- IMI launches EUR 45m Call for proposals on the coronavirus
- IMI can help advance regulatory science for advanced therapies and digital tech, stakeholders say
IMI launches EUR 45m Call for proposals on the coronavirus
IMI has launched a fast-track Call for proposals on the development of therapeutics and diagnostics to tackle current and future coronavirus outbreaks. The Call, launched on 3 March, focuses on:
- the development of treatments to rapidly respond to the current COVID-19 outbreak and/or future coronavirus outbreaks;
- the development of diagnostic tests to rapidly and reliably identify people infected with the coronavirus that causes COVID-19, and for use in clinical trials of new drugs.
Preventive vaccines are not included in the Call, as IMI does not want to duplicate the work of other organisations in this area.
Dr Pierre Meulien, IMI Executive Director commented: ‘Collaborative projects involving companies, universities and public bodies have the potential to dramatically accelerate the development of new treatments and diagnostics to tackle this threat to global public health. During the outbreak of Ebola in western Africa, we demonstrated that IMI can rapidly launch projects and deliver results in an outbreak setting, and I am confident that we can do it again for the coronavirus.’
Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, said: 'I welcome the rapid response of IMI to the coronavirus outbreak. This collaboration between the public and the private sectors brings their expertise and resources together in our fight against the coronavirus outbreak. This will help speed up the development of treatments and diagnostics in face of this global emergency and increase our preparedness for future outbreaks.'
The Call has a budget of EUR 45 million – this comes from the EU’s Horizon 2020 research and innovation programme. Large pharmaceutical companies that are members of EFPIA and IMI2 Associated Partners will not receive EU funding through this Call, but are expected to contribute to the projects with their own resources (e.g. staff time) and funds. The deadline for proposals is 31 March 2020.
The IMI Call for proposals is part of the European Commission’s wider response to the coronavirus outbreak.
- Read our press release
- Visit the Call web page
- Catch up on our webinar
- Watch our video on IMI coronavirus Call
- Factsheet on IMI coronavirus Call
IMI can help advance regulatory science for advanced therapies and digital tech, stakeholders say
Unblocking the regulatory challenges surrounding advanced therapies and digital technologies could be game-changing for all players, said attendees at IMI’s recent regulatory science summit. Every few years, IMI teams up with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) to organise a regulatory science summit. The last summit, held in Brussels in December 2019, brought together over 50 people from different stakeholder groups.
Over two days, they discussed regulatory science challenges that, if unblocked, could be game-changers for the use of advanced therapy medicinal products (ATMPs), and digital technologies for research and development, as well as digital health products. The summit participants’ conclusions and recommendations are summarised in a report.
They conclude: ‘There are numerous regulatory science challenges and opportunities related to new types of therapeutic interventions such as ATMPs as well as to integration of digital technologies in product development or combinations of medicines and digital products, that – when unblocked – would be game changers for all players. None of these challenges can be addressed by one party in isolation and collaboration is key.’
‘Regulators’ input is key to the success of IMI, as it helps ensure our project results can have a real impact on drug and technology development and ultimately, patients’ lives,’ says IMI Executive Director Dr Pierre Meulien. ‘The convergence of different technologies in the health space will only increase our need to work closely with regulators from different sectors in the future.’
- Report from the IMI-EMA-FDA Regulatory Science Summit of December 2019
- How regulators can get involved in IMI
(this page also includes the report from the previous summit, in 2017)
- Advice for IMI projects on engaging with regulators
COVID-19 is a sign of the times – an opinion piece by IMI’s Pierre Meulien
This month IMI announced a new funding Call in reaction to the spread of COVID-19. The process is being fast-tracked, just like the call for Ebola projects in 2014. However, as IMI Executive Director Pierre Meulien points out in a new opinion piece published on the IMI website, there’s nothing unexpected about the emergence of these epidemics.
‘Every year, viruses jump from animals to the human population, including certain strains of influenza,’ he writes. ‘The closer we live to animals, the more of these ‘jumps’ we’re going to see.’
The scientific community needs to get ready to respond regardless of where the next virus comes from. In that respect, two ongoing IMI projects now look particularly prescient: the ZAPI project was set up to deliver a platform and technologies to facilitate a rapid response to future disease outbreaks. In 2019, the project demonstrated that certain antibodies can stop the MERS coronavirus from infecting new cells, and they’re now assessing whether the antibodies could also be effective against SARS-CoV-2, the virus that causes COVID-19. COMBACTE-NET, part of the antimicrobial resistance programme, has set up a network of clinical and laboratory sites across Europe that has been mobilised to support global efforts to standardise the information gathered from patients with suspected or confirmed COVID-19.
COVID-19 has put everyone on the alert because there’s so much we don’t know about it. Dr Meulien concludes: ‘In the coming months, the scientific community will no doubt be able to answer more questions about the epidemiology and modes of transmission of the virus, and the story will gradually recede from the headlines. Meanwhile, the projects that will result from the IMI coronavirus call will outlast the news cycle, putting everything in place for the next outbreaks, wherever or however they may emerge.’
- Read Pierre Meulien’s opinion piece in full
IMI’s ZAPI project: ‘This is like a real-life experiment for us’
Zoonotic diseases are those that are transmitted from animals to humans. COVID-19 is zoonotic in origin, and experts believe such outbreaks could become increasingly frequent in the future. The best we can do - and must do - is be prepared. In 2015, IMI launched ZAPI (Zoonotic Anticipation and Preparedness Initiative) to set up tools and platforms that would be ready to put into production for vaccines and monoclonal antibodies (cloned copies of the body’s natural defences) to efficiently counter emerging or remerging diseases. Much of the project’s work on the Middle East respiratory syndrome (MERS) coronavirus, can be directly applied to SARS-CoV-2, the virus that causes COVID-19, as the two are closely related.
‘This scenario with COVID-19 is exactly the scenario that we are working to prevent in the future – of course it’s never exactly the same virus but one of our models, the MERS coronavirus that occurred a few years ago, has taught us a lot about how to design and manufacture antibodies and to test them,’ says project coordinator Jean-Christophe Audonnet of Boehringer Ingelheim.
‘As we have seen, the diseases are coming very fast, and it’s very difficult to react very efficiently to the different factors. We want to show, however, what is technically possible,’ he continues. ‘It’s a real life experiment now for us. A factor that we need to explore better through dialogue is how we can reduce the timelines for the key decisions - political and regulatory ones. Maybe we have to reflect all together as a society how to overcome this.’