Dr. Barbara Bonamassa holds a 3-year Bachelor’s degree in Biological Sciences and a 2-year Master’s degree in Cellular and Molecular Biology from the Alma Mater Studiorum - University of Bologna, Italy. She earned her PhD in Pharmacology and Toxicology at the same University. She then joined several national laboratories and the University of Pittsburgh, School of Pharmacy (PA, USA), as a postdoctoral researcher supported by national and international fellowships. Her focus was the study of gene expression regulation, the development of viral and non-viral gene delivery/transfer techniques as well as the identification of genes that code for therapeutic proteins and the unravelling of their mechanisms of action. After earning a II level master degree in Drug Regulatory Affairs and an Advanced study course degree in Statistical Methods for the Biomedical Research and Practice, from the University of Rome “Sapienza” (Italy), she joined the Italian Medicines Agency (AIFA). There, she holds a position as an executive biologist, serving as quality assessor for biological medicinal products with emphasis on ATMPs and Italian Alternate Member at the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA). Further, at AIFA, she is the coordinator of the technical-scientific secretariat supporting the Italian Ethics Committee for clinical trials with investigational ATMPs. Until 2024, she was also a quality assessor for biotherapeutic products within the World Health Organization (WHO) Prequalification Team – Medicines Assessment Team (PQT/MED).