IMI Stakeholder Forum – Registration now open
Registration is now open for IMI’s Stakeholder Forum, which will be held on Monday 13 May at the Sheraton Hotel in central Brussels. IMI’s annual Stakeholder Forum provides an opportunity to catch up on and discuss IMI’s activities, successes and plans. This year, the morning of the event will be dedicated to brain research, an area where IMI is particularly active and where there is an urgent need for new drugs. The afternoon will focus on IMI’s place in the European Research Area. The event will close with a keynote speech by Nobel Laureate Rolf Zinkernagel who will focus on immunology research. IMI already has a number of projects in this area and it is likely to be the subject of future Calls for proposals.
- View the latest version of the agenda
- Sign up by filling in the online registration form
- Registration is free but obligatory
Countdown to the European Month of the Brain
Brain disorders affect 1 in 3 Europeans and cost the economy €798 billion every year. However, there are few effective treatments in this area and developing new drugs to treat brain disorders takes longer and costs more than for other diseases. To highlight the issues and challenges surrounding brain research, the European Commission has declared May 2013 to be the European Month of the Brain . Events focusing on the brain (including IMI’s Stakeholder Forum) will take place throughout the month. The European Commission is organising two major conferences on the topic, one of which will be held in Brussels on 14 May, the day after IMI’s Stakeholder Forum.
- Find out more about the Month of the Brain
- Follow the discussions on Twitter the hashtag #brainmonth
EFPIA sets out priorities for drug R&D, regulation
In a comment piece in Nature Reviews Drug Discovery, EFPIA has set out seven areas it believes should form the focus of future efforts to improve drug research, development and innovation. Top of the list is the need to redefine diseases by the underlying molecular mechanisms, and not just their symptoms; this was the subject of two topics in IMI’s 8th Call for proposals. Another priority is the need to develop novel trial designs and statistical methods. Many of the recommendations focus on regulators, for example the need to adapt regulatory frameworks to new science; the importance of cutting bureaucracy in regulatory procedures; the need for a new approach to benefit-risk assessment by regulators; and the urgency of exploring new ways of granting earlier patient access to important new medicines. Finally, the group underline the need to promote global medicines development. Some of the priorities are already the subject of ongoing IMI projects, and the authors conclude that the priorities will also be used to identify future projects.
IMI featured in articles in Science and Nature
IMI was highlighted in recent articles in Science and Nature’s careers sections. An article on industry-academia partnerships in the Science Careers section includes a section on IMI which explains the organisation’s role as a neutral platform for bringing diverse partners together to tackle major challenges in pharmaceutical research. The article also refers to IMI’s five Education & Training projects.
Meanwhile a recent article in the Nature Jobs section focuses on regulatory issues, and highlights IMI’s PharmaTrain and Eu2P projects as initiatives that run both short and longer courses in the regulatory area.
Japan launches life sciences PPP
Japan has announced the launch of its first life sciences public-private partnership (PPP), the Global Health Innovative Technology (GHIT) Fund, with the aim of contributing to the fight against infectious diseases in the developing world. The new organisation, which is based in Tokyo, is a partnership between the Japanese government, five pharmaceutical companies, and the Bill & Melinda Gates Foundation. Over 1 billion people globally suffer from diseases such as HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases (NTDs). Tackling these diseases requires medicines, vaccines and diagnostics that are effective yet cheap. By drawing on the advanced science and technology capacities of Japan’s universities and pharma companies, the GHIT Fund hopes to be able to bridge the gap between basic research and clinical studies, allowing for new advances in this area.
News from the projects
- U-BIOPRED hits patient recruitment target
IMI's U-BIOPRED project has achieved its goal of recruiting 1 025 people (including almost 300 children) into its pan-European study on severe asthma. Severe asthma is notoriously difficult to treat, and the aim of U-BIOPRED is to find out why. For their study, the researchers recruited different kinds of asthma patients, include non-smoking adults and children with severe and mild asthma and smokers with severe asthma, as well as small children with wheezing, and healthy adults. The study participants have provided blood and tissue samples, exhaled air samples, and reports of their symptoms. They have also undergone 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. 'We are now starting to perform analyses on the data,' explained project coordinator Peter Sterk of the University of Amsterdam. 'This is being done by a strong, collaborative effort – the most modern analytical and statistical technology is available and is being worked with during the interim analyses of the data'. Patients are heavily involved in the project; as well as taking part in the clinical study, they have provided advice on ethical, scientific, and communication issues, giving the patient's perspective throughout.
- Babies at risk of autism show reduced response to social cues, EU-AIMS study reveals
Babies aged 4-6 months that are at risk of autism show a reduced response to social cues compared to other babies, according to new research from IMI’s EU-AIMS project published in the Proceedings of the Royal Society B. The symptoms of autism, which include difficulties in social interactions and communication, emerge gradually during early childhood, and firm diagnoses are only made in children aged two and up. Until now, little research has focused on what happens in children below that age. In this study, the team studied brain activity in babies that are known to be at risk of autism as they have an older brother or sister with autism (autism being a highly heritable condition) and infants with no family history of the condition. Wearing caps bearing sensors, the babies watched videos of human actions (such as the game of ‘peek-a-boo’) or listened to human sounds (laughter, yawning) and non-human sounds (e.g. running water). The results showed that the high-risk babies responded less to the social cues than the low-risk babies, and furthermore the brain activity patterns seen closely resemble those of children and adults with autism. The researchers point out that the next step would be to assess the children when they are older to see which youngsters, if any, actually develop autism symptoms. In a press release by Birkbeck College (which is not an EU-AIMS partner), a mother of one of the babies involved in the study said: ‘Having been through this myself, I felt it was my duty to ensure I helped in any way I could by involving [my son] in the Babylab research. I feel very strongly that this is a very important start towards improving the lives of many families with children on the autistic spectrum.’
- Students go head to head at Eu2P economics course
A team of students from the Netherlands, Panama and the UK was judged to have submitted the best research proposal during a competition run during a recent Eu2P module, developed by Utrecht University in collaboration with GSK, on pharmacoeconomics. The students were split into teams and worked on the assignment of writing the research proposal throughout the course; at the end of the module, the teams had to present their proposals to an expert jury during a web-based live session. The challenge was made tougher by the fact that the students were scattered across the globe, and so the teams could not meet in person to work on the assignment. Instead, they kept in touch via e-mail, Skype, and Whatsapp. The winning proposal addressed the economic evaluation of triple therapy in metastatic breast cancer. Team member Zeshan Iqbal, who works in pharmacovigilance for Johnson & Johnson in the UK, described the competition as an 'invaluable experience', explaining that the way the assignment ran through the whole module meant that the team could continuously apply what they were learning in the classes to the assignment. According to Zeshan, picking the Eu2P course was an easy decision. 'The diversity and more importantly the flexibility of the Eu2P course was extremely attractive especially as I have a full time job and a young family,' he explains. So far, the modules have met his expectations, and the level of support has been exceptional, he says. Looking to the future, he is optimistic that the course will help him in his career. 'Doing projects and assignments such as the one we did as a competition allow us to learn and benefit from many different people,' he says. 'This course being under the umbrella of IMI, different universities and companies also gives the course credibility which will also be helpful in my career.'
- Interested in applying for an Eu2P course? View the online course catalogue
- BIOVACSAFE clinical studies get underway
The vaccine safety project BIOVACSAFE has started a series of clinical studies that will pave the way for novel tests to predict the safety of new vaccines. Vaccine safety is of paramount importance; and although vaccines are widely recognised as one of the most effective public health interventions available, concerns about vaccine safety may lead some people to hesitate about having themselves and/or their children vaccinated. Vaccines are thought to work by triggering a mild and localised inflammatory response that will create the appropriate environment to establish immunity against the disease in question. However, excessive inflammation can result in serious complications. Currently, it is hard to predict when severe inflammation will occur, and this has led to some vaccines being withdrawn from the market. In BIOVACSAFE, researchers are using licensed vaccines to identify biological markers (biomarkers) that can predict beneficial and harmful responses to a vaccine. One study that is currently underway is a 'training' study, in which the licensed hepatitis B vaccine, Engerix B, is being evaluated. This vaccine was selected because it is a good representative of a particular class of vaccines and is used in a particular target group. In this study, participants receive two immunisations six months apart. For each immunisation, participants will have to spend a week at the study centre, during which physiological parameters (such as temperature, heart rate and blood pressure) and immunological parameters are investigated in detail. The data from this study will then be used to identify potential biomarkers. Ultimately, the objective is to develop novel tests using biomarkers identified in such studies. These tests can then be integrated into vaccine development programmes to identify new vaccine candidates with the best safety profiles.