- IMI Scientific Committee issues recommendations on rare diseases, data infrastructure, and regulatory science
- COVID-19 diagnostics project DECISION gets underway
- Previous IMI investments are proving prescient in the current COVID-19 crisis – an opinion piece by Pierre Meulien
- IMI-supported Ebola vaccine regimen gets green light
- IMI’s EHDEN and ConcePTION projects to work with EMA on COVID-19
- Regulatory decision gives boost to development of potential new TB drug
- PharmaLedger selects use cases to advance adoption of blockchain in healthcare
- Got questions about the European Lead Factory? Join their weekly Q and A sessions!
IMI Scientific Committee issues recommendations on rare diseases, data infrastructure, and regulatory science
The IMI Scientific Committee has issued three sets of recommendations on rare diseases; data infrastructure and integration; and the involvement of regulators and regulatory science. All three documents are publicly available via the Scientific Committee page of the IMI website.
The papers on rare diseases and data set out the context and offer suggestions on how public-private partnerships like IMI could help to move the field forward. For example, on rare diseases, the committee flags up how digital technologies could help to integrate patients’ voices into both research and their own care. On data integration, they list 10 areas where a PPP could operate, including the development of solutions to connect the data, software and computational resources necessary to solve biomedical questions; the integration of artificial intelligence in research; and capacity building.
The paper on regulatory science notes that the involvement of regulatory authorities is key to the success of many projects, and discusses ways of addressing potential conflicts of interest this involvement could raise. The committee sets out areas that would benefit from regulatory research, such as clinical trial design; the use of innovative technologies for rapid development of medicines and diagnostics; and data sharing practices.
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- Scientific Committee recommendations regarding rare diseases
- Scientific Committee recommendations regarding data infrastructure and integration
- Scientific Committee recommendations regarding involvement of regulators and regulatory science
- Scientific Committee web page
COVID-19 diagnostics project DECISION gets underway
The DECISION project aims to develop an easy-to-use, low-cost, disposable test for COVID-19 that can give results within minutes. The idea is that it can be deployed anywhere; at drive-through testing centres, airports, physician offices, hospitals, quarantine centres, and even in people’s own homes.
‘Few novel amplification technologies exist that can deliver miniaturised, low-cost systems for molecular diagnostics, and the infectious disease outbreaks we are seeing globally are proof of just how necessary new approaches are to fight against these unpredictable threats,’ said DECISION project lead Anastasia Liapis of German SME GNA Biosolutions GmbH. ‘Our perspective was that a simple, portable, fast molecular test is a critical tool missing from the current landscape, and we have the core technology to enable that.’
The project hopes that the first demonstrators of the disposable molecular platform and coronavirus test will be available in 2021 and could be provided to emergency first responders and public health authorities. The priority will be validation with healthcare professionals.
DECISION is the first IMI COVID-19 project to officially get underway following the signature of the Grant Agreement. The other projects selected for funding by IMI are being finalised now.
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Previous IMI investments are proving prescient in the current COVID-19 crisis – an opinion piece by Pierre Meulien
‘As the world battles COVID-19, it’s useful to reflect on where IMI has been active over the past decade in fighting infectious diseases,’ writes IMI’s Pierre Meulien in a new opinion piece on the IMI website. ‘Investment in AMR, vaccines and infectious disease preparedness research are proving extremely valuable in the current pandemic, as are the relationships and networks we’ve built around the globe.’
Infectious diseases account for around 30 % of IMI’s budget, and this investment is bearing fruit and contributing to the fight against COVID-19. ‘Large clinical and laboratory networks have been built across Europe so that new antibiotics can be tested clinically and efficiently wherever outbreaks occur. This is epitomised in one of IMIs largest projects called COMBACTE-NET,’ Dr Meulien writes. ‘The Ebola vaccine project used a new technology based on a prime boost vaccine strategy – and as this platform has now been now accepted by EMA for the Ebola vaccine – then the regulatory hurdles to approve such a vaccine adapted to contain the relevant antigens from SARS-CoV-2 will be much lower.’
Dr Meulien concludes: ‘More can and needs to be done. More project-to-project cross-fertilisation needs to be integrated from the beginning of each project. More connectivity with global initiatives is required, and this is now built in as a prerequisite of each project in the new IMI COVID-19 programme, which was launched on 4 March.’
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- Read the opinion piece in full
- Read about how ongoing IMI projects are helping to fight COVID-19
IMI-supported Ebola vaccine regimen gets green light
The European Commission has officially granted market authorisation for an IMI-supported Ebola vaccine regimen, which represents a vital tool in the fight against the deadly disease. The marketing authorisation is for Janssen, a Johnson & Johnson company, for its two-dose ‘prime-boost’ Ebola vaccine regimen. It is specifically designed to induce long-term immunity against the Ebola virus in adults and children aged one year and up. As such, it can be used to support preventive vaccination in countries most at risk of outbreaks. A number of organisations contributed to the development of the vaccine regimen, including IMI through the Ebola+ programme.
‘IMI is immensely proud to have contributed to the development of this much-needed Ebola vaccine regimen. Through our Ebola+ projects, we brought together some of the world’s leading experts in Ebola from universities, the pharmaceutical industry, small companies, and the charity sector in Europe, Africa and the US,’ said IMI Executive Director Pierre Meulien. ‘By working together, often in challenging circumstances, they were able to significantly advance the development of this Ebola vaccine regimen and so pave the way for today’s decision.’
‘The investment from the EU's research programme Horizon 2020 into several Innovative Medicines Initiative Ebola projects is now bearing fruit,’ said Mariya Gabriel, European Commissioner in charge of Research. ‘This demonstrates, yet again, the power of collaboration and European R&I leadership to tackle global health threats.’
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IMI’s EHDEN and ConcePTION projects to work with EMA on COVID-19
The EHDEN and ConcePTION projects plus the ADVANCE/VAC4EU initiative will help the European Medicines Agency (EMA) gather real world data on COVID-19 vaccines and treatments once they are approved and being used in day-to-day clinical practice.
EHDEN is already working with 25 data partners across Europe, to help them map COVID-19 data to a common data model. Now, it is set to collaborate with the EMA on the creation of a framework for multicentre cohort studies on the use of medicines in COVID-19 patients.
ConcePTION will collaborate with the EMA on a project that will collect data on the impact of COVID-19 in pregnancy and follow up the baby to monitor long-term outcomes in order to guide decision-making about vaccine indications, vaccination policies and treatment options for COVID-19 in pregnant women.
The international association VAC4EU (Vaccine Monitoring Collaboration for Europe) is set to work with the EMA to prepare for the monitoring of the benefits and risks of COVID-19 vaccines in Europe. VAC4EU was born out of IMI’s ADVANCE project.
‘The inclusion of EHDEN, ConcePTION and VAC4EU in the EMA’s work is testament not only to their scientific excellence but to their ability to adapt to the challenges posed by the COVID-19 pandemic,’ said IMI Executive Director Pierre Meulien. ‘I am confident that the projects will make a valuable contribution to this important initiative which is a key part of the global fight against the disease.’
The outcomes of the projects will feed into the work of EMA’s COVID-19 EMA pandemic Task Force (COVID-ETF) and EMA’s scientific committees, to ensure that the evidence is translated into scientific opinions on the optimal use of the medicines and vaccines concerned.
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Regulatory decision gives boost to development of potential new TB drug
A decision by US regulators is set to speed up reviews of a potential new TB drug being developed by IMI’s TRIC-TB project.
Tuberculosis is a major public health threat. In 2017 alone, over 10 million people developed active TB and it killed 1.7 million, making it one of the top 10 causes of death worldwide. Treatment is via a six-month course of four antibiotics.
IMI’s TRIC-TB project was set up to advance the development of molecules that could boost the infection-fighting ability of the anti-TB drug Ethionamide. Now, the US Food and Drug Administration (FDA) has given Qualified Infectious Disease Product (QIDP) designation to one of the compounds (BVL-GSK098) in a fixed combination with Ethionamide for the treatment of pulmonary TB.
QIDP designation is given to antibacterial or antifungal drugs designed to treat serious or life-threatening infections. Crucially, QIDPs are eligible for priority and fast track review by the FDA. This will therefore help TRIC-TB to speed up the development of the compound.
Ultimately, if clinical trials are successful, BVL-GSK098 could allow doctors to reduce the dose of Ethionamide typically given to patients, something that would also reduce the side effects associated with the drug.
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PharmaLedger selects use cases to advance adoption of blockchain in healthcare
The goal of IMI’s PharmaLedger project is to deliver an open source, blockchain-based platform for the healthcare sector, using the supply chain, clinical trials, and health data as case studies. Now, it has selected use cases in these areas to validate the blockchain platform architecture.
In the supply chain area, one of PharmaLedger’s selected use cases will help to boost trust in medicines. A patient could simply scan a data matrix (QR) code on a packet of medicine to obtain (via a mobile app or website) a blockchain-anchored ‘eLeaflet’ on the medicine inside. The blockchain technology would guarantee the reliability of the information, and the solution could also be used to implement an anti-counterfeit feature where the user would be able to check product authenticity. Looking to the future, the eLeaflet could also be used to provide updates on the medicine, manage recalls, and offer advice on the safe (environmentally friendly) disposal of the drug.
In the health data field, PharmaLedger has selected a use case that will make it easier to match up patients with clinical trials (all while preserving patient privacy). In the clinical trials field, a use case on medical devices will integrate device data (‘Internet of Things’) with advanced analytics. This will support remote data capture during clinical trials, cutting down on the number of times patients would need to visit the clinic for tests.
In the health data and clinical trials fields, the project will also work on a use case that will strengthen patients’ ownership of their data, giving them greater control over who can access their health data and when, with a view to enabling a health data marketplace.
PharmaLedger plans to open up the platform for external parties to connect their own use case solutions. The platform will work in a similar way to an app store which requires a minimum standard of compliance but which is open and flexible to the needs of different use cases.
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- Read the full news story
- PharmaLedger website
- Learn about the blockchain thanks to PharmaLedger’s short video explainer
Got questions about the European Lead Factory? Join their weekly Q and A sessions!
The European Lead Factory comprises a collection of over half a million compounds and a state-of-the-art high throughput screening centre. Scientists in universities, small biotechs and large companies can apply to access the European Lead Factory’s resources to advance their own medical research and drug development programmes.
The next deadline for submitting a screening proposals is 4 September 2020. To help people who are planning to submit a proposal, the project is organising weekly Q&A sessions with the project’s programme office and assay transfer teams. The online sessions take place every Thursday afternoon at 16:00 CET (Central European Time). The first session is on Thursday 30 July.
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