Delivering regulatory affairs and biotech leadership to the advanced therapies ecosystem.

Head of Regulatory Affairs: Apr 2024 - PresentHead of Translational Project Management & Regulatory Affairs - Feb 2023 to Apr 2024: Supported the re-organisation of the R&D group of Telethon, identifying key hires needed across the different development functions and supporting the transition of activities between the newly identified area leads

Leading the QA function ad interim in addition to holding the role of VP, Regulatory Affairs.

Achilles Therapeutics’ mission is to develop next-generation, patient-specific therapies that harness the immune system to destroy cancer cells. The therapies will target clonal tumour neoantigens, unique flags to the immune system present on the surface of every cancer cell.

Diamond Pharma Services is a leading technical and scientific consulting group serving the biotechnology and pharmaceutical industry.Diamond Pharma Services offers regulatory affairs, pharmacovigilance, quality and medical expertise to support product development of recombinant DNA products and hybridoma technology, nucleotide based products (RNA and DNA), synthetic peptides, innovative and generic chemical entities, vaccines, blood products and gene therapy products. In 2013, Diamond BioPharm Ltd won the TOPRA “Innovation” Award having played an integral part in achieving regulatory approval of the first gene therapy medicinal product, Glybera, in Europe in November 2012. http://regulatoryaffairsawards.org/shortlists/3148.htmSean's role involves providing regulatory advice to clients and undertaking regulatory activities throughout product development, registration and lifecycle. This includes; review of EU and other market requirements, orphan drug designation applications, paediatric investigation plans, scientific advice, writing and submission of marketing authorisation documents and post-approval activities. Sean has spoken on a variety of topics at several conferences and provided training sessions on various regulatory affairs topics.In addition to consulting activities, Sean was a member of the British Society for Gene and Cell Therapy (BSGCT) Regulatory and Clinical Sub-Committee and a member of the Diamond BioPharm Senior Management Team.

Diamond Pharma Services, Inc., founded in February 2015, is the US subsidiary of Diamond BioPharm Ltd and provides support for the US market, initially focusing on regulatory affairs and product development.In addition to overseeing the day-to-day running of the US subsidiary in a remote manner from the Diamond Pharma Services headquarters in the UK, including line management, financial oversight and business development, Sean maintains an active role in leading numerous client projects (primarily ATMPs) from pre-clinical studies through to post-authorisation, providing strategic and operational regulatory support and guidance to companies ranging from Top 10 pharma through to virtual start-ups.Sean is actively involved in business development in the biologics and ATMP space, always looking to make connections, be it personally, for the Diamond group of companies or for his clients and contacts.

Working with other TOPRA volunteers to organise and contribute to the CRED SmPC course held each year. Chairman of the course for 2013 and 2014.