Michela Gabaldo is Head, Alliance Management & Regulatory Affairs at Fondazione Telethon in Milan (Italy). She is an talented leader and expert in regulatory affairs with more than 20 years experience in drug development . She’s currently supporting the 2 internal Scientific Institutes in Italy, SR-TIGET (San Raffaele-Telethon Institute for gene therapy in Milan) and TIGEM (in Naples) in providing global strategic direction in regulatory affairs for the progression of gene therapy (ex-vivo and in-vivo) and gene editing projects tackling rare genetic disease at different stages of development spanning from research and pre-clinical up to patient access. These programs are developed both internally and in partnership with relevant pharmaceutical industries or through start-ups. Within this role she’s been actively involved in the development and access of the 1st ex-vivo gene therapy registered worldwide – Strimvelis – in 2016 and in the Libmeldy program who has reached recently the EU approval.