Hello, healthcare colleagues, and welcome to the first weekly update from the European Alliance for Personalized Medicine (EAPM) – we have news of an upcoming EAPM event in September which will take place during the ESMO Congress , writes Denis Horgan, executive director of EAPM.
‘The need for change ‘
The conference, EAPM’s ninth annual event, is titled “The Need for Change – and How to Get It: Defining the Healthcare Ecosystem to Determine Value”. The event will take place on Friday September 17th from 8:30 am to 4:30 pm CET; here is link to register and here is the link to the agenda.
Keynote speakers and attendees will come from a wide range of stakeholder groups including patients, healthcare professionals, academics, industry representatives, politicians and legislators, the media and more Again. Given that there is clearly an opportunity to contribute to European thinking, what contribution should be made in the field of cancer? The most obvious need, given the current level of fragmentation of policies and practices, is a new degree of coherence…
But consistency is not enough. Top-down imposition of new rules cannot be the answer if the essence of the EU’s concern – the well-being of its citizens – is to take priority. The oft-cited mantra of patient-centered health care must also have real meaning, and this also involves a careful and thoughtful complement to bottom-up thinking …
Sessions during the event will run as follows:
Session I: Gaining stakeholder confidence in sharing genomic data and using real-world evidence / data
Session II: Integrating molecular diagnostics into health systems
Session III Regulating the Future – Balancing Patient Safety and Facilitating Innovation – IVDR
Session IV: “Saving lives through the collection and use of health data
High-level speakers will include Christian Busoi, MEP, Christine Chomian, Vice President, Cancer Mission Boards and Professor Sir Mark Caufield, former Chief Scientist, Genomics England.
All stakeholders will need to play their part in discussions and policy development, and they will all need to accept that the ultimate goal is better health for patients. Their own interests and priorities must adapt to this priority – EAPM is looking forward to a great event, see you on September 17th!
Artificial intelligence in the regulation of medicine
The International Coalition of Drug Regulators (ICMRA) has made recommendations to help regulators address the challenges that the use of artificial intelligence (AI) poses for global drug regulation, in a report released today. hui. AI includes various technologies (such as statistical models, various algorithms and self-modification systems) that are increasingly applied at all stages of a drug’s lifecycle: from preclinical development to registration. and analysis of clinical trial data, including pharmacovigilance and optimization of clinical use.
This range of applications brings regulatory challenges, including transparency of algorithms and their meaning, as well as the risks of AI failure and the wider impact this would have on the adoption of AI in development. medication and patient health. The report identifies key issues related to the regulation of future therapies using AI and makes specific recommendations for regulators and stakeholders involved in drug development to drive adoption of AI.
The European Medicines Agency (EMA) writes: “There is a need to establish clear mechanisms for regulatory cooperation between the competent authorities for medicines and medical devices and notified bodies in order to facilitate the monitoring of software based on the ‘AI intended for use with drugs.
Spitting jabs booster
World Health Organization chief called for a two-month moratorium on the administration of COVID-19 vaccine boosters as a way to reduce global vaccine inequalities and prevent the emergence of new variants of coronavirus. WHO Director-General Tedros Adhanom Ghebreyesus told reporters in Hungary’s capital Budapest he was “really disappointed” at the scale of vaccine donations around the world as many countries struggle to provide first and second doses to more than a small fraction of their populations while richer countries maintain increasing stocks of vaccines. Tedros called on countries offering third doses of vaccine “to share what can be used for boosters with other countries so (they) can increase their first and second immunization coverage.” However, the wealthy western countries ignore the global health institution. France, Germany, UK, Israel and Hungary have plans for third doses, or are already rolling them out.
The World Health Organization, however, has condemned the rush by rich countries to provide COVID vaccine boosters, when millions of people around the world have yet to receive a single dose. Speaking before U.S. officials announced that all vaccinated Americans would soon be eligible for additional doses, WHO experts insisted there was not enough scientific evidence that Boosters were needed and said providing them when so many others were still waiting to be vaccinated was immoral. “We plan to distribute additional life jackets to people who already have life jackets, while we let others drown without a single life jacket,” said WHO emergency director Mike Ryan, to reporters at the headquarters of the United Nations agency in Geneva.
But senior health officials in the Biden administration have concluded that most Americans will need coronavirus booster shots soon after examining a slew of new data from the U.S. Centers for Disease Control that showed a worrying decline in vaccine effectiveness over time.
Commission concern about possible return from EU internal borders
The Commission faces a situation it would like to avoid at all costs: a return to internal EU travel restrictions like those imposed last year as the coronavirus swept the world.
The Schengen Borders Code (CFS) allows Member States to temporarily reintroduce internal border control in the event of a serious threat to public order or internal security. The reintroduction of border control at internal borders must be applied as a last resort, in exceptional situations, and must respect the principle of proportionality. The duration of such a temporary reintroduction of border control at internal borders is limited in time, depending on the legal basis invoked by the Member State introducing such border control.
The scope and duration of the reintroduced border control should be limited to the strict minimum necessary to respond to the threat in question. The reintroduction of border control at internal borders is normally only used as a last resort and is a prerogative of the Member States. The Commission can issue an opinion on the need for the measure and its proportionality, but cannot veto a Member State’s decision to reintroduce border control.
Bruno Ciancio, the medical epidemiologist who heads ECDC’s surveillance activities, dismissed the travel restrictions as unsupported by scientific evidence.
“I don’t think at this point any travel measures within the EU would be justified,” Ciancio said. The scientist explained that travel, with the exception of the very beginning of the pandemic, “has not played a major role in the infection rates we have seen in Europe.”
“It’s really a minor effect,” he said, as the main factor behind the transmission of the virus was behavior within individual countries.
Seasonal viruses like the flu start spreading in “November, or December, not August,” Ciancio said. On the other hand, it is clear that the coronavirus “can peak in summer as in winter”.
Good news to finish – ‘Lights at the end of the COVID tunnel’
François Balloux, director of the Genetics Institute at University College London, predicts “some outbreaks and epidemics” in Europe this winter, but Professor Balloux says he is “fairly confident” that in countries with high vaccination rates, including the Kingdom – United, the pandemic phase of the virus will be over in the spring. “We see the lights at the end of the tunnel,” he said.
That’s it for EAPM for now – make sure you stay safe and healthy, have a great week, and don’t forget the next EAPM event – here’s the link to register and here is the link to the agenda. Goodbye!