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