Galien Forum 2025: A New Era of Collaboration and Patient-Centered Healthcare
The Galien Forum 2025, a prestigious gathering of experts, researchers and policymakers, took place on June 5th at the Science Museum in London. This influential event, celebrated for its ability to foster dialogue among leaders in the life sciences industry, explored the intersection of technology, healthcare and patient care.
At the heart of this year’s discussions were two major themes: the importance of global collaboration in advancing science and the need for a more patient-centric approach in the development of treatments for complex diseases such as ultra-rare diseases, obesity and mental health disorders.
Collaboration: Key to advancing science
This year, the European Union's (EU) Health Technology Assessment (HTA) framework became a focal point for discussions at the Forum. The EU Joint Clinical Assessments (JCA) represent a significant step toward improving access to healthcare technologies across Europe. With oncology and advanced therapy medicinal products at the forefront, the implementation of JCAs attempts to streamline the evaluation process and expedite patient access to groundbreaking treatments.
The JCA initiative presents substantial opportunities for cross-border collaboration within the healthcare sector. By harmonizing clinical assessments across member states, the EU seeks to reduce redundancy, improve efficiency and enhance access to innovative medicines. However, as with any large-scale regulatory change, significant challenges remain. Among these are procedural uncertainties, the integration of local and EU HTA processes and the substantial investment required from manufacturers to ensure compliance with the new regulations. Despite these hurdles, the potential for a more unified, efficient healthcare landscape in Europe holds promise for improved patient outcomes.
As highlighted in the forum discussions, one key life science field that would benefit from enhanced collaboration is the treatment of rare – particularly ultra-rare – diseases. For (ultra-) rare diseases, regulators and healthcare systems are confronted with significant challenges in ensuring the timely development and commercialization of highly individualized treatments. These treatments often require specialized approaches, tailored to the unique genetic and molecular characteristics of each patient – making them even more complex to develop. One of the most pressing issues is the small size of patient populations, which complicates the typical clinical trial model that relies on large, diverse groups to generate statistically significant data.
Regulatory bodies must therefore collaborate more effectively, not only across national borders but also with industry leaders and patient advocacy groups. Coordinating these efforts is crucial for establishing more flexible and adaptive regulatory pathways that can expedite the approval of treatments without compromising safety and efficacy. By harmonizing regulatory standards and streamlining approval processes, especially for therapies that address unmet medical needs, regulators can create an environment that supports innovation while maintaining rigorous oversight.
Furthermore, regulators must work alongside healthcare systems to ensure that approved treatments can be made accessible to patients. This includes addressing reimbursement challenges and setting appropriate pricing models that reflect the high cost of development while also ensuring equitable access. Additionally, fostering collaboration between the public and private sectors is essential for sharing resources, data and expertise, enabling the rapid development of new treatments. By forging stronger partnerships, regulatory bodies and healthcare systems can collectively drive progress in the fight against ultra-rare diseases.
One notable example of regulatory collaboration is the RealiseD project, funded by the Innovative Health Initiative (IHI) and due to run until 2029. This initiative aims to transform clinical trial methodologies for rare and ultra-rare diseases by bringing together stakeholders from academia, regulatory bodies, clinical research institutes, patient organizations and the pharmaceutical industry. The project's goal is to develop new standards for clinical trials that accommodate the unique challenges posed by small patient populations.
Patient-centric approach: Reversing the lab-to-patient model
Another pivotal topic featured at the Galien Forum was the need to rethink the traditional "lab-to-patient" model of healthcare. Experts argued that in order to drive meaningful innovation, we must adopt a "patient-to-lab" approach, placing the patient at the center of the development process. This shift is particularly crucial in the treatment of chronic conditions such as obesity and mental health disorders.
In the case of obesity, the current treatment paradigm often resorts to drugs as a last resort, after significant weight gain and associated health complications have already developed. Discussions centered around a more patient-centric approach that could involve earlier intervention, focusing on prevention through lifestyle modifications such as diet, exercise and behavioral changes. Obesity treatments, like incretin-based weight loss drugs, may show short-term benefits, but without addressing the underlying behavioral factors, the impact is often fleeting. A more personalized approach that integrates prevention and long-term patient support could make a significant difference in managing this widespread health issue.
Similarly, mental health was highlighted as an area that could greatly benefit from a patient-centered approach. By focusing on the patient experience – acknowledging the stigma surrounding mental health and addressing issues like cost and accessibility – healthcare providers could improve both treatment outcomes and the overall quality of care. Digital health solutions, including AI-driven platforms and telehealth interventions, were discussed as key tools in reshaping the mental health landscape, offering new ways to deliver care that are more accessible and personalized to the individual.
Moving forward together
The discussions at the Galien Forum 2025 underscored the urgent need for collaboration and patient-centered innovation in advancing healthcare. As we move forward, it is crucial for stakeholders across the healthcare spectrum – regulatory bodies, pharmaceutical companies, academic institutions and patient organizations alike – to work together to address the challenges posed by evolving frameworks like the EU JCA.
In the realm of patient care, a shift towards a more inclusive, patient-first model is essential to developing treatments that are not only effective but also equitable. By integrating patient perspectives into the research and development process, healthcare providers can ensure that treatments are better tailored to meet the unique needs of individuals, rather than merely fitting a one-size-fits-all model.
