- Major new report reveals socio-economic impact of IMI projects
- Meet IMI at BIO 2016
- IMI taking patient engagement strategy to next level
- RADAR-CNS project gets underway
- Contribute to IMI’s consultation on advanced therapies
- IMI Stakeholder Forum – save the date!
- EPAD recruits first volunteer in major study on preventing dementia
- COMBACTE-CARE study recruits first patient
- European Lead Factory selects first Spanish programme
- U-BIOPRED produces booklet on patient engagement
- WEB-RADR launches Croatian version of side effect reporting app
- Advance your education with Eu2P’s courses
Major new report reveals socio-economic impact of IMI projects
IMI projects are generating socio-economic impacts on a number of fronts, reveals a major new analysis by independent experts. The report shows how the first projects launched by IMI are making concrete improvements to pharmaceutical research and development (R&D); leveraging funding; creating new knowledge and tools; and making Europe an attractive place to carry out research. Importantly the report notes that many of the projects’ achievements would not have been possible without IMI. The report was produced by a panel of independent, high-level experts from the fields of health economics and research and innovation policy. The group analysed in detail the outputs and impacts of the first nine IMI projects to finish. Between them, they have a total budget of €217.6 million, and cover areas such as diabetes, medicines safety, schizophrenia and depression, education and training, chronic pain, and severe asthma. Carlos Moedas, European Commissioner for Research, Science and Innovation, said: ‘This independent report confirms that IMI is delivering on its objectives. Public-private partnerships such as IMI are making the lives of Europeans better, create jobs and boost our competitiveness. They deliver results that single companies or countries could not achieve alone.’
Read IMI’s press release.
Meet IMI at BIO 2016
- Workshop on novel anti-infectives, coorganised with our ENABLE project and the Community For Open Antimicrobial Drug Discovery (CO-ADD) - Monday 6 June, 11:00.
- IMI session in the educational programme on ‘Revolutionising Clinical Trials for Alzheimer’s: An International Perspective on Adaptive Clinical Trials’ – Monday 6 June, 14:30.
- IMI Executive Director Pierre Meulien will speak at a session on ‘Bridging the Gap: Alignment of Global Antibiotic R&D Partnerships’ - Wednesday 8 June, 15:30.
In addition, IMI will be present at the European Commission’s booth (no. 5978) at the BIO Exhibition. There will be people on hand throughout the event to answer questions about IMI as well as the European Commission’s wider research programmes. There will also be regular mini sessions at the stand on IMI and other EU research programmes. The BIO International Convention (BIO) attracts over 15 000 biotechnology and pharma leaders who come together for a week of intensive educational, networking and partnering opportunities.
IMI taking patient engagement strategy to next level
On 28 April, IMI held a Patient Engagement Strategy Workshop in Brussels Belgium, with the goal of optimising IMI’s efforts to be more patient-centric. Over 50 people attended the workshop, including representatives of patient organisations, foundations, consumer organisations, regulatory bodies, EFPIA, and non-profit organisations. The event also saw the publication of a new IMI brochure on patients as well as a booklet on patient involvement in research by the U-BIOPRED project. During the workshop it was very much emphasised that patient involvement is critical and should be encouraged, facilitated and embedded in IMI at all levels. It was also pointed out that IMI needs a robust patient engagement strategy to ensure that patient engagement is universally understood, recognised and effectively upheld where appropriate. More information on the event and its outcomes can be found in the report and presentations which are on the event page of the IMI website.
RADAR-CNS project gets underway
Work has begun on the new IMI project RADAR-CNS, which aims to develop new ways of monitoring major depressive disorder, epilepsy, and multiple sclerosis using wearable devices and smartphone technology. The key goal of the project is to improve patients’ symptoms and quality of life and also to change how these and other chronic disorders are treated. Epilepsy, depression, and multiple sclerosis are distinct disorders that affect 400 million people worldwide, with different causes and symptoms, all of which can be severely detrimental to patients’ quality of life and life expectancy. For all three disorders, patients often experience periods where their symptoms are manageable, followed by periods of deterioration and acute illness (relapse). Patient surveys have repeatedly highlighted the need to predict when relapses will happen and to improve the treatments which are available to stop them from occurring. Continuous remote assessment using smartphones and wearable devices provides a complete picture of a patient’s condition at a level of detail which was previously unachievable. Moreover, it could potentially allow treatment to begin before a patient’s health deteriorates, preventing the patient relapsing or becoming more ill before they seek treatment.
Contribute to IMI’s consultation on advanced therapies
The field of advanced therapy medicinal products (ATMP) is scientifically progressing at a very fast pace, as demonstrated by the number and variety of clinical trials conducted over the last five years, yet there are numerous factors that have complicated the translation from research into patient access.
IMI, in collaboration with key stakeholders, has developed a concept paper on advanced therapies which we are posting for public consultation. The aim of the concept paper is to identify the potential of IMI as a platform for enhancing ATMP research and development.
Contributors who wish to submit comments on the concept paper are encouraged to consider in particular the following questions:
- Have the key challenges that can be addressed through collaborative, public-private initiatives been properly identified?
- Which of the proposed potential initiatives should be prioritised?
- Are any areas missing?
- What are the key European or national initiatives that IMI shall synergise with?
Deadline for submitting comments: 25 July 2016.
More information on the consultation, including details of how to submit comments, can be found on the IMI website.
IMI Stakeholder Forum – save the date!
IMI will hold its Stakeholder Forum on 28-29 September 2016 in Brussels, Belgium. The event will be an excellent opportunity to find out about IMI’s news and activities and provide input on our future plans. More information will be published on the website shortly, so stay tuned!
EPAD recruits first volunteer in major study on preventing dementia
IMI Alzheimer’s project EPAD has recruited its first volunteer in a major study that aims to add to our understanding of the earliest stages of dementia, before symptoms appear, and open up new avenues to prevent it. Julie Duffus from Scotland was inspired to take part in the project by her parents, both of whom had dementia. ‘My mum and dad both had Alzheimer’s disease so I’ve seen first-hand the devastating effects it has on patients’ lives and those around them,’ she said. ‘I hope that my contribution will in some way help scientists to find better ways of diagnosing the disease and potentially, one day, to prevent it.’ The project aims to recruit a total of 6 000 people from across Europe to take part in the project. Participants will have regular health checks including blood tests and brain scans. Researchers will also track their thinking skills over time using tests of mental agility. The team hopes to develop tests to identify early signs of Alzheimer’s disease that may indicate when a person is at risk of dementia before symptoms appear. They will then invite these people to take part in clinical trials aimed at testing interventions that could delay, or even prevent, the onset of dementia.
Read EPAD’s press release.
COMBACTE-CARE study recruits first patient
Antimicrobial resistance (AMR) project COMBACTE-CARE has recruited the first patient in the REJUVENATE study, a clinical trial of a novel antibiotic designed to tackle drug-resistant infections that are particularly hard to treat. The goal of the REJUVENATE study is to assess the workings and safety of a novel antibiotic combination product called Aztreonam-Avibactam (ATM-AVI) in 40 hospitalised adults with ‘complicated intra-abdominal infections’. The first patient was enrolled at the University Hospital Virgen del Rocio in Seville, Spain. Other study sites recruiting patients are based in Germany and France. The COMBACTE-CARE project focuses on tackling bacteria known as ‘carbapenem-resistant enterobacteriaceae’ (CRE), which are resistant to most available antibiotics and are so difficult to treat they are considered to be an urgent global threat. Worryingly, cases of CRE infections are on the rise in Europe and globally.
European Lead Factory selects first Spanish programme
The European Lead Factory has selected its first drug target programme from Spain, in the form of a cancer drug development programme led by the Center for Applied Medical Research (CIMA) at the University of Navarra. The CIMA has pioneered the development of molecules that show signs (in animal tests) of being effective in the treatment of blood and liver cancers. According to Julen Oyarzabal, Director of Translational Science and the Molecular Therapy Program at CIMA, the goal of this project is to ‘identify new molecules that enable more effective treatments with fewer side effects’. He adds: ‘Our study also allows us to assess their impact on other diseases of the central nervous system, cardiac complaints and metabolic illnesses.’ The intellectual property model of the European Lead Factory will allow CIMA to file patents on the identified molecules for future development of a possible new drug.
Read the CIMA press release.
U-BIOPRED produces booklet on patient engagement
IMI severe asthma project U-BIOPRED has produced a short, practical guide on how to involve patients across all stages of healthcare research. Aimed at people planning on applying for, or developing EU healthcare research projects, the booklet sets out top tips for successful patient involvement based on the experiences of the project’s Patient Input Platform (PIP). The project’s advice can be summarised as follows:
- Before the project starts, get patients involved as soon as possible, budget for their involvement, and set up a patient input platform.
- During the project, provide coordination and support for patients and communicate with them regularly and clearly. Patients can provide input on all aspects of projects, especially issues such as patient ecruitment in clinical studies, and communication with wider (non-scientific) audiences.
- As projects draw to a close, patients can play a key role in gaining visibility for projects in public, patient and policy settings, and encouraging other patients to get involved in research.
U-BIOPRED proved successful at integrating patients’ input into its work. ‘U-BIOPRED PIP members hope that by sharing their experiences of involvement, they can provide practical guidance to achieve successful and meaningful patient involvement to optimise your research outcomes,’ the authors write.
WEB-RADR launches Croatian version of side effect reporting app
Croatia has become the third country in Europe to benefit from the WEB-RADR mobile app for reporting suspected adverse drug reactions (side effects). The Croatian app, which is available via both Apple’s App Store and Google Play was launched by HALMED, Croatia’s Agency for Medicinal Products and Medical Devices, at a conference in Zagreb. The mobile application allows patients, healthcare professionals, carers and others to directly report ADRs as well as receive the latest information concerning medicinal products using their mobile devices. ‘After HALMED was the first in the world to begin using the online application of the World Health Organization (WHO), the introduction of our mobile application represents the logical continuation of our efforts to apply new digital technologies in order to make the ADR reporting system more accessible to patients and health care professionals. Croatia, the United Kingdom and the Netherlands are the first member states of the European Union which have implemented such applications, and a mobile application meant for use in all the other member states of the European Union will be developed based on our experiences,’ said Darko Krnić, Head of HALMED’s Department for Pharmacovigilance and Rational Pharmacotherapy.
Read HALMED’s press release.
Advance your education with Eu2P’s courses
IMI’s Eu2P project runs numerous courses covering various aspects of medicines research and development, including pharmacovigilance. The courses range from short, ‘bite-sized’ online courses to full Master’s programmes. Now the project has produced a handy ‘at a glance’ guide that provides students with a simple overview of the types of courses available, the workload involved, and the certificates offered upon successful completion of the course. Applications for the short online courses are always open. The deadline for applications for the next intake of Masters students is 26 June. The Eu2P Master is an academic post-graduate training in pharmacovigilance and pharmacoepidemiology that leads to a MSc degree jointly awarded by the European Universities working together as Eu2P partners. Finally, the next deadlines for applying for the shorter certificates are in early September.