Monika Swietlicka is Senior Vice President of Regulatory Affairs at Immusoft. She leads development and implementation of regulatory strategy and quality systems, including overseeing regulatory submissions and compliance. She is responsible for quality oversight and program management of Immusoft’s clinical pipeline.
Monika has broad knowledge of the product lifecycle from Investigational New Drug approval through the Biologics License Application process with the U.S. Food and Drug Administration and the European Medicines Agency. She brings to Immusoft extensive experience in various biotechnology settings, having specialized in discovery, pre-clinical, clinical, commercial and translational research. She is versed in all stages of cellular therapeutics and biologics drug development, and manufacturing.
Previously, Monika managed a continuous improvement program for a first in class immunotherapy product, Provenge (Sipuleucel-T), for which she also developed new processes to monitor method lifecycle. She has authored content for FDA and EMA submissions, led Contract Manufacturing Organization tech transfer activities and compliance audits.
Immusoft is Monika’s third experience with a biotech startup. Earlier, she worked on in-situ therapeutic antibody rescue technology, T-cell activation platform, and the first autologous antigen-presenting cells vaccine designed to stimulate an immune response to a variety of tumor types. She was part of early collaborative efforts with the International AIDS Vaccine Initiative to develop HIV-neutralizing antibodies and has worked on broadly neutralizing antibodies for treating pandemic influenza and severe seasonal influenza.
Monika has degrees from Seattle Pacific University, having earned an M.B.A. in International Business and a B.S. in Biochemistry and Molecular Biology. While earning her master’s, she co-authored an operations management textbook now used by the graduate business program. As an undergraduate, her senior thesis focused on studies of NKG2D and MICA on Surface and in Solution in which MICA ligands were mutated at residues that do not contact NKG2D.
Monika is a strong advocate for disruptive biotechnologies and passionately supports all regulatory activities to advance Immusoft’s strategic initiatives.