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Cell & Gene Therapy Manufacturing & Commercialization US

Early Registration Savings Deadline Expires In

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Delivered as a Hybrid Event
September 27-30, 2022Boston Convention and Exhibition Center

Francesco Cicirello
Director, Quality Assurance at Evelo Biosciences


I am currently Director of Quality Assurance at Evelo Biosciences in Cambridge MA, and I am enjoying helping to bring to the market a transforming entirely new therapeutic modality.

Prior to Evelo I was Site Quality Head at Adaptimmune an ATMP company headquartered both in UK and USA, with a gene therapy drug products with PRIME and RMAT designation.

Before joining Adaptimmune, I worked in a Regulatory Agency, I was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. I also was elected to several roles in PIC/S (Pharmaceutical Inspection and Cooperation Scheme) including Chairperson of the Working Group that revised the PIC/s Annex 2 and Deputy Chair of the Subcommittee on Harmonization. I also represented PIC/S at the EMA IWG and was a member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs. I am the author of the recently published PIC/S Annex 2A & 2B, contributed to the revision of the latest published draft of the EU Annex 1 and the PIC/S transposition of Annex 16.

I have a Degree in Chemistry and Pharmaceutical Technology from the University of Florence, a MSc in Oncology Pharmacology from the University of Milan and a MSc In Cosmetic production from the University of Siena (I may still remember how to make sunscreens!)

I am a member of the PDA ATMP board, and of the ISPE SIG Biotech and CoP in ATMP.

Agenda Sessions

  • How Non-EEA ATMP Pharma/Biotech Can Leverage Compliance to the New Revision of EU Annex 1 to Achieve Cross Border Manufacturing Compliance with a Simple Approach