The EU’s Innovative Medicines Initiative has proved an important force for change over the first decade of its existence in streamlining the complex, expensive and risky process of medicines development.
IMI was created in 2008 as a partnership to increase the competitiveness of research and development in the European biopharma sector by encouraging companies to work with each other and with the public sector.
Its new strategy has a still broader mandate to bring groups involved in health together, extend its reach beyond Europe and prepare for digital disruption.
When the IMI began, many questioned whether companies would feel comfortable sharing their data and knowledge. More than 100 projects later, IMI has created an ecosystem that is catalytic in changing the way modern medicines development is carried out, and has paved the way for accelerated innovation.
Over the past decade, the EU and the European Federation of Pharmaceutical Industries and Associations have committed €5bn through cash and in-kind support to researchers in companies working alongside academics. This has supported a series of large-scale, ambitious projects.
By funding national regulators, health technology assessment groups, patient organisations and advocates, IMI has given a stronger voice to the fuller range of stakeholders involved in medicines alongside traditional researchers, clinicians and industrialists.
More recently, IMI has attracted investments from new public and private partners, including the Wellcome Trust and the diabetes charity JDRF, as well as GE Healthcare and Illumina.
The results have been impressive. IMI-supported projects have generated almost 4,000 peer-reviewed research papers. Its partners have developed numerous new tools, methodologies and infrastructure to help researchers in industry and academia get better results, faster. Most significantly, there are projects that have influenced regulatory frameworks and helped patients directly.
One of these produced the first patient-reported outcome in chronic obstructive pulmonary disease to be accepted by the European Medicines Agency. Another has created a Europe-wide clinical trial network specifically to test new antibiotics for resistant infections.
In autism spectrum disorders, our projects have linked groundbreaking work on both sides of the Atlantic, enhancing collaboration and reducing duplication. In Alzheimer’s disease, one UK-led project is creating a clinical research platform that seeks ways to prevent its onset.
Medical research and drug development are evolving fast, and one challenge for IMI is to adapt to and anticipate new advances. The rise of “big data” is a case in point. The challenges cannot be overestimated: to integrate high-end research data from genomics, imaging and proteomics with clinical data; how to safely interrogate patients’ electronic health records for research purposes; and how to scale health informatics across Europe to harness knowledge for better patient intervention.
One of IMI’s biggest efforts has been to develop a co-ordinated approach under an initiative called Big Data for Better Outcomes. These projects, with more than €100m from public and private parties, develop ways to address technical and ethical questions on data management. It supports disease-specific projects that aim to put big data to work on conditions including Alzheimer’s disease, heart disease, haematological malignancies and prostate cancer.
Another example in digital technology is WEB-RADR, led by the UK’s medicines regulatory agency. It developed an app that allows patients and healthcare providers to easily report side-effects of medicines to the relevant authorities. It is now available in the UK, Croatia and the Netherlands, as well as Burkina Faso and Zambia.
The future will build on all that has been achieved in IMI’s first decade. IMI will deepen and broaden its engagement with other sectors in health research, including digital, imaging, diagnostic, medtech and other emerging technologies.
IMI will also further strengthen links with global initiatives on antimicrobial resistance and autism. These challenges are too big to be limited to individual regions.
We need collectively to take advantage of the great science being funded in North America and Asia to avoid duplication, optimise synergies and accelerate progress.
A growing number of patients have said their lives have changed as a result of IMI projects. We need this pattern to be generalised across whole populations and translated into healthcare delivery, so society can benefit to maximum effect.
Pierre Meulien is executive director of the Innovative Medicines Initiative, a partnership between the EU and the European pharmaceuticals industry.
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