Luca Pani, MD

Dr. Luca Pani is the former Director General of the Italian Medicines Agency and a former member of the Board of Directors of the Committee for Human Medicines (CHMP) and of the Scientific Advice Working Party (SAWP) for the European Medicines Agency (EMA) in London.

Luca is a recognized expert in basic and clinical pharmacology and regulatory science with particular emphasis on health technology assessments linked with novel negotiation strategies for the reimbursement of precision medicines. In his roles, he negotiated the reimbursement for the world’s first gene therapy (Strimvelis®) and implemented very 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 pathological ailments and designing decision tree algorithms to negotiate drug pricing under conditions of uncertainty by using clinical and sensor-generated data to continuously populate the unknown variabilities of effectiveness and by linking them to outcome values dynamically recorded in real-world evidence.

He is a Professor of Pharmacology and Clinical Pharmacology, University of Modena and Reggio Emilia in Italy and a Professor of Clinical Psychiatry, University of Miami.

Dr. Pani earned his medical degree from the University of Cagliari, psychiatry degree from the University of Naples, and completed post-doctoral training in molecular biology and pharmacology at the University of Illinois at Chicago and Georgetown University.

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