Current position and relevant professional experience:
Sean is an experienced regulatory leader with over 15 years’ regulatory experience and working knowledge across a vast cross-section of human pharmaceutical regulatory affairs, from generics to medical devices to advanced therapies; from pre-clinical to commercial; and across CMC, non-clinical and clinical development.
He currently holds 3 leadership positions in regulatory affairs concurrently: SVP Regulatory Affairs for UK cell therapy biotech, Achilles Therapeutics; Head of Regulatory Affairs for Italian rare disease charity, Fondazione Telethon; and Managing Parter of the consulting firm, PrimeRA Pharma Partners.
Sean has worked on many pioneering regulatory projects including working on the first ever gene therapy approved in Europe; the development of one of the first CAR-T cell products; the worlds’ first charity to hold an advanced therapy medicinal product marketing authorization; and a project included in the EMA ATMP Pilot Scheme for Academics. He is well versed in the needs of the industry to deliver regulatory solutions to advance the products he works on for the ultimate benefit of the patients.
In addition to regulatory strategy and operational delivery to ensure the very best outcomes for his projects, Sean is an active participant in regulatory advocacy activities to pave new regulatory innovation and precedent via the Alliance for Regenerative Medicine, where Sean in an EU Regulatory Advisory Group Member, and via the EU funded academic consortium JOIN4ATMP.
Current or previous involvement in TOPRA activities:
Sean has contributed to a significant cross-section of TOPRA activities during his career:
- Member of the Innovation Award winning team, Diamond BioPharm Ltd for the work on the approval of the world’s first gene therapy (2013)
- SmPC CRED Course Chair (2014-2015)
- Author of two articles on advanced therapy medicinal products published in Regulatory Rapporteur (Vol. 14, No. 1, Jan 2017 and Vol. 16, No. 4, Apr 2019)
- Biotech SPIN Steering Group member (2018-2021)
- Mentor to a TOPRA ATMP Apprentice (2020-present)
- Module 22 Masterclass on ATMPs: Day 3 Chair & Lecturer (2023-present)
Personal statement:
The next generation of regulatory professionals are critical to the future of healthcare and as a TOPRA Board Director I will strive to further regulatory education and understanding across all healthcare stakeholders.
I simultaneously hold regulatory leadership positions in biotech, academia and consultancy which enables me to bring skills to this role far beyond regulatory knowledge, such as broad sector awareness, financial prudence and adaptable communication styles.
As an advocate for continuous development, I am keen to contribute to TOPRA at this pivotal moment in the organizations’ current strategic plan and drive the success of our profession in the future.
Nomination information
Proposer: Daniel Rabbie; Seconders: Michaela Palmisano, Florence Salmon