36th Edition – June 2014

European Lead Factory proves potential with first results

IMI’s European Lead Factory project has proven its potential for drug discovery with the delivery of its first results in the form of four ‘qualified hit lists’ – lists of up to 50 compounds identified as showing activity against a drug target submitted to the European Lead Factory’s screening programme. One of the beneficiaries of these results is the Netherlands Cancer Institute, which stated that access to the European Lead Factory had fast-forwarded its oncology drug discovery work ‘by several years’. Another list went to pharmaceutical company UCB, which noted that access to the 300 000-strong Joint European Compound Collection had provided it with a list of ‘highly interesting’ compounds that would allow it to take a fresh look at a particularly challenging drug target.

Organisations wishing to take advantage of the project’s extensive compound collection can submit target proposals via the project website. The project is also accepting proposals for external compound libraries via its website. If proposals result in the addition of over 50 compounds to the library, the proposer receives a payment.

• Read the project’s press release on the results
• Find out how to submit compounds to the library
• Find out how to submit target programmes to the project

Clinical trials could be shorter, NEWMEDS paper suggests

Early clinical trials of schizophrenia drugs could be made shorter and more efficient if more women and more people with certain types of symptoms and/or younger patients were recruited, according to research from the NEWMEDS project published recently in the Journal of Clinical Psychiatry. This would dramatically reduce patients’ exposure to the trial drug or placebo. Conventional trials of schizophrenia drugs typically last between six and eight weeks, and many have questioned their usefulness as nearly half of the patients drop out before the end of the trial. The NEWMEDS team pooled study data from 29 trials of antipsychotics run by 5 different pharmaceutical companies. This revealed that trials could be cut to as little as 4 weeks while the number of patients could be cut to 49 per trial arm if more women, more people with both positive and negative symptoms, and more young non-first episode patients were included, as these groups respond more strongly to the medicine compared to the placebo. (Positive symptoms are those which are not normally found in healthy people, such as hallucinations, while negative symptoms are those where patients lack behaviours found in healthy people like the ability to feel pleasure or act spontaneously.) A 6-week trial with 79 patients per arm would result in 474 weeks of patient exposure to the placebo and drug; cutting the trial to 4 weeks and 49 patients per arm would cut this figure to just 196 weeks of patient exposure.

PROTECT survey to improve communication of benefits & risks

IMI’s PROTECT project is running a survey that will feed into efforts to improve the way the benefits and risks of medicines are communicated to patients and health professionals alike. All medicines come with both benefits and risks, and understanding the balance between these is essential when making treatment decisions. Benefits and risks can be communicated in diverse ways, including written texts and different kinds of graphics. The PROTECT survey sets out different ways of presenting benefits and risks and asks which are best for making treatment decisions. The project has designed different surveys for patients, healthcare professionals, and those responsible for assessing medicines in three areas: breast cancer, diabetes, and atrial fibrillation. It takes 30-65 minutes to complete, depending on the disease area. No personal identifying information is collected and all answers are kept confidential

COMBACTE’s new video on AMR released

COMBACTE has released a short video on antibiotic resistance (AMR) and how the project is working to fight AMR.

The video explains why COMBACTE is in a unique position to tackle AMR and how it is pioneering new ways of designing and implementing efficient clinical trials for new antibiotics. COMBACTE is creating a new environment for the clinical development of new antibiotics to fight AMR. By 2020 COMBACTE aims to show that high quality, cost-effective clinical trials characterised by a shorter recruitment period can be a reality.

COMBACTE is the first public-private partnership with pharmaceutical companies in drug development for infectious diseases. With this initiative, Europe takes the lead in tackling the global threat of AMR.

Bacterial infections are becoming more and more resistant to antibiotics. However, only two new classes of antibiotics have been brought to the market in the last three decades. According to the World Health Organization (WHO), AMR is becoming a public health emergency of yet unknown proportions. In the European Union, AMR is responsible for some 25 000 deaths every year.

• Watch the video

EUPATI infographics reveal public attitudes to medicines development

EUPATI, IMI’s education and training project for patients and patient advocates, has recently published a series of infographics on its website summarising the results from its 2013 survey on the public’s knowledge, attitudes and understanding of medicines development. Over 7 000 members of the public from 6 EU countries took part in the survey.  

Participants rated their current knowledge on medicines development highest on those aspects relating to drug safety, discovery and clinical trials. Almost half of those who responded were interested in learning more about drug safety, personalised medicine and predictive medicine. According to the survey, people felt most comfortable asking for information about drug development from either medical staff or academic and patient organisations, and continue to look to their doctor, the internet and patient organisations as preferred sources of information about medicines research and development.

K4DD professor knighted

Meindert Danhof, Professor of Pharmacology at the University of Leiden and a partner in IMI’s K4DD project has been appointed as Knight in the Order of the Netherlands Lion. Professor Danhof received the royal decoration for his research and development of models that have made an important contribution to better predicting the efficacy of medicinal products.

Within the K4DD project framework, Professor Danhof's group, together with other academic and pharmaceutical industry research groups, focuses on better understanding the kinetics of the interaction between a drug molecule and its disease target within the human body. There is growing evidence that this kinetic information is important to predict how fast a drug effect will appear in a patient, and how long it will last.

Translating research findings from the ‘test tube’ stage to the clinical stage requires comprehensive pharmacological models. These models not only need to take into account the interaction of a drug with its disease target at a cellular level, but also to account for the human body’s reaction to the drug. Ultimately, the aim of pharmacological models developed within K4DD is to further optimise the prediction of the efficacy of medicinal products early on in the drug discovery process.