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Dr. Del Tito possesses twenty-plus years of experience in both large pharmaceutical and small to mid-sized biotechnology companies specializing in a range of products from protein therapeutics to vaccines to diagnostics. His career has focused on the areas of analytical development, quality control, pre-clinical assay development and validation, quality assurance, and regulatory affairs. He is knowledgeable in global drug development (Phase I-IV), IND, IMPD, NDA and BLA submissions, regulatory interactions, and regulatory inspections for both US and Europe/UK. He has extensive experience in building teams of development and quality professionals for phases of drug development including early development, clinical manufacturing, licensure and commercial manufacturing. He currently serves as Executive Vice President of Regulatory Affairs and Project Management where he oversees the Regulatory Affairs and Project Management/Alliance Management departments for this specialty biopharmaceutical company. Prior to March 2010, Dr. Del Tito served as Senior Vice President of Quality and Regulatory Affairs for Auxilium. Prior to Auxilium, Dr. Del Tito served as Vice President, Analytical and QC Operations at Neose Technologies, Inc., a biotech company that develops second generation therapeutic proteins using proprietary enzymatic technology for post expression modifications. Prior to Neose, Dr. Del Tito served as Senior Director, QC Operations at MedImmune Vaccines, Inc. (formerly Aviron, Inc.) a wholly-owned subsidiary of MedImmune, Inc. (now part of Astra Zeneca), a biopharmaceutical company with several commercial products for infectious diseases. Prior to joining MedImmune, Dr. Del Tito was director of biotechnology and microbiology at AAI, Inc. He has also held positions at North American Vaccine, Inc., SmithKline Beecham Pharmaceuticals (now GlaxoSmithKline), and Centocor, Inc. Dr. Del Tito earned a B.A. in Biology from Millersville University, an M.S. in Biochemistry from Western Kentucky University and a Ph.D. in Molecular Biology from Lehigh University. |