Luca Pani

Prof. Luca Pani is a dual Italian-US citizen and holds dual academic appointments as Clinical Professor of Psychiatry at the University of Miami (USA) and Professor of Pharmacology at the University of Modena and Reggio Emilia (Italy). He has served as Director General of the Italian Medicines Agency (AIFA) from 2011–2016 and held key roles in the European Medicines Agency (EMA), including participation in the CHMP and SAWP committees. His work includes pioneering advanced Managed Entry arrangements for gene therapies like Strimvelis® and developing real-world data analysis frameworks. Currently, he coordinates FACILITATE, a €100M EU-funded IMI-2 project (2022–2025) redefining ethical and regulatory frameworks for patient-centered clinical trials under GDPR. He also holds industry leadership roles as Chief Advisor at Relmada Therapeutics (USA), Chief Regulatory & Innovation Officer at NetraMark (Canada), and Chief Scientific Officer at EDRA Publishing (Italy/USA).

His research focuses on translational medicine, regulatory science, and healthcare innovation. With over 200 peer-reviewed publications and 26 authored books, his work bridges academia and industry, emphasizing practical solutions for drug reimbursement, clinical trial optimization, and real-world evidence utilization.