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Presidency conference building consensus for progress on innovative personalised medicine in a COVID 19 and post-COVID 19 world



The third Presidency Conference, organized by the European Alliance for Personalised Medicine (EAPM) saw multi-stakeholder consensus reached on many facets of facilitating innovation in modern-day European healthcare systems, writes EAPM Executive Director Denis Horgan.

The event held during the auspices of the Germany EU Presidency and is entitled Ensuring Access to Innovation and data-rich biomarker space to speed better quality of care for Citizens’, and took place in a virtual environment on 12 October.

 The meeting of multidisciplinary personalised medicine experts followed three successful annual congresses in Belfast, Brussels and Milan, plus seven annual Presidency Conferences.

What happened this morning?

As ever, the Presidency conference showcased different objectives which both the public and private sector can support, with a view to allowing the EU to present a common objective. It took place in a focused format to allow concrete issues to be tackled and to have a dialogue with policymakers.

EU4Health programme leader Cristian Busoi MEP spoke in the morning and, for the afternoon session, further MEPs are headlined to speak, as well as EMA and Commission representatives. There were more than 200 attendees at the conference this Monday morning, marking the conference as a singular success. And the EU4Heath programme, which is destined to take a big step forward, was also discussed at the conference. The draft compromise amendments will be voted on in the ENVI committee, which means that, for the first time, the European Parliament will be having its say on the proposal. 

For the afternoon session which starts at 14h, sessions include  a) Biomarker testing in the field of Alzheimer's and related dementia; b) Session IV: Propelling Health Care with Advanced Therapy Medicinal Products (ATMPs) and c) Closing Session: Realising the Potential of Data & Early Diagnosis through Biomarker Testing & Molecular Diagnostics.

The day featured a full and productive session on the current hot topic of the Pharmaceutical Strategy, rational allocation of resources in a COVID and post COVID world, European Data Space, Gene therapy plus value-based outcomes and biomarkers/molecular diagnostics.

Biomarkers were discussed recently at an EAPM satellite event which took place at the ESMO Congress and a pre-event round table on the topic of biomarkers and molecular diagnosis took place ahead of the main Conference in Brussels which led to the academic publication entitled ‘Bringing Greater Accuracy to Europe’s Healthcare Systems: The Unexploited Potential of Biomarker Testing in Oncology’

Key statements

Christian Busoi MEP said: “Action is necessary at a co-operative and EU level - in gaining new insights into diseases, personalised medicine is already becoming the dominant therapy for cancer and a host of other afflictions.

Quality assurance needs to be further developed to respond to patients requirements. And affordability is the most crucial issue - can we afford’ to beat cancer?” 

AstraZeneca Europe and Canada Executive Vice President Iskra Reic said: “It is vital to learn from the crisis and share and come together and learn. It needs multiple partners working together across health-care ecosystems.”

On the topic of cancer, meanwhile, Christine Chomienne, vice chairwoman, Mission Board for Cancer, and professor of cellular biology at the Université Paris Diderot said: “We need to change the frame of mind on cancer culture – for prevention, for policymakers, for reimbursement, but always with very strong evidence.”

During the conference, EUnetHTA Chief Operating Officer Marcus Guardian said: “We have proven efficiency gains from EU-level co-ordination – but this requires a robust mechanism with clear rules, balanced by flexibility in national implementation.” 

He added: “We also need to recall that reimbursement and pricing are not covered by the proposal and that will remain a competence of member states. EU cooperation is needed to ensure constant exchange of information between HTA authorities in the EU.”

Among those speaking at the event were Mary Baker, former president of the European Brain Council. She said: “There is a need for the cooperation of society. We need the science to get the answers but they are no use if they just stay in the laboratories. We need to show we can work together.” 

In more sobering news, the health programme has seen its budget slashed by the Council  to €1.7 billion from the €9.4bn proposed by the Commission in May — which has provoked criticism in the Brussels health bubble, described as “short-sighted penny-pinching in the face of a once in a lifetime health crisis”. And, in September, Commission President Ursula von der Leyen called on MEPs to fight for more health money.

 The report on the conference will be issued later this week.


Coronavirus disinformation: Online platforms take new actions and call for more players to join the Code of Practice



The Commission has published the reports by Facebook, Twitter, TikTok, Microsoft and Google on measures taken in June to combat coronavirus disinformation. The current signatories and the Commission are also calling on new companies to join the Code of Practice on disinformation as it will help broaden its impact and make it more effective. Values and Transparency Vice President Věra Jourová said: “The COVID-19 disinformation monitoring programme has allowed to keep track of important actions put in place by online platforms. With new variants of the virus spreading and vaccinations continuing at full speed, it is crucial to deliver on the commitments. We look forward to the strengthening of the Code of Practice.”

Internal Market Commissioner Thierry Breton added: “The EU stood by its promise to deliver enough doses to safely vaccinate every EU citizen. All stakeholders now need to assume their responsibility to beat vaccine hesitancy spurred by disinformation. While we are strengthening the Code of Practice with platforms and signatories, we are calling for new signatories to join the fight against disinformation”. 

For example, TikTok's campaign supporting vaccination, with the Irish government, reached over one million views and over 20,000 likes. Google continued to work with public health authorities to show information about vaccination locations in Google Search and Maps, a feature available in France, Poland, Italy, Ireland, and Switzerland. On Twitter, users can now train automated systems to better identify violations of the platform's COVID-19 disinformation policy.

Microsoft extended its partnership with NewsGuard, an Edge extension that warns about websites spreading disinformation. Facebook cooperated with international health authorities to increase public awareness of vaccine efficacy and safety and with Michigan State University (MSU) researchers to better detect and attribute deepfakes. These joint efforts need to continue in view of the persisting and complex challenges that online disinformation still presents. The Commission's COVID-19 disinformation monitoring programme has been extended until the end of 2021 and reports will now be published every two months. The next set of reports will be published in September. Following the recently published Guidance, the signatories have kicked off the process to strengthen the Code and launched a joint call for interest for potential new signatories.

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Coronavirus: Commission signs contract to procure monoclonal anti-body treatment



Yesterday (27 July), the Commission signed a joint procurement framework contract with the pharmaceutical company Glaxo Smith Kline for the supply of sotrovimab (VIR-7831), an investigational monoclonal antibody therapy, developed in collaboration with VIR biotechnology. It is part of the first portfolio of five promising therapeutics announced by the Commission in June 2021, and is currently under rolling review by the European Medicines Agency. 16 EU member states are participating in the procurement for the purchase of up to 220,000 treatments. Sotrovimab can be used for the treatment of coronavirus patients with mild symptoms who do not require supplemental oxygen, but who are at high risk for severe COVID-19. Ongoing studies suggest that early treatment can reduce the number of patients that progress to more severe forms and require hospitalisation or admission to the intensive care units.

Health and Food Safety Commissioner Stella Kyriakides said: “We committed in our COVID-19 Therapeutics Strategy to have at least three new therapeutics authorised by October. We are now delivering a second framework contract that brings monoclonal antibodies treatments to patients. Alongside vaccines, safe and effective therapeutics will play a pivotal role in Europe's return to a new normal.”

Monoclonal antibodies are proteins conceived in the laboratory that mimic the immune system's ability to fight the coronavirus. They attach to the spike protein and thus block the virus' attachment to the human cells. The European Commission concluded nearly 200 contracts for different medical countermeasures worth over €12 billion.

Under the current framework contract with Glaxo Smith Kline, member states can purchase sotrovimab (VIR-7831) if and when needed, once it has received either emergency use authorisation in the member state concerned or a (conditional) marketing authorisation at EU level from the European Medicines Agency. Further information can be found here.

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With vaccines lagging, treatments offer key to stemming India’s COVID death toll



A report by the Washington-based Center for Global Development has revealed that, while official figures set India’s Covid-19 death toll at just over 420,000, the real figure could be up to ten times greater. According to the Center, that would make India the country with the highest coronavirus death toll in the world, far surpassing the United States and Brazil, and would also make the pandemic “arguably India's worst human tragedy since partition and independence", writes Colin Stevens.

Covid-19 deaths have likely been underestimated in Europe as well, with the World Health Organization (WHO) reporting deaths worldwide are likely to be “two to three” times higher than official figures. But in India, four in five deaths were not medically investigated even before the pandemic; now, due to a lack of hospital beds and oxygen, an unknown number of coronavirus sufferers are dying untested and unregistered at home. Widespread social stigma surrounding COVID-19 has compounded this phenomenon, with families often declaring a different cause of death.

While India’s coronavirus infections and deaths have sharply decreased from the peak of the second wave in May, the country has still lost over 16,000 people to Covid since the start of July. Public health experts warn India should brace for a third devastating wave by October, adding urgency to the hunt for tools to help patients who contract severe cases of Covid.

India’s vaccine drive misses targets

Vaccines are the main preventative tool to keep severe infections at bay, and India has already distributed some 430 million doses—more than any other nation after China. Even so, only 6.9% of the Indian population has been fully vaccinated so far, out of a population of 1.4 billion citizens. Since the emergence of the highly contagious Delta variant in October 2020, India’s immunisation drive has been plagued with vaccine shortages, broken supply chains, and vaccine hesitancy.

This month, the WHO announced India will receive 7.5 million doses of the Moderna vaccine via the COVAX facility, but India’s domestic vaccine rollout continues to hit stumbling blocks. Bharat Biotech – who produce the country’s only approved homegrown vaccine, Covaxin – this week projected further delays, making it impossible for India to meet its target of distributing 516 million shots by the end of July.

International disagreement on treatments

With herd immunity still far out of reach, India’s medical services still desperately need effective treatment solutions to help hospitalised patients. Fortunately, life-saving therapeutic options now being tried and tested in Europe could soon offer powerful weapons against the most dangerous infections.

While the number of Covid treatments available are growing as drugs complete clinical trials, global public health bodies are still divided as to which ones are most effective. The only treatment to receive the European Union’s greenlight is Gilead's remdesivir, but the WHO actively advises against that particular antiviral treatment, recommending instead two ‘interleukin-6 receptor blockers’ known as tocilizumab and sarilumab. Tocilizumab has also been proven effective by the wide-ranging RECOVERY trial in the UK, reducing time in hospital and the need for mechanically-assisted breathing.

Despite being a global hub for drug manufacturing, India is not always as quick to approve them. US pharmaceutical company Merck boosted India's manufacturing capacity for the antiviral medicine molnupiravir to help fight the second wave this past April, but local drug trials will not be completed until September at the earliest. In the interim, Indian authorities have awarded emergency approval to a different treatment for Covid-19, 2-DG, despite a lack of published trial data for the molecule.

New treatments like Leukine in the pipeline

This limited set of extant Covid-19 drugs will soon be bolstered by other promising therapies. One such treatment, Partner Therapeutics’ sargramostim – known commercially as Leukine – is currently undergoing testing in both Europe and the United States with a view towards rapid approval. In February, trials led by University Hospital Ghent and bringing together five Belgian hospitals found that Leukine “can significantly improve oxygenation in COVID-19 patients with acute hypoxic respiratory failure,” increasing oxygenation in the majority of patients by at least a third from baseline levels.

After noting Leukine’s potential, the US Department of Defence signed a $35 million contract to fund two Phase 2 clinical trials in order to supplement preliminary data. This past June, the results of the second randomized US trials of inhaled Leukine once again showed positive improvements in the lung functions of patients with the acute hypoxemia caused by severe Covid, confirming the Belgian findings that oxygen levels in patients who had received Leukine were higher than those who did not.

Effective Covid treatments would reduce pressure on Indian healthcare providers not only by improving chances of survival, but also by accelerating recovery times and freeing up hospital beds for other patients, including those dealing with other ailments. Faster treatments would also reduce the dangers posed to patients by contagious conditions such as black fungus, which has already been implicated in the deaths of over 4,300 hospitalised Covid patients in India. Greater clarity and accessibility surrounding treatments would also curb the worrying uptick in Indian families turning to the black market to purchase medical supplies of unknown provenance at hugely inflated prices.

Treatments that improve recovery rates and prevent fatal cases of Covid will remain crucial for as long as most Indians remain unvaccinated. Provided new drugs are approved in a timely manner, improved medical understanding of the virus means new Covid patients should have a better prognosis than ever.

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