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Dr. Breaux joined PharmaDirections in 2008. In his current role he is a senior drug development expert. Dr. Breaux has more than 20 years experience working with both innovator and contract research organizations. His primary focus is in the areas of Chemistry, Manufacturing and Controls (CMC) project coordination and CMC regulatory affairs. Before joining PDI, Dr. Breaux worked as a Director of Medicinal Chemistry at King Pharmaceuticals and as a Senior Director of Analytical Chemistry at AAI Pharma. In addition, he previously worked at Cato Research and Aventis as a CMC expert. Dr. Breaux has led project teams and functioned as a CMC expert on a variety of discovery and development projects. Dr. Breaux has authored and reviewed CMC and other sections of INDs, NDAs, BLAs and other regulatory submissions. He has participated in FDA meetings and authored responses to FDA questions. Dr. Breaux currently holds the Regulatory Affairs Certification and was recertified in 2008. Dr. Breaux earned a B.S. in Biochemistry from Louisiana State University and a Ph.D. in Chemistry from Johns HopkinsUniversity. He subsequently completed a NIH Post-Doctoral Fellowship at Northwestern University in the area of Medicinal Chemistry. |
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