"I am working with non-clinical development of biopharmaceuticals with focus on designing, monitoring and interpreting nonclinical safety studies. I have a broad drug development experience covering discovery, early exploratory safety assessment and preparation of safety assessment packages supporting regulatory submission documentation (IB, IND, NDA/BLA). My main drive is to assure optimal design and execution of nonclinical safety strategies through close interaction with discovery, clinical and regulatory functions. I enjoy the process of getting the overview of complex projects to deliver clear messages for internal decision making as well as authority review. I am experienced in managing regulatory toxicology studies as well as safety studies of more exploratory character. In addition, I have worked with pharmacological in vitro and in vivo models as well as set-up of analytical methods for determination of e.g. biomarkers and immunogenicity. My scientific background is within neuroscience and molecular/cellular biology, and I have throughout my career worked with projects focusing on neurodegenerative diseases (e.g. Alzheimer´s Disease, Parkinson´s disease, Huntington´s Disease) and stroke. My motivation is a strong wish for being part of work creating innovative solutions for improved treatments for patients with CNS diseases."
Cell, Cell Culture, Drug Discovery