Birge is a pharmaceutical physician with a background in clinical medicine, oncology and rheumatology/immunology and brings to tranScrip more than 25 years’ experience in R&D, spanning all aspects of early and late development, including clinical, strategic, regulatory and market access, globally.
Birge received her medical qualification and MD from the University of Erlangen/Nürnberg, Germany. She gained her clinical training in general medicine/rheumatology and oncology in the UK National Health Service. She has extensive drug development experience, covering small and large molecules. Birge joined the industry at Hoechst/Aventis, right into the successful development of leflunomide for rheumatoid arthritis and then moved on to develop levofloxacin, specifically in febrile neutropenic oncology patients. From there she moved into oncology clinical development, eventually setting up and leading the European clinical oncology group for Centocor/Johnson&Johnson, devising early development strategies for their biological molecules in multiple oncology indications.
Birge moved on to Janssen (Johnson&Johnson) Immunology Global Regulatory Affairs (GRA), leading multiple early and late phase global regulatory biologic teams, integrating inputs from regional and functional Regulatory Teams to create a coherent and unified global regulatory strategy. She has specific experience with US, EU, Japan and Chinese authorities. She led the integration of the Actelion regulatory affairs group into Janssen GRA. Birge is now looking to apply her broad clinical and regulatory R&D experience with tranScrip.
Birge maintains links with the Faculty of Pharmaceutical Medicine (FPM), Institute of Cancer Research (ICR), London as well as Imperial College Business School to become a change agent for healthcare innovation.