A new Antimicrobial Resistance (AMR) Accelerator Programme is part of new Calls for proposals launched today by the Innovative Medicines Initiative (IMI). Of the other topics launched in the Calls, many address brain disorders (e.g. Alzheimer's disease, Parkinson's disease, Huntington's disease, major depression) and immune-mediated diseases (e.g. rheumatoid arthritis and lupus as well as inflammatory bowel diseases such as Crohn's and colitis, and skin diseases like dermatitis and psoriasis). Among other things, the topics aim to make clinical trials more patient-centric, contribute to medicines safety, and apply blockchain technologies to the drug development and health sectors.
The two Calls for proposals launched today (IMI2 - Calls 15 and 16) have a total budget of EUR 434 million. Around half of this comes from Horizon 2020, the EU's framework programme for research and innovation. The other half comes from EFPIA companies and IMI Associated Partners; these do not receive any funding from IMI but contribute to projects, mainly through 'in-kind' contributions (e.g. researchers' time).
Pierre Meulien, IMI Executive Director commented: "Our new Antimicrobial Resistance Accelerator programme represents a strategic, coordinated response to one of the biggest challenges facing the world today. Meanwhile the topics on digital health and the blockchain highlight IMI’s commitment to working with all sectors involved in healthcare."
Introducing the AMR Accelerator
The aim of the new IMI AMR Accelerator is to progress the development of new medicines to treat or even prevent resistant bacterial infections in Europe and worldwide. The programme comprises three pillars. A Capability Building Network will coordinate the programme and carry out research to strengthen the scientific basis in the AMR field, while the Tuberculosis Drug Development Network will work to accelerate the discovery of new combinations of drugs to treat TB. Finally, Portfolio Building Networks will support collaborative efforts to discover, develop and advance new and innovative agents to prevent or treat AMR. The scope of the AMR Accelerator is broad; under one structure, it will address many of the scientific challenges of AMR, and it will support the development of new ways to prevent AMR (including vaccines) and treatments (including new antibiotics). More broadly, the IMI AMR Accelerator also contributes to the European action plan on AMR, which includes a chapter on boosting research, development and innovation for AMR.
Research platforms for patient-centric drug development
Currently, clinical trials are generally carried out in silos and all too often, they are not patient friendly, making it hard to enrol enough patients. This topic aims to develop and disseminate reusable best practices, tools and guidelines for establishing multi-company platform trials capable of running patient-friendly clinical trials that test multiple treatments in parallel. The topic focuses on developing platform trial designs and protocols in four disease areas: major depressive disorder, tuberculosis, the liver disease non-alcoholic steatohepatitis (NASH), and neurofibromatosis. In the short term, the research platforms will speed up the enrolment of patients in clinical trials and increase the likelihood that participating patients are allocated a promising treatment instead of the placebo. In the longer term, this will help to accelerate medicines development.
Clinical trials go digital
Current clinical trial assessments are often based on subjective clinical scoring systems, which do not provide an accurate, detailed picture of a patient's condition. This topic aims to tackle this problem by identifying, assessing and validating digital technologies (e.g. wearable and home-based devices) that could reliably and sensitively measure patients' clinical conditions in their homes or as they go about their daily lives. The project will focus its efforts on technologies capable of monitoring patients with neurodegenerative disorders (namely Parkinson's disease and Huntington's disease) and inflammatory diseases (rheumatoid arthritis or lupus, and inflammatory bowel disease). The project will ultimately result in better clinical trials that provide more detailed data on patients' condition and also allow more patients to take part in clinical trials.
A better understanding of immune-mediated diseases
New biological treatments have provided relief for many patients with immune-mediated diseases. However, the treatments do not work for all patients. This topic aims to identify signatures in bodily fluids that could predict how a disease will progress and whether a patient's response to a treatment could change over time. The project will focus on inflammatory bowel disease (Crohn's disease and ulcerative colitis) and skin-related diseases (e.g. atopic dermatitis, cutaneous lupus, psoriasis). In the long term, the project will improve our understanding of these diseases, make it easier to identify patients whose disease is likely to progress, and lead to more tailored treatments.
Towards safer immune therapies
Certain treatments for cancers and immune diseases work by altering the immune system. However, a major challenge for researchers is identifying potential safety issues with these treatments early in drug development, before they are tested in humans. The goal of this topic is to deliver a range of tools that will enhance our ability to assess the safety of these immunomodulatory therapies. In the long term, this will help to deliver safer medicines for patients and also contribute to the ‘3Rs’ (i.e. the drive to replace, reduce and refine the use of animals in research).
Joining the dots on brain disorders
Synapses are the junctions between nerve cells, and are responsible for ensuring nerve signals are correctly transmitted from one nerve cell to another. Synapse malfunctions have been identified in a number of brain disorders, but questions about their role in disease remain. This topic aims to study the synapses in detail; to understand the extent to which synapse problems are a cause of brain disorders, and whether this information could be used in drug development. The topic also aims to find out if they synapse problems found in different neurodegenerative and psychiatric diseases (e.g. Alzheimer’s, Parkinson’s, major depression, and schizophrenia) have the same underlying cause or not. The project results will help to speed up the development of more effective treatments for these diseases.
Bringing the blockchain into healthcare
This topic aims to establish a common blockchain ecosystem for pharmaceutical development, manufacturing and distribution. By bringing together all parties, including patients, healthcare providers and health authorities, it will establish an agreed framework and reference implementation that addresses data integrity, security and privacy as well as regulatory compliance and efficiency. This framework will act as an integration layer linking underlying blockchain technologies with specific business applications in areas such as the supply chain, clinical development, and health data. Long-term impacts of the project will be greater trust between all participants in the sector and the more efficient use of resources.
About IMI2 - Call 15
IMI2 - Call 15 is a standard two-stage Call for proposals with the following topics:- Integrated research platforms enabling patient-centric drug development
- Blockchain enabled healthcare
- Microenvironment imposed signatures in tissue and liquid biopsies in immune-mediated diseases
- Emerging translational safety technologies and tools for interrogating human immuno-biology
- Development and validation of translational platforms in support of synaptopathy drug discovery
- Digital endpoints in neurodegenerative and immune-mediated diseases
- AMR Accelerator programme Pillar A: Capability Building Network to accelerate and validate scientific discoveries
- AMR Accelerator programme Pillar B: Tuberculosis drug development network to accelerate and validate scientific discoveries and advance the R&D pipeline of new and innovative agents to address the global tuberculosis epidemic
Deadline for short proposals: 24 October 2018
For further information, please visit:
https://www.imi.europa.eu/apply-funding/open-calls/imi2-call-15
About IMI2 - Call 16
IMI2 - Call 16 is a single-stage Call for proposals dedicated to Pillar C of the AMR Accelerator programme 'Portfolio Building Networks to advance the R&D pipeline of new and innovative agents to address AMR'Deadline for proposals: 24 October 2018
For further information, please visit:
https://www.imi.europa.eu/apply-funding/open-calls/imi2-call-16
About the Innovative Medicines Initiative
The Innovative Medicines Initiative (IMI) is working to improve health by speeding up the development of, and patient access to, the next generation of medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research, including universities, pharmaceutical companies, other companies active in healthcare research, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. This approach has proven highly successful, and IMI projects are delivering exciting results that are helping to advance the development of urgently-needed new treatments in diverse areas.IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through the IMI2 programme, IMI has a budget of €3.3 billion for the period 2014-2020. Half of this comes from the EU's research and innovation programme, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects 'in kind', for example by donating their researchers' time or providing access to research facilities or resources.