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Dr. Elliott Berger joined BioCryst in August 2007. Dr. Berger has more than 30 years of experience in the pharmaceutical industry including over 25 years devoted to management of regulatory affairs supporting new drug and biologic development. Prior to joining BioCryst he was Vice President Regulatory Affairs and Quality Assurance Head of Global Regulatory Strategy at EMD Pharmaceuticals the North American subsidiary of Merck KGaA. As part of the EMD start-up team Dr. Berger built and managed the EMD Regulatory Affairs Clinical Quality Assurance and Drug Safety Groups as well as the Global Regulatory Strategy Group. At EMD Dr. Berger submitted and managed over 10 Investigational New Drug Applications in areas of oncology diabetes cardiovascular disease and neurology. Dr. Berger also prepared and submitted the NDA for Cyanokit® which was approved within 6 months of submission to the FDA. Prior to EMD Dr. Berger was a member of the Senior Executive Team at Astra Pharmaceuticals most recently serving as Vice President Regulatory Affairs.
Dr. Berger received both his Ph.D. and M.S. degrees in Biometrics as well as his B.A. degree in Mathematics from Temple University. | 