This session, hosted by IUK, will bring together key stakeholders from across the advanced therapies ecosystem, including regulators, therapy developers, technology providers, and the NHS, to share perspectives on the real-world challenges and opportunities of decentralised manufacturing.
Through a series of short presentations followed by facilitated breakout discussions, attendees will explore operational, technical, and regulatory considerations, while contributing directly to conversations that will help shape future guidance, support mechanisms, and potential funding priorities in this space.
By taking part, you will gain first-hand insights from organisations actively navigating decentralised manufacturing, benchmark your own approach against peers, and have the opportunity to influence how this emerging model is supported and implemented across the UK.
What we aim to achieve
- Identify key technical, operational, and regulatory challenges in adopting decentralised manufacturing
- Explore what therapy developers need to make informed decisions between decentralised and centralised models
- Understand system readiness requirements across NHS pharmacy and clinical sites
- Capture industry input to help shape future guidance and support mechanisms
Agenda
13:30 - 13:40 | Introductions from IUK
13:40 - 13:50 | MHRA presentation
Ian Rees, Assessor
13:50 - 14:00 | Autolus presentation
Darren Blamire, VP, Managing Director, UK and Ireland
14:00 – 14:10 | Ori Biotech presentation
Jason Foster, Chief Executive Officer
14:10 – 14:20 | Pan UK PWG for ATMPs' session
Anne Black, Chair
14:20 – 15:00 | Breakout sessions
15:00 – 15:25 | Summary of breakout discussions
15:25 – 15:30 | Closing remarks
Who should attend?
This workshop is designed for professionals working across advanced therapies, medicines manufacturing, and healthcare delivery who are involved in, or exploring, manufacturing strategy and implementation.
We encourage attendance from:
- Therapy developers assessing manufacturing models
- Manufacturing and technical operations leads
- Regulatory and quality professionals
- Technology and platform providers
- NHS pharmacy, clinical, and operational stakeholders
- Innovation leads and decision-makers involved in ATMP delivery