IMI 9TH CALL FOR PROPOSALS: FOCUS ON FRAILTY, USE OF SOCIAL MEDIA TO MONITOR DRUG SAFETY, AND ANTIBIOTIC DEVELOPMENT

IMI 9th Call for proposals has total budget of €135 million.
Topics included in this Call:
 - Paving the way for new treatments to prevent or delay frailty and muscle loss in the elderly
 - Harnessing the power of the internet and social media to detect reports of adverse reactions to medicines and monitor drug safety
 - Development of a new business model for antibiotic resistance
 - Clinical development of antibiotics against resistant pathogens

BRUSSELS, 9 July 2013 – Today, the Innovative Medicines Initiative (IMI) is launching its 9th Call for proposals, with a total budget of €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).

Action on age-related conditions

The incidence of frailty, and a loss of muscle strength, rises with age. Those affected often experience tiredness, weight loss, frequent infections, falls, and confusion, as well as difficulties with mobility. Many will need assistance to carry out simple daily tasks and activities. Although frailty is widespread, it is often under-diagnosed.

The Call includes a topic that will use frailty and the associated loss of muscle mass and strength as a paradigm for the development of better treatments for other age-related conditions. Although the number of Europeans aged 65 and over is set to rise from 85 million in 2008 to 151 million in 2060, today's healthcare and associated regulatory systems are not geared towards this growing segment of the population.

This topic will help to speed up the development of new, more effective treatments for frailty and muscle loss. The project will include a large-scale clinical study to compare the effectiveness of a state-of-the-art treatment programme centred around physical activity with a healthy ageing counselling programme without regular physical activity.

IMI Executive Director Michel Goldman commented: 'All too often, frailty goes undiagnosed and untreated, with serious consequences for patients' mobility and quality of life. This project demonstrates how IMI, by bringing together all stakeholders involved in health research, can make progress in areas where effective treatments are currently lacking.'

Tapping into social media to monitor drug safety

Recent years have seen an explosion in the use of social media, applications ('apps') and online platforms that allow people to share news and information and connect with one another in unprecedented ways. At the same time, legislation requires the relevant authorities to monitor the safety of medicines by gathering information on adverse drug reactions (ADR) experienced by patients. Currently this takes place via official forms. Nevertheless, for a variety of reasons, many ADRs go unreported.

One of the main objectives of the proposed WEBAE ('Web Adverse Events') project is to develop tools to tap into the wealth of content that is openly available online to both detect ADRs, and provide patients with the most up-to-date drug safety information.

Tackling the challenges of antimicrobial resistance

The 9th Call also expands IMI's programme on antimicrobial resistance, 'New Drugs for Bad Bugs' (ND4BB). The focus of one of the topics is the urgent need to develop a new business model for antibiotic development that will reinvigorate investments in this vital area. The project resulting from this topic will have to tackle a contradiction at the heart of antibiotic development: on the one hand, pharmaceutical companies make money by selling large volumes of the drugs they develop. On the other hand, the use of new antibiotics should be restricted, so as to minimise the risk of bacteria developing resistance to them. As a result of this situation, sales are low and the costs of development often exceed the potential return on investment. This new project will develop concrete recommendations for new commercial models that provide industry with an incentive to invest in this area while ensuring that new antibiotics are used wisely.

In addition, IMI's 9th Call for proposals includes a topic on the clinical development of antibiotics to treat resistant Gram-negative pathogens, such as Escherichia coli. Drug resistant Gram-negative bacteria are responsible for two thirds of the 25 000 deaths resulting from antimicrobial resistance reported in Europe annually. This new topic focuses on gathering data on the best-available therapy for hospitalised patients with serious infections caused by multi drug resistant organisms. These data will help to better design clinical studies, thereby increasing the efficiency of antibiotic R&D. This will be tested with a new combination medicine targeting serious Gram-negative infections.

 - For more information on IMI's 9th Call for proposals, including details of the topics as well as budgets and key documents for applicants, visit the 9th Call web pages 
 - The deadline for submitting Expressions of Interest is 9 October 2013.

________________________________________
Press contact:

Catherine Brett – External Relations Manager
Tel: +32 2 541 8214 - Mobile: +32 484 896227 - E-mail: [email protected] 
________________________________________

Notes for Editors

IMI 9th Call for proposals – budget breakdown

Topic IMI JU contribution * EFPIA in kind contribution * Total budget *
WEBAE - leveraging emerging technology for pharmacovigilance 2.27 2.29 4.56
Developing innovative therapeutic interventions against physical frailty & sarcopenia (ITI-PF&S) as a prototype geriatric indication 24 25.31 49.31
Driving re-investment in R&D and responsible use of antibiotics 6.3 3.1 9.4
Clinical development of antibacterial agents for Gram-negative antibiotic resistant pathogens 30.55 41.55 72.1
TOTALS 63.12 72.25 135.37

* € million

About IMI's antimicrobial resistance (AMR) programme

AMR represents a serious and growing threat to human and animal health worldwide. Resistance can also spread from animals to humans through the food chain or direct contact. 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 some €1.5 billion (ECDC/EMEA joint technical report "The bacterial challenge: time to react", 2009). 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– put simply, a lot of patients have to be recruited to the major studies of efficacy performed for each clinical indication sought in order to be sure of having enough patients with the resistant bacteria under investigation and to demonstrate that the new antibiotic is not inferior to comparable antibacterial drugs. These issues mean that the costs of carrying out a clinical trial on a new antibiotic are extremely high.

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 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. This 9th Call for proposals will bring the total number of projects in the ND4BB programme to 5.

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 areport that also highlights the challenging economics of antibiotic development (see page 83). 
________________________________________

About IMI

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.

 - More info on IMI: www.imi.europa.eu
 - Follow us on Twitter: @IMI_JU

Suggested Articles

There's no evidence personal patient information leaked during the 11-week breach, but the same can't be said about Sangamo's own secrets.

Through a new online tracker, AllTrials names sponsors who fail to report clinical trial results on time per the FDAAA Final Rule.

The new solution aims to streamline the incorporation of human genomic data into clinical trial designs.