Catalyst Pharmaceuticals
David Axmann has a diverse work experience in quality management and compliance. David is currently serving as the Associate Director of Quality Systems and Compliance at Catalyst Pharmaceuticals. Before that, they worked as the Manager of Quality Management Systems at Esperion. Prior to that, they had a role as a Quality Compliance Auditor at Glenmark Pharmaceuticals. David also served as a Quality Supervisor at Kenco Group and held various positions at Alexion Pharmaceuticals, Inc., including Quality Systems. Their early career includes roles at Merial, where they worked as a Laboratory Technician and Quality Assurance Inspector. Throughout their career, David has demonstrated expertise in conducting audits, developing quality systems, and ensuring compliance with regulatory standards.
David Axmann has a Bachelor of Science degree in Business Management from Western Governors University. David also holds a Master of Business Administration degree in Healthcare Management from the same institution. Additionally, they have certifications including Certified Quality Auditor (CQA) and Certified Supplier Quality Professional (CSQP) from ASQ - World Headquarters, as well as certifications from MasterControl and Veeva Systems.
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Catalyst Pharmaceuticals
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Catalyst Pharmaceuticals is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for other rare diseases. Catalyst's New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS") was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and FIRDAPSE is commercially available in the United States as a treatment for adults with LEMS. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS.