Our board member, Giovanni Migliaccio, representing EPTRI in TRANSFORM Alliance, has participated in the ATMPs: Gateway to European Global Leadership, an informal roundtable on the Pharmaceutical Package and forthcoming biotech legislation, held online on July 16th.
Dr. Migliaccio is a coordinator of the Advanced Therapies Thematic Research Platform within EPTRI. This platform is a collaborative initiative to advance the development and accessibility of innovative therapies across Europe.
It focuses on supporting the scientific, regulatory, and technological needs specific to ATs, including gene therapies, cell therapies, tissue-engineered products, and similar emerging advanced technologies by providing a set of services in these areas.
After the adoption of the first reading on the proposed Pharmaceutical Package in 2024, Member States continue their work on the package within the Council – soon foreseen to enter Trilogue negotiations. Despite its significant impact on the future of patient access to medical innovation in the EU and the competitiveness of the EU biotech sector, multiple bottlenecks along the development and delivery pathway for medical biotechnologies – including Advanced Therapy Medicinal Products (ATMPs) – remain beyond the scope of the proposal.
Considering the Irish Presidency of the Council in H2 2026, the TRANSFORM MEP Interest Group and Alliance wish to convene a closed-door roundtable with policymakers from Ireland.
Dr. Migliaccio participated in the session entitled TRANSFORM’s vision for a competitive Europe that supports patient access to innovative therapies. This session discussed the potential of the Pharma Package, the upcoming Life Sciences Strategy, and the Biotech Act for the development and access to innovative therapies in Europe, particularly the improvement of the regulatory framework by increasing its streamlining and flexibility, providing equitably accessible and cross-border healthcare and the role of European Reference Networks (ERNs) and the need of a robust industrial base in Europe.