TEDDY's Post-Event Considerations
The XVII Foresight Training Course, held online on 3-4 November 2025, was organised by the Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus and supported by the European Paediatric Transnational Research Infrastructure (EPTRI), and served as a pivotal gathering of experts and stakeholders from the pharmaceutical, regulatory, and clinical research sectors, including several members of #TEDDY. For more details, you can find the agenda and the Course Scientific Committee at the following LINK.
The course kicked off with an introductory speech by Dr. Fedele (Duccio) Bonifazi, President of Fondazione Gianni Benzi and a member of TEDDY Board of Directors, who highlighted the significant shifts taking place within the pharmaceutical sector, underscoring how these changes are reshaping clinical research and drug access, particularly in areas of high unmet need.
3 November
Session 1 – Advancements in Clinical Research
The first session, introduced by Prof. Adriana Ceci, Past President of the Fondazione Gianni Benzi and of the TEDDY Network, delved into the latest advancements in clinical research. One of the central discussions was on the “Accelerating Clinical Trials in the European Union (ACT EU) initiative for paediatric research”, by Dr. Donato Bonifazi, aimed at advancing clinical trials for children and ensuring that small populations in paediatric and rare disease fields are not left behind in the race for medical innovation. Dr. Donato Bonifazi, member of TEDDY Board of Directors, Chair of the TEDDY Working Group (WG) on Children Empowerment and permanent member of the ACT EU Multi-stakeholder platform Advisory Group (MSP AG), presented TEDDY’s commitment to drive change in clinical trials. TEDDY adopts a progressive approach to engage children in health and biomedical research, focusing on enhancing their involvement, knowledge, and experience.
A crucial part of the discussions focused on the regulatory landscape surrounding innovative research methodologies for rare diseases. Dr. Viviana Giannuzzi, Head of Research and Innovation Department at Fondazione Gianni Benzi and TEDDY’s Referent of the INVENTS project, explored the challenges and opportunities related to new technologies in clinical research, particularly in the rare disease sector. Giorgio Reggiardo, head of Biostatistics at Clinical Validation from Biopharmaceutical Findings (CVBF), member of TEDDY Board of Directors and Chair of TEDDY WG on Paediatric Research Methodologies, contributed by discussing the gaps and synergies between the United States and European Union in the application of innovative methodologies for paediatric clinical trials.
Valentina Jalby, a 12-year-old patient with Juvenile Idiopathic Arthritis (JIA) and a member of the Patients Expert Group (PEG) in the INVENTS project, shared her experience in the PEG highlighting the critical need for adolescent engagement in clinical trials. The INVENTS project optimizing study designs through innovative approaches like in silico trials and Real-World Data (RWD). TEDDY has played a key role in INVENTS in the set-up of the PEG, and fostering the empowerment of patients living with chronic conditions, such JIA and Multiple Sclerosis (MS).
4 November
Session 2 – Funding and investments for Research and Development (R&D)
The second day of the course turned its focus to funding, a critical issue for the continued development of medicines for rare diseases and paediatrics. A session led by Lucia Ruggieri, Senior researcher at Fondazione Gianni Benzi and Chair of TEDDY WG on Off-Label Uses Mitigation, examined the complex landscape of research funding, especially for not-for-profit entities working in the rare disease and paediatric sectors. The session also explored the impact of the Paediatric Regulation on encouraging pharmaceutical companies to invest in medicines for children. Attendees discussed how financial support and regulatory incentives can combine to drive research that might otherwise be overlooked due to limited market opportunities.
Session 3 – Access to medicines and medical devices in Europe
The final session included discussions on the barriers to access, such as joint procurement and Health Technology Assessment (HTA). The session also highlighted the importance of patient involvement in decision-making processes, particularly when it comes to expanding access to treatments for vulnerable populations.
Conclusion and Reflections
Dr. Fedele (Duccio) Bonifazi closed the event, offering a brief reflection on the discussions and emphasizing the importance of collaboration across various sectors to address the challenges of ensuring timely access to medicines for those with unmet needs.
The XVII Foresight Training Course successfully fostered meaningful dialogue on the latest challenges and innovations in the pharmaceutical sector. With a strong emphasis on paediatric research, rare diseases, and the involvement of vulnerable populations in clinical trials, the event helped shape more effective and inclusive strategies for drug development and research in Europe. With 310 registred participants from 35 countries, the event highlighted the significant interest in the topics discussed. Presentation slides are available on the Fondazione Gianni Benzi website, while session videos are being uploaded to the Fondazione Gianni Benzi YouTube channel at the following LINK.
You can explore these topics further by reading the TEDDY News on the recent publication by Giorgio Reggiardo, Viviana Giannuzzi, Donato Bonifazi, and Adriana Ceci, in collaboration with others TEDDY’s experts: please, visit the following LINK.