Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Presenter
Kevin Bugin, PhD, MS, RAC
Deputy Director
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). 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 an 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. Kevin received a BS in Biology and Chemistry from Virginia Tech in 2005, a 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.
Abstract
In this session, Dr. Kevin Bugin discusses the launch of the CDER Center for Clinical Trial Innovation (C3TI) at the FDA, which was established on April 15th to enable and amplify innovative approaches in clinical trial design and conduct, ultimately improving the efficiency and effectiveness of drug development. He highlights the need for C3TI, drawing on challenges and lessons learned during the pandemic regarding the adoption of innovation. C3TI focuses on sharing lessons learned, enhancing communication and collaboration with external stakeholders, and expanding opportunities for innovation through key activities like a central inquiry mailbox, a searchable knowledge repository (Compass), and targeted demonstration programs. Initial demonstration projects include Bayesian supplementary analyses, selective safety data collection, and streamlined trials embedded in clinical practice (STEP). The session also covers C3TI’s role in facilitating interactions with review divisions for demonstration trials and the potential for expanding focus areas to include earlier-stage development, AI, and technologies developed by service providers, aiming to promote the broader adoption of innovative methods and ultimately improve patient outcomes.