A Drug Developer's Experience

Laura Fabbri is a Biologist with a PhD in Clinical Pharmacology (University of Bologna and Milan; Italy).  She has been working in Chiesi Pharmaceutical (Corporate R&D) for 20 years, at Global Clinical Development department; for the first 4 years as Neurology and Psychiatry Clinical Area Manager and then up to April 2021 she was the of Head of Neonatology Clinical Unit. She is currently covering the role of Head of Real-World Evidence (RWE).

Previously Laura worked at GlaxoSmithKline for 14 years, engaged in clinical product developments at local level (Verona; Italy) and at corporate level for 1 year (Greenford; UK).

She has large experience in the coordination and management of different clinical team groups to deliver clinical projects on phase I-IV drugs, nationally and worldwide, in writing clinical development plans and single clinical protocols, study reports and manuscripts for national and international journals; furthermore, always collaborates in writing the clinical sections of Pediatric Investigational Plans and other documents for EMA or FDA or other Agencies.

Laura has consolidated relationships with worldwide neurologists and neonatologists, because of reciprocal faith and friendship due to the long- lasting collaboration; she is member of the International Neonatal Consortium (INC), committed to organizational plans processes, improvement, and global standardization in neonatology research. In the last 2 years, she is building the unit of RWE in Chiesi for the first time, and creating the connections with networks / registries /agencies and most proper internal and external groups for regulatory and post- approval RWE activities. With this role, she has also become member of EFPIA Integrated evidence generation and use working group and of Duke Margolis RWE group.