Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Presenter
Dave Burrow, PharmD, JD
Director
Office of Scientific Investigations (OSI)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Dr. David Burrow serves as the Director of the Office of Scientific Investigations (OSI), within the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). In this role, Dr. Burrow leads efforts to shield the American public from unsafe and ineffective drug products. His leadership in the Agency’s Bioresearch Monitoring (BIMO) program includes the development and implementation of policies, surveillance activities, and compliance strategies for CDER-regulated products. Additionally, he oversees the enforcement of clinical and non-clinical drug product studies, bioequivalence studies, human subject protections, post-market adverse drug experience reporting requirements, risk evaluation and mitigation strategies, and post marketing requirements. Dr. Burrow holds a Doctor of Pharmacy from Duquesne University, and a Juris Doctorate from Widener University School of Law. He is licensed to practice law in the State of Maryland.
Abstract
This presentation, “Reimagining Clinical Research: Transformation of Trial Design and Conduct,” given by David Burrow from the FDA’s Office of Scientific Investigations (OSI), encourages a shift in perspective within the complex, global, and dynamic clinical research industry. OSI oversees clinical trial assessment, compliance, enforcement, regulations, and guidance. The industry functions as a fluid ecosystem, constantly evolving. The core message is that reimagining clinical research centers on changing how the clinical research workforce views itself and its role within this dynamic environment, as the workforce is the constant. Innovation is inherent in clinical research, and true innovation is driven by an intentional “why” aimed at improving operations, not simply adopting new things. A key concept is Quality by Design (QbD), which focuses on establishing systems and preparation to minimize errors that impact critical outcomes, acknowledging that perfection is unattainable. Successful QbD implementation is an ongoing process requiring continuous adaptation. The FDA supports innovation through resources like CTTI, guidances, and the new C3TI center. Regulation balances specificity and flexibility, guided by the critical interest in reliable data for safety and efficacy. FDA inspection practices are discussed, emphasizing that sponsors do not know which sites will be inspected, selection is risk-based, and a 483 notes observations but isn’t a final compliance outcome. Avoiding poor outcomes involves open dialogue and providing explanations in responses to agency findings. The presentation concludes with a forward-looking vision of clinical research integrated into clinical care, recognized as a profession, and maximizing the use of available resources, urging attendees to make “one day” “day one” for positive change.