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DRIVE EUROPEAN ACTIVITIES FOR
ADVANCED THERAPY MEDICINAL PRODUCT
DEVELOPMENT AND IMPLEMENTATION

The JOIN4ATMP project aims to accelerate and de-risk European ATMP development and ensure wide-spread access of ATMPs, through the mapping of obstacles to such development, the audit of real-world-based solutions and the definition of new paths forward.

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Join4ATMP’s Second Webinar Charts the Path Toward Streamlined CAR-T Therapy Development in Europe

The second Join4ATMP webinar, titled "Streamlining the CAR-T Development Pathway in the EU", convened a diverse panel of experts and stakeholders on 12th of May 2025 to address the opportunities and challenges surrounding CAR T-cell therapies—an innovative form of gene therapy offering new hope to patients with certain cancers. The event, part of the EU-funded Join4ATMP initiative and hosted by project partner EURORDIS, brought together over 130 registrants, including clinicians, patient advocates, researchers, and developers, with 69 attendees participating live.

Panelists at the webinar included:

  • Antonia Mueller, Medical University Wien
  • Reno Debets, Erasmus University Medical Center
  • Silva Martin Lluesma, Vall d’Hebron Institute of Oncology & CEU San Pablo University
  • Natacha Boplaños, Lymphoma Coalition
CAR-T: Promise and Barriers

Chimeric Antigen Receptor (CAR) T-cell therapy has proven to be a game-changer in the treatment of blood cancers like B-cell lymphomas and leukaemia. However, only 30–40% of patients achieve long-term remission, and access across Europe remains highly uneven.

During the webinar, speakers underscored the urgent need to address regulatory fragmentation, access delays, and disparities between countries. Fewer than 12% of eligible European patients currently receive CAR-T therapy. These delays, sometimes caused by manufacturing bottlenecks or complex reimbursement procedures, can cost lives.

Expanding Innovation and Access

The event highlighted several scientific and systemic innovations designed to overcome existing hurdles:

  • Next-generation CAR-T cells that feature molecular "on/off" switches are in development, promising improved safety and better control.
  • Researchers are broadening the use of T-cell therapies to target solid tumours using novel antigens like MAGE-A2, moving beyond the traditional focus on blood cancers.
  • Clinical trials such as those involving tumour-infiltrating lymphocytes (TIL) and TCR T-cell therapies have begun to show promise in treating melanoma and synovial sarcoma.

However, regulatory roadblocks—particularly those that complicate cross-border trials—remain a significant barrier. Harmonisation of EU regulations and smarter, adaptive clinical trial designs were highlighted as crucial steps forward.

A Patient-Centric Approach

Speakers also emphasised the human dimension of CAR-T access. Research from 99 patients across 18 countries reveals significant emotional and psychological burdens throughout the treatment journey, including anxiety, cognitive challenges, and inadequate support.

"Success isn’t just about tumour shrinkage—it’s about returning to a meaningful life," said Natacha Boplaños. Recommendations included earlier patient involvement in trial design, improved communication, and outcome measures that reflect what truly matters to patients.

Manufacturing and Commercialisation Models

The discussion also turned to practical challenges in manufacturing. European stakeholders are considering hybrid models that blend centralised expertise with decentralised production through national and cross-border consortia like EUCAT and Darnaal. Automation platforms such as Cocoon and CliniMACS Prodigy offer a path to scale-up, while maintaining quality and efficiency.

Producing 200–300 therapies per year is seen as the minimum for sustaining GMP-compliant facilities. Collaboration between regulators, developers, and clinicians is seen as essential to making this feasible.

Call to Action

The webinar concluded with a clear message: realising the full potential of CAR-T therapies in Europe will require more than scientific breakthroughs. It demands funding to support innovation, reforms to streamline regulation, platform technologies to reduce costs and a patient-first perspective at every stage.

“There’s growing consensus that Europe must act now to remain competitive and deliver on the promise of ATMPs,” said Silva Martin Lluesma. The Join4ATMP initiative continues to work toward this vision, catalysing change and uniting stakeholders across the continent.

The recording of the webinar will be shared with all registrants to allow continued engagement and knowledge sharing.