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EAPM and ESMO bring innovations to health policymakers

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For the eighth year in succession, the European Alliance for Personalised Medicine (EAPM) has held a high-level conference series alongside the annual ESMO Congress, writes EAPM Executive Director Denis Horgan.

The EAPM conference was opened with the announcement that the following article was published and contributed to by more than 40 experts across the EU on how to bring Greater Accuracy to Europe’s Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology.  Please click here to have access.

Sessions include: Session I: Tumor Agnostic, Session II: Biomarkers and Molecular Diagnostics, and Session III: Utilising Real-World Evidence in a health-care setting.  The conference runs from 08.00 – 16.00. Here is the link to the agenda. The conference aims to bring  key recommendations to the EU level, so as to shape the EU Beating Cancer Plan, EU health Data Space, the updating EU Pharmaceutical Strategy as well as the EU Health Union. 

The conference is held following the first State of the Union address by European Commission President Ursula von der Leyen on Wednesday (16 September) – in her first annual address, von der Leyen said the coronavirus pandemic had underlined the need for closer cooperation, stressing that people were “still suffering”.

For me, it is crystal clear – we need to build a stronger European Health Union,” she said. “And we need to strengthen our crisis preparedness and management of cross-border health threats.” Von der Leyen said her commission would try to reinforce the European Medicines Agency and European Centre for Disease Prevention and Control.

And she also raised the importance of the European Beating Cancer Plan as well as European Health Data Space. “This will show Europeans that our Union is there to protect all,” she said.

Fabrice Barlesi, medical director of Gustave Roussy, said: “RCTs are no longer the way to go. A way ahead could be EU support for trialing a new drug and delivering data to a centralised registry, which could give good consolidated data from across Europe.”

Divided into three sessions, the EAPM conference at the ESMO Congress, as mentioned,  dealt with such diverse issues as tumour agnostics, biomarkers and molecular diagnostics and real-world evidence in a health-care setting. Concerning cancer, specifically tumours, the congress stated that  tissue-agnostic cancer drugs are antineoplastic medicines that treat cancers based on the mutations that they display, instead of the tissue type in which they appear.

These drugs include, for example, Entrectinib, Pembrolizumab and Larotrectinib. Former Spanish health minister and MEP Dolors Moseratt highlighted her support for the work of EAPM and looks forward to getting the recommendations of the outcomes from the conference.  “The European added value of health is obvious. It would avoid duplication and enable a better allocation of resources. And it will minimize the risk of fragmented access to therapy across member states.”

And the EAPM conference is at pains to seek the best ways forward for the implementation of Real-World Evidence (RWE) into health care in Europe – looking to find consensus with key decision makers, including at member state level, not least with representatives in the European Parliament, on how to proceed in this area. RWE for health care is a simple concept – harnessing various health data in real time to help make faster and better medical decisions.

Real-World Evidence is an umbrella term for different types of health-care data that are not collected in conventional randomised controlled trials, including patient data, data from clinicians, hospital data, data from payers and social data.

Rosa Giuliani, consultant in medical oncology at the Clatterbridge Cancer Center, said: “Key elements to advance the use of TACs is to conduct dialogue that transcends silos, and to explore re-engineering of the development pathway.” And, as far as biomarkers and molecular diagnostics are concerned, a lot has been said about testing, and often the lack of it, in terms of the COVID-19 outbreak, with different countries adopting different strategies and, also, having different resources when it comes to acquiring necessary kits.

The key focus in the ESMO session was on better and more equitable access to biomarkers and molecular diagnostics across Europe.  This is a must, but, as the attendees acknowledged, we’re a long way short of it. Access to personalised medicine and new diagnostic technologies can help resolve many inefficiencies, such as trial-and-error dosing, the potential for increased hospitalisation time due to adverse drug reactions and the problem of late diagnoses. It may also enhance the effectiveness of therapies through better tailored treatment administration.

In conclusion for the morning session, Giuseppe Curigliano, associate professor of Medical Oncology at the University of Milano, and head of the division of Early Drug Development, at the European Institute of Oncology said: “A real challenge to overcome is the different endpoints between investigators and payers. Policy frameworks and co-operation is essential.” The session in the afternoon will focus on utilizing real-world evidence in a health-care setting.

A report will be available next week. 

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Merkel plans circuit-break lockdown as German virus cases surge

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Chancellor Angela Merkel pressed regional leaders on Wednesday (28 October) to agree to a partial lockdown in Germany which would see restaurants and bars closed but keep schools open, a draft document seen by Reuters said, write and

The drastic measures, to take effect from 4 November, are aimed at curbing the spread of the coronavirus in Europe’s biggest economy as the number of new cases hit a record high.

Under the planned new restrictions people would only be able to go out with members of their own and one other household. Fitness studios, discos and cinemas would close, as would theatres, opera houses and concert venues.

Restaurants would only be allowed to offer takeaways, the document said. Shops could remain open if they implement hygiene measures and limit customer numbers.

Merkel will hold a virtual conference with the country’s 16 state premiers later to try to agree the nationwide rules and ditch a confusing patchwork of regional measures.

Almost all regions of Germany face an exponential increase in infection rates, said the document to be discussed, and local health authorities can no longer trace all infections.

“The aim is to interrupt the dynamic of the infection fast so no far-reaching limits on personal contact and economic activity are needed over the Christmas period,” it said.

Germany was widely praised for keeping infection and death rates below those of many of its neighbours in the first phase of the crisis but is now in the midst of a second wave. Cases rose by 14,964 to 464,239 in the last 24 hours, the Robert Koch institute for infectious diseases said on Wednesday.

Deaths jumped by 85 to 10,183, fuelling fears about the health system after Merkel warned on Tuesday it could hit breaking point if infections continue to spiral.

“If we wait until intensive care is full, it is too late,” Health Minister Jens Spahn, who last week tested positive for the virus, told broadcaster SWR.

The government has long insisted it wants to avoid a second blanket lockdown after an initial one this year hit economic growth, with the economy shrinking by a record 9.7% in the second quarter.

While economists expect a rebound for the July-Sept period, they warn that a further lockdown could wipe out growth in the last quarter. Third quarter data is due on 30 October.

Under the plans, the government aims to provide aid to firms hit by closures, including the cultural event sectors.

Only necessary overnight stays would be allowed, according to the document. Brothels, swimming pools, beauty and tattoo studios would close but physiotherapists and hairdressers could stay open. The steps would run until the end of November but are subject to review.

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Italy approves trial of osteoporosis drug to treat COVID-19

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Italy’s main medicines regulator gave the go-ahead on Tuesday (27 October) for human clinical trials on raloxifene, a generic osteoporosis drug that researchers hope may also help reduce COVID-19 symptoms and make patients less infectious, writes .

The drug was identified as a potential COVID-19 treatment by researchers using supercomputers to screen more than 400,000 molecules for chemical characteristics that might inhibit the virus, focusing on those already approved for use in humans.

Andrea Beccari, from Excalate4Cov, a public-private consortium led by Italy’s Dompé Farmaceutici, said researchers hoped that raloxifene - a generic drug known as a selective oestrogen receptor modulator - would block replication of the virus in cells and thus slow down progress of the disease.

“It inhibits virus replication, thus preventing the worsening of patients with mild symptoms, and also decreases infectivity, limiting the viral load,” said Marco Allegretti, head of research at Dompé Farmaceutici.

There was some evidence early in the coronavirus pandemic that oestrogen present in pre-menopausal women might have a protective effect against the virus. Some scientists think raloxifene, which is prescribed to strengthen the bones of older women with lower levels of oestrogen, the female hormone, may provide the same kind of protection.

The trial will involve 450 hospital and home patients at Rome’s Spallanzani Hospital and Humanitas in Milan in the initial phase.

They will be given a seven-day treatment of raloxifene capsules in a randomised sample and 174 more people may be added in the final stage. Enrolment will last 12 weeks.

The Excalate4Cov platform is backed by the European Commission and coordinates supercomputing centres in Italy, Germany and Spain with pharmaceutical companies and research centres, including the University of Louvain, Fraunhofer Institut, Politecnico di Milano and Spallanzani Hospital.

It uses a chemical library of 500 billion molecules and can process 3 million molecules per second using four supercomputers of more than 122 Petaflops, a unit of computing speed equal to one thousand trillion floating-point operations a second.

Researchers harnessed the power of the supercomputers to create a three-dimensional structure of 12 coronavirus proteins and conduct simulations to see where the proteins may be attacked by a drug.

“It took a million hours of calculation,” Beccari said, adding that, as research continued, it may be possible to develop second-generation drugs superior to raloxifene.

($1 = €0.8443)

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France sees highest number of COVID-19 patients going into hospital since April

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French hospitals registered 1,307 new coronavirus patients on Monday in the highest one-day increase since 2 April, which saw 1,607 new patients, as the health system comes under increasing stress from a runaway infection rate, writes Geert De Clercq.

French health ministry data showed that France now has a total of 17,784 coronavirus patients in its hospitals, compared with a record 32,292 on 14 April, at the height of the March-May lockdown.

The ministry also reported 26,771 new confirmed coronavirus cases in past 24 hours, from 52,010 on Sunday (25 October). On Monday, the tally usually drops sharply because of reporting lags over the weekend.

The death toll went up by 257, taking the cumulative total since the start of the epidemic to 35,018. The number of people in intensive care units rose by 186 to 2,770.

Several regions in France have implemented emergency plans in hospitals, delaying non-essential operations to make space in ICU units for COVID-19 patients and cancelling staff holidays.

Sources told Reuters that authorities were looking at options for still tighter measures to fight COVID-19, including starting a 9 p.m. to 6 a.m curfew earlier, confining people to their homes at weekends except for essential trips, and closing non-essential shops.

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