For immediate release
BRUSSELS, 10 July 2013 – The Innovative Medicines Initiative (IMI) welcomes the decision to launch a proposal for IMI 2, and hopes it will build on the successes and lessons learnt from IMI 1. IMI is convinced that public-private partnerships (PPPs) have a vital role to play in boosting competitiveness and improving Europeans’ health and quality of life.
Michel Goldman, IMI Executive Director commented: ‘Since IMI launched its first Call for proposals back in 2008, we have enjoyed some significant successes and learnt a lot about how to set up and run large-scale projects in which partners from industry, academia, small businesses, patient groups and others join forces to tackle some of the biggest challenges in drug research and development. As a result of these efforts, Europe is now globally recognised as a pioneer in open collaboration for health research. We hope that IMI 2 will build on the successes and lessons learnt from IMI 1, and continue to deliver breakthroughs that will make a real difference to patients, their families and carers, and society as a whole.’
The Innovative Medicines Initiative (IMI) was launched in 2008 with a €2 billion budget and the goal of speeding up the development of safer and more effective medicines through a public-private partnership (PPP). Today, IMI has established itself as a pioneer of open collaboration, a novel way of working that is radically changing the shape of the pharmaceutical research and development (R&D) landscape. The benefits of open collaboration are evident from the many significant results generated by IMI’s consortia, which gather together the key stakeholders in healthcare. Meanwhile, new projects on issues such as antimicrobial resistance demonstrate the value of the PPP model in tackling major public health challenges.
IMI’s 40 projects launched to date represent a community of 4 000 researchers drawn from academic teams, pharmaceutical companies, small and medium-sized enterprises (SMEs), patient organisations and regulators. Many projects focus on diseases and conditions for which effective treatments are lacking.
Further projects are in the pipeline; IMI launched its 9th Call for proposals on 9 July 2013.
Catherine Brett – Communication and Events Manager
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Notes to Editors
Examples of IMI project successes
- Action on autism – the EU-AIMS project
- A world first for diabetes researchers – the IMIDIA project
- Sharing old data to generate new results in schizophrenia and depression research– the NEWMEDS project
- Spotlight on safety – the eTOX project
- Patients as partners in research into personalised treatments for severe asthma – the U-BIOPRED project
- Tackling threats to society – the IMI antimicrobial resistance programme
- Training the next generation – IMI’s education and training projects
Autism spectrum disorders (ASD) refers to a diverse group of development disorders that are characterised by difficulties in social interaction and communication, and the presence of unusual repetitive behaviours. It affects one child in 110 and is a lifelong condition, yet there are currently no drugs designed specifically to treat the main symptoms of those affected.
The goal of IMI’s EU-AIMS project is to generate tools that will enhance our understanding of ASD, and ultimately pave the way for the development of new, safe and effective treatments for use in both children and adults. As well as dramatically improving quality of life, good treatments would help to cut the social and economic costs of ASD.
Among other things, EU-AIMS has discovered that some of the brain changes associated with autism could be reversible. The findings, published in the journal Science, focus on a gene called neuroligin-3, which has been linked with inherited cases of autism. Mice that are missing the neuroligin-3 gene have overactive glutamate receptors and this causes problems with learning and brain development. When the mice were triggered to produce normal levels of neuroligin-3, the glutamate receptor activity returned to healthy levels, but more significantly, the autism-like changes in the mouse brains returned to normal.
EU-AIMS will also embark on the two largest-ever clinical studies of ASD. The first study will look at the risk of autism in a younger brother or sister of a child with autism, while the second will track how symptoms change with age. These will involve around a thousand patients and will kick off in 2014. The EU-AIMS team has already demonstrated that 4-6 month old babies who have an older brother or sister with autism show a reduced response to social cues (such as the sound of laughter or someone playing ‘peek-a-boo’) compared to other babies.
A down to earth and practical outcome of the project is its contribution to the development of new treatment guidelines that are being put together by the European Medicines Agency. The guidelines will be available over the next 18 months or two years.
Diabetes is a chronic disease in which patients’ blood sugar levels are elevated because the beta cells in the pancreas fail to produce enough insulin. It is estimated that diabetes affects around 366 million people worldwide, and that figure is likely to rise to 552 million by 2030.
Patients are at risk of a number of serious complications, including heart disease and stroke, and damage to the blood vessels, kidneys, and eyes. Diabetes therefore has a major impact on sufferers’ quality of life. Currently there is no cure for diabetes, and treatment options are limited.
For many years, a major challenge for diabetes researchers was the lack of a human pancreatic beta cell line that survived (and so could be studied) in the lab; instead, scientists had to use rodent beta cell lines. Now, IMIDIA researchers including scientists from French SME Endocells have developed a human pancreatic beta cell line that not only survives in the lab, but also behaves in much the same way as beta cells in the body. The result has been hailed as a breakthrough for diabetes research.
In total, IMI has three projects working on diabetes. IMIDIA focuses on studying the pancreatic beta cells which are responsible for producing insulin; it aims to use this knowledge develop treatments that can slow down the progress of diabetes. Meanwhile, SUMMIT’s work addresses the urgent need for new treatments to tackle the complications associated with diabetes, such as eye, kidney, and blood vessel problems. Finally, DIRECT takes a personalised medicine approach to diabetes, as it works to identify different varieties of diabetes and effective treatments to tackle them.
Schizophrenia affects around 24 million people globally, and depression up to 15 times as many, according to the World Health Organization. However, few truly game-changing medications have reached the market in the last few years. Enter the IMI project NEWMEDS, which brings together seven academic research institutions, nine major pharmaceutical companies and three small and medium-sized enterprises (SMEs). NEWMEDS’s goal is to overcome the hurdles that are slowing the research and development of more effective treatments for these disabling mental disorders.
The project has made a number of breakthroughs. For example, clinical trials in which patients on active treatment are compared to patients taking a placebo normally take six weeks. However, NEWMEDS has found that these trials could be shortened by a week or two. NEWMEDS research also suggests that more women should be included in trials; currently they account for under a third of trial participants yet they respond less to placebos than men. The project has also found that so-called negative schizophrenia symptoms (e.g. an inability to feel pleasure or act spontaneously) could respond better in these studies than was previously thought, something that has been largely overlooked before.
These results were made possible because the companies involved in NEWMEDS have pooled their data to create the largest-known database of studies on schizophrenia, including information on over 23 000 patients from 67 studies in over 25 countries. The database offers the industry and the academic community unique opportunities for the development of tools and models that will help find targeted treatments for schizophrenia.
A major challenge in drug development is identifying potential drugs that may have unintended, harmful side effects by damaging vital organs such as the heart, liver, or kidneys. All too often, toxicity issues are picked up very late in development, when vast amounts of time and money have been spent on a potential drug. With this in mind, many IMI projects are developing tools and methodologies to detect drug safety issues much earlier in drug development.
For example, scientists in the IMI project eTOX have developed a computer model to test potential medicines for cardiotoxicity. Users simply have to enter the molecular formula of the compound into the tool, and the system generates a simulated ECG (electrocardiograph). Clinicians routinely use ECGs to diagnose heart problems in their patients; in the same way, users can study the simulated ECG generated by the eTOX system to determine whether or not a compound is toxic to the heart. According to the project team, it provides better results than the currently-used computational systems. Details of the new tool were published in the Journal of Chemical Information and Modelling.
Most people with asthma are able to control their symptoms with medication. However, for patients with severe asthma, this is not always the case, even though they take large amounts of medication every day. Severe symptoms include chest tightness and breathlessness and affect around 6 million people in Europe. A severe attack can require hospitalisation and be life threatening; asthma kills 12 000 Europeans annually. On a day-to-day basis, severe asthma profoundly impacts patients’ lives, hampering their ability to work, go to school, engage in physical activity, and spend time in areas with high levels of traffic congestion or where smoking is allowed. There is therefore a clear and urgent need for new treatments for severe asthma. However, it is not always easy to identify the patients who will benefit from a particular drug and find enough patients to participate in clinical trials.
IMI’s U-BIOPRED project is working to enhance our understanding of the different types of severe asthma and determining which drugs will prove most effective at treating them. The project recently achieved its goal of recruiting 1 025 people (including almost 300 children) into its pan-European study on severe asthma. Study participants provided blood and tissue samples, exhaled air samples, and reports of their symptoms. They also underwent lung function tests and examinations of their airways. The researchers are now drawing on this data to build up a detailed picture (or ‘handprint’) of each individual’s condition. By comparing data from so many different people, the team hopes to identify groups of patients with similar handprints. These groups will allow researchers to define different kinds of severe asthma, paving the way towards personalised treatments for patients.
Patients are heavily involved in U-BIOPRED and are key to its success – as well as taking part in the clinical study, they have given advice and offered the patient’s perspective on ethical, scientific and communication issues throughout the project.
Antimicrobial resistance (AMR) represents a serious and growing threat to human and animal health worldwide. According to the World Health Organization (WHO), ‘antibiotic resistance is becoming a public health emergency of yet unknown proportions’. In the EU, AMR is responsible for some 25 000 deaths every year, and the annual treatment and social costs have been estimated at €1.5 billion. Meanwhile, new forms of resistance continue to arise and spread, leaving clinicians with few weapons to bring infections under control. Yet despite the recognised need for new antibiotics, the reality is that only two new classes of antibiotics have been brought to the market in the last three decades.
The reasons for this are manifold. On the scientific front, there is an urgent need for a greater understanding of how antibiotics work, how bacteria develop resistance to them, and what molecular mechanisms could be exploited to get round bacterial defence mechanisms. Running clinical trials on new antibiotics is also problematic due to regulatory requirements and the large numbers of patients required.
At the same time, because some antibiotics will only be used on a very small number of patients, the costs of development often exceed the potential return on investment. In other words, antibiotic development is simply no longer a financially viable option for pharmaceutical companies, and just a handful of pharmaceutical companies remain in the field.
In its Action Plan against the rising threats from Antimicrobial Resistance of November 2011, the European Commission called for ‘unprecedented collaborate research and development efforts to bring new antibiotics to patients’ by, among other things, launching an IMI programme ‘for research on new antibiotics aimed at improving the efficiency of research and development of new antibiotics through unprecedented open sharing of knowledge’.
The result is the New Drugs for Bad Bugs (ND4BB) programme. The first two projects under the programme, COMBACTE-CARE,
COMBACTE-MAGNET, COMBACTE-NET and TRANSLOCATION, were launched in early 2013. A third topic under ND4BB was launched as part of IMI’s 8th Call for proposals in December 2012; the resulting project should be ready for launch by the end of 2013. A further two topics were launched as part of IMI’s 9th Call for proposals in July 2013; one of these focuses on developing new business models for antibiotic development.
Since the launch of ND4BB, the European Parliament has also weighed in on the issue. In December 2012 it adopted a resolution on the rising threat of AMR that highlights the important role of public-private partnerships in reinvigorating antimicrobial R&D. More recently, the UK’s Chief Medical Officer issued a report that also highlights the challenging economics of antibiotic development (see page 83).
In addition to its research and innovation projects, IMI also boasts a number of education and training projects. Designed to both train the next generation of drug development experts and help current professionals stay up to date with the latest scientific, technological and regulatory developments, the projects offer a broad array of courses, ranging from short courses lasting just a few days to full Masters and even PhD courses and including face-to-face and distance learning options.
IMI project PharmaTrain has successfully launched the Cooperative European Medicines Development Course (CEMDC), a postgraduate qualification in medicines development. The CEMDC was set up to provide a university network that could provide pharmaceutical medicine training in countries where no such education was established. The universities involved in the CEMDC are located in Estonia, Hungary, Lithuania, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, and Turkey. The initiative therefore gives students from the central and Eastern European and Mediterranean regions the opportunity to benefit from the very best teaching offered jointly by all participating universities. The university network concept was developed because in small countries, or countries with small pharmaceutical industries, only a network concept can guarantee the long-lasting sustainability of the programme.
IMI project EMTRAIN has launched on-course® - Europe’s most comprehensive biomedical and medicines research and development postgraduate course portal. The portal gathers together information on almost 5 000 courses taught in 20 languages in 39 countries and covering over 60 scientific and therapeutic areas. Free and easy to use, on-course allows users to search for courses by type (Masters, PhD, short course), schedule (full or part time, modular), learning type (distance, face-to-face, mixed), language, location, and scientific / therapeutic area. Users can also search for courses delivered by IMI’s Education & Training projects. For each course on the site, on-course® provides a course description, list of modules (if relevant), details of fees, contact information, and links to the course website. In addition, users can compare courses quickly and easily. Finally, for people looking for courses while on the move, there is the on-course® app, which can be downloaded to smartphones for free from Google Play (for Android phones) or the AppStore (for Apple products).
The Innovative Medicines Initiative (IMI) is the world’s largest public-private partnership in health. IMI is improving the environment for pharmaceutical innovation in Europe by engaging and supporting networks of industrial and academic experts in collaborative research projects. The European Union contributes €1 billion to the IMI research programme, and this is matched by in kind contributions worth at least another €1 billion from the member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The Innovative Medicines Initiative currently supports 40 projects, many of which are already producing impressive results. The projects are all working to address the biggest challenges in drug development, with the goal of accelerating the development of safer and more effective treatments for patients.