Luca Pani

  • Professor of Clinical Psychiatry at University of Miami and full professor of Pharmacology at University of Modena and Reggio Emilia

Luca Pani, MD, with dual citizenship in Italy and the United States, serves as a Professor of Clinical Psychiatry at the University of Miami, USA, and a Professor of Pharmacology at the University of Modena and Reggio Emilia, Italy. His distinguished tenure includes serving as the Director-General of the Italian Medicines Agency (AIFA) from 2011 to 2016, and a key role in the Committee for Human Medicines (CHMP) and the Scientific Advice Working Party (SAWP) at the European Medicines Agency (EMA). Prof. Pani played a pivotal role in the negotiation for the reimbursement of Strimvelis®, the first gene therapy globally, and he has been a forerunner in developing advanced Managed Entry Agreements integrated with regulatory validated registries for thorough real-life data analysis. As an accomplished author, he has contributed over 200 peer-reviewed scientific papers and 26 books. Presently, Luca is one of the Coordinators of FACILITATE, an innovative IMI-2 project funded by the European Commission, set to run from January 2022 to December 2025. This project is at the forefront of developing a new ethical, legal, and regulatory framework for clinical trials, concentrating on patient-centered, data-driven platforms that aim to optimize the use of clinical trial data within GDPR-compliant and ethical boundaries. In addition, Prof. Pani holds prominent industry positions, including Chief Advisor at Relmada Therapeutics, USA, Chief Regulatory and Innovation Officer at NetraMark, Canada, and Chief Scientific Officer at EDRA Publishing, Italy and USA. These roles underscore his extensive contributions across both the academic and healthcare sectors.