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Position
Head of Regulatory Affairs, North America
Company
CEPI (Coalition for Epidemic Preparedness Innovations)
Location
Oslo NORWAY
Bio
Debra Yeskey, Pharm.D., is the Head of Regulatory Affairs, North America for the Coalition for Epidemic Preparedness Innovations (CEPI), a partnership of public, private, philanthropic and civil organizations that will finance and co-ordinate the development of vaccines against high priority public health threats and vaccine platform technologies to respond rapidly to emerging infectious diseases with pandemic and epidemic potential. Prior to joining CEPI, Debra served as the Director of the Regulatory and Quality Affairs Division (RQA) within the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services. She served as Director of RQA for 10 years. She was responsible for creating and staffing the RQA Division. She also instituted many significant internal and external processes for RQA and BARDA. While under her direction, numerous BARDA-funded medical countermeasures were approved, licensed and cleared by the United States Food and Drug Administration (FDA). Debra also served a commissioned officer in the U.S. Public Health Service (USPHS) and created the Office of Regulatory Affairs at the National Center for Infectious Diseases within the Centers for Disease Control and Prevention (CDC). In this position, Dr. Yeskey was responsible for the regulatory preparedness of all the medical countermeasures within the Strategic National Stockpile (SNS). Within her tour with CDC, Dr. Yeskey was co-located within the Office of Research and Development Coordination (the predecessor to BARDA) where she was a Special Regulatory Advisor to the ASPR. In this position, she provided expert advice, guidance, and regulatory policy with regard to the regulatory readiness of the SNS and the status of all the Investigational New Drug Applications and pre-Emergency Use Authorization requests held by CDC. As a USPHS officer, Dr. Yeskey also worked with the FDA and the National Institutes of Health (NIH). In addition, Dr. Yeskey has a response background; she has been trained as an Emergency Medical Technician and was a member of the PHS Disaster Medical Assistance Team. She has responded to numerous natural disasters such as Hurricane Katrina, has pre-deployed for planned mass public events, and was part of the CDC’s response to the events of 9/11 and the anthrax attacks in 2001. Dr. Yeskey received a Bachelor’s of Science degree in Pharmacy from Duquesne University in Pittsburgh, PA, and a Doctor of Pharmacy from Creighton University in Omaha, NE.