Fabienne Pietravalle Elson, PhD
About Fabienne Pietravalle Elson, PhD
Fabienne Pietravalle Elson, PhD, is the Deputy Head and Senior Director of Oncology Regulatory Science, Europe at Bristol Myers Squibb, based in Boudry, Neuchâtel, Switzerland.
Company
Fabienne Pietravalle Elson, PhD, is currently serving as the Deputy Head and Senior Director of Oncology Regulatory Science in Europe at Bristol Myers Squibb. She is based in Boudry, Neuchâtel, Switzerland. Bristol Myers Squibb is a leading global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
Titles and Roles
Fabienne Pietravalle Elson holds the position of Deputy Head and Senior Director, Oncology Regulatory Science at Bristol Myers Squibb. Her career includes notable roles such as Senior Director Regulatory Affairs at Celgene, Executive Vice President - Head of Global Regulatory Affairs at Finox Biotech AG, and Director Regulatory Affairs - Strategy at Shire Pharmaceuticals. She has also worked as Global Regulatory Affairs - Associate Director and Manager at Merck Serono, and started her regulatory affairs career at Serono.
Education and Expertise
Fabienne Pietravalle Elson earned her Doctor of Philosophy (Ph.D.) in Immunology from Universite de Medecine - Paul Sabatier - Toulouse. She also holds a Master's degree in Immunology from Université des Sciences - Montpellier. Additionally, she completed a DEA - Diplome d'Etudes Approfondies in Immunopathology - Immunogenetics from Universite de Medecine - Paul Sabatier - Toulouse. She has a 1-year Advanced Certificate of English from Universite de Cambridge. Her extensive expertise spans across regulatory strategy for the entire drug development process, particularly in hematology and oncology.
Background in Regulatory Affairs
Fabienne Pietravalle Elson has a rich background in regulatory affairs, beginning her career at Serono and progressing through various senior roles at major pharmaceutical companies. Her expertise includes regulatory strategy for Phase I-IV drug development, Clinical Trial Applications, Scientific Advice, Orphan Designations, Pediatric Investigation Plans, Marketing Authorization Applications, Biologics License Applications, New Drug Applications, Risk Management, and Life Cycle Plans. She has led diverse teams across Europe and globally, demonstrating effective leadership and strategic planning capabilities.
Skills and Specializations
Fabienne Pietravalle Elson is highly skilled in regulatory applications for biological products, with specialized knowledge in hematology and oncology, particularly involving monoclonal antibodies and checkpoint inhibitors. Her expertise includes acute myeloid leukemia (AML), myelofibrosis, myelodysplastic syndrome (MDS), melanoma, and bladder cancers. Additionally, she has experience with genetic and rare metabolic disorders like Gaucher and Fabry diseases, as well as neurodegenerative diseases such as Multiple Sclerosis and Parkinson's disease. She is fluent in English and French, with good proficiency in Spanish.