56th Edition – April 2016

IMI Ebola vaccine project publishes positive data

Data from an early stage clinical trial of a novel Ebola vaccine regimen show that it produces a long-lasting immune response and is well tolerated, with minimal side effects. The study, supported in part by IMI through the Ebola+ project EBOVAC1, is published in the Journal of the American Medical Association (JAMA). In the trial, healthy volunteers in the UK received a two-part ‘prime boost’ regimen comprising an initial vaccine dose to ‘prime’ the immune system and a subsequent dose of a different vaccine to ‘boost’ the immune response. Significantly, eight months after immunisation, 100% of those vaccinated still had Ebola-specific antibodies. This long-term protection is important. ‘Recent evidence highlighting the persistence of the Ebola virus in bodily fluids, and the potential for sexual transmission from Ebola survivors, reinforce the importance of finding a robust and durable vaccine for this disease,’ explains Matthew Snape of the Oxford Vaccine Group and the study’s lead author. In total, 10 clinical studies on this regimen are taking place in Europe, Africa and the US. The west African Ebola outbreak has infected over 28 600 people and killed more than 11 300. Flare-ups continue to occur in the region due to the persistence of the virus among survivors.

• Read the press release
• Read a blog article on the findings by Paul Stoffels, Chief Scientific Officer of Johnson & Johnson
• Find out more about IMI’s Ebola+ programme 

PROTECT project’s legacy on assessing benefits and risks of medicines

One of IMI’s first projects, PROTECT was set up to develop innovative methods for monitoring the benefits and risks of medicines. Although the project is over, its legacy lives on in the knowledge and tools generated by the project, many of which are presented in a special issue of the journal Pharmacoepidemiology and Drug Safety and a short report published by the European Medicines Agency (EMA), which coordinated the project. ‘PROTECT has made a significant contribution to the body of scientific knowledge of benefit-risk monitoring methodologies,' said Peter Arlett, Head of the EMA’s Pharmacovigilance department. ‘Results are being implemented into routine pharmacovigilance and regulatory practice. They have already started to improve day-to-day medicines monitoring operations of regulators and pharmaceutical companies, for better safety of European patients.’

Highlights from the project include:

• Good Signal Detection Practice was integrated into tools and regulatory guidance for national authorities and companies.
• Recommendations for observational studies on medicines were integrated into scientific guidance and will be integrated into regulatory practice.
• Recommendations for benefit-risk assessment methodologies and visual representations have led to initiatives that explore practical application of harmonised methods and the involvement of patients and the wider public in the assessment of benefits and risks of medicines.
• Exploring new methods to collect data directly from patients, including via the internet.
• A specific PROTECT benefit-risk website.
• 72 articles in peer-reviewed scientific journals, 14 doctoral theses and 3 master theses.

PREDECT project delivers ‘potential game-changer’ for breast cancer research

Scientists from IMI’s PREDECT project have developed the first animal model of a common form of breast cancer that faithfully replicates the human disease, opening up new avenues for studying breast cancer and developing and evaluating treatments. The findings are published in the prestigious journal Cancer Cell. Some three quarters of breast cancer cases feature tumours that have a receptor for the hormone oestrogen. Efforts to study these ER+ cancers have been hampered by the fact that animals (like mice) used to study the disease do not accurately replicate how the disease behaves in human patients. Now, PREDECT researchers have created a mouse model that mimics human ER+ cancer better than any other existing model. ‘With this breakthrough, breast cancer disease, progression and metastasis now become amenable to study,’ said George Sflomos of EPFL, the first author of the paper. ‘We can now study crucial factors, such as the action of hormones and molecular responses to therapies, for the first time in a relevant context. But more importantly, this model opens up new opportunities not only for the development but also for the evaluation of breast cancer therapies.’ Meanwhile an accompanying editorial states: ‘This finding is a potential-game changer for breast cancer research, and we predict that it will likely translate into new therapeutic strategies for ER+ breast cancer in the near future’.

EBiSC launches European Stem Cell Bank

IMI’s EBiSC project has launched its online catalogue of induced pluripotent stem cells (iPSCs) which are available to academic and commercial scientists alike for use in research. IPSCs are created by taking ordinary adult cells (such as skin cells) and reprogramming them to make them ‘pluripotent’, i.e. able to give rise to all the different kinds of cell that make up the human body. EBiSC was set up to build a robust, reliable supply chain for iPS cell lines, including the generation of disease specific cell lines through standardised, quality controlled processes for banking and worldwide distribution. The cell lines in the EBiSC catalogue were made and deposited by both EBiSC project partners and external organisations. They include cells taken from people with neurodegenerative, heart, and eye diseases as well as from health donors. Further lines, covering Parkinson’s and Alzheimer’s diseases and diabetes for example, will be added in the near future. ‘The launch of the on-line catalogue  will allow EBiSC tosupport stem cell researchers in Europe and elsewhere,’ said Aidan Courtney, CEO of Roslin Cell Sciences. ‘The organisations making up the EBiSC Consortium are each leaders in their own area of expertise. We have been fortunate to have the support of IMI to combine these skills from across Europe to create this major research resource.’

• Read the project’s press release 

DRIVE-AB to hold conference on sustainable development and use of antibiotics

IMI’s DRIVE-AB project will hold a high-level conference entitled ‘Stimulating innovation, sustainable use and global access to antibiotics’ on 2 June in Amsterdam, the Netherlands. The goal of the event is to bring together policy makers, regulatory and public health experts, and economists to identify and evaluate reward models that are feasible, practical and can be implemented globally. At the event, DRIVE-AB will present the preliminary results of its research and seek feedback from stakeholders regarding feasibility and implementation of research and development (R&D) incentive policies. The conference also seeks to determine how on-going European and international initiatives addressing antimicrobial resistance can complement each other, and to identify opportunities for DRIVE-AB to interact with other initiatives. If you would like to apply for a space at the conference, contact DRIVE-AB Communications Officer Victoria Wells at vwells@bsac.org.uk.

Eu2P launches new bite-sized online courses in pharmacovigilance

IMI education and training project Eu2P has officially launched short online courses in pharmacovigilance. The courses take account of healthcare professionals’ and organisations training needs and the fact that students may have limited study time. As such, they consist of self-paced learning activities (the average work load per course is under two hours) followed by a final evaluation test. Students who pass the test receive a certificate of training achievement.

Eu2P has short courses covering a range of areas, including safety, benefit-risk assessments, pharmacovigilance, and public health. Courses are built and recognised by the project’s academic, regulatory and industrial partners, meaning that the content is grounded in the real world.

Join LifeTrain in Heidelberg for a conference on lifelong learning

The IMI-funded LifeTrain initiative is organising a conference on lifelong learning in the biomedical sciences in Heidelberg, Germany, on 5-7 July. The event represents a new international forum to bring together the key influencers, policymakers, trainers and stakeholders from academia, industry and the professional bodies who will shape and implement how career-long continuing professional development is managed in the future. It will encompass career-long continuing professional development for both the academic and industry sectors. Participants will benefit from:

• insights into the latest developments in education and training for biomedical professionals;
• an introduction to competency profiles as effective means to support recruitment and retention of key staff;
• means to empower your staff to manage their own continuing professional development (CPD);
• an opportunity to promote your organisation at the free showcase event;
• networking with other course providers and trainers, employers, professional bodies, researchers and policy makers;
• a choice of interactive workshops to assist delegates to implement continuing professional development practices in their organisations or contribute to further discussions of conference topics.