The EUPATI Team co-hosts the Patient Engagement Open Forum in Baveno, Italy

The EUPATI team was out in full force at this year’s in-person edition of the Patient Engagement Open Forum (PEOF), held in Baveno, Italy.

Co-organised with our partners PFMD and EPF, the event brought together 200+ participants from five continents — including patient groups, researchers, regulators, pharmaceutical leaders and tech innovators — to co-create a collaborative space focused on patient engagement in health innovation and healthcare and finding new solutions facilitating meaningful integration of patient voices across the lifecycle of medicines R&D.

Over the course of three impactful days, challenging discussions were embraced, the true need for patient-centred approaches which include the voices of underserved and underrepresented patient populations were called for and the stark statistics of the inequities of health systems were addressed.

What became undeniably clear is that — in a world facing health crises, conflict, digital disruption, and systemic restructuring — the need for co-creation and collective action across all sectors of the healthcare system is more critical than ever.

What Did EUPATI Bring to the Table This Year?

As a co-organiser of the event, EUPATI brings emphasis on the importance of training and education, the power of lived experience fuelled by technical knowledge about research.

We were proud to host an interactive booth, staffed by a passionate team of EUPATI members eager to connect with attendees. Alongside them were EUPATI Fellows, ready to share their lived experiences and training journeys, and representatives from our EUPATI National Platforms — including some first-time attendees, demonstrating their strong commitment to advancing meaningful patient involvement.

EUPATI was directly involved in 5 sessions during this face-to-face event.

1. Embracing Uniqueness to Empower Engagement – Boost Your Capacities!

This “back to school” session focused on how comprehensive, practical training can expand and strengthen inclusive, representative patient involvement. Tamás Bereczky (Deutsche Aidshilfe and EUPATI) and Lara Bloom (Ehlers-Danlos Society) led the session.

The session provided an introduction to the theoretical concepts around diverse communities and their involvement in medicines research and development. The topics discussed include intersectionality, cultural sensitivity and the different ‘labels’ and representations linked to all of us as individuals, and how science needs to reflect the reality of patients, different life trajectories and experiences. In addition, the contradictions between an epidemiological and an individualised approach in medicine were discussed, as well as the implications of diversity on real-world data & real-world evidence and the use of artificial intelligence in research.

Key takeaways from the session included:

• There is a critical need for greater knowledge of diverse patient populations.
• Integrating biomedical data with social and psychological insights is vital to shift the paradigm toward better outcomes.
• We must know our patients better — and share that understanding across all stakeholder groups.
• Creating a conscious map of existing gaps and biases can better connect us with patient communities.
• Encouraging collaboration — even among those working in different ways — strengthens the ecosystem and leads to more inclusive solutions.

This session made it clear: empowering engagement starts with understanding, representation, and connection.

2. Elevating Partnerships: Real-World Data/Evidence – Boost Your Capacities!

This session aimed to demystify Real-World Data (RWD) and Real-World Evidence (RWE) while highlighting their growing significance in modern healthcare and decision-making. Andreas Christodoulou (Cyprus Federation of Patients’ Associations and EUPATI Fellow) and Daniel Weibel (VAC4EU) led the session.

Key takeaways from this session included:

• RWE provides powerful insights that complement traditional clinical trial data and help improve real-world healthcare outcomes.
• Identify treatment patterns – Understand how treatments are used in everyday clinical settings across diverse populations.
• Spot high-risk patient groups – Detect trends and vulnerabilities to improve targeted care and early interventions.
• Evaluate cost-effectiveness – Assess how different treatments perform in real life to guide smarter resource allocation and policy decisions.

The newly launched IHI-GREG project was highlighted during the session. This project focuses on the testing and creation of guidelines on RWE. The resulting guidance produced will be shared and used by decision makers in HTA and regulatory bodies. As part of this project EUPATI is co-authoring a new course on RWE, leading a training session for all consortium members on patient involvement as well as coordinating a patient advisory group.

This session reinforced the importance of elevating patient partnerships in generating real-world insights that are robust, ethical, and impactful. Patients can really shape RWE/RWD in a number of ways for example; by generating health data through wearables, mobile apps and home monitoring devices; they can add to disease specific databases when enrolling in

registries, help design research by sharing their input, advocate for ethical and transparency use of their data as well as engage with advocacy groups and promote informed, diverse data representation.

3. Reaching the Unreached: Patient-Centric, Holistic Clinical Studies in Europe

This co-led session focused on advancing our collective understanding of the barriers preventing specific populations from participating in clinical studies — with a particular emphasis on underrepresented groups. The session spotlighted the IHI-READI project, an exciting new initiative aiming to build a cohesive and integrated patient-centered ecosystem for clinical studies. Partners from the project came together to present the main objectives of the project, their expectations on the outcomes and facilitated an insight-gathering exercise around the different workpackages.

The co-hosts of the session were: Amanda Bok (PFMD, The Synergist) Maria Dutarte (EUPATI), Léa Proulx (Roche), Paloma Moraga Alapont (SERMAS), Nadine Boesten (EPF), Valentina Strammiello (EPF), Mitchell Silva (Patient Centrics and Esperity), Begonya Nafria Escalera (San Joan de Déu Children’s Hospital), Nersey Rastan (The Synergist)

Participants explored practical solutions across key domains, including:

• Clinical trial protocol design
• Site-level competencies
• Community engagement strategies
• Existing tools, materials, and training

Delivered in a World Café format with five interactive tables, the session encouraged collaboration and idea-sharing. EUPATI, as co-lead of Work Package 4 (Training & Capacity Building) in the IHI READI project, focused on Table 2, which addressed the topic of inclusive tools, materials, and training — especially from the perspective of healthcare professionals (HCPs) and researchers.

Key takeaways from table 2 included:

Essential Skills for HCPs & Researchers to Promote Inclusive Research:

• Training on language diversity and awareness of health literacy levels
• Embedding inclusion principles early in medical education
• Prioritising shared decision-making across all stakeholder groups

The group also emphasised the need to:

• Develop soft skills training, especially in effective communication
• Promote a deeper understanding of the value of patient engagement
• Acknowledge and support the role of patient mediators as vital bridges between patients and healthcare professionals

This session reinforced the critical role of education and training in building a more inclusive, patient-centric clinical studies ecosystem in Europe.

4. HTAR Under the Microscope: Making Patient Involvement Work

This session opened with an introduction to the evolving Health Technology Assessment (HTA) regulation followed by a dynamic panel discussion offering both European and U.S. perspectives on patient involvement. The European Access Academy was mentioned aiming to identify key challenges and provide sound input for the implementation of the EU HTA Regulation. The session was supported by Finn McCartney (EUPATI), Valentina Strammiello (EPF), Cat Koola Fischer (Institute for Clinical and Economic Review – ICER) and Jörg Ruof (European Access Academy).

The session then moved into breakout groups where participants explored Key Performance Indicators (KPIs) for short-, mid-, and long-term goals across four key focus areas:

• Patient participation & representation
• Quality & impact of patient input
• Transparency & accessibility
• Satisfaction & process efficiency

Key Themes & Recommendations from the Breakout Discussions:

• Equity, Diversity & Inclusion: A strong emphasis was placed on ensuring evaluation processes truly reflect the diversity of patient populations. Participants recommended enhancing involvement criteria to better represent underrepresented groups and foster equal, respectful partnerships — for example, by aligning product development with patient needs from the earliest stages of trials and therapies.
• Sustainable Patient Involvement: There was consensus on the need for a financially supported, sustainable system that ensures patients can participate meaningfully over time, rather than through ad-hoc or one-off engagements.
• Pool of Trained Patient Experts: The idea to establish a pool of trained patients with specific disease-area expertise was proposed, enabling HTA bodies to engage with informed contributors who bring both lived experience and relevant knowledge.
• Transparency & Early Involvement: Participants emphasized that patients should be informed and involved at every stage of the HTA process, with communication that is transparent, clear, and timely. To aid this, a centralized and trustworthy repository of patients’ unmet needs—potentially supported by AI tools—could guide HTA decisions and industry priorities.
• Accessibility of Information: The group recommended that HTA documents be made available in lay-friendly language and supplemented with visual aids, ensuring better understanding for diverse audiences.
• Patient Education & Training: Finally, participants agreed that education and training are essential components for empowering patients to contribute meaningfully to HTA processes.

5. Vaccine Awareness & Literacy: Powered by Patients & Patient Communities

This dynamic session explored the full vaccine lifecycle, pinpointing the critical stages where patients and caregivers can offer valuable insights. The main message that emerged was clear: Collaboration is essential — we must deeply understand the communities we serve to develop vaccines that genuinely meet their needs. The speakers of the session were Charlotte Vernhes (Vaccines Europe), Mariano Votta (Active Citizenship Network) and Daniel Weibel (VAC4EU)

Key themes and insights from participants:

• Health Literacy & Empowerment: A major emphasis was placed on improving health literacy so individuals can better understand healthcare language and actively engage in decisions around vaccination.
• Patient & Caregiver Involvement: Case studies from EU public-private partnerships showed that involving patients and caregivers in vaccine development and delivery helps raise awareness and leads to more person-centered outcomes.
• Vaccine Safety & Hesitancy: Addressing vaccine hesitancy requires not only raising awareness, but also offering accessible, real-world evidence to foster public trust.
• Long-Term Vision for Vaccination in Europe: Vaccination should be viewed as a long-term health commitment, not just a crisis response. Best practices shared included civic evaluation programmes and open-door vaccination center initiatives.

An interactive exercise with breakout groups echoed these themes with important questions emerging such as what about immunocompromised individuals? What are the risk ratios for these groups, & how can trust be built around vaccines for them? How can we combat misinformation?

Breakout highlights included:

• Barriers to Engagement: Participants identified the top reasons for low engagement in vaccine initiatives as: ➤ Lack of accessible information ➤ Poor communication from healthcare professionals
• Trust & Representation: Trust must be built especially with immunocompromised populations and marginalised groups. Strategies like training local community ambassadors were proposed to tailor messaging to cultural and religious contexts.
• Misinformation & Social Media: While social media can raise awareness, it often amplifies rare adverse events, fueling fear and misinformation. A balanced narrative rooted in real-world evidence is crucial.
• Epistemic Injustice: A recurring concern was that although healthcare professionals are trusted, patients’ perspectives are too often dismissed. Tackling this imbalance was seen as essential to restoring trust.
• Transparency in Research: There is a gap even within the research community, where findings aren’t consistently shared. This limits collective learning and progress.
• Emotional & Behavioural Drivers: Vaccine decisions are not only rational—they are emotional and behavioural. Engagement strategies must address these dimensions.

As one participant aptly stated: “If we build trust and change at the micro level, we can drive transformation at the systemic level.”

A big thank you to all the participants, facilitators and speakers who made these sessions possible! We are incredibly proud to have had this valuable space to present, exchange ideas, and learn from one another and we look forward to continuing this important work together!