VP, Regulatory and Market Access Strategies
Luca Pani, MD is Professor of Clinical Psychiatry at the Department of Psychiatry and Behavioral Sciences, University of Miami, and Professor of Pharmacology and Clinical Pharmacology, University of Modena in Italy. He is also VP for Regulatory Strategy and Market Access Innovation at VeraSci in Durham, NC.
As the former Director General of the Italian Medicines Agency (AIFA, 2011-2016) and former member of the Committee for Human Medicines (CHMP) and Scientific Advices (SAWP) for the European Medicines Agency (EMA) in London (2010-2017), he is a recognized expert in psychopharmacology, clinical psychiatry and regulatory science with particular emphasis on health technology assessment linked with novel negotiation strategies for the reimbursement of precision medicines.
In his roles he negotiated the world 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 mental disorders 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.