Biotech - Advanced Therapies

Key obstacles include lesser and fragmented public R&D in the EU, lesser private R&D, regulatory complexity, and fragmented pricing and reimbursement across Member States, which hinder the scaling of manufacturing and the deployment of, and access to, innovative treatments.

The Advanced Therapies CCT Initiative is intended to help address most of these challenges by creating a more coordinated ecosystem, bringing together key stakeholders such as Member States, industry, investors and national infrastructures from across the EU. 

In line with the EU Life Sciences Strategy and the European Biotech Act proposal, the initiative will build stronger connections across the ATMP value chain, from research and clinical development to manufacturing, standardisation and deployment. It will identify key bottlenecks and incentivise all stakeholders to tackle them.  Initial actions include direct support to the clinical development of innovative regenerative treatments, improving clinical site and manufacturing readiness and capacity building through a European network for Centres of Excellence. 

By fostering cooperation, supporting innovation and helping align expertise and capabilities across Europe, the Advanced Therapies CCT Initiative will transform the field toward scalable clinical and commercial success and a more competitive European health innovation ecosystem. In the longer term, it will lay the foundations for broader access to advanced therapies and support Europe’s ambition to remain a global leader in life sciences and biotechnology. Creating a more coordinated and supportive ecosystem for advanced therapies, will turn more cutting-edge science into practical health solutions for patients.