2024 PDA/FDA Joint Regulatory Conference

Francesco Cicirello, PharmD, MSc BioNTech

Francesco Cicirello, PharmD, MSc

Francesco Cicirello, PharmD, MSc BioNTech Senior Director Global BioNTainer Quality Compliance

Francesco Cicirello is Senior Director, Global BioNTainer Quality Compliance at BioNTech US.

Before joining BioNTech from Evelo Biosciences and Adaptimmune , Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. While at TGA, he was elected to several roles in PIC/S. He was the Chairperson of the Working Group revising the Annex 2 and the Deputy Chair of the Subcommittee on Harmonisation. The latter role included overseeing the revision of the EU/WHO/PIC/S Annex 1. Francesco initiated the PIC/S transposition of EU Annex 16 and supported the one of Annex 13.

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