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A FEW WORDS ON THE SESSIONS

European Parliamentary Dinner - MEGA

Key topics at the conference will include EAPM's MEGA project, which as mentioned stands for 'Million European Genomic Alliance'.

With rising healthcare costs and individual health systems being increasingly challenged, genomics has the potential to impact the health of all of us and provide diagnostic, economic and efficiency benefits, ensuring that patients receive the right information and the right treatment at the right time.

This will ease the burden on healthcare systems and lead to a healthier and, thus, wealthier, Europe.

The availability of genetic data from a large number of individuals increases the ability to investigate questions across many rare and common diseases and in different populations, and also provides more information for understanding the results for clinical care in a patient.

MEGA aims to form a coalition of the willing Member States to work together and reach the million genome figure.

There are already major projects being undertaken in the EU, such as the UK's 100,000 Genomes Project, that are looking to address some of these issues at a national level. Coordinating across these projects and implementing supportive regional and national policy and activities can overcome these challenges to ensure maximal health system and patient benefit while ensuring public engagement with how this is done.

EAPM's project aims to stimulate the life sciences economy, and improve patient care as a response to the Precision Medicine Initiative (PMI) in the US, which received initial funding of $215 million under former-president Obama and similarly aims to build a research cohort of at least a million individuals that will include their genomic data.

This MEGA project will take into account that every country has bigger or fewer resources, but the concept would ideally see a linking together of the efforts in order to reach the one million figure.

If the US can achieve it with a population of 320 million, EAPM believes that Europe can achieve it with around 500 million citizens of its own.

This would certainly represent a real breakthrough and allow the utilisation of the research across different health domains.

A coordinated, pan-European MEGA project would garner crucial genetic information that could have an immeasurable benefit when it comes to the health of current and future citizens across the EU.

Session I - A broad picture of profiling, genomics and personalised healthcare

Another session will highlight that genomic scientific and technology advances have the potential to reduce costs while having clinical relevance in rare disease, cancer, infectious diseases, and increasingly complex diseases.

Better use of our increasing understanding of the genome is recognised as being one of the main determinants of future improvement in healthcare as part of personalised medicine, and is already being increasingly deployed in routine clinical practice.

Sequencing of the all the genetic material of an individual, whole genome sequencing, is becoming an affordable and achievable test for clinical use and creates a powerful resource for research. Arguably, information is the main value asset of 21st century.

Big Data and digital technologies are here and here to stay, and bring many benefits to the rapidly growing area of eHealth, mHealth, the aforementioned treatment of rare diseases and more.

n a wider personalised medicine basis, Europe needs synergies to be realised at Member State level, a topic to be discussed at length while specific disease areas, such as haematology and Big Data, will come under the Alliance microscope.

Medical research, clinical trials and more are generating unprecedented amounts of Big Data that is moving treatments forward in many disease areas. However, rare diseases present their own challenges, and in this sense the need for cross-border, pan-European collaboration is greater than anywhere.

Big Data can also be put to excellent use by providing the evidence base for treatments, not least in neurology, which will be discussed at the conference, alongside public health genomics and diabetes.

The World Health Organisation estimates that there are some 60 million people with diabetes in Europe, which equates to around 10.3% of men and 9.6% of women aged more than 25 years.

Its prevalence is increasing among all age groups, for the most part due to increases in obesity, unhealthy diets and physical inactivity. Europe needs better access to data to tackle this issue and more.

Session II - Haematology and Big Data

Recent advances in widening the knowledge of haematological malignancies (HMs), coupled with the availability of detailed information relating to individual patients from clinical trials, have led to major changes in healthcare, increasing HM patient survival rates and improving quality of life.

However, a substantial proportion of patients with HMs still have a poor prognosis due to relapse and refractory disease. The molecular characterisation achieved in the past years has revealed HMs to be genetically complex and heterogeneous diseases, and there is still an urgent need to develop innovative therapeutic approaches for the majority of HM patients.

Clinical and non-clinical data are of enormous value for the development of new treatment options and for clinical decision-making when treating HM patients.

While large data collections of specific patient populations can only be realised through a pan-European approach, there is also an unmet need to harmonise outcome measures and endpoint definitions for HMs and their collection at the European level.

HARMONY is a European Network of Excellence that captures, integrates, analyses and harmonises Big Data from high-quality sources to acquire valuable knowledge across the spectrum of HMs, to enable the rapid definition of promising treatment strategies, and prediction of adverse events likely to be associated with such strategies.

This project will uniquely enable all key healthcare system stakeholders (regulators, HTA, physicians and patients) to assemble, connect, analyse and interpret Big Data.

The definition of HM outcome indicators that are relevant and meaningful to all stakeholders will contribute to harmonising the pan-European approach towards the measurement-based decision-making in HMs at all levels of the healthcare system.

Member State collaboration and European Commission support is vital in this context.

Session III - Providing the Evidence Base through Big Data

A further session will raise and discuss the topic of realising the vision of personalised healthcare through Big Data, while another will cover the broad picture of profiling, genomics and personalised healthcare.

MEPs have been very supportive of EAPM down the years and work hard with us as part of the STEPs group in the European Parliament. STEPs stands for Specialised Treatment for Europe's Patients and we will be delighted to welcome MEPs once again to our conference.

On top of this, the event will also be working to realise the Council Conclusions of the Estonia Presidency, with which EAPM was highly involved, and these come on the back of our input into the groundbreaking Luxembourg Council Conclusions on personalised medicine.

Many of Estonia's conclusions on Health in the Digital Society - making progress in data-driven innovation in the field of health' echo those reached at EAPM's several conferences and particularly at the inaugural congress held in Belfast at the end of November.

The Alliance has played a major role in many of the sections, not least regarding genomics, and the draft notes that new opportunities are arising from big data and improved data analytics capabilities, as well as from personalised medicine, use of clinical decision support systems by health professionals and use of mobile health tools for individuals to manage their own health and chronic conditions.

New knowledge and skills are needed in the health sector to be able to utilise this potential.

The Conclusions invite the Member States and Commission to build on the existing national and EU initiatives and public-private partnerships, and consider creating decentralised data networks and common platforms to enable data integration and analysis in a secure environment.

This would be while supporting large-scale cross-border implementation projects, for example in the field of personalised, including genomic, medicine.

Yet another area of discussion will be providing the evidence base through Big Data, and also cover ethics, healthcare system efficiency and new value frameworks.

On top of this, up for discussion at Bibliothèque Solvay will be the vital role of biomarkers as we move forward and develop personalised medicine and the necessary next steps required to integrate innovation into healthcare.

A biomarker is any substance, structure, or process that can be measured in the body or its products and influence or predict the incidence or outcome or disease. Biomarkers are also used for disease prognosis, the patient likelihood of responding to a given treatment, to monitor treatment response but also throughout the cancer drug discovery process.

Yet biomarkers are still largely unknown by cancer patients and are insufficiently used by physicians, according to a survey conducted by the European Cancer Patient Coalition and EAPM.

Physicians use diagnostic tests for various levels of clinical decision support (i.e. to confirm a diagnosis, to estimate prognosis, or to make a therapy selection, etc).

Poor patient knowledge surrounding diagnostic technologies and biomarkers, and lack of reimbursement for biomarker testing in many European countries creates an obstacle for improving cancer patients' clinical outcomes.

Session IV - Commissioners' discussions

EAPM hopes to have input from two European Commissioners - Vytenis Andriukaitis, Commissioner for Health and Food Safety, and Andrus Ansip, the Commissioner for the Digital Single Market Setting.

These two European heavyweights and influencers will set out their frameworks for the future of healthcare and allow interaction with EAPM stakeholders.

Session V - Role of Biomarkers

In medicine, a biomarker is a measurable characteristic that reflects the severity or presence of some disease state. More generally a biomarker is anything that can be used as an indicator of a particular disease state or some other physiological state of an organism. How can policy and regulation facilitate the better update in clinical practice?

Concluding session

At the end of the conference, one of our STEPs MEP champions and former Prime Minister of Slovenia Alojz Peterle will set out key take-home messages while outlining what conference has

 

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