Bridging the gap between medical research and approved therapy
All too often, researchers who secure medical breakthroughs in the laboratory find themselves at a loss when it comes to turning their findings into health products. This blockage is due to the slow, cumbersome and failure-prone testing and approvals mechanism, which involves lengthy inter-disciplinary dealings amongst basic scientists, clinicians, regulators and more. But a new European project is simplifying the system and speeding the journey from science to therapy.
This project is called European Advanced Translational Research InfraStructure in Medicine (EATRIS). It is a framework decided at Member States level linking scientists to expertise in areas that are poorly represented in academia, such as regulatory experts, professional project management capacity, and product development specialists. By improving access to a new pan-European infrastructure, EATRIS aims to accelerate the development of novel medical products.
EATRIS focuses on five different platforms: small molecules, vaccines, advanced therapy medicinal products (like gene therapy and tissue engineering), biomarkers and imaging and tracing. These platforms integrate with specialised services such as legal, quality assurance and regulatory. They work with clinical experts and patient organisations to select and perform high quality translational projects, especially in the field of rare and neglected diseases.
EATRIS received €4.2 million in European Commission funding over three years to address all key issues necessary to move towards the implementation of a new research infrastructure. It was born out of necessity, according to the project's scientific director Giovanni Migliaccio. He saw valuable findings disappearing into a black hole as researchers floundered with the bureaucracy and costs of dealing with testing and regulators. "Something is broken in the long, complex chain of innovation that turns new findings in science into new products that benefit patients," he says.
Translational research is the moment scientific discoveries at the level of basic biomedical research have to be translated into practical, clinical applications, but Migliaccio describes it as "the valley of death" because of the relative lack of funding and high failure rates. This is a particular problem with biomedical discoveries for novel preventive, diagnostic or therapeutic products.
"Currently, translational research in novel biological targets is too advanced to be heavily funded by science ministries, too early for health ministries, too risky for industry and too complex for academia," says Migliaccio, who also advises on cell and gene therapies for the Italian government, the European Medicines Agency (EMA) and the European Department for Quality of Medicines (EDQM).
Migliaccio says EATRIS will draw inspiration from one of Europe's greatest research success stories. "We see with such mega-infrastructures as the Large Hadron Collider at CERN that there is merit in joining forces, and this philosophy is starting to gain traction within distributed infrastructures also. EATRIS is one such distributed infrastructure," he says.
EATRIS aims at advancing translational science in Europe by providing a research infrastructure to allow a faster and more efficient transfer of research discoveries into new products to prevent, diagnose or treat diseases, such as cardiovascular diseases, cancer, metabolic syndromes, brain disorders, and infectious disorders. By extending the size of the community that interacts and shares experiences on a regular basis, EATRIS will also aim to raise overall standards and increase the knowledge spillovers that drive innovation. "EATRIS will encourage and coordinate the input of each stakeholder, so that they can do what they do best, and contribute to the common goal of improved output of high impact medicines and diagnostics," Migliaccio says. "Over time, EATRIS will thus help improve the productivity of the translational process, resulting in more cost-effective development of high-impact therapeutics, diagnostics and medical devices for the patient."
EATRIS, whose headquarters are based in Amsterdam, will start operations in December 2012, and is expected to reach full capacity around 2016. Migliaccio hopes that by setting up a platform for dialogue and building a sense of urgency it will create an arena "where academia, governments, regulators and industry apply their skills in a more cohesive manner to improve productivity."
Project acronym: EATRIS
Participants: Germany (Coordinator), United Kingdom, Italy, France, The Netherlands, Spain, Sweden, Denmark, Finland, Norway