Bringing advanced therapies from research to patients requires more than scientific excellence. It also depends on access to the right infrastructure, specialised services, expertise and collaboration at the right moment in the development pathway.
Through Work Package 5 – Multistakeholder infrastructure to enable access to ATMP on large scale, PRECISEU has developed three complementary resources designed to make Europe’s ATMP infrastructure easier to access, understand and connect.
Together, they address three practical questions:
- How can developers access the right ATMP infrastructure?
- How can they understand what services and capabilities are available?
- And how can ATMP centres themselves be planned, governed and connected more effectively?
In this three-part series, we introduce the newly approved WP5 results and explore how they can support ATMP developers, infrastructure providers and regional innovation ecosystems across Europe. We begin with the first of these resources: the Blueprint for Multi-Stakeholder ATMP Infrastructure Access.
Making the first step towards ATMP infrastructure easier
For ATMP developers, one of the first practical challenges is often deceptively simple: where should I go, who should I contact, and how do I start? Across Europe, valuable ATMP expertise, infrastructure and Good Manufacturing Practice capacities already exist. Yet the pathways for accessing them are not always clear or easy to navigate, particularly for startups, SMEs and academic research groups.
The PRECISEU Blueprint for Multi-Stakeholder ATMP Infrastructure Access addresses this challenge by proposing a clearer and more transparent pathway for collaboration between ATMP developers and infrastructure providers. Developed under Work Package 5, with BioRN as lead beneficiary, together with EATRIS, Clust-ER Health and BIOPRO, the blueprint provides a practical reference both for centres looking to review and improve their access procedures and for developers trying to understand what to expect when approaching an ATMP infrastructure.
Making access easier and more transparent
ATMP development is complex, expensive and highly regulated. Smaller developers in particular may have strong scientific ideas but limited internal capacity to navigate manufacturing, regulatory and clinical translation requirements.
This makes access to specialised infrastructure and expertise critical. The PRECISEU blueprint proposes an exemplary access process that can help both ATMP centres and potential users better understand how collaboration can begin and progress.
The proposed pathway includes eight key steps:
- Transparent access rules
- Request submission
- Initial feedback
- Formal application
- Project prioritisation
- Access decision
- Project initiation
- Governance oversight
By making these steps more visible and structured, the blueprint aims to reduce uncertainty and make collaboration easier to initiate. For ATMP centres, it offers a practical reference for reviewing and improving existing access procedures. For developers, it provides greater clarity on what information may be needed, how projects can be assessed and what to expect from the first contact through to project initiation.
Supporting startups, SMEs and academic teams
The blueprint is particularly relevant for smaller ATMP developers. Startups, SMEs and academic research groups often need to rely on external infrastructure for areas such as manufacturing, regulatory expertise, quality systems and clinical translation. Clearer access pathways can help them understand how to present their project, what requirements they may need to meet and how their needs can be matched with the right expertise and capacity.
The aim is not to duplicate existing infrastructure, but to help innovators find the right place and the right partners. The blueprint therefore also highlights the importance of routing projects towards the most appropriate support pathway according to their needs, maturity, required expertise and available capacity.
Building trust through transparent decision-making
Access to specialised ATMP infrastructure must be not only efficient, but also fair and transparent. ATMP centres often operate with limited resources and capacity, meaning that projects may need to be evaluated and prioritised.
The blueprint therefore places emphasis on structured decision-making. Relevant considerations may include:
- clinical need;
- scientific and technical feasibility;
- alignment with the centre’s capabilities;
- innovation potential;
- public value;
- operational requirements.
A transparent approach to project evaluation can help centres balance patient benefit, scientific quality, operational feasibility and long-term sustainability while giving developers a clearer understanding of how access decisions are made.
From individual infrastructures to a European ATMP community
The access blueprint is part of a broader PRECISEU effort to strengthen Europe’s ATMP ecosystem. Rather than creating new infrastructure from scratch, PRECISEU works to better connect and optimise existing platforms, facilities, services and expertise.
In this context, the blueprint is more than an internal process tool. It can contribute to creating a shared language between ATMP centres and developers and support more coordinated infrastructure access across regions. This is also an important step towards building an ATMP centre community within PRECISEU – a virtual ecosystem of infrastructures that can support collaboration, knowledge exchange and future joint action.
For patients, better access to the right infrastructure ultimately matters because it can help promising therapies progress more efficiently along the development pathway. By making access clearer and collaboration easier to initiate, PRECISEU is helping strengthen the foundations needed to move advanced therapies from research towards clinical application and patient impact.
Explore the full deliverable
The Blueprint for Multi-Stakeholder ATMP Infrastructure Access is now publicly available as one of the newly approved results developed under PRECISEU Work Package 5.
PRECISEU WP5 deliverables PRECISEU D 5.2
Stay tuned for the next article in this series, where we will introduce the PRECISEU Multi-Stakeholder Infrastructure Service Catalogue and explore how it can help make ATMP capabilities and services across Europe more visible and easier to identify.