Katja brings over 20 years of experience within all aspects of Regulatory Affairs in a HQ setting (CMC, pre-clinical, clinical and LCM), driving global submissions and approvals of various pharmaceutical products. She is experienced in lifecycle management of nationally-, de-centralised and centrally approved products in the EU as well as NDA submissions in the USA, JAPAN, China and over 120 other countries
Katja joins Hansa Biopharma from NDA Group, where she was Senior Consultant. Prior to this she spent 18 years in Global Regulatory Affairs with Ferring Pharmaceuticals. Katja has been regulatory lead for several development projects and has a MSc (Pharm) from the Royal Danish School of Pharmacy.
Anne Säfström Lanner, Vice President Global HR at Hansa Biopharma AB, commented, “I am delighted to welcome Katja to our global team. Her expertise in regulatory affairs will be highly valuable in furthering the development of Hansa Biopharma’s enzyme technology and developing the next generation of immunomodulatory treatments.”
Thomas Schleimer, Managing Partner at The RSA Group, commented, “We are pleased to have been part of helping Hansa Biopharma in securing the services of Katja Gustafsson in such a vital position.”
Hansa Biopharma is leveraging its proprietary enzyme technology platform to develop immunomodulatory treatments for rare immunoglobulin G (IgG)-mediated autoimmune conditions, transplant rejection and cancer. The Company’s lead product candidate, imlifidase, is an antibody-cleaving enzyme being developed to enable kidney transplantation in highly sensitized patients and may be further developed for use in other organ and tissue transplantation and acute autoimmune indications. Imlifidase is currently under review for a potential marketing authorization by European Medicines Agency (EMA).