ATMPs in clinical practice (ATMPclinic)

Purpose and goal:

The JOIN4ATMP mission is to accelerate and de-risk European ATMP development and ensure wide-spread ATMP access. JOIN4ATMP will also foster development of an innovative and competitive European GMP landscape, consistent with expected impacts of the Strategic Call Destination, “Maintain an innovative, sustainable and globally competitive healthcare industry”.

The overarching goal is facilitating ATMP translation through preclinical studies to clinical use and market access. Coherently with the work program topic “Mapping the hurdles for the clinical applications of ATMPs" Expected results and effects:

JOIN4ATMP will achieve its goal by (i) rigorously mapping and categorizing hurdles in the aforementioned areas; (ii) charting solutions proposed in real-world use cases from ATMP developers or regulators in and outside the EU and (iii) designing recommendations for paths forward with regulatory, economics and policy-making advisors. These are measurable and verifiable objectives, delivering coherent and comprehensive packages of documents; curated databases and

recommendations, guidelines and ready-to-adopt standard operating procedures. Approach and implementation:

JOIN4ATMP joins 5 work packages that put different areas under a microscope to map hurdles and chart solutions in worldwide approaches, then design ways to improve the EU ATMP strategy and frameworks as well as communication, dissemination and exploitation. The work packages addresses topics such as preclinical testing, frameworks for standardized decentralized ATMP manufacture, sustainable solutions in healthcare systems and accessible patient service, regulatory hurdles, ethical and gender/diversity aspects and general ATMP acceptance.