- Cancer, tuberculosis and vaccines in new IMI Call for proposals
- Catch up on the IMI2 – Call 20 webinars
- What patients really want: "Nothing about us without us” – opinion piece by Pierre Meulien
- A school for patients? Yes, you can be an expert in that
- PARADIGM: a ‘game changer’ for patient engagement in R and D
- PET scans that show brain changes caused by Alzheimer’s give doctors confidence in diagnosis
- Web search keywords can help spot early Alzheimer’s cases
- Identifying potential antibiotic leads is painfully slow, but these researchers identified 5 in only 6 years
Cancer, tuberculosis and vaccines in new IMI Call for proposals
On 22 January, IMI launched IMI2 – Call 20 with funding opportunities in cancer, tuberculosis, vaccines, psoriatic arthritis and drugs based on proteins. The Call has a total budget of EUR 273 million. IMI will contribute EUR 133 million to the projects funded under the Call; these funds come from Horizon 2020 and will support the participation in the projects of organisations such as universities, small and medium-sized enterprises, and patient groups. EFPIA companies and IMI Associated Partners will contribute EUR 140 million, mostly as ‘in kind’ contributions (e.g. staff time, access to equipment, etc.). The full list of topics is:
- Early diagnosis, prediction of radiographic outcomes and development of rational, personalised treatment strategies to improve long-term outcomes in psoriatic arthritis
- Innovations to accelerate vaccine development and manufacture
- Academia and industry united innovation and treatment for tuberculosis (UNITE4TB) (This topic is part of the IMI AMR Accelerator Programme)
- Tumour plasticity
- Proton versus photon therapy for oesophageal cancer – a trimodality strategy
- Handling of protein drug products and stability concerns
The deadline for submitting short proposals is 21 April 2020.
- Read IMI’s press release
- Get details of the topics and information on how to apply on the IMI2 – Call 20 page
Catch up on the IMI2 – Call 20 webinars
IMI is holding webinars on IMI2 – Call 20 from Wednesday 22 January to Tuesday 31 January inclusive. All webinars on the Call topics feature a presentation by the EFPIA topic coordinator and time for questions and answers. The webinars represent an excellent opportunity to learn more about the Call topics, interact directly with the topic coordinators, and get in touch with potential project partners.
The webinar on IMI’s rules and procedures covers IMI's intellectual property policy and tips on the preparation of proposal submissions. IMI is also holding a dedicated webinar for small and medium-sized enterprises (SMEs). This covers elements of the different Call topics that may be of particular relevance for SMEs, as well as a presentation of IMI’s rules and procedures with a focus on aspects that are most important for SMEs.
- Missed a webinar? All slide decks and recordings of the webinars can be found on the webinar page.
What patients really want: "Nothing about us without us” – opinion piece by Pierre Meulien
Drug-makers have only recently started to give drug-takers a say in how their medicines are made, turning patients into a new generation of experts. Why has medicine taken so long to consult its end users? In an opinion piece on the IMI website, Executive Director Pierre Meulien sets out how IMI works to promote patient involvement in R&D. For example, our EUPATI project, which set up a training academy to teach patients and the people who care for them the basics of drug development; was the first of its kind for European patients. EUPATI was followed by the launch of a number of research projects that are establishing the goals and ground rules for citizen involvement in the high-stakes world of making medicines. At the IMI Programme Office, we recently set up a pool of around 150 patients and carers who contribute to our activities as experts in their own right. Among other things, they are invited to take part in project reviews, contribute to consultations and assess project proposals. ‘Drug development is an enormously complex process, and at the other end of the process is a human being,’ Dr Meulien concludes. ‘As another of our patient advocates once remarked: “Nothing about us without us!”, a sentiment we fully support.’
A school for patients? Yes, you can be an expert in that
If patients are to be involved in medicine R&D, it’s to everyone’s benefit that they understand how the process works. Tamás Bereczky is a course coordinator for the IMI-funded EUPATI, an ‘academy’ that helps turn patients into patient experts, so that they can contribute as equals to the drug development process. He is also a vocal campaigner for the rights of people living with HIV/AIDS and has a PhD in the social psychology of patient advocacy.
‘The tradition of patient involvement in science and research and development originates to a large extent from the HIV tradition and to some extent, breast cancer,’ explains Tamás in an interview with the IMI Programme Office. ‘These are the two pioneering fields where this kind of work started.’ EUPATI, he says, was a major step forward when it was launched in 2012.
‘EUPATI was the first project where IMI consciously did something with patients, for patients,’ he says. ‘It's not about medicine development or technology, it is specifically for patient education in a public private partnership form, which at the time was very new.’ EUPATI has enjoyed success, with 154 graduates, several courses per year for patients, industry and academia representatives, and expansion into 19 countries.
In the interview, Tamás looks back on his own experiences of patient advocacy, which started when he was diagnosed with HIV 15 years ago. ‘I got very scared, and I suddenly realised that there wasn't any information available in my native Hungarian. So I started by translating stuff and publishing it on my blog and then I made a website… Step by step I became an advocate; I realised that this is actually my calling. So I started by disseminating information and then I became a member of the European Aids Treatment Group and then one thing followed the other.’
PARADIGM: a ‘game changer’ for patient engagement in R and D
There is now growing recognition that patients and their representatives can and should be involved in all stages of medicines development (R&D). But how do you do this in practice, and is it worth it? IMI’s PARADIGM project was set up in 2018 to create a framework for structured, effective, meaningful and ethical patient engagement, and to demonstrate the ‘return on engagement’ for all stakeholders.
The project focuses on patient involvement in three key points in the medicines R&D process: research and priority setting; clinical trial design; and early dialogues with regulators and health technology assessment (HTA) bodies. So what have they delivered so far? With just months to go before the end of the project in August this year, the IMI Programme Office caught up with project coordinator Mathieu Boudes of the European Patients’ Forum (EPF).
‘PARADIGM is an atypical project – very short and most of the tangible achievements are due at the end of the project,’ explains Boudes. ‘We have robustly identified what is still very much needed by all actors involved in the development of medicines and that will make the most impact in terms of patient engagement. The consortium is currently developing a monitoring and evaluation framework for stakeholders who are doing patient engagement to help them measure the impact of their initiatives. It will be a game changer to bring patient engagement to the next level.’
PET scans that show brain changes caused by Alzheimer’s give doctors confidence in diagnosis
Being able to visualise the pathology linked to the disease is a big benefit for diagnosis and patient management. This is what physicians are telling researchers from IMI’s AMYPAD project, which is working to get definitive data on the role of amyloid PET (positron emission tomography) scans in Alzheimer’s disease diagnosis.
The ability to show patients the presence of amyloid plaque in the brain allows physicians to have ‘more meaningful’ conversations with their patients. Alzheimer’s disease is currently diagnosed based on cognitive symptoms, a clinical examination and a combination of brain scans such as CT or MRI which show structural abnormalities. Amyloid PET scans are a newer technology and researchers from the AMYPAD project are trying to understand in which circumstances these PET scans are best deployed. They also want to find out at what stage in the disease they are most beneficial, and how an early PET scan might lead to a change in patient management.
An ongoing clinical trial is examining how the PET scan influences the diagnosis of patients with cognitive complaints. ‘The hypothesis we are testing in the clinical study is that an early scan leads to a higher confidence in the diagnosis of the patient,' explains AMYPAD co-leader Gill Farrar of GE Healthcare. ‘Physicians involved in the trials are also finding that it is useful to use the images to show the patient the presence or absence of pathology in the brain.’
Web search keywords can help spot early Alzheimer’s cases
The earlier Alzheimer’s is diagnosed, the better the outlook. Though there is no medication that can stop or reverse the disease, there are medications and lifestyle changes that can help alleviate its effects. The problem is that people with memory problems tend to seek out help when their caretakers no longer feel able to cope with their worsening symptoms. The MOPEAD project research entailed a kind of pilot awareness-raising campaign that set out to test different ways of spotting sufferers in the population and directing them towards services that can diagnose and educate, and if necessary, treat them. In an interview with the IMI Programme Office, Assistant Professor Milica G. Kramberger from the University Medical Centre Ljubljana in Slovenia explains how the project used web searches, memory clinic open days, and visits to the doctor to identify people who could have Alzheimer’s.
‘The interesting thing we found was that we noticed, in Slovenia, that as a result of the awareness campaign, people started to worry about their own health, and started going to the doctor to get their memory checked a lot earlier,’ said Dr Kramberger. ‘In the past people went to the doctor only when their caregiver could not cope anymore.’
The MOPEAD research was carried out in Slovenia, Spain, the Netherlands, Germany and Sweden. The project also includes a feasibility study of cultural differences, healthcare system differences and the differences in models of patient engagement throughout Europe. The team will produce recommendations for policymakers based on their findings.
Identifying potential antibiotic leads is painfully slow, but these researchers identified 5 in only 6 years
The IMI project ENABLE was launched in 2014 to speed up the development of new antibiotics for the treatment of Gram-negative systemic infections. The project has achieved and surpassed its initial goals, having so far identified 5 antibacterial leads, selected 2 antibacterial development candidates and advanced 1 compound into preclinical and phase one clinical studies.
With several promising compounds in the pipeline, IMI granted the project a one year no-cost extension (i.e. total spend will remain within original budget). Here’s a breakdown of the achievements of the research teams so far:
- ENABLE currently has 10 active programmes: 6 are in Hit to Lead, 2 in Lead to Candidate, 1 in Candidate to Phase I and 1 in Phase I.
- ENABLE selected its first candidate – Juvabis’ apramycin programme – in October 2018. Mutabilis’ candidate MUT485 received candidate status in November 2019.
- Juvabis’ clinical candidate apramycin is currently evaluated in a Phase I randomised, double-blind, placebo-controlled single ascending dose study in healthy volunteers. Apramycin is an aminoglycoside antibiotic which has demonstrated promising efficacy against multidrug-resistant bacteria. First results are expected in 2020.
Anders Karlén, leader of ENABLE Managing Entity and professor at Uppsala University, said: 'This achievement is an immense success given the complexity and number of partners involved. We have brought the leading experts in the antimicrobial resistance field together, set up a unique and effective collaboration and delivered.'