DIRECT, or Diabetes Research on Patient Stratification, will get the most money at €43.1 million.
Europe’s Innovative Medicines Initiative (IMI) has launched its third wave of industry-academic projects, all set to run for five years at a total cost of €215 million ($267.7 million). The new projects bring to 30 the number of IMI research initiatives, at a combined cost of €650 million ($809.6 million). All IMI projects are multicompany efforts jointly supported through funding from the EU and in-kind contributions from member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
IMI’s costliest new project, at €43.1 million ($53.7 million), is called DIRECT, or Diabetes Research on Patient Stratification. Sanofi-Aventis Deutschland is coordinator for the project. It will work with Eli Lilly, Novo Nordisk, Servier, and 20 nonprofit institutions led by the project’s managing entity University of Dundee to identify subtypes of type 2 diabetes and determine which existing drugs are most appropriate treatments for patients.
As part of DIRECT, researchers will gather data as well as samples from people at risk of diabetes, people with diabetes, and people undergoing diabetes treatment. The data will be used for identifying biomarkers associated with different subtypes of type 2 diabetes and different rates of disease progression. Researchers also plan to develop and validate tests to predict who will get diabetes, whose condition will deteriorate rapidly after diagnosis, and who will respond well or badly to certain drugs.
IMI says DIRECT will complement the work of two other diabetes projects: IMIDIA (Improving beta-cell function and identification of diagnostic biomarkers for treatment monitoring in diabetes), which is studying the beta cells of the pancreas with the ambitious goal of a cure for diabetes; and SUMMIT (Surrogate markers for micro- and macro-vascular hard endpoints for innovative diabetes tools), which is developing tools to identify patients at greatest risk of developing diabetes-related complications.
The next-costliest new IMI project, at €35.9 million ( $44.7 million), is EU-AIMS, or European Autism Interventions—a Multicentre Study for Developing New Medications. Roche is coordinator for the project, in which it will join with Eli Lilly, Servier, Janssen, Pfizer, Vifor, and 15 nonprofit institutions led by project managing entity King’s College London to generate tools toward enhancing understanding of autism spectrum disorders (ASD) and ultimately enable development of new treatments for children and adults.
Researchers will gather samples from people with mutations associated with ASD to test treatments. The project will also advance the use of brain scans as a tool toward ASD drug discovery and identify patients most likely to respond best to an ASD drug. The project will also create a pan-European network of clinical sites, making it easier to run clinical trials, as well as create an interactive platform for those with ASD and professionals.
IMI’s five other projects are:
- Anti-Biopharmaceutical Immunization—Prediction and Analysis of Clinical Relevance to Minimize the Risk is a €34.9 million ($43.5 million) project to discover factors behind the immune response of patients to biologics. GlaxoSmithKline (GSK) is project coordinator; Institut National de la Santé et de la Recherche Médicale (INSERM) is managing entity.
- Mechanism-Based Integrated Systems for the Prediction of Drug-Induced Liver is a €32.4 million ($40.3 million) effort to develop new tests designed to help researchers detect potential liver toxicity issues much earlier in development. AstraZeneca is project coordinator; University of Liverpool is managing entiry.
- Biomarkers for Enhanced Vaccine Immunosafety is a €30.2 million ($37.6 million) project to develop new tools to speed up and improve the testing and monitoring of vaccines. University of Surrey is project coordinator and managing entity; Novartis is EFPIA coordinator.
- Model-based preclinical development of antituberculosis drug combinations is a €28.6 million ($35.6 million) initiative aimed at tackling preclinical research barriers to the discovery and development of new TB drug combinations. GSK is project coordinator; University of Liverpool is managing entity.
- European Patients’ Academy on Therapeutic Innovation is a €10.1 million ($12.6 million) patient-led initiative that aims to develop the first European Patients’ Academy on Therapeutic Innovation, with training courses, educational material, and an online public library that will empower patients to engage more effectively in the development and approval of new treatments. European Patients’ Forum is project coordinator; German-based VFA is EFPIA’s coordinator.
“These projects are all taking on research challenges that would be too big for one company or academic team to tackle on its own,” IMI executive director Michel Goldman said. “They therefore demonstrate IMI’s value in creating pan-European teams of experts that are in a position to make major advances in these critical areas.”