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Diane Scudiery has over 25 years of domestic and international experience in the pharmaceutical industry. She has held positions of increasing responsibility in clinical operations, data management and regulatory affairs at leading pharmaceutical and biotechnology companies. She has extensive experience in managing clinical programs for oncology products, and in the development and execution of facilitating regulatory activities with the FDA, EMEA, Health Canada and the TGA (Australia). She has also led successful efforts to obtain Orphan Drug designations in the US and Europe, as well NDA orphan drug approvals. Prior to joining Alfacell, Ms. Scudiery served as Director of Clinical Research at Enzon Pharmaceuticals, and was a key member of the team responsible for regulatory approvals of their first two marketed products, ADAGEN® and ONCASPAR.® Prior to Enzon, Ms. Scudiery held clinical and regulatory positions at Aventis and Schering-Plough. Ms. Scudiery earned a B.A. from William Paterson University, a M.Ed. from Rutgers University and a M.A. from Farleigh Dickinson University.
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