- IMI 9th Call for proposals launched
- European Commission launches proposal for IMI 2
- Have your say on the IMI 2 Strategic Research Agenda
- WHO report on priority medicines puts focus on PPPs
- Translational immunology and PPPs: IMI at ICI
- IMI to focus on innovation through collaboration at EACPT congress
- News from the projects
- Meet the projects!
IMI 9th Call for proposals launched
IMI has officially launched its 9th Call for proposals with the following topics:
- WEBAE – Leveraging emerging technologies for pharmacovigilance
- Developing innovative therapeutic interventions against physical frailty and sarcopenia (ITI-PF&S) as a prototype geriatric indication
- Driving re-investment in R&D and responsible use of antibiotics (ND4BB topic 4)
- Clinical development of antibacterial agents for Gram-negative antibiotic resistant pathogens (ND4BB topic 5)
The total budget for the Call stands at €135 million (€63 million of which comes from the EU’s Seventh Framework Programme, and €72 million of which comes from EFPIA companies’ in kind contributions). The deadline for submitting Expressions of Interest is 9 October 2013. The full Call text and details of how to apply can be found on the 9th Call – Stage 1 web page
- Read IMI’s press release on the 9th Call for proposals
- View presentations on the topics plus IMI’s rules and procedures on the 9th Call webinars page
- Questions? Contact the IMI Infodesk
European Commission launches proposal for IMI 2
The European Commission has formally launched its proposal for IMI 2 with a total budget of €3.45 billion and a number of specific goals for speeding up drug development and boosting the competitiveness of Europe’s pharmaceutical industry.
On the budget front, IMI 2 will benefit from an industry in kind contribution of up to €1.725 billion. While €1.5 billion of this will come from EFPIA companies, the remaining €225 million could come from other large companies that wish to contribute to projects but are not EFPIA members. The European Commission will match industry’s contribution with up to €1.725 billion from Horizon 2020.
Máire Geoghegan-Quinn, European Commissioner for Research, Innovation and Science, commented: ‘Chronic and degenerative diseases are placing a growing burden on our health systems. The second more ambitious phase of the Innovative Medicines Initiative will help develop the next generation of cost-efficient vaccines, medicines and treatments that Europe desperately needs. By working together, IMI2 partners can share the risks and high development costs to make the innovative breakthroughs needed to keep Europe's citizens healthier for longer.’
Find out more:
- Read the European Commission’s press release – memo – factsheet
- Read EFPIA’s press release - IMI 2 web page
- Read IMI’s press release
- Download the legislative proposal
Have your say on the IMI 2 Strategic Research Agenda
EFPIA is currently preparing the Strategic Research Agenda (SRA) for IMI 2. An initial round of consultations earlier this year attracted over 50 responses from a wide range of umbrella and individual organisations representing patients, professional groups, learned societies, academia, regulators, etc. EFPIA is now seeking feedback on a revised version of the SRA, with a view to fine tuning the document and collecting input on potential projects which could be part of the scientific programme of IMI 2. The vision of the IMI 2 SRA, which is closely aligned with the World Health Organization’s new Priority Medicines Report, is to address R&D challenges in areas of unmet medical need across the entire healthcare chain.
WHO report on priority medicines puts focus on PPPs
A new report from the World Health Organization (WHO) sets out a number of priority disease areas where research is urgently needed to meet the healthcare needs of the population. The report was commissioned by the European Commission and is designed to aid policy making. ‘Priority medicines for Europe and the World’ identified the disease areas on the basis of ‘treatment gaps’.
Treatment gaps may exist because although treatments exist, they are likely to become ineffective in the near future (e.g. antimicrobial resistance and pandemic influenza). Elsewhere, treatments exist but the delivery mechanism is not patient friendly – an example here is depression, where many medicines come with side effects so unpleasant that many patients stop treatment. Another type of gap identified is where effective treatments simply do not exist yet; this is the case for Alzheimer’s disease, chronic obstructive pulmonary disease (COPD), and many rare diseases. Finally, the report underlines the importance of prevention, with a focus on tobacco use, alcohol, and obesity.
A large section of the report is devoted to public-private partnerships (PPPs), including IMI, whose first Strategic Research Agenda was based on the previous Priority Medicines Report from 2004. A background note explores the successes of and challenges faced by PPPs. Meanwhile the report’s conclusions state that IMI and other PPPs have ‘developed into effective partnerships focusing on precompetitive research’.
Translational immunology and PPPs: IMI at ICI
On 26 August 2013, IMI will hold a symposium at the 15th International Congress of Immunology (ICI2013) in Milan, Italy.
This event will focus on public-private partnerships (PPPs) as an innovative way of working which is radically changing research in healthcare and drug development. Bringing together different parties and stakeholders through open collaboration, PPPs are delivering significant results that are set to speed up the development of better, safer treatments for patients.
This symposium will bring together leading immunologists from around the world who are pioneering this new way of working. The session will focus on case studies demonstrating how PPPs are transforming the translational immunology landscape and accelerating breakthroughs in research and drug development.
Speakers: Michel Goldman (Executive Director of IMI), Jeffrey A. Bluestone (University of California San Francisco, USA), Marc Feldmann (University of Oxford, UK) and Paul-Peter Tak (GlaxoSmithKline, UK).
IMI to focus on innovation through collaboration at EACPT congress
IMI will hold a scientific symposium entitled 'Innovation through collaboration' at the 11th Congress of the European Association for Clinical Pharmacology and Therapeutics (EACPT 2013) in Geneva, Switzerland, on Thursday 29 August 2013. Over a working lunch, participants will have the opportunity to hear about the latest developments in three key therapeutic areas where IMI projects are currently very active. After an introduction to IMI’s public-private model for innovative life science research and development (R&D), representatives from IMI’s ongoing projects on autism, diabetes and antimicrobial resistance will present how this model works in practice, as well as providing details of the many concrete results already achieved.
News from the projects
- EU-AIMS researcher scoops prestigious prize for women in science
Emily Jones, a Birkbeck College researcher working on IMI’s autism project EU-AIMS has won a prestigious L’Oréal-UNESCO UK & Ireland For Women In Science (FWIS) Fellowship. Dr Jones is particularly interested in the early development of basic skills in children with autism spectrum disorder (ASD), as this contributes to our understanding of the underlying causes of autism and could pinpoint targets for intervention. In EU-AIMS, Dr Jones coordinates a large cross-European study of infants at high familial risk for autism.
The FWIS award is worth GBP 15 000 (approx. EUR 17 500), and winners can spend it on whatever they need to further their career, including equipment, travel, and childcare costs. ‘The fellowship will allow me to buy crucial equipment that I require to investigate the link between attention and arousal in the development of autism,’ says Dr Jones. ‘Combining a research career with family responsibilities can be challenging, and the flexible support provided by the fellowship will help me achieve the right balance.’
Now in their seventh year, the FWIS awards were established with the goal of promoting the greater participation of women in science by offering awards to outstanding female postdoctoral researchers.
- Model research wins DDmore scientist award at conference
DDMoRe’s Nadia Terranova, who recently completed her PhD at the University of Pavia, was awarded a Lewis Sheiner award at the recent conference of PAGE (‘Population Approach Group in Europe’). The Lewis Sheiner award is a distinguished prize which recognises work performed by MSc and PhD students; winners receive €300 and present their work during a special session at the conference.
Dr Terranova’s award-winning work, carried out under DDMoRe, focuses on combination therapies which are widely used to treat cancer. ‘We developed a new mathematical model to describe tumour growth in mice treated with two drugs given in combination, and asses the strength of the drug effect interaction.’ explains Dr Terranova. On DDMoRe, Dr Terranova comments: ‘I think that the possibility to work within a public-private partnership gives a great added value especially for young people like me. The partnership allows the identification of the most strategic points of action for improving modelling approaches, and offers the opportunity to compare, present and share research activities and in some cases experimental data.’
DDMoRe focuses on facilitating Model Based Drug Development (MBDD), which enables the integration of information collected from diverse sources during drug development to describe and predict the behaviour of complex diseases, biological systems and drug actions. As such, MBDD provides decision-makers with a rationale to select drug candidates, targets, trial designs, dose regimens, patient populations and suitable endpoint measures.
- Sign up to the DDMoRe newsletter
- Follow DDMoRe on twitter @DDMoRe_IMI
- PROactive and COPDMAP projects join forces
IMI project PROactive has signed a Memorandum of Understanding (MoU) with the UK's COPDMAP initiative. Like PROactive, COPDMAP is a public-private partnership (PPP) working on chronic obstructive pulmonary disease (COPD); it is supported by the UK’s Medical Research Council (MRC) and the Association of the British Pharmaceutical Industry (ABPI).
Under the MoU, COPDMAP will become the first external party to use PROactive’s newly-developed Patient Reported Outcome (PRO) tools. COPDMAP is running a study where pharmacotherapy and pulmonary rehabilitation are used to increase exercise tolerance and physical activity, and it will use PROactive’s tools to gather information on how these interventions change the experience of physical activity for patients with COPD. The COPDMAP study will help the PROactive team to calibrate its PRO tools against other relevant exercise tolerance outcomes, including laboratory tests (endurance and incremental cycle tests) and field based tests (6 Minute Walking Test, Incremental and Endurance Shuttle Walking Test, Short Physical Performance Battery). This information will be important to for PROactive’s efforts to get its PRO tools approved by regulatory authorities.
PROactive Managing Entity, Thierry Troosters of KU Leuven, comments: ‘This win-win collaboration is an excellent example of the mutual benefits of collaborations across large consortia.’
- EUPATI publishes draft training programme syllabus
Patient education project EUPATI has published the first version of the syllabus for its high-level certificate training course. EUPATI aims to educate patients to enable them to play a stronger role in medicines research and development, for example by contributing to the work of research groups and ethics and regulatory committees. The new syllabus sets out the training programme for the EUPATI certificate training programme, a 12-18 month course featuring face-to-face and online learning. The course’s six modules cover all aspects of drug development, including clinical trials, regulatory affairs, safety, and health technology assessment. The syllabus benefited from input from diverse stakeholder groups, including patients, academics, ethics experts, industry, and teachers. The courses are expected to start in 2014 and are designed for 100 patient experts.
In addition to the certificate, EUPATI is developing an educational toolbox that patient advocates can download and use to learn about drug development, and an internet library that will provide patients with easy-to-understand information on drug development.
- PROTECT releases reviews of benefit - risk methods and their visualisation
IMI project PROTECT has published reviews of the available methodologies for the assessment, integration and visualisation of the risks and benefits of medicines. The project team analysed a wide range of methodologies for assessing the benefits and risks of medicines; the report on this shows the links between different methods and groups them. Finally, the report sets out recommendations on the methods that merit further consideration for decision-making on medicines in different contexts. These methods will be explored further in the next stage of the PROTECT project.
PROTECT also analysed different ways of visualising benefits and risks. The report presents visual representations that could be associated with the 13 benefit-risk methodologies recommended in the benefit-risk methodology review, assesses their suitability and offers recommendations for suitable visuals for each benefit-risk assessment approach.
- Both reports, along with a number of case studies, can be found online
- PharmaCog completes patient recruitment for clinical trial of biomarker matrix
IMI’s Alzheimer’s disease project PharmaCog has completed the recruitment of 150 patients with mild cognitive impairment for a clinical trial of a matrix of biomarkers. The human and financial costs of Alzheimer’s disease are growing rapidly as the population ages, but the results of recent clinical trials for Alzheimer’s drugs have been disappointing. The main reason for the failure of these trials is a lack of demonstration of significant efficacy.
The working hypothesis of PharmaCog is that no single physiological, functional or biochemical marker will be sensitive enough to respond to a drug sufficiently to provide the confidence to progress to later clinical phase studies, but that a collection of markers will be necessary. With this in mind, the project is working to develop a biomarker matrix to track disease progression in patients with Alzheimer’s disease and patients with mild cognitive impairment as a novel tool to detect the efficacy of treatments.
PharmaCog’s matrix is a unique tool for the study of Alzheimer’s disease and potential treatments, as it can be applied to laboratory models, human volunteers and patients. By achieving this latest recruitment goal, PharmaCog is on track to test and reach conclusions on the value of the matrix as a tool for tracking disease progression in people with mild cognitive impairment.
Meet the projects!
- Open PHACTS training event – sign up now!
IMI‘s Open PHACTS project is organising a course on applications and its application programming interface (API) to support pharmacological research on 19-20 September 2013, within the Vienna Summer School for drug design taking place at the Department of Medicinal Chemistry, University of Vienna. The event will provide an introduction to the Open PHACTS project, but it will also include:
- a hands-on demo session on the Explorer, which provides a web-based user interface for querying and viewing the integrated data within the Open PHACTS Discovery Platform;
- an overview of Open PHACTS eApps
- an Open Innovation session
- break-out groups working with Open PHACTS eApps and API.
Open PHACTS is a consortium focused on reducing the barriers to drug discovery in industry, academia, and small businesses. The Open PHACTS API provides a developer interface for integrated querying of multiple publicly available pharmacological and physicochemical data sources. Participation in the Open PHACTS training is free of charge.
- To register, e-mail email@example.com
- Learn more about the Vienna summer school on drug design
- Discover Open PHACTS’s API
- EU-AIMS to hold symposium at European Behavioural Pharmacology Society
The IMI autism project EU-AIMS will organise a symposium entitled Autism spectrum disorders: Transgenic models, tests and procedures on 6 September 2013 within the biennial meeting of the European Behavioural Pharmacology Society (EBPS) in La Rochelle, France.
The event will focus on three key questions:
- What are the best animal models replicating key ASD symptoms?
- What are the best test procedures to assess these ASD symptoms?
- What are procedures that could be translated from animals to humans and/or from humans back to animals?
Speakers include Declan Murphy from IoP and the EU-AIMS project (UK), Dan Smith of Autism Speaks (US), Michael Saxe of Roche (Switzerland) and Andreas Meyer-Lindenberg from the Central Institute of Mental Health Mannheim (Germany).
- More information about the EU-AIMS project
- Find out more about the symposium
- NEWMEDS workshop on machine learning for neuroimaging - registration open
Registration is now open for a workshop entitled Machine learning for neuroimaging and its relevance to drug discovery which is organised by the NEWMEDS project and will be held in London on 30 September and 1 October 2013. During the two-day workshop, participants will receive an overview of machine learning techniques as well as information on specific examples of their application to neuroimaging data. Attendees will also gain insight into the first prototoypes of a machine learning toolbox developed as part of the NEWMEDS project and have the opportunity to discuss what it means for drug discovery. Day 2 will involve a hands on session with the toolbox for which participants are invited to bring along their own datasets to gain their own experiences.
Participation in the workshop is free.
- For more information and to register, visit the NEWMEDS website
- IMI projects join forces at major diabetes conference
IMI’s diabetes projects will present their findings at a joint symposium in Barcelona, Spain on 22 September 2013 on the occasion of the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD). The symposium is entitled 'Opening a new chapter in diabetes research' and it will focus on recent results from the IMI diabetes consortia SUMMIT and IMIDIA as well as DIRECT. During the event, the projects will present their results on the pancreatic beta cell, the development of personalised medicine for type 2 diabetes, and new approaches focusing on complications in diabetes. The projects hope to attract a wide range of people to the symposium, including researchers, clinicians, patient groups, and healthcare providers, as well as politicians and decision makers.
- Participation in the event is free of charge and open to non-EASD delegates. No registration is required.