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Update: EAPM B1MG meeting to bring together national genomics and data infrastructures online for 21 October

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Greetings colleagues, and welcome to the final European Alliance for Personalised Medicine (EAPM) update of the week. We hope you are looking forward to your weekend, and that you enjoy news of the upcoming B1MG Conference on 21 October and the update of recommendations from our recent German EU Presidency Conference, writes European Alliance for Personalised Medicine, Executive Director, Denis Horgan.

B1MG Stakeholder Co-ordination Group Meeting

Registration is still very much open for the B1MG meeting on 21 October. The aim of the the B1MG is to support the connection of national genomics and data infrastructures, co-ordinate the harmonization of the ethical and legal framework for sharing data of high privacy sensitivity, and give practical guidance for the pan-European co-ordination of implementing genomic technologies in national and European health-care systems. 

Thus, the B1MG is a means to bring the different stakeholders together on Oct 21st so as to act as a catalyst to provide a benchmark approach for alignment of complex, fractionated health-care provisions into health-care systems.  The objective of the meeting is to discuss the key drivers which are the stakeholders to make this a reality. Register here and read the full agenda here.

German EU Presidency Conference

 Held during the auspices of the Germany Presidency of the Council of Ministers on 12 October, EAPM's conference was very successful in its own right, with an agenda packed with insights from distinguished speakers on ‘Ensuring access to innovation and data-rich biomarker space to speed better quality of care for citizens’. 

The report, which will be issued on Monday (19 October), delivered a message on the immediate need for a new way of thinking about health care. It presented this urgency through discussions on adequate health care frameworks, better allocation of resources, the potential of advanced testing, co-ordinated approaches to cancers and of the deployment of advanced therapy medicinal products - all against the background of the ongoing battle against COVID.

More than 200 delegates attended, and there were contributions from European politicians, officials from the European Commission and the European Medicine Agency, and a multitude of key stakeholders from countries including Germany, which is presently hosting the EU Presidency.

Principal Recommendations:Although there was no formal process of agreeing recommendations at the meeting, the following are among the recurring elements from the discussions which will be elaborated on the report which will be issued on Monday. 

  • Inequalities in access to testing and treatment across Europe must be addressed.
  • Adequate data infrastructure and processing capacity must be available.
  • Real-world evidence must be developed and acceptance criteria agreed with regulators, HTA agencies and payers.
  • Greater flexibility in regulatory requirements is needed to accommodate evaluation of products destined for small populations.
  •  Multi-stakeholder collaboration must be developed to agree research priorities, standards and quality assurance of testing, and evaluation criteria for testing and treatments.
  • Trust must be developed among citizens about the security and possible use of their data.
  • Communication must be developed by healthcare stakeholders to persuade policymakers to effect constructive change

No Strasbourg plenary...again

European Parliament President David Sassoli has cancelled next week’s trip to Strasbourg. The Parliament plenary “will not take place in Strasbourg, but will be held remotely,” he wrote on Twitter. “The situation in France and Belgium is very serious and travelling is not advised.” Sassoli said his decision to cancel “was a very difficult choice for me because I was convinced this time that I could manage the transfer to Strasbourg.” But it’s about something bigger than managing a move, he suggested: “We must do everything possible … to avoid the closure of the Parliament” and commit to “make sure that democracy is not blocked, above all in a moment like this one.”

Spain imposes state of emergency in Madrid 

The Spanish government has ordered a 15-day state of emergency to bring down Covid-19 infection rates in the capital, after a court overturned a partial lockdown imposed a week ago. Madrid and nearby cities will see restrictions enforced by 7,000 police. The capital has been at the centre of a political row, with the centre-right city authorities challenging the Socialist-led government's demands. Cases are down and a state of emergency is unjustified, say city officials. Madrid health minister Enrique Ruiz Escudero insisted that measures already in place were working and that the national government order was "a measure no Madrileño will understand". 

World Health Organization (WHO) reform

 The German Council presidency has set October 30 as its date for a formal meeting of health ministers. Officials have given member states an overview of the COVID-19  response to date and provided updates on the changes that have taken place within the organization to support coronavirus response efforts. These changes include the creation of WHO’s science division — which initiated the Solidarity Trial to compare COVID-19 treatments and assess their effectiveness — and the new emergency preparedness division under the WHO Health Emergencies Programme.

Great and good in place

The Council is meeting for a two-day summit today (16 October) and COVID-19 is obviously high on the agenda. Conclusions ahead of the EU summit read: “The Council calls on the Commission and the member states to continue the overall coordination effort, notably regarding quarantine regulations, cross border contact tracing and the joint assessment of testing methods.” Vaccines are also on the list of topics up for discussion.  The Council will discuss “overall co-ordination and the work on the development and distribution of a vaccine at the EU level”.

UK government has 'powers to enforce Manchester restrictions' in lockdown row 

 The government has the power to impose tougher COVID restrictions in Manchester and other towns amid a growing row over tough new measures, foreign secretary Dominic Raab has said. Raab told Sky News that Westminster will “keep talking” with local leaders over further coronavirus restrictions but said the "government has the powers to proceed in any event" should these talks fail. He accused Labour of sending mixed messages and accused the opposition of "political confusion". 

Worried Merkel lays down the law in Germany 

Germany’s states agreed on Wednesday (14 October) to extend measures against the spread of the coronavirus to larger parts of the country as new cases soared, but Chancellor Angela Merkel warned even tougher steps may be needed. “What we do in the coming days and weeks will be decisive for how we get through this pandemic,” Merkel said at a news conference after a meeting with the heads of Germany’s 16 states, adding that the goal was to safeguard the economy. 

Under Wednesday’s agreement, the threshold at which tougher measures such as late-night curfews on bars and tighter restrictions of private gatherings kick in will be lowered to 35 new infections per 100,000 people over seven days, compared with 50 before. If these measures fail to halt the rise in infections, further measures will be introduced to avoid a second full lockdown that could have a devastating impact on the economy.

Catalonia closes restaurants and bars for two weeks

The Catalan government on Wednesday approved the closure of all bars and restaurants in the region in a bid to slow the spread of the coronavirus. According to data from the regional health department released earlier today, the 14-day cumulative number of coronavirus cases in Catalonia has risen to 290 per 100,000 inhabitants – a figure not seen since the beginning of April. 

Netherlands in ‘partial lockdown’

 Dutch Prime Minister Mark Rutte announced a ‘partial lockdown on Tuesday (13 October), adding that masks will become mandatory in places such as stores and museums — a departure from the country’s longstanding resistance to requiring them in public. Furthermore, restaurants and bars will temporarily shut their doors. The new measures are expected to last for four weeks, but will be re-evaluated in two weeks.

Not so dolce-vita

Italy’s nightlife is under new restrictions with the latest act signed by Prime Minister Giuseppe Conte and Health Chief Roberto Speranza. New rules include closure of all bars and restaurants by midnight, while patrons are required to be served sitting down at a table from 9 p.m. Masks are required inside private businesses and on the street.

Belgium set to tighten restrictions as well

The Belgian government may well announce tighter restrictions today (16 October) as the number of cases reported in the country continues to rise. Options may include a stricter mandate for home working to tighten rules on bars and restaurants. Restrictions on sports are also coming into effect.

And that is everything for this week – have an excellent weekend, stay safe and well, and remember: Register here and read the full agenda here for the B1MG meeting on 21 October. 

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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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