Dr Philip Krause has a unique combination of scientific, regulatory, clinical and public health experience. He is a physician with board certification in internal medicine and infectious diseases, and a researcher with over 100 publications on topics spanning clinical evaluation of vaccines, viral pathogenesis and immunology, and biological product development.
Dr Krause was the deputy director of the Office of Vaccines Research and Review at the US Food and Drug Administration's Center for Biologics Evaluation and Research for a decade. He has also been chair of the World Health Organization COVID Vaccines Research Expert Group, and shared responsibility for regulatory authorisations of COVID-19 vaccines in the US. His experience includes regulation and development of biological products including interdisciplinary team-based review process for clinical (safety and efficacy) and CMC (product quality) issues throughout the product life cycle, through Phase 3 clinical development and post-marketing phases.
In a 30-year career at the US Food and Drug Administration, Dr Krause has collaborated with international and US domestic stakeholders including the European Medicines Association, Biomedical Advanced Research and Development Authority, and the National Institutes of Health.
