Michela Gabaldo is VP ATMP Global Regulatory Affairs at EVOTEC SE.
She brings more than 20 years experience in orphan drug and gene therapies development having worked for 12 years for Fondazione Telethon and San Raffaele Hospital as Head, Alliance Management & Regulatory Affairs. In her role, she has supported the 2 internal Scientific Institutes in Italy, SR-TIGET (San Raffaele-Telethon Institute for gene therapy in Milan) and TIGEM (in Naples) in the progression of gene therapy projects (ex-vivo and in-vivo) for rare genetic disease at different stages of development spanning from research and preclinical 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 patient access of the 1st ex-vivo gene therapy registered worldwide, Strimvelis in 2016 and Libmeldy in 2020.
Before joining Telethon in 2011 she has been working in the pharma industry for GlaxoSmithKline (GSK) in Clinical Operations and CMC Regulatory Affairs areas for New Chemical Entities (NCE) development.
After graduation in Pharmaceutical Chemistry and Technology, she granted a Master Degree in Regulatory Affairs and Market Access for NCEs and Biopharmaceuticals.
Winner of 2017 edition of TopRA Award in the Future category, Michela offers up to date knowledge of the most recent regulations in ATMPs and Orphans.
She’s currently a member of the IRDIRC (International Rare Disease Reasearch Consortium) Regulatory Scientific Committee.
She brings more than 20 years experience in orphan drug and gene therapies development having worked for 12 years for Fondazione Telethon and San Raffaele Hospital as Head, Alliance Management & Regulatory Affairs. In her role, she has supported the 2 internal Scientific Institutes in Italy, SR-TIGET (San Raffaele-Telethon Institute for gene therapy in Milan) and TIGEM (in Naples) in the progression of gene therapy projects (ex-vivo and in-vivo) for rare genetic disease at different stages of development spanning from research and preclinical 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 patient access of the 1st ex-vivo gene therapy registered worldwide, Strimvelis in 2016 and Libmeldy in 2020.
Before joining Telethon in 2011 she has been working in the pharma industry for GlaxoSmithKline (GSK) in Clinical Operations and CMC Regulatory Affairs areas for New Chemical Entities (NCE) development.
After graduation in Pharmaceutical Chemistry and Technology, she granted a Master Degree in Regulatory Affairs and Market Access for NCEs and Biopharmaceuticals.
Winner of 2017 edition of TopRA Award in the Future category, Michela offers up to date knowledge of the most recent regulations in ATMPs and Orphans.
She’s currently a member of the IRDIRC (International Rare Disease Reasearch Consortium) Regulatory Scientific Committee.