Federica Martini is a regulatory professional with 10+ years of experience in the pharmaceutical and biotech industry and brings an extensive background in cell and gene therapies. Federica first joined the pharma industry in 2012 working in basic and applied research and progressively took on regulatory positions of increasing responsibility and leadership as she moved through various pharma companies and CROs. She has supported pre-approval biologics for allergy, oncology, neurology, ophthalmology, dermatology, pediatric and rare disease indications. Federica has experience in developing EU regulatory strategies, leading cross-functional teams in health authority interactions, and in regulatory applications, including document development to support applications such as Scientific Advice, PRIME, Clinical trial Applications (CTA), Orphan Drug Designations (ODD), Pediatric Investigation Plans (PIP), and Development Safety Updated Reports (DSUR). Federica also supports regulatory activities with the FDA, including participating in FDA meetings, Investigational New Drug [IND] applications and amendments, initial Pediatric Study Plans, ODD, and more.
Federica holds a Bachelor of Veterinary Medicine from the University of Camerino in Italy, a Master of Medicine in Research and Development from the University Autonoma of Madrid, and a Ph. D. in Veterinary Pharmacology and Toxicology from the University Complutense of Madrid in Spain.