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

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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.

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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. 

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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.

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Pfizer begins study of oral drug for prevention of COVID-19

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Pfizer Inc (PFE.N) said on Monday (27 September) it has started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus.

The drugmaker and its rivals, including US-based Merck & Co Inc (MRK.N) and Swiss pharmaceutical Roche Holding AG (ROG.S), have been racing to develop an easy-to-administer antiviral pill for COVID-19. Read more.

The mid-to-late-stage study will test Pfizer's drug, PF-07321332, in up to 2,660 healthy adult participants aged 18 and older who live in the same household as an individual with a confirmed symptomatic COVID-19 infection.

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In the trial, PF-07321332, designed to block the activity of a key enzyme needed for the coronavirus to multiply, will be administered along with a low dose of ritonavir, an older medication widely used in combination treatments for HIV infection.

To date, Gilead Sciences Inc's (GILD.O) intravenous drug remdesivir is the only approved antiviral treatment for COVID-19 in the United States.

Pfizer has also started another study of PF-07321332 in non-hospitalized, symptomatic adult patients.

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Merck and partner Ridgeback Biotherapeutics recently launched a late-stage trial of their experimental drug molnupiravir for prevention of the COVID-19 infection. Read more.

Molnupiravir is also being studied in a late-stage trial in non-hospitalized patients to see if it reduces the risk of hospitalization or death.Reporting by Manojna Maddipatla and Amruta Khandekar

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EU Digital COVID Certificate: Commission awards €95 million to boost access to tests

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The Commission has awarded grants to 20 member states totalling €95 million to purchase COVID-19 diagnostic tests to facilitate the delivery of the EU Digital COVID Certificate. This goes hand-in-hand with the continued roll-out of COVID-19 vaccinations and is part of the Commission's commitment to support affordable access to fast and accurate testing for those citizens who have not yet been fully vaccinated, in particular those who cannot get vaccinated due to medical reasons.

The grants, financed through its Emergency Support Instrument (ESI), will allow member states to provide tests. This support, channelled through the national authorities, will cater for the various needs in the different member states. Health and Food Safety Commissioner Stella Kyriakides said: “The EU Digital COVID Certificate allowed Europeans to resume safe travelling over the summer and has become a symbol of an open and safe Europe. Whilst vaccination is key and our strongest asset to put an end to the pandemic, fast and accurate testing remains important to tackle the spread of COVID-19. The 20 million rapid tests we purchased for member states earlier this year and today's announcements of additional funds prove that we stand firm on our commitment to ensure that citizens have access to tests and that our digital certificates are available for everyone, in particular those who cannot get vaccinated.”

Justice Commissioner Didier Reynders said: “Over 400 million Europeans have so far benefited from the Certificate, and 42 countries are already linked to the EU certificate system. This is a major European achievement which has been highly valued by our citizens. Today's grants will further contribute to the use of the certificates and ensure that people can continue to move freely and safely. I welcome this decision and I call on the 20 member states to make the best use of those additional tests.”

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The ESI provides a needs‐based, co-ordinated emergency response to help member states address needs related to the immediate acute phase of the COVID-19 pandemic, as well as the exit, recovery and prevention of any resurgence.

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US-EU agenda for beating the global pandemic: Vaccinating the world, saving lives now, and building back better health security

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Vaccination is the most effective response to the COVID pandemic. The United States and the EU are technological leaders in advanced vaccine platforms, given decades of investments in research and development.

It is vital that we aggressively pursue an agenda to vaccinate the world. Co-ordinated US and EU leadership will help expand supply, deliver in a more coordinated and efficient manner, and manage constraints to supply chains. This will showcase the force of a Transatlantic partnership in facilitating global vaccination while enabling more progress by multilateral and regional initiatives.

Building on the outcome of the May 2021 G20 Global Health Summit, the G7 and US-EU Summits in June, and on the upcoming G20 Summit, the US and the EU will expand cooperation for global action toward vaccinating the world, saving lives now, and building better health security.  

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Pillar I: A Joint EU/US Vaccine Sharing Commitment: the United States and the EU will share doses globally to enhance vaccination rates, with a priority on sharing through COVAX and improving vaccination rates urgently in low and lower-middle income countries. The United States is donating over 1.1 billion doses, and the EU will donate over 500 million doses. This is in addition to the doses we have financed through COVAX.

We call for nations that are able to vaccinate their populations to double their dose-sharing commitments or to make meaningful contributions to vaccine readiness. They will place a premium on predictable and effective dose-sharing to maximize sustainability and minimize waste.

Pillar II: A Joint EU/US Commitment to Vaccine Readiness: the United States and the EU will both support and coordinate with relevant organisations for vaccine delivery, cold chain, logistics, and immunization programs to translate doses in vials into shots in arms. They will share lessons learned from dose sharing, including delivery via COVAX, and promote equitable distribution of vaccines.

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Pillar III: A Joint EU/US partnership on bolstering global vaccine supply and therapeutics: the EU and the United States will leverage their newly launched Joint COVID-19 Manufacturing and Supply Chain Taskforce to support vaccine and therapeutic manufacturing and distribution and overcome supply chain challenges. Collaborative efforts, outlined below, will include monitoring global supply chains, assessing global demand against the supply of ingredients and production materials, and identifying and addressing in real time bottlenecks and other disruptive factors for global vaccine and therapeutics production, as well as coordinating potential solutions and initiatives to boost global production of vaccines, critical inputs, and ancillary supplies.

Pillar IV: A Joint EU/US Proposal to achieve Global Health Security. The United States and the EU will support the establishment of a Financial Intermediary Fund (FIF) by the end of 2021 and will support its sustainable capitalization.  The EU and United States will also support global pandemic surveillance, including the concept of a global pandemic radar. The EU and the United States, through HERA and the Department of Health and Human Services Biomedical Advanced Research and Development Authority, respectively, will cooperate in line with our G7 commitment to expedite the development of new vaccines and make recommendations on enhancing the world's capacity to deliver these vaccines in real time. 

We call on partners to join in establishing and financing the FIF to support to prepare countries for COVID-19 and future biological threats.

Pillar V: A Joint EU/US/Partners Roadmap for regional vaccine production. The EU and the United States will coordinate investments in regional manufacturing capacity with low and lower-middle income countries, as well as targeted efforts to enhance capacity for medical countermeasures under the Build Back and Better World infrastructure and the newly established Global Gateway partnership. The EU and the United States will align efforts to bolster local vaccine manufacturing capacity in Africa and forge ahead on discussions on expanding the production of COVID-19 vaccines and treatments and ensure their equitable access.

We call on partners to join in supporting coordinated investments to expand global and regional manufacturing, including for mRNA, viral vector, and/or protein subunit COVID-19 vaccines.

More information

Joint statement on the launch of the joint COVID-19 Manufacturing and Supply Chain Taskforce

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