45th Edition – April 2015

IMI-supported Ebola vaccine trials get underway in Africa

A clinical trial of an Ebola vaccine regimen run through the IMI project EBOVAC1 has started in Kenya and Uganda. The trials are Phase I studies designed to evaluate the safety of the vaccine regimen and evaluate the long-term immune response to a regimen developed at the Janssen Pharmaceutical Companies of Johnson and Johnson. In each of the Phase I trial sites, 36 healthy adult volunteers receive either a placebo, or a two-part ‘prime-boost’ vaccine regimen, comprising an initial dose to prime the immune system and a ‘boost’ to enhance the immune response in the longer term. Similar studies are already underway in the UK and US and further studies in Africa, including in Sierra Leone, are anticipated to receive approval soon. The EBOVAC1 project is part of IMI’s wider Ebola+ programme, which currently covers vaccines and diagnostics and it is hoped will deliver results that will contribute to efforts to tackle both the current and future outbreaks.

According to WHO reports, as of mid-April there had been over 25 000 confirmed, probable, and suspected cases of Ebola in the current outbreak and over 10 000 deaths, most of them in Guinea, Liberia, and Sierra Leone

EUPATI paper in BMJ OPEN puts spotlight on public knowledge of medicines research

A research paper by IMI’s EUPATI project reveals that the majority of people in Europe (three quarters) have either no or ‘less than good’ knowledge of medicines research. However, people who have been involved in medical research themselves generally have much greater knowledge of medicines research. The findings, published in BMJ Open, are based on a survey of 7 000 people across Europe. The study also questioned participants on their interest in learning more about medicines research and development. The most popular areas (with around half of participants showing interest) were medicines safety, personalised medicine and predictive medicine.

‘We are all potential patents,’ said Kathy Oliver, Co-Chair of EUPATI’s Project Advisory Board and Chair of the International Brain Tumour Alliance. ‘This possibility emphasises the crucial need for the general public to really understand the numerous stages of medicines development and realise the complex processes that take place before a medicine is available for general use. EUPATI’s newly-published paper throws a fascinating light on what people already know about medicines research and development, and where the gaps are. In addition, the paper’s findings are of great value to us as patient advocacy groups because they validate the need for organisations like ours to help increase public knowledge and awareness about medicines research and development.’

Read EUPATI’s press release

EUPATI training course: very successful interactive face-to-face meeting of trainees

EUPATI's Patient Expert Training Course educates patient advocates about the whole medicines research and development process over a period of 14 months. After six months of e-Learning, the first face-to-face part of the EUPATI course turned out to be a huge success. The five-day training event, held at the end of March in Barcelona, Spain, covered topics as diverse as medicines regulation, clinical trials, statistics, evidence, and ethics. It also featured "mock" ethics panel meetings and pharmacovigilance risk assessment meetings. The students have been following the course via distance learning since autumn 2014, and will continue to study this way until the second face-to-face training meeting in September. They will graduate in November 2015. The course is designed to provide patient advocates with the knowledge and skills to participate effectively in medicines research and development.

‘I am deeply impressed by this group of highly engaged patient advocates from 21 countries all across Europe, who are investing a significant share of their volunteer time over a period of more than a year to become knowledgeable patient experts in medicines R&D,’ commented EUPATI Director Jan Geissler. ‘The great spirit, the depth of discussions and the energy level every day was truly inspiring and is an amazing reflection of the power of patient advocacy.’

He added: ‘We are receiving lots of constructive feedback - very positive, as well as lots to learn from and improve for our next course, not surprising as this is a pioneer course - the first of its kind.’ Applications for the 2015/16 EUPATI course have now closed; the project received 187 applications for 60 places. The project is also developing a range of online information and educational materials for patients and patient advocates which will launch in seven languages by the end of 2015.

How green are your reactions? CHEM21 delivers toolkit to find out

The CHEM21 project has developed a unified metrics toolkit to comprehensively evaluate the sustainability of chemical and bio-chemical reactions. Details of the toolkit are published in the journal Green Chemistry. The toolkit uses a blend of both qualitative and quantitative criteria to assess how green a reaction is, as well as considering factors both upstream and downstream of the reaction itself. This ensures a truly holistic approach.

The Toolkit allows the user to assess/demonstrate the ‘green credentials’ of their research; benchmark against current state of the art for a particular reaction or pathway and evaluate new methodologies to ensure that solving one problem does not give rise to others elsewhere in the process. The Toolkit is specifically structured with a series of ‘passes’ to cover everything from bench top research right through to industrial scale with increasing levels of complexity.

The acceptability of a particular process or reaction step is shown by a system of flags: green denotes ‘preferred’, amber is ‘acceptable – some issues’ and red is ‘undesirable’. The purpose of the toolkit is to ensure a holistic approach is taken so that no parameter is looked at in isolation. CHEM21’s aim is that this Toolkit will encourage continuous improvement whilst training researchers to think critically about sustainability and environmental acceptability, making analysis of their synthetic routes and the use of greener and more sustainable techniques part of everyday practice.

European Lead Factory launches new animations

IMI’s European Lead Factory has published four short videos to help SMEs and academics understand how the programme works. The videos explain the programme’s aims and give an overview of how target assays are introduced and handled, as well as how to test chemical scaffold ideas using the European Lead Factory’s online compound tool. Programme owners' rights & obligations are also covered in this light-hearted series of animations.  

• Watch the videos
• Find out more about the European Lead Factory
• Read the latest European Lead Factory newsletter

imi-train website goes live

April saw the launch of the imi-train website. imi-train is a new joint European platform that provides education and training solutions in the medical, biomedical and pharmaceutical sciences. Established by the IMI Education and Training projects EMTRAIN, Eu2P, PharmaTrain and SafeSciMET, imi-train is set to become the most broadly recognised point of reference for scientists who seek guidance for their continuing professional development. Visitors to the website, such as course providers, professional bodies, employers and individuals, can browse academic postgraduate programmes and short courses, benefit from career development services and find information and access to course portals, quality standards, accreditation and e-learning possibilities.

Forthcoming project events

Save the date! U-BIOPRED results symposium

Save the date! IMI’s project U-BIOPRED is holding a results symposium on Wednesday 24 June in Leuven, Belgium. Project partners will showcase major achievements and findings from the project and outline future steps for the consortium, building upon the results of this multi-centre project. The event will also present the U-BIOPRED experience of patient-research collaboration to support the clinical trials and ensure relevance of the project to the lives of people living with asthma.  

U-BIOPRED is one of IMI’s first projects and is due to finish in September 2015. The project has been working over the last 5 years to speed up the development of personalised and targeted treatment of patients with severe asthma by creating a novel way to identify different types of chronic asthma using a ‘handprint’ – a combination of biological characteristics (biomarkers) that indicates what type of asthma a patient is suffering from. 

Open PHACTS workshop

The IMI Open PHACTS project is organising a workshop for the users of their Open PHACTS Discovery Platform, and especially for the users of their workflow tools ‘Pipeline Pilot’ and ‘KNIME’ tools. The platform provides a convenient API (application programming interface) to query across multiple pharmacology datasets.

The workshop will take place on 19 and 20 May at the VU University in Amsterdam, The Netherlands. This will be a small, informal workshop to introduce users to how the Open PHACTS API can help answer scientific questions. The workshop will explore how the Open PHACTS Discovery Platform can be used to develop solutions for scientific use cases. The Open PHACTS Pipeline Pilot components and KNIME nodes to access the Open PHACTS API will be demonstrated during the workshop in order to learn how different nodes and components can be linked together. The workshop will also look at how data of interest can be extracted from API results, and used as input for downstream nodes and components to generate meaningful results.

The IMI Open PHACTS project’s online data platform is an online; an open access platform that uses semantic web technology to allow scientists to easily access and process data from multiple sources to rapidly solve real-world drug discovery problems.

The workshop is free of charge. More information about the workshop

DDMoRe to hold workshop during the 24th PAGE meeting

 DDMoRe will hold a workshop during the 24th PAGE meeting in Crete, Greece on 2 June 2015. Using real model examples from the pharmaceutical industry and academic world, DDMoRe consortium partners will give an overview of the project’s concept and demonstrate its platform. Information from a wide array of sources can be integrated into models to describe and predict the behaviour of complex disease/biological systems and drug actions. The goal of the DDMoRe platform is to improve the quality, efficiency and cost effectiveness of model-informed decision making in drug development and therapeutic use of marketed drugs. The added value of DDMoRe and how it can support Model Informed Drug Discovery and Development (MID3) and Model Informed Patient Care (MIPC) will be discussed. The elements that make up the DDMoRe platform are the Model Repository, Model Certification, Exchange Standards, Interoperability Framework, Pharmacometric Workflow and Training. The workshop is free of charge and registration is now open

Catch up on previous IMI project events

If you missed some recent IMI project events, you can catch up online! Presentations and video recordings from the Final Symposium Training of the PROTECT are now available online. The material covers:

• the main concepts of benefit-risk assessment,
• a range of methodologies used in connection with benefit-risk assessment,
• key methodologies via worked examples,
• a range of visual representations to accompany benefit-risk assessment and
• a selection of visual displays via worked examples, and the role of patient and public involvement in benefit-risk assessment

Also available for download are the materials from the recent LifeTrain workshop. Claire Johnson of EMBL, who was the head of this year’s workshop programme committee concluded after the event that ‘with the 2015 LifeTrain workshop we have made yet another significant step in creating awareness for education and training in biomedical research among the very heterogeneous group of signatories, supporters and friends….’ A summary of the conclusions, presentations, agenda, photos and posters from the LifeTrain workshop are now available online.