Date: 2015-09-16
Type of information: Nomination
Compound:
Company: Avexis (USA - IL)
Therapeutic area: Rare diseases - Genetic diseases - Neurological diseases
Type agreement: nomination
Action mechanism:
Disease:
Details: * On September 16, 2015, AveXis, a gene therapy company developing treatments for rare and life-threatening neurological genetic diseases, announced recent key appointments to its executive management team. The appointments include Thomas J. Dee, Senior Vice President and Chief Financial Officer; James J. L’Italien, Ph.D., Senior Vice President, Chief Regulatory and Quality Officer; Andrew Knudten, Senior Vice President, Manufacturing and Supply Chain; and Sukumar Nagendran, M.D., Senior Vice President and Chief Medical Officer. These executives will report to Sean P. Nolan, President and CEO of AveXis. Thomas J. Dee, Senior Vice President, Chief Financial Office, has responsibility for all aspects of the company’s finance functions, including treasury, tax and controllership. Prior to joining AveXis, Mr. Dee worked as an independent consultant supporting start-up businesses following a successful 24-year career with Abbott Laboratories, where he most recently served as Vice President, Finance Operations. Additional experience includes a variety of management positions at Abbott, including Vice President, Controller Pharmaceutical Products; Vice President, Controller Abbott International; Vice President, Internal Audit; Controller, Manufacturing Operations; Director, Acquisition Integration Management; and Finance Director, Europe Area. Prior to joining Abbott, Mr. Dee worked for Arthur Andersen LLP and Carson Pirie Scott. James J. L’Italien, Ph.D., Senior Vice President, Chief Regulatory and Quality Officer, is responsible for developing the company’s regulatory filing strategies in support of domestic and international filing initiatives, and for assuring compliance with regulatory requirements. Before joining AveXis, Dr. L’Italien served as Senior Vice President of Regulatory Affairs and Quality Assurance for InterMune (2012-2015) where he oversaw all global regulatory affairs and quality assurance activities in support of its commercial- and development-stage pharmaceutical programs. He is credited with overseeing the regulatory process for Esbriet®, including the granting of a Breakthrough Designation by the U.S. Food and Drug Administration; the submission of the U.S. new drug application (NDA) in less than 90-days from top-line clinical trial results; the approval of the NDA in less than five months from submission; and a major European Medicines Agency revision/expansion of the product label to include mortality data less than four months from submission. Prior to that, Dr. L’Italien served as Vice President of Regulatory Affairs and Quality Assurance for Geron (2009-2012), where he supported development-stage programs in oncology and stem cell therapy. Before joining Geron, he served as Senior Vice President of Regulatory Affairs and Quality Assurance for Somaxon Pharmaceuticals (2007-2009), and held the global position of Senior Vice President of Regulatory Affairs and Compliance at Ligand Pharmaceuticals (2002-2007). Andrew Knudten, Senior Vice President, Manufacturing and Supply Chain, brings strong experience to the manufacturing, technical operations and supply chain aspects of the business. Prior to joining AveXis, Mr. Knudten accumulated 23 years of experience working in a variety of biopharmaceutical roles, including at Amgen, CoDa Therapeutics, Novartis and most recently, Hospira. Recent roles include Vice President of Operations (Site Head for Hospira sterile injectable plant), Vice President API Operations at Hospira and Global Head of Contract Manufacturing and Strategy for Novartis Vaccines. Previously he served in key research, product development, finance and operations roles at Amgen, supporting the development of numerous pipeline products and more than five eventual commercial products now being marketed by Amgen. Sukumar Nagendran, M.D., Senior Vice President and Chief Medical Officer, is responsible for overseeing and driving all clinical development and medical affairs strategies and efforts for AveXis and its pipeline. Dr. Nagendran has significant clinical development, medical affairs and diagnostics experience with increasing roles and responsibilities at Pfizer, Novartis, Daiichi Sankyo, Reata and Quest Diagnostics. Dr. Nagendran has held key leadership positions across multiple medical functions to drive support for many innovative products, including clinical trials/operations, field medical, medical product team, national and regional payer efforts, publications, advocacy and genetic counseling activities/oversight. He was instrumental in building the medical affairs function at Quest Diagnostics, the largest lab/diagnostics provider in the world. Dr. Nagendran is a Mayo Alumni Laureate and founding member of the Robert Wood Johnson Legacy Society. He is also the sponsor for the Vivian Fonseca Scholar award at the ADA to enhance research in minority populations.
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