PharmD, PhD in cellular biochemistry and pharmacology, post-graduate degree master in Clinical Research of Medicines. Her main areas of expertise are: ethics and regulatory, informed consent and assent, health data processing for research purposes, European medicine regulatory procedures, R&D for rare and paediatric diseases. Currently, she coordinates the Research & Innovation Department of Fondazione per la Ricerca Farmacologica Gianni Benzi and participates in international and national research projects and consortia; in most of them, she leads the ethics and regulatory activities. She is also member of the Paediatric Committee, European Medicine Agency (EMA), as delegate of the European Commission to represent patient' organisations. She performed non-clinical research in rare diseases, and she was the Secretariat Scientific Assistant of the Ethics Committee in Lecce (IT). She is/was member of international and national research groups: INHERENT (International Hemoglobinopathy Research Network); TEDDY network (he European Network of Excellence for Paediatric Research); EPTRI (European Paediatric Translational Research Infrastructure); EURORDIS Therapeutic Action Group; Regulatory & Ethics workstream of GA4GH (Global Alliance for Genomics and Health); Ethics Working Group of EnprEMA; Working Group on Rare Cancers of ECPC (European Cancer Patient Coalition); paediatric pharmacology Working Group of the Italian Society of Pharmacology. Author/co-author of peer reviewed publications and abstracts, reviewer for indexed journals and speaker at national and international congresses/meetings in the relevant fields of expertise.
What does this mean for R&D of medicines for small populations?
How will the new mechanism of action provisions impact rare tumours and paediatric diseases with unmet needs?