Luca Pani, MD, is a Professor of Clinical Psychiatry at the Department of Psychiatry and Behavioral Sciences, University of Miami, and a Professor of Pharmacology and Clinical Pharmacology, at the University of Modena in Italy.
As the former Director General of the Italian Medicines Agency and former member of the Committee for Human Medicines (CHMP) and Scientific Advice (SAWP) for the European Medicines Agency (EMA) in London, he is a recognized expert in psychopharmacology, clinical psychiatry, and regulatory science with particular emphasis on regulatory and health technology assessments linked with novel strategies for the approval and the reimbursement of precision medicines. In his roles, he negotiated the world's first gene therapy (Strimvelis®).
He implemented advanced Managed Entry Agreements linked to regulatory validated registries for real-life data follow-up and further evaluations based on bioinformatics. His current interests lie in virtual reality assessment tools to detect early signs of human disorders and designing decision tree algorithms to negotiate drug pricing under conditions of uncertainty by using clinical and sensor-generated data to populate the unknown variabilities of effectiveness continuously and by linking them to outcome values.