BOOSTING RESEARCH AND INNOVATION IN A CHANGING REGULATORY FRAMEWORK

15 -16  December, 2022
Online and Ex Palazzo delle Poste, piazza Cesare Battisti 1  – Bari (Italy)

The XV Foresight Training Course was jointly organised by Fondazione Gianni Benzi and Università degli Studi di Bari Aldo Moro. The event aimed to showcase the efforts made across Europe to enhance research and innovation in a dynamic scientific, social, and economic environment.

Key topics included:

• The impact of the new Clinical Trials Regulation and the Accelerating Clinical Trials in the EU initiative on clinical research.
• The integration of innovative methodologies—such as digital tools and in silico techniques—into all stages of drug development, particularly for paediatric and rare disease treatments.
• The potential of Real-World Data and patient-centric models to advance research and innovation.

The course highlighted recent advancements, including gene therapies for rare inherited conditions and personalised treatments in oncology, which had started reaching clinical practice. The COVID-19 pandemic was also noted as a catalyst that mobilised scientific and regulatory communities towards essential transformation in the research ecosystem.

Experts from the European Medicines Agency, research centres, and infrastructure projects shared insights on the evolving regulatory framework, especially regarding orphan medicinal products. Researchers from Fondazione Gianni Benzi presented innovative methodologies in paediatric and rare disease research. Contributions also came from industry representatives, such as Amgen and Valuevector, and from EURORDIS, offering a patient perspective.

The course was free for students, researchers, patient associations, and non-profits, with a fee applicable only to company and for-profit participants. The full agenda of the event was made available for deeper exploration.