Marie Vodicka
About Marie Vodicka
Marie Vodicka serves as the Senior Director of Regulatory Affairs at Sonoma Biotherapeutics, where she has worked since 2022. With extensive experience in regulatory affairs across various organizations, she specializes in regulatory strategy for therapeutic biologics and cell therapies.
Work at Sonoma BioTherapeutics
Marie Vodicka has been serving as the Senior Director of Regulatory Affairs at Sonoma BioTherapeutics since 2022. In this role, she leads regulatory strategy and oversees FDA interactions for early-stage therapeutic biologics. Her focus includes initiating first-in-human studies, which is critical for advancing innovative treatments in the biotechnology sector.
Previous Experience in Regulatory Affairs
Prior to her current position, Vodicka held multiple senior roles in regulatory affairs. She worked at Silverback Therapeutics as Senior Director Regulatory Affairs for nine months in 2021-2022. Before that, she was with Iovance Biotherapeutics, where she served as Senior Director Regulatory Affairs for one month and as Director of Regulatory Affairs for one year. Her experience also includes a three-year tenure at Pharmacyclics, an AbbVie Company, as Associate Director Regulatory Affairs.
Educational Background
Marie Vodicka has a strong academic foundation in biology. She earned her Doctor of Philosophy from the University of California, Berkeley, where she studied from 1989 to 1995. Additionally, she holds a Bachelor of Arts in Biology from Amherst College, completed in 1988. Vodicka has also pursued further education at the Food and Drug Law Institute, obtaining a Master of Arts.
Expertise in Regulatory Strategy
Vodicka possesses extensive expertise in regulatory strategy, particularly for autologous and allogeneic cell therapies. Her work focuses on treatments targeting autoimmune and inflammatory diseases. She has a proven track record in leading FDA interactions, which is essential for the successful development of new therapeutic biologics.
Career Milestones
Throughout her career, Vodicka has held significant positions in regulatory affairs. She worked at Hogan Lovells as Regulatory Affairs Director for six years and served as Associate Vice President of Scientific & Regulatory Affairs at PhRMA for two years. Her early career included roles at the U.S. Department of State and Fred Hutchinson Cancer Research Center, where she was a Post-doctoral Fellow for seven years.