The opening day of the Third Annual Congress organized by the European Alliance for Personalised Medicine (EAPM) saw a multitude of stakeholders working hard to bring innovation into modern-day health care, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Tuesday’s (3 December) gathering coincided with yesterday’s meeting of EU health attachés on HTA. The Finnish presidency of the Council was looking for a compromise at the meeting – the last under its presidency of the Council. All the key actors on that topic were also in the room at EAPM’s Congress.

The Alliance event, held under the auspices of the Finnish Presidency of the EU, is titled Forward together with Innovation: The importance of policy making in the era of personalised Medicine’, and is being held at the Fondation Universitaire in Brussels (3-4 December).

The meeting of multidisciplinary personalised medicine experts follows two successful annual congresses in Belfast and Madrid, plus seven annual Presidency Conferences.

The potential of personalised medicine

We live in an age promising routine delivery of personalised health care driven by rapid and substantial developments in the understanding of the molecular basis of disease, coupled with the in-parallel development of new therapeutics, and diagnostic modalities designed to specifically target and treat mechanisms thought to drive the disease/cancer process.

It is a simple central tenet – match a medicine and its mechanism of action to patients identified with a selection marker(s) predictive of response, and more durable clinical benefit should be achieved.

However, the current established healthcare systems come from a pre-precision time, and more traditional medicine-development strategies are less aligned to todays needs.

Different processes and metrics are required; new ways of working together, and the need to ensure that the current misalignment does not hamper chances of advancement towards better future healthcare provision.

Ultimately, the patient benefits, but the system needs to be sustainable and deliverable. And innovation must be encouraged and fostered.

What happened on Day One

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

The key thrust of Day One of the event looked at facilitating an environment for delivery of better healthcare for the EU and member states.

It included sessions on Big Data and healthcare, public health, translational research and bringing innovation into health-care systems.

After pre-meetings on the topic of biomarkers and molecular diagnosis, the first afternoon of the main event saw sessions on facilitating an environment for delivery of better healthcare for the EU and member states, Big Data and healthcare, public health (including rare diseases), plus translational research and brining innovation into healthcare systems.

Gordon McVie, co-chairman of the European Alliance for Personalised Medicine, and EAPM’s executive director Denis Horgan set the scene for attendees.

McVie reminded delegates that it had been a busy year, dominated by the Parliamentary elections, the setting up of a new European Commission under Ursula von der Leyen, a review of the Orphan Regulation, wrangling over mandatory aspects of HTA and, of course, Brexit.

He said: “Whenever the true repercussions of the departure of the UK from the EU start to become clear and really kick-in, some reshuffling of the pack in the vast EU-wide health arena is absolutely necessary.

This is not so much the obvious and visible things, such as the relocation of the European Medicines Agency from London to Amsterdam, but the less immediately tangible things such as research cooperation, cross-border healthcare, Europe-wide standards, the movement of vital medicines, and more.

All would be discussed at Congress, he added.

Horgan told the Congress: “Taking into account all that Gordon has mentioned, the truly awesome developments in personalised medicine are happening on the ground. Not as quickly as the majority of us would like, of course. But it is undeniably happening.

What once seemed opportunities for the future are with us here, right now, today. These opportunities are ready to be grasped and moulded into realities,” the Alliance chief added.

MEP Toine Manders told attendees that: “Making better use of Big Data in a medical sense will achieve several things, including reducing current inequalities in access to innovative technologies such as genetics.

“It would also lead to the development of deeper and broader collaborations across European researchers and provide a database of enormous lasting value to all in the EU,” the MEP added.

The Big Data session heard from, among others, Marco Marsella, head of unit in DG Connect, at the European Commission.  Marco said that, in February 2019, The European Commission adopted Recommendations on a European Electronic Health Record exchange format to improve interoperability and  access to data across border.   “This is a very good beginning to support cross border access to data that will benefit European citizen who have moved in another European country.”

And Mario Romao, of Intel, speaking about artificial intelligence (AI), said: “Today, health care accounts for 30% of world data production. The economic value of AI will thrive with a good regulation. The digital revolution will happen even if we don’t do anything, but a policy transformation is required to reap its benefits. The approach should be the establishment of a health data space. The challenge should be to digitalize health care: 100% digital in five years.”

And Bruno WohlschlegelHead of Europe, Merck, meanwhile said: “Tangible progress on personalised medicine will bring huge benefits to patients, but also to clinicians and the health-care system.

“However, there are many challenges to address in a rapidly evolving landscape.  All health-care stakeholders need to collaborate with a robust code of ethics to provide meaningful solutions to issues such as definition and collection of health data, access to data, and integrating data into healthcare decision-making,” the Merck man added.

Later, talking about the rare disease perspective, Stephen McMahon, President of the Irish Patient Associationtold attendees that: “In the EU, as many as 30 million people may be affected by one or more existing rare diseases, which run into their thousands now. Almost 6,000, in fact, according to the European Commission.

“And let’s be clear, this is also a global public health problem, not least in developing countries.

Stephen pointed out that these diseases are distinctive in that there are, obviously, a limited number of patients with them and often a lack of long-term research and therefore knowledge regarding them.

These life-threatening or chronically debilitating diseases affect so few people that combined efforts are needed to reduce the number contracting the diseases,” she said, adding: “Work also needs to be done to prevent newborns and young children dying from them, and preserve sufferers’ quality of life and their socio-economic potential.

Stephen also spoke about cervical cancer yesterday. He referred to a just-published review of Ireland’s national cervical screening programme, which found that in the region of one third of cancer cases studied may have received incorrect results.

In many cases, the review found that the original result had “an adverse effect on the woman’s outcome”. Stephen described these as “missed opportunities either to prevent cancer, or to diagnose it at an earlier stage”.

Meanwhile, attendees at the session on translational research and bringing innovation into healthcare systemsheard Indridi Benediktssonpolicy office, DG Resarch at the European Commission, say that: There is a misunderstanding on what personalised medicine is and is not. This is not an expensive medicine for the rich. We need to tackle this misunderstanding.   

We want to help people have better access to medicine, but we also want more prevention of disease. We need to change our mindset. It is not only about spending more money on medicine, it is also about improving quality of life and prevent expenses on the wrong drug or at the wrong time.” 

Android added: “We know that five to seven percent of hospital admissions are due to bad drug reactions. Personalised medicine would prevent this.

Happening today…

Day Two should be full and productive with sessions on the current hot topic of the Orphan regulation, evidence frameworks, plus value-based outcomes and biomarkers.

Biomarkers were discussed recently at an EAPM satellite event which took place at the ESMO Congress in Madrid and two pre-Congress round tables on the subject of biomarkers and molecular diagnostics are on the agenda today.

Meanwhile, consistency across disease areas is required, and potential efficiencies for agencies need to be identified – with the ultimate aim of faster patient and citizen access to companion and 
molecular diagnostics with proven value.

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