Francesco Cicirello

Evelo Biosciences
Senior Director, Quality Assurance
Francesco Cicirello is Director, Quality Assurance at Evelo Biosciences.

Before joining Evelo, Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. He was elected to several roles in PIC/S including Chairperson of the Working Group revising the PIC/s Annex 2 and Deputy Chair of the Subcommittee on Harmonisation.

Francesco represented PIC/S at the EMA IWG and was member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs.

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ATMPs, Cell and Genetic therapies - or whatever other jurisdictions use – have come a long way. I am unsure how many of us have forgotten the early failures and setbacks. There was a time, in the early years, when serious side effects, such as deaths, endangered the field. It prompted the regulators to halt research, introducing various constraints and safeguards. In Europe, it felt like every...