IMI Newsletter: Switzerland in H2020, IMI at DIA EuroMeeting, project successes

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64th Edition – January 2017

  IMI2 – Call 10: submission open   Good news for Swiss scientists applying for IMI funding   Patient centricity: what is it and how to make it meaningful? IMI at the DIA EuroMeeting   MARCAR project results will contribute to making drugs safer for patients   ‘We took the lead over US-based projects’ – an interview with SUMMIT project coordinators   SAFE-T project generates promising clues for detection of drug-induced injuries   News from the projects

IMI2 – Call 10: submission open

Submission is now open for the 10th Call for proposals under the IMI2 programme. >From this Call on, short proposals must be submitted via the electronic submission system of the Horizon 2020 Participant Portal.

The deadline for short proposals is 28 March 2017. Details of all topics and information on how to apply can be found on the IMI website.

Catch up on the webinars on the Call topics and IMI's rules and procedures Read the press release

Good news for Swiss scientists applying for IMI funding

Swiss researchers and organisations can now fully participate in the whole Horizon 2020 programme, including IMI, on equal terms with entities from EU Member States and other associated countries. This is because on 1 January 2017, Switzerland became fully associated to Horizon 2020 following the country’s ratification, on 16 December 2016, of the Protocol extending the EU-Switzerland Free Movement of Persons agreement to Croatia. >From December 2014 to December 2016, Swiss scientists could only receive funding under parts of Horizon 2020 (not including IMI). ‘Switzerland has now fulfilled the EU's condition on free movement of people and can be fully associated to Horizon 2020,’ said Carlos Moedas, EU Commissioner for Research, Science and Innovation. ‘This is good news for Switzerland, and good news for the EU. It will further strengthen our scientific communities and our very substantial cooperation in research and innovation.’ The Swiss have already nominated an IMI States Representatives Group (SRG) member – Isabella Beretta. Among other things, SRG members can provide advice to local researchers on applying for IMI funding and help them to find partners.

For more information, read the European Commission’s information note on Swiss participation in Horizon 2020 or view the full list of countries associated to Horizon 2020.

Patient centricity: what is it and how to make it meaningful? IMI at the DIA EuroMeeting

IMI and DIA, the Drug Information Association, are organising a roundtable discussion on early patient engagement that will take place during the 29th DIA Annual EuroMeeting in Glasgow, Scotland on 29 March 2017.

Patient centricity has never been so much in the spotlight. Patient insights and patient data play an increasingly established role in the valuation of healthcare offerings once a drug is on the market, but the role and value of an enhanced patient voice during R&D, in particular during clinical development, is yet to be established.

This roundtable discussion will focus on patient engagement during research & clinical development. Panellists will present case studies, lessons learned and examples of best practice, and will address the following questions:

What does patient centricity mean to different stakeholders? Why do we need patients to be engaged at an early stage of medicines development? What are the lessons learned from existing cases? What are the challenges in early patient involvement? How should patients be engaged for the impact to be real and meaningful?

To find out more about patient involvement in IMI, please visit the patients' page of our website.

MARCAR project results will contribute to making drugs safer for patients

Cancer risk assessment is one of the most important steps during the development of new medicines. Launched in 2010, IMI’s MARCAR project aimed to develop early biological clues – biomarkers – which could help predict which drugs might lead to tumour growth. In an interview with the IMI Programme Office at the end of the project, MARCAR project coordinator Jonathan Moggs of Novartis spoke about the main project achievements and explained how MARCAR project outputs will make drugs safer in the future. ‘MARCAR contributed to the scientific rigour and strength of the cancer risk assessment, by which we will ensure that safer medicines reach patients, and in some cases accelerate the time it takes for those medicines to reach patients,’ said Moggs. ‘What causes delays is having an unexpected tumour finding in pre-clinical animal studies that we cannot easily explain; this prevents us from having a good way of making an accurate cancer risk assessment for humans. MARCAR’s science, technology and models should enable those kinds of questions to be answered more quickly and more comprehensively.’

Read the full interview Find out more about the project's achievements in the project factsheet Visit the project website

‘We took the lead over US-based projects’ – an interview with SUMMIT project coordinators

Before SUMMIT started in 2009, ongoing research on diabetic complications in Europe was scattered amongst various countries. Fast forward six years, and Europe – by joining forces and activities – has climbed to the top of the research ladder in this field, coming close to or even surpassing similar research projects in the US. In an interview with the IMI Programme Office, SUMMIT project coordinator Michael Mark of Boehringer-Ingelheim, and scientific coordinator Leif Groop of Lund University, explain how SUMMIT contributed to the diabetes complications field. ‘This IMI project also showed that academic centres and pharmaceutical industry can work together in a structured and collaborative way – something that has never been done before in this field,’ said Mark. ‘This IMI framework was new for the European academia as well as for the industry, but thanks to it we are now well positioned to compete or even surpass our colleagues in the US.’

Read the full interview Find out more about the project's achievements in the project factsheet Visit the project website

SAFE-T project generates promising clues for detection of drug-induced injuries

SAFE-T was among the first IMI projects which started in 2009. Seven years later, the project came to a close, having achieved most of its objectives and made significant progress in developing improved tools for the prediction, detection, and monitoring of drug-induced injuries to the kidney, liver, and vascular system. In an interview with the IMI Programme Office, project coordinator Michael Merz of Novartis, and scientific coordinator Thomas Joos of the Natural and Medical Institute at the University of Tübingen (NMI), share their thoughts on the project’s successes. ‘We have generated a lot of data on new biomarkers – molecules that we can measure in the blood or urine – that allow us to detect drug side-effects earlier and more accurately than has been feasible in the past,’ said Merz. ‘In addition to helping detect drug-related injuries, these biomarkers will also help improve diagnosis and monitoring in chronic disease patients. They will help clinicians make better decisions on specific treatment alternatives and other things, such as when to stop treatment. I think there will be lots of benefits to patients across a large variety of different diseases.’

Read the full interview Find out more about the project's achievements in the project factsheet Visit the project website

News from the projects

Smartphone microscope can sequence DNA on the spot

An international team of scientists has developed a smartphone-based microscope that can analyse DNA sequences and spot genetic mutations in samples of bowel cancer cells and tissues. This information is vital to help doctors determine which treatments are likely to work in a patient, and the new device will make this technology more readily accessible to people in remote areas and poorer parts of the world. The novel device, funded in part through IMI’s bowel cancer project OncoTrack, is described in the journal Nature Communications. DNA sequencing is increasingly used in cancer treatment; if you know which mutation is driving a patient’s cancer, you can determine which treatment is most likely to beat it. However, to get this information, doctors usually have to send cell and tissue samples away to large, specialist laboratories. This new microscope, which is created by 3D printing, would allow doctors to carry out the test on the spot. When hooked up to a smartphone, it can read the DNA sequence of a tumour and flag up specific mutations. The researchers estimate that if produced in large quantities, the cost of manufacture of the microscope could be as low as USD 500 (EUR 466). For comparison, prices for standard microscopes used for sequencing start at USD 10 000 (EUR 9 300). Although the researchers focused initially on cancer, they believe the microscope could play a vital role in diagnosing infectious diseases. ‘Antibiotics are effective against bacteria. But now we are losing that weapon when bacteria become resistant,’ said Mats Nilsson of the Universities of Stockholm and Uppsala. ‘However, if we could look at the DNA level and find out if a bacterium is sensitive to a certain type of antibiotics, we could choose the right treatment from the very beginning. This is where I think this concept has its great strength.’

Read the press releases of Stockholm University and the University of California

COMBACTE-MAGNET launches clinical study of promising antibiotic

Scientists from IMI’s antimicrobial resistance project COMBACTE-MAGNET have launched a clinical study of a promising antibiotic called AIC499. Developed by German company AiCuris, the drug appears to be effective against a range of multi-drug resistant bacteria in complicated urinary tract infections and intra-abdominal infections. A phase I trial to evaluate the safety of AIC499 in healthy volunteers is now underway at the Medical University of Vienna in Austria. AIC499 is designed to tackle so-called Gram-negative bacteria, which are surrounded by a tough cell wall that forms a solid defence against many antibiotics. ‘Gram-negative pathogens are considered to be amongst the most serious threats to public health and a major unmet medical need,’ said AiCuris CEO Holger Zimmermann. ‘We are convinced that, with its unique profile and extensive coverage, AIC499 has the potential to become a highly effective antibiotic for patients with severe infections including those caused by multi-resistant pathogens.’ The first results from this Phase I study should be available in mid-2017.

EMIF opens up catalogue to research community

The EMIF project has announced that it is extending access to the EMIF Data Catalogue to the wider research community. The online catalogue currently includes 14 population-based data sources (e.g. electronic health records, regional databases) and 46 cohorts (mainly in the Alzheimer’s field) where the project partners have consented to providing information to bona fide researchers who want to explore potential data partners for their own work. At the moment, the catalogue provides basic information to help users investigate the data sources, but further developments are planned. ‘This is the first tool of the EMIF platform to have wider access, and in the coming final year we plan to have deployed platforms for researchers to be able to go beyond the Catalogue phase right through suitability evaluation and ultimately conducting studies with data source collaborators,’ the project leaders write. ‘On behalf of EMIF we hope that this wider access to the first tool of the EMIF platform will be a significant asset to the EU research community, and very much look forward to its continued development and use, eventually within a broader research platform and communities.’

Find out how to access the catalogue

EUPATI issues guidance on patient involvement in R&D

The EUPATI project has published a set of guidance documents to facilitate patient involvement in research and development (R&D). The documents focus on interactions between patients and regulatory agencies, health technology assessment (HTA) bodies, ethics committees and the pharmaceutical industry. The guidance documents suggest approaches to allow structured interaction with patient organisations on the national and European level and will support the integration of patient involvement across the entire process of medicines research and development. The guidance documents were developed on the basis of an extensive consultation with patient advocacy groups, regulators, pharmaceutical companies, HTA bodies, academic groups and clinicians, and incorporate feedback gathered during these reviews.

ADAPT SMART issues discussion paper on engagement criteria for MAPPs

The ADAPT SMART project has issued a discussion paper on engagement criteria for MAPPs (medicines adaptive pathways to patients) to aid in debates on how and when a MAPPs approach should be used and for which medicines and diseases/conditions. The paper proposes the following set of six questions to consider when selecting individual products for a MAPPs pathway.

Can we define a target population with a high unmet need? Does the product hold sufficient promise to address the unmet need? Can a prospective iterative post- (initial) marketing authorisation development plan be proposed, developed, implemented and agreed? Are there workable tools to ensure appropriate product utilisation? Are there workable ‘strategies’ for payers in case the product under-performs? Is there sufficient commitment and resources from relevant stakeholders to ensure successful interactions? Which critical aspects for pharmaceutical development would need to be considered?

The questions are designed to initially trigger discussions at the company level (i.e. the medicine developer) and subsequently during discussions between the company and other stakeholders. These questions were designed on the basis of input gathered from a wide range of stakeholders, including regulators, payers, HTA bodies, prescribers, patients and companies. The paper is intended to inform and drive future discussions on MAPPs, both within the ADAPT SMART consortium and in the wider scientific and healthcare communities.

EBODAC project organises symposium in Senegal

IMI’s EBODAC project is developing strategies and tools to promote the acceptance and uptake of new Ebola vaccines in local communities in Africa. In this context, the EBODAC consortium is organizing a symposium entitled ‘Community engagement, communications and enabling technology in Ebola clinical trials’.  The symposium will take place on 20-21 February in Dakar, Senegal. It will gather experts from around the world to discuss communications, community engagement strategies, and technologies used in clinical trials during the Ebola outbreak. Moreover, the event will offer an opportunity to exchange lessons learned, develop recommendations for future trials occurring in outbreak settings and gather insights to develop an open source online training tool focusing on community engagement. Prominent speakers will include Professor Peter Piot, Director of the London School of Hygiene & Tropical Medicine and co-discoverer of the Ebola virus, and Dr Awa Marie Coll-Seck, Senegal’s Minister of Health. The event is by invitation only. If you are interested in attending please contact Valérie Heywood: 

The Innovative Medicines Initiative is the largest public-private partnership aiming to boost pharmaceutical innovation in Europe and to speed up the development of better and safer medicines for patients. IMI is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA.

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