterology and Inborn Errors Products within OND as a Regulatory Health Project Manager in 2010, and as the Chief of Project Management from 2015 to 2017. From 2017 until 2020, he served as the Director of Special Programs and the lead of CDER’s New Drugs Regulatory Program Modernization.
Prior to joining the FDA, Dr. Bugin held roles in multiple areas and phases of drug development, including discovery (molecular biology) at the Virginia Bioinformatics Institute, translational research and technology transfer at the National Institute of Health’s Office of Technology Transfer, safety and pharmacovigilance with NIH’s National Cancer Institute’s Cancer Therapy Evaluation Program, and regulatory affairs and quality assurance at Amarex Clinical Research.
Dr. Bugin received a BS in Biology and Chemistry from Virginia Tech in 2005, an MS in Biotechnology from American University in 2006, and a PhD in translational health science from George Washington University in 2020, with a focus on the Science of Team Science in drug development and regulatory science teams. He is certified in US regulatory affairs (RAC) and participates in numerous policy and regulatory science program working groups across the FDA.

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