IMI Newsletter: IMI2 – Call 1 0 launched, project successes

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63rd Edition – December 2016

  IMI2 – Call 10 launched   IMI2 – Call 10: Switch to the H2020 submission system   Have your say – contribute to the consultation on IMI   IMI at the PSWC   News from the projects

IMI2 – Call 10 launched

IMI has launched its 10th Call for proposals under the IMI2 programme, with the following topics:

Topic 1: Understanding hypoglycaemia: the underlying mechanisms and addressing clinical determinants as well as consequences for people with diabetes by combining databases from clinical trials Topic 2: How big data could support better diagnosis and treatment outcomes for prostate cancer (part of the Big Data for Better Outcomes programme) Topic 3: Improving the care of patients suffering from acute or chronic pain (this topic includes three subtopics on patient reported outcomes; biomarkers; and chronic pelvic pain) Topic 4: Creation of a pan-European paediatric clinical trials network Topic 5: Biomanufacturing 2020: development of innovative high throughput analytical tools and methods to characterize cell culture fluid during development and commercial cell culture processes Topic 6: Unlocking the solute carrier gene-family for effective new therapies (unlock SLCs) Topic 7: Patient perspectives in medicines lifecycle Topic 8: Personalised medicine approaches in autism spectrum disorders

The deadline for short proposals is 28 March 2017. Details of all topics and information on how to apply can be found on the IMI website

Catch up on the webinars Read the press release

IMI2 – Call 10: Switch to the H2020 submission system

From IMI2 – Call 10 onwards, IMI will use the electronic submission system of the Horizon 2020 Participant Portal. The submission system will open for proposals under this Call on 4 January 2017. Guidance on how to submit a proposal, including a detailed user manual and frequently asked questions, can be found under the Submit a Proposal section of the Participant Portal Horizon 2020 Online Manual.

To submit a proposal via the electronic submission system, applicants will need to have an EU Login account and ensure that their organisation is registered as a beneficiary.

Have your say – contribute to the consultation on IMI

IMI is currently undergoing an interim review, and as part of this exercise, all citizens and organisations are invited to contribute to a public consultation on IMI. Contributions are particularly sought from researchers, industry, entrepreneurs, innovators and all types of organisations that have participated in IMI Calls for proposals. The goal of the consultation is to gather information from a wide audience on different aspects of the implementation of the Joint Undertakings (JUs) operating under Horizon 2020 for the period 2014 to 2016. The consultation runs until 10 March 2017. There are 6 sections and it should take around 20 minutes to complete. The results of the public stakeholder consultation will feed into the interim evaluation of the JUs as well as to the interim evaluation of Horizon 2020 overall. The results of the interim evaluation will be used as a basis to improve the performance of the JUs and will be communicated to the European Parliament and the Council, national authorities, the research community and other stakeholders.

IMI at the PSWC

On 23 May 2017, IMI will hold a symposium on ‘Putting open innovation into practice’ at the 6th Pharmaceutical Science World Congress (PSWC) in Stockholm, Sweden. In a video produced for the event, IMI Executive Director Pierre Meulien explains: ‘IMI is a large public-private partnership in the area of innovative medicines and it aims to make R&D processes more efficient. We want to bring companies together and share risks and, in a new approach, share data. PSWC2017 will provide an opportunity to get all stakeholders together and facilitate open innovation.’

News from the projects

NEWMEDS highlights benefits of PPPs for schizophrenia & depression research

The ability of public-private partnerships (PPPs) to drive progress in drug development is highlighted in a comment piece in Nature Reviews Drug Discovery written by members of IMI’s NEWMEDS project. NEWMEDS was launched in 2009 with the goal of developing new tools and techniques to speed up the development of new drugs for schizophrenia and depression. In the paper, the authors note that pre-competitive and competitive areas were clearly defined, providing a ‘fertile environment’ for scientists to openly discuss technical questions and work together. Some of the results of this open collaboration are summarised in the paper, including work on different brain circuits, knowledge on the genetics of schizophrenia, and the validation of new technologies. According to the authors, the public-private collaboration enabled ‘major synergies’ as they could cross-validate each other’s work, thereby helping the field to move forward ‘more rapidly, while not needlessly duplicating animal work’. The authors conclude: ‘Where research is clearly precompetitive, there are immense benefits for open discussion between competitive companies, and this should be the rule rather than the exception. Furthermore, psychiatric drug discovery must make translational effects on brain circuits a priority.’

Da Volterra and The Medicines Company join COMBACTE-NET

Antimicrobial resistance (AMR) project COMBACTE-NET has gained two new partners in the form of French small and medium-sized enterprise (SME) Da Volterra and US-based The Medicines Company. The companies were selected to join the project following an open Call for proposals for antimicrobial agents or approaches that could benefit from COMBACTE-NET’s pan-European clinical and laboratory networks and the expertise of the current partners. As a result, COMBACTE-NET will now run a study on the incidence of Clostridium difficile infections in hospital patients. This will pave the way for a phase 2/3 clinical trial of Da Volterra’s DAV132 product, which is designed to protect bacteria that live in the gut, but do not cause disease, from the effects of antibiotics. The Medicines Company’s intravenous formulation of minocycline is the subject of another forthcoming trial in COMBACTE-NET. Injected minocycline is one of just a few treatments available for certain multi-drug resistant infections. Finally, the open Call also allowed the project to extend its ongoing SAATELLITE study to Phase 3. SAATELLITE focuses on MEDI4893, which is designed to tackle Staphylococcus aureus infection, which is commonly associated with hospital-acquired infections.

INNODIA recruits first patients for diabetes study

The INNODIA project has recruited the first patient in a major clinical study of type 1 diabetes. The goal of INNODIA is to improve our understanding of type 1 diabetes and so pave the way for the development of novel treatments to prevent and cure it. In the new study, scientists will collect blood samples and data from people just diagnosed with type 1 diabetes and their relatives. They will then follow the evolution of the disease in the study participants. ‘This way we will be able to better understand the relationship between changes in beta cell function, immune profiles, genetic and environmental factors and their role in the onset of the disease,’ says INNODIA coordinator Chantal Mathieu of the University of Leuven in Belgium. Patients were heavily involved in the design of the study. ‘Listening to the patient’s voice and following their advice was crucial in setting up this effort,’ said Olivier Arnaud of JDRF International. Looking to the future, the project will open further study centres in Europe, giving more patients the opportunity to take part. In a video, diabetes patient and INNODIA Patient Advisory Committee member Kyle Rose explains: ‘These [studies] are what are going to allow new therapies, new drugs to be developed so that we can all lead healthier lives as people with diabetes. It can really make a difference.’

European Lead Factory results in PhD thesis

The assay and compounds screened through the European Lead Factory are an important part of the PhD thesis of Freek Janssen of Leiden University in the Netherlands. Freek was studying a protein called diacylglycerol lipase (DAGL) that makes endocannabinoids, molecules that are made by the body and have a similar effect to marijuana. He was interested in whether DAGL could be a target for treatments of obesity or neurodegenerative disorders for example. When a screen of a commercial library failed to deliver results, he turned to the European Lead Factory. ‘The access to the expertise and the very high quality drug-like compounds in the Joint European Compound Library is unique,’ he said. Janssen and his colleagues optimised the results obtained from the European Lead Factory to create a ‘drug-like’ compound. Some of the developed compounds have undergone further tests and initial results are promising. A number of Freek’s colleagues are also busy working on results from European Lead Factory screens. ‘The EU Lead Factory doesn’t just boost a single drug discovery project; but it can boost the research of several people,’ he says. ‘My advice to other academics with a high quality assay: apply for the EU Lead Factory as soon as possible!

SPRINTT enrols first 500 participants in frailty study

IMI’s SPRINTT project has enrolled the first 500 participants in a pan-European study on whether it is possible to prevent physical disability in older people with physical frailty and sarcopenia (loss of muscle mass and strength). The study, which should eventually recruit 1 500 participants over the age of 70 from across Europe, will compare two interventions. Some participants will follow a multi-component programme, based on exercise with a trainer plus a nutritional programme. Others will follow a healthy ageing lifestyle education programme. More information on the trial can be found on the project website.

New PreDiCT-TB test to speed up tuberculosis drug development

Current methods of diagnosing tuberculosis (TB) and measuring the effect of potential new treatments in clinical and pre-clinical trials depend on either culturing TB bacteria from a patient-derived specimen, or DNA-based diagnostic tests. Growing a culture is very slow, taking up to three months before a result is available. DNA tests on the other hand are fast, but they remain positive even after the bacteria is dead, making them unsuitable for tracking the effectiveness of potential new treatments. A new method fine-tuned by the PreDiCT-TB project offers a much faster way to diagnose tuberculosis and has the potential to improve both the speed and effectiveness of preclinical and clinical TB trials. The method is based on measuring ribosomal RNA, which is part of the structure of the organisms’ protein synthesis machinery. The RNA is easy to detect even when there are very few organisms present, and unlike the DNA, it does not survive long after the bug is killed by antibiotics. The method gives an answer in as little as four hours, and might also be able to identify a population of more persistent, antibiotic-resistant bacteria. Although the test was initially developed prior to PreDiCT-TB, the work done within the consortium enabled the creation of a test that is easier to use and is more reliable. ' PreDiCT-TB has increased the speed with which we have been able to apply this test to defined regimens and the consortium has allowed us to draw on the expertise from across the community,' said Justin Green, PreDiCT-TB project coordinator. ‘We believe this test may contribute to the speeding up of the evaluation of new drugs. It also has the potential to improve clinical management of hard to treat patients.’ PreDiCT-TB aims to speed up the search for new, more effective combinations of treatments to tackle TB, and is one of the world’s only initiatives focused on tackling pre-clinical research barriers to the discovery and development of new drug combinations for this deadly disease.

ABIRISK discovers risks that drive immune response to biopharmaceuticals

Biopharmaceuticals have the potential to improve lives, but they can also trigger an immune reaction in some patients. When this happens, the immune system produces antibodies (ADAs) that neutralise the drug, which can reduce the effectiveness of the biopharmaceutical and lead to severe side effects. In a new study, ABIRISK project scientists discovered that age, gender and even the time of the year can increase the risk of an immune reaction. As part of the study, ABIRISK researchers gathered data from more than 20 000 multiple sclerosis patients who were tested for ADAs in routine clinical testing or research studies in four countries: Sweden, Austria, Denmark and Germany. By analysing the data, scientists discovered that males and older adults are at a higher risk of developing an immune response when receiving the biopharmaceutical called IFNβ. In patients from Sweden and Germany, the start of therapy in April also coincided with a higher likelihood of developing an immune response, indicating that seasonal factors might also play a role. When it comes to a biopharmaceutical called Natalizumab, researchers discovered that females and older people are at a higher risk. According to the scientists in the study, the findings could be used to develop more personalised monitoring programmes and interventions for patients who are at a higher risk. For example, if the seasonal factor behind the higher risk is due to lower vitamin D levels, vitamin D supplementation at the start of therapy could be used to decrease the risk of the immune response. ‘This study was a direct outcome of the collaboration of different research labs, hospitals and industrial partners within the ABIRISK project who shared data from local routine ADA testing labs and research studies’, said Marc Pallardy, the ABIRISK managing entity. ‘The expertise from the industrial partners was essential to coordinate and manage the collaboration between the partners and to build the standardised database, while the academic partners were crucial in data collection and curation, and in the scientific design of the study. It is the first big collaborative achievement of the ABIRISK consortium.’

The Innovative Medicines Initiative is the largest public-private partnership aiming to boost pharmaceutical innovation in Europe and to speed up the development of better and safer medicines for patients. IMI is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA.

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