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As Senior Director of Operations and Scientific Affairs at Certus International, Inc., Dr.Wolfangel provides strategic scientific and regulatory guidance to start-up companies and major pharmaceutical firms engaged in the research and development of new diagnostic and therapeutic drugs. This guidance includes development of clinical protocols, audit of manufacturing and quality processes, stability protocol design, process validation and preparation of regulatory submissions for diagnostic imaging drugs, including radiopharmaceuticals, ultrasound contrast agents and diagnostic devices. Prior to joining Certus, Dr. Wolfangel was Vice President of Imaging Regulatory Affairs at Mallinckrodt, Inc. (St. Louis, MO), where he directed the preparation and submission of INDs, NDAs (including approval of the diagnostic imaging agent OptiMARK®), DMFs and manufacturing change supplements for the diagnostic imaging division. He provided technical and regulatory leadership for a staff of six direct reports, as well as for numerous product development and process improvement teams. Dr. Wolfangel began his career as a radiopharmaceutical research chemist at Mallinckrodt and achieved the position of Associate Director of Nuclear Medicine R&D. He initially performed the chemical and biological work leading to the development and registration of new radiopharmaceuticals and later directed the development of 11 new radiopharmaceutical products and a large number of process improvements to approved products. In this capacity Dr. Wolfangel developed a very interactive and productive relationship with the FDA. As a member of the Nuclear Medicine R & D department, he accumulated extensive experience in preparing and labeling inorganic, protein and peptide structures with radionuclides including I-131, Tc-99m, Re-186, In-111, and Lu-177. Dr. Wolfangel has a wide breadth of knowledge of chemistry and good manufacturing requirements essential for the successful development and registration of diagnostic imaging agents. He served on the US Pharmacopoeia committee of experts for radiopharmaceutical imaging agents establishing quality and cGMP requirements for the preparation of monoclonal antibody, peptide and positron emitting imaging agents. | 