Axel Perlwitz Ph.D. is Transpire Bio’s Chief Regulatory Affairs Officer, responsible for providing leadership in all areas related to compliance with regulatory requirements, policies, and procedures, and Transpire Bio’s drug submissions to global regulatory health authorities. As a member of the leadership team he is also responsible for developing the strategic direction of the company including the development of the company’s pipeline.
He started his career as a chemist graduating from the University of the Witwatersrand in Johannesburg, South Africa, and transitioned into pharmaceuticals while serving as a post-doctoral fellow at the College of Pharmacy at the University of Kentucky. After leaving academia Axel spent some years working in the pharmaceutical CRO field supporting clients in their development of orally inhaled and nasal drug product. He later transitioned from product development into regulatory affairs and worked in this capacity at IVAX and Teva supporting the development and registration of Teva’s first branded MDI and DPI products in the US. Subsequently he joined the generics industry for several years with regulatory positions at Glenmark Pharmaceuticals, and Lupin Inc., supporting the development and registration of these organizations’ first orally inhaled products in the US, UK and EU.
Axel has been working with inhalation drug-device combination products for 25 years, with 20 of these years focused on Regulatory Affairs. Throughout his time in industry, he has served on the Board of the International Pharmaceutical and Aerosol Consortium on Regulation and Science.