Kati is a seasoned regulatory affairs professional with over 30 years’ experience in the Life Sciences and a strong multifunctional regulatory, quality and technical background. Her regulatory experience spans pre-IND through BLA submissions to life cycle management, forging pathways for new technology products, sustaining product supply and developing a viable regulatory compliance infrastructure for clinical sample testing laboratories. She has extensive experience in cross-functional teams to develop, negotiate and implement regulatory strategy in alignment with the regulations and business goals, with significant experience and successful interaction, both formal and informal, with the FDA and other regulatory authorities.

Prior to joining Tunnell, Kati worked in the biopharmaceutical industry both in biotech and in big biopharma. At VaxInnate Corporation, she was VP, Regulatory Affairs with responsibilities for development and execution of regulatory strategy for the products at all stages of development as well as for managing QA and support for the company’s contracts and partnerships. At Merck & Co, Inc., Kati held roles with increasing responsibility in the vaccine analytical laboratories, QC, CMC regulatory, regulatory compliance management for vaccine clinical testing and regulatory affairs international for I/O. While at GSK, she worked in North American Regulatory Affairs, supporting licensed and in development flu vaccines, including adjuvanted, cell culture-based and pandemic indication products, and she filed the first adjuvanted pandemic indication avian flu vaccine in the US. Kati’s first position in industry was in R&D at Centocor (now Janssen Biotech). Kati started her career at Children’s Hospital of Philadelphia where she worked in infectious diseases and cancer research.