Giovanni Migliaccio, the Scientific Director of CVBF, recently participated at the MEP Interest Group 2023 Conference organized by the European Alliance for Transformative Therapies (TRANSFORM) and held at the European Parliament on 12 October 2023. The event provided a platform for profound deliberation on various critical issues concerning highly specialized Advanced therapy medicinal products, known as ATMPs.

The TRANSFORM conference posed several essential questions, the answers to which would significantly shape the future of healthcare in the European Union:

• Recognizing the Uniqueness of ATMPs: Have Current EU Healthcare Legislative Proposals Adequately Addressed Their Specificities?
• Enabling Access and Integration: How Can EU-Level Action Support Healthcare Systems in Embracing Innovation and Ensuring Patient Access to Advanced Therapies?
• Beyond Legislation: Actions for Ensuring Safe and Timely Access to Transformative Treatments in the EU

Giovanni Migliaccio’s presentation, titled “ATMPs through the Lens of Researchers,” provided a thought-provoking exploration of advanced therapies, particularly from the perspective of those at the forefront of innovative medical research.

In this dynamic presentation, Dr. Migliaccio emphasized the significance of academia’s contribution to recent breakthroughs in ATMPs and underscored the necessity of integrating academic research findings into the regulatory framework. Additionally, he highlighted the importance of aligning the interests of academia and pharmaceutical companies to facilitate the development of superior products. Furthermore, he underscored the need for regulatory flexibility, allowing agencies to adapt to novel concepts and approaches while ensuring the safety of new medicines for the patient population.

A Workplan for 2024 was discussed on December 6, including a strong discussion on the role of Hospital Exemption in the new Pharmaceutical Regulation. The main activities planned included a strengthening of the engagement with Member States and developing ATMP explainer materials in the first half of 2024, while focusing on rebuilding the MEP Interest Group in the second half of 2024, following the European Parliament elections in June.

In April 2024 an Alliance strategy workshop (in Brussels) is planned to discuss the collective vision, including exploring advocacy on legislative and non-legislative topics. The topics suggested in addition to the HE include access, newborn screening, the HTA Regulation, GMO rules surrounding ATMPs, as well as funding opportunities for ATMP research, and academic development of ATMPs. Should you have other suggestions, do not hesitate to contact the Secretariat. The MEP Interest Group will be reconstituted after the Parliament election putting ATMPs on the new Parliament’s agenda. The annual conference will be held in November 2024.