Luca Pani, MD, is Professor of Clinical Psychiatry and Medical Director of Continuing Education Programs at the University of Miami, and Full Professor of Pharmacology and Toxicology at the University of Modena and Reggio Emilia. His work spans basic and clinical pharmacology, regulatory science, and the integration of artificial intelligence and machine learning into R&D, clinical research, and health technology assessment, with a particular focus on leveraging clinical datasets to inform innovative regulatory frameworks and approval pathways.

Dr. Pani served as Director-General of the Italian Medicines Agency (AIFA) from 2011 to 2016, with responsibilities spanning both regulatory and payer functions. He previously held key roles at the European Medicines Agency (EMA), including membership on the Management Board, the Committee for Human Medicinal Products (CHMP), and the Scientific Advice Working Party (SAWP).

Dr. Pani is the author of 245 peer-reviewed scientific publications and 26 books. He is one of the coordinators of FACILITATE, an Innovative Medicines Initiative (IMI-2) project funded by the European Commission (2022-2026) to establish a patient-centered, GDPR-compliant framework for returning clinical trial data to participants. He is the Immediate Past President (2024–2026) of the International Society for CNS Clinical Trials and Methodology (ISCTM), Member of the Scientific Committee of the Italian Human Technopole (2026-2030).  He serves as Chief Advisor at Relmada Therapeutics (USA) and Chief Regulatory and Innovation Officer at NetraMark (Canada).