IMI 2 – Call 5 launched with focus on Alzheimer’s disease, diabetes & patient engagement
IMI has launched its 5th Call for proposals under the IMI 2 programme, featuring four topics on Alzheimer’s disease and one each on diabetic kidney disease and patient input on assessments of the benefits and risks of medicines. Irene Norstedt, IMI Acting Executive Director commented: ‘With the launch of this Call for proposals, IMI once again affirms its commitment to tackling some of the biggest public health challenges facing Europe today – Alzheimer’s disease and diabetes. At the same time, the fact that we have two topics dedicated to patient engagement underlines IMI’s role as a platform for multi-stakeholder collaboration.’
The full list of topics is:
- Patient perspective elicitation on benefits and risks of medicinal products, from development through the entire life cycle, to inform the decision-making process by regulators and health technology assessment bodies
- Diabetic kidney disease biomarkers (DKD-BM)
- Inflammation and Alzheimer's disease (AD): modulating microglia function – focussing on TREM2 and CD33
- Understanding the role of amyloid imaging biomarkers in the current and future diagnosis and management of patients across the spectrum of cognitive impairment (from pre-dementia to dementia)
- Evolving models of patient engagement and access for earlier identification of Alzheimer’s disease: phased expansion study
- From ApoE biology to validated Alzheimer’s disease targets
Deadline for submitting short proposals: 13 October 2015
More information on the new €95 million Call for proposals, including all topic texts and details of how to apply, can be found on the IMI website.
Download the presentations from IMI’s webinars on the Call topics
Find partners for your applicant consortium
If you are looking for partners there are several possibilities.
- Use your existing networks to find possible partners.
- The IMI Partner Search Tool has been updated with the topics and keywords for the new Call. You can search for potential partners after you have created your profile.
- Register with CORDIS (the European Commission's partner search portal)
- Post your search criteria on social networking sites like IMI’s LinkedIn group and the Horizon 2020 LinkedIn group
- Contact your IMI State Representatives Group (SRG) member or National Contact Point for information on professional networking in your area.
- Fit for Health 2.0 offers a matchmaking portal
- The German IMI SRG has is a dedicated partner search platform for IMI Calls
Due to potential conflicts of interest, the IMI Programme Office is not able to recommend partners for potential participants in its Calls.
Tips for applicants
There are a lot of things applicants can do to increase their chances of submitting a successful proposal.
- Read the Call documents carefully and make sure you understand what is required of you.
- If something in the Call documents is unclear, or if you have any questions about the Call topics or the rules and procedures, contact the IMI Programme Office.
- Make sure your proposal addresses all the objectives of the topic, and that your consortium includes all the expertise needed to carry out the tasks expected of it.
- Your proposal will be evaluated by a panel of independent experts. You should ensure it includes all the information they will need to assess it. The evaluation form is online and tells you what the evaluators are looking for.
- Don’t forget to address any ethical issues.
- Ensure your proposal meets the basic requirements for the Call. In other words, make sure you submit on time, in the correct format, and that your consortium respects the basic eligibility criteria (e.g. number and location of partners).
Big data consultation outcomes published
The results of the recent IMI/EFPIA consultation on an IMI programme on big data for better health outcomes are now available on the IMI website. Overall, the responses to the consultation revealed a high level of interest in the programme, with many participants suggesting ideas for projects in various therapeutic areas. Other points raised include:
- the importance of ensuring the sustainability of the programme;
- the need to address data privacy and data interoperability;
- the central role of patients in the programme;
- the involvement in the programme of other stakeholders, including healthcare providers, physicians, regulatory bodies, health technology assessment bodies, payers, academics, experts in governance, ethics experts, and data software companies;
- the need for a central coordination point for the programme.
Responses to all these points can be found in the response paper. Looking to the future, EFPIA, in collaboration with IMI, will continue to develop the programme in the coming months. The first topics under this new programme will come under new IMI Calls for proposals scheduled for launch in autumn 2015.
Future Call topics published
The following topics are under consideration for inclusion in Calls for proposals to be launched in the autumn.
- Joint influenza vaccine effectiveness surveillance
- Development of quantitative system toxicology (QST) approaches to improve the understanding of the safety of new medicines
- Establishing impact of RSV (respiratory syncytial virus) infection, resultant disease and public health approach to reducing the consequences
Topics under the Big Data for Better Outcomes programme:
- Coordination and Support Action (CSA) for the Big Data for Better Outcomes programme
- Real world outcomes across the AD (Alzheimer’s disease) spectrum (ROADS) to better care
- Development of an outcomes-focused platform to empower policy makers and clinicians to optimize care for patients with haematologic malignancies
More information on these and other topics will be published on the Future Topics page in the coming weeks.
All information regarding future IMI Call topics is indicative and subject to change. Final information about future IMI Calls will be communicated after approval by the IMI Governing Board.
News from the projects
WEB-RADR launches mobile app for medicines safety monitoring
IMI project WEB-RADR has launched a smartphone app that will make it easier for patients, carers and healthcare professionals to report side effects of medicines. The app, which is available via the UK iTunes App Store and Google Play, is the only app that allows people to report side effects directly to the UK Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme. The MHRA uses the scheme to collate and review reports of suspected adverse drug reactions, and if needed, make changes to the warnings and advice given to people taking a medicine or vaccine. Users can select specific medicines or vaccines to track and receive news and alerts about them. In a video, UK Life Sciences Minister George Freeman commented: ‘The Yellow Card Scheme has played a vital role in the safety of medicines for the last 50 years and the launch of this new mobile app brings it into the 21st century. By making the scheme accessible to researchers, healthcare professionals and millions of patients, it will not only improve the safety of reporting but ultimately better protect people's health and support research.’ WEB-RADR will draw on user feedback to develop the app further and adapt it for additional countries. Over the coming year, the WEB-RADR project will launch versions of the app in the Netherlands and Croatia, and by the end to the project will have a generic version of the app which will be available for adoption by Member States who wish to use the technology to supplement existing reporting mechanisms.
- For more information on the app, read the MHRA press release
CHEM21 scientists go green to create chemicals
Austrian scientists working on IMI’s CHEM21 project have successfully used yeast and bacteria to generate complex molecules such as carotene and violacein. They achieved this by inserting up to nine genes into yeast, which allowed the yeast to carry out the series of reactions needed to synthesise these molecules in parallel. Scientists have inserted foreign genes into yeast before. However, to insert so many genes successfully is a real achievement, and the scientists, who work at the Austrian Centre of Industrial Biotechnology, have filed a patent for the method used. The researchers’ findings are published in a paper in Chemical Communications. The team is now looking at ways of increasing the number of genes inserted to constitute biosynthesis pathways for valuable products. CHEM21’s goal is to develop new, more sustainable ways of synthesising medicines, as current methods can be energy and resource intensive and require the use of rare substances such as precious metals.
U-BIOPRED gives advice on meaningful patient involvement in research
IMI’s severe asthma project U-BIOPRED has pioneered a patient-centric approach to research since before the start of the project. Now the project’s Patient Input Platform has drawn on its experience to produce five recommendations for meaningful patient engagement in research. The group’s findings are published in the journal Research Involvement and Engagement and combine concrete advice as well as case studies from the U-BIOPRED project and can be summarised as follows:
- Involve early (i.e. during project formation);
- Involve deeply (i.e. in all day-to-day activities of the project);
- Gain patient feedback on the project’s progress;
- Include patients in dissemination;
- Encourage patients to tell their own story.
The authors acknowledge the barriers that may hinder greater patient engagement in research and propose solutions to get round these. ‘The journey for patients working in EU projects has only just started, and the future is exciting,’ the authors conclude. ‘The more patients get involved, the more opportunities for impact can be realised.’
The U-BIOPRED project is now drawing to a close; in June, the project presented its latest results at a symposium; the key achievements are summarised in a report on the project website.
Antimicrobial resistance project DRIVE-AB seeks stakeholders
Antimicrobial resistance project DRIVE-AB is looking for stakeholders willing to provide input on its reports and recommendations. Launched in 2014, the project’s goal is to develop economic models that would simultaneously incentivise the development of new antibiotics while reconciling this with the need to use new antibiotics wisely. The project is keen to gather input from a broad range of stakeholders to ensure their findings are as robust as possible. Groups interested in becoming stakeholders should fill in the form on the DRIVE-AB website. The project has already attracted a number of high profile stakeholders including international institutions like the World Bank and European Medicines Agency, as well as clinical societies and universities. DRIVE-AB was also instrumental in the creation of the BEAM Alliance (‘Biotechs from Europe innovating in Anti-Microbial Resistance’), which is working to improve the regulatory, investment, and commercial environments in Europe for research, development, approval and market viability of new products combating antimicrobial resistance.
Project courses and events
Sign up for the DDMoRe course on model-informed drug development in oncology
Registration is open for a DDMoRE project course on model-informed drug development in oncology which will be held in Pavia, Italy on 7-11 September 2015. The programme covers model-informed drug development in the area of oncology and will include a two-day introduction to the DDMoRe framework (new modelling & simulation language, model repository, interoperability platform). The course will feature lectures, hands-on sessions, student group work, workshops, and student presentations. The course is intended primarily for PhD students and postdoctoral fellows doing research in the quantitative life sciences field. The most important prerequisite is a willingness to actively participate in the course and give constructive feedback to further improve the DDMoRe developments.
- Deadline for applications: 3 August 2015
- Details of how to apply can be found on the DDMoRe website
Cooperative European Medicines Development Course – registration open!
Registration is now open for the third edition of the Cooperative European Medicines Development Course (CEMDC) course which will kick off in September this year. The course, which was designed under the IMI project PharmaTrain, aims to educate experts in the process of medicines development and train them to apply this knowledge in large or small, innovative or generic pharmaceutical companies, regulatory agencies, healthcare and health research or insurance management. The course material was carefully compiled by academic and industry experts to meet the needs of both the pharmaceutical industry and health care and covers the following areas:
- drug development and clinical trials;
- regulatory affairs and safety of medicines;
- life cycle management and medical marketing of medicines;
- healthcare and professionalism.
The teaching follows the international, harmonized modular training programme and quality standards developed by PharmaTrain. The CEMDC is Coordinated by the Semmelweis University in Hungary and is accredited as a PharmaTrain Center of Excellence. The Diploma Course contains 8 modules, and students can opt to follow selected modules only or the entire course.
- Deadline for registration: 31 August 2015
- Details of how to register can be found on the CEMDC website
EUPATI to hold webinar on patient involvement in HTA
Patient education project EUPATI will hold a webinar entitled 'Strengthening Patient Involvement in Health Technology Assessment (HTA)’ on 28 September at 17:00 CET (Central European Time). HTA is a multidisciplinary process that examines the information about medical, cost-effectiveness, social, political, legal and ethical considerations of the application of a health technology – usually a medicine, medical device or clinical/surgical procedure. The main purpose of such an assessment is to inform access policy decision-making, which has an impact on patients, physicians, payers and the broader health ecosystem.
The webinar will examine the need for patient involvement in HTA and look at the HTA landscape in Europe. It will also feature a case study and a review of how the EUPATI toolkit can help informed patients engage in HTA. There will also be time to ask questions and engage in discussions.
- Information on how to register can be found here