VHIO Participates in the JOIN4ATMP Project, which aims to accelerate European Advanced Therapy Medicinal Product (ATMP) development and ensure wide-spread ATMP access

On January 25-26, 2024, in Berlin, Germany, the JOIN4ATMP project held its Kick-off meeting, an initiative created to map, join and drive European activities for Advanced Therapy Medicinal Product (ATMP) development and implementation for the benefit of patients and society (JOIN4ATMP).

JOIN4ATMP aims to accelerate European ATMP development and ensure wide-spread ATMP access while fostering the expansion of strong Good Manufacturing Practices (GMP) on a European level. Categorizing obstacles to ATMP progress, mapping potential solutions based on real-world use cases, and designing actionable recommendations will be the three processes on which the project will focus to achieve its ambitious goal.

The consortium brings together specialists, physicians, and researchers from fourteen partners based in Europe, and it aims to foster collaboration from academic and industrial players both at national level and across Europe. JOIN4ATMP is coordinated by Charité-Universitätsmedizin Berlin, supported by the Berlin Institute of Health (BIH), and will be funded with EUR 3 million from the European Union’s Horizon Europe Framework Programme—Coordination and Support Action (CSA) over the next three years.

The Vall d’Hebron Institute of Oncology (VHIO) is member of the consortium and will be actively participating in JOIN4ATMP by leading Work Package 3, which aims to streamline clinical ATMP development from the early phases to marketing authorization.

“We are thrilled and excited to be a part of this project, which will enable VHIO to collaborate with esteemed experts and institutions to accelerate and streamline the effective development and implementation of ATMPs in Europe. It is an ambitious challenge, for the benefit of patients and society.” says Silvia Martin-Lluesma, Advanced Therapies Manager at VHIO and JOIN4ATMP WP3 leader.

Our team at VHIO will also participate in other Work Packages, working on better defining preclinical studies with ATMPs, as well as coordinating GMP facilities at European level, among other activities within the consortium.

Advanced Therapy Medicinal Products (ATMPs)

Advanced Therapy Medicinal Products (ATMPs) are effective medicine products based on genes, cells and tissues for human use that can sustainably improve or even cure diseases that currently have no or inadequate standard-of-care options. This therapy has presented impactful solutions for rare genetic diseases, common immune diseases, cancer and tissue injury.

However, significant challenges remain for the scientific, clinical and patient communities as well as commercial entities and regulatory, policy-making and technology-assessing bodies. Various initiatives in the EU and from the European Medicines Agency (EMA), like RESTORE and the T2EVOLVE, are aimed at improving ATMP growth and use. Yet, several regulatory, clinical, economic and ethical issues remain unsolved.

JOIN4ATMP as initiative for ATMP access facilitator

The JOIN4ATMP initiative sets out to expand ATMP access in Europe by focusing on three axes: first a novel information package on currently existing and potential future hurdles preventing rapid and streamlined ATMP development and clinical translation, second a defined set of recommendations, including proposals for changes to laws and regulations, with concrete guidance on how to overcome these hurdles and encourage equitable ATMP access for patients throughout Europe, and last a sustainable model for long-term consortium operation (GMP coordination platform and EU ATMP expert platform) beyond CSA funding to coordinate activities in Europe for this important field.

“Advancements in European ATMPs represent a progressively significant domain that will shape the landscape of medical and research sectors in Europe. Through the JOIN4ATMP project, we want to give to the European society an easier access to efficient and safe treatment options to specific diseases.”, says Prof. Dr. med. Annette Künkele-Langer, Pediatric Oncologist and ATMP developer at Charité – Universitätsmedizin Berlin.