Presidential Session Narrative

European Congress on Personalised Medicine, Belfast 2017

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Personalising Your Health: A Global Imperative!

 

27 November

Opening Plenary Session – 12.00 – 14.00


Growth in Healthcare – The promise for future generations

Session Organiser: Denis Horgan
Executive Director, EAPM
Whether it is post-Brexit growth in the UK or resilience in China, improved healthcare supports economic activity.
A healthier Europe will mean citizens spending less and less time in hospitals under expensive treatment regimes, often at a direct cost to the taxpayer, and it will also mean that people receiving the right treatment at the right time are more able to stay in the workplace, thus generating wealth rather than whittling it away.

By the same token, a shift towards preventative medicine will reduce costs still further.

A focus on research into new medicines and cutting-edge treatments will also create jobs – whether they be in research itself, education, design and manufacture of in-vitro products or within the pharmaceutical industry. Such a focus will clearly benefit society and, if Europe is in the vanguard of developing new ways of keeping citizens healthy, it will inevitably attract investment from outside of the bloc.

It’s fair to say that the financial crisis challenged the principle of solidarity in Europe. Austerity measures are always unpopular wherever they occur and the impact upon citizens is abrupt and painful. Governments often opt for the short-sharp-shock solutions and focus on the ‘easy’ targets. Healthcare (and the people who need it) is always one of the first victims. But this is a short-sighted view. The maths doesn’t work.

The road to better health must have personalised medicine as its destination. This innovative method of treating patients utilises research, data and up-to-the-minute technology to provide better diagnostics and follow-up for citizens than is currently the case.
With the backing of the European Union, Europe can work towards building a healthy and wealthy Europe, one worthy of its stated goals – not only for our current 500 million potential patients across28 Member States, but for generations to come.


Presidential Session – 16.30 – 18.30


US – UK – EU – UN Developing a special Relationship – Is precision medicine the route to a healthy world?

Session Organiser: Alexander M.M. Eggermont, MD,PhD
Directeur Général Gustave Roussy, Professeur Oncologie, Université Paris-Sud

2016 was certainly an interesting year. Quite apart from rock stars dying left, right and centre, there were at least two major political upsets: Brexit and the US presidential election result.

Civic unrest, hate crimes, denial, the blame game and more ensued and it all seems to be in direct opposition to Robert Kennedy’s famous ‘ripple of hope’ speech in South Africa when he said: “…each time a man stands up for an ideal or acts to improve the lot of others or strikes out against injustice…he sends forth a tiny ripple of hope…those ripples build a current that can sweep down the mightiest wall of oppression and resistance”.

For many people, these testing times are offering up more fear than they are hope, despite great leaps in technology as well as more involved, knowledgable and, thus, empowered patients.

The trouble is, there is still much discrimination in healthcare (on both sides of the Atlantic) and there is a real need to ensure inclusivity and make certain that technology is integrated to allow for the right treatment for the right patient at the right time.
The challenges are many, and include providing real patient-centric care as well as an end to silo thinking across and within stakeholder disciplines, more incentives for research, more and better guidelines for, say, screening programmes and a new model for clinical trials that takes into account genetically sourced sub-groups in the rare diseases arena.

These are just a few barriers to integrating personalised medicine into the lives of people of the European Union, UK, the United States and the UN. Everyone certainly needs a ripple of hope, a way to mend the fences (arguably rather than building walls, metaphorical or literal), and a change to these chaotic and times.

Whatever becomes of a multi-faceted Brexit, whatever becomes of Obamacare and PMI, the idea of keeping citizens as healthy as is humanly possible has to lie at the core of civilised society. This session will examine the potential, the barriers and enablers for personalised medicine.


28 November

Presidential Session – 09.00 – 10.45


Shaping Future Healthcare Systems

Session Organiser: Peter Hongaard Andersen
Director, Innovation Fund Denmark
A healthier Europe will mean citizens spending less and less time in hospitals under expensive treatment regimes, often at a direct cost to the taxpayer, and it will also mean that people receiving the right treatment at the right time are more able to stay in the workplace, thus generating wealth rather than whittling it away. In order to be successful with that, the way health care system is operating will change.

Personalised healthcare will need to start with prevention to be truly successful and individual, it will move from disease management to health management which will change the cost structures and prevent loss of quality life and generate wealth. In order to be effective in personalised medicine and specifically prevention the way therapy is approved and subsidized will need significant modernization to be successful. Individual responsibility in risk reduction and cost sharing/insurance is foreseen to develop. The medical structures and citizen involvement will also need development to optimize the best use of the new possibilities.

To develop these opportunities focus on research into new medicines and cutting-edge treatments is key and this will already in the shorter run create jobs – whether they be in research itself, education, design and manufacture of in-vitro products or within the pharmaceutical industry. Such a focus will clearly benefit society and, if Europe is in the vanguard of developing new ways of keeping citizens healthy, it will inevitably attract investment from outside of the bloc.

With the backing of the European Union, Europe can work towards building a healthy and wealthy Europe, one worthy of its stated goals – not only for our current 500 million potential patients across 28 Member States, but for generations to come.


Presidential Session – 13.00 – 14.15


Female Leaders and Innovators Forum

Session Organiser: Mary Baker
past President, European Brain Council

As with the development in science, the world and the ways of networking and collaborating on scientific projects have changed dramatically, even in the past decade. The opportunities available to women, the pathways to success, and the heights that they can reach are unlike those of previous generations.

The rise of women into society’s most powerful leadership roles—across sectors, around the globe—ranks among the most profound social transformations of recent decades.

As well, today it is better recognized that there are opportunities and demands to use gender and sex in an advantageous manner for scientific discovery and engineering innovations. Unfortunately, extra challenges, including implicit bias and poor workplace climates, impede women from reaching their true potential and contributing fully to society. International variations are significant; some hinder progress while others help.

For example, many Scandinavian countries have superb parental care and leave policies, and yet women have not reached equity.
This session will examine the different issues relating to this from a political, social, economic, cultural, regional and international level.


Presidential Session – 16.30 – 18.00


Clinical Innovation – from Local to Global

Session Organiser: Mark Lawler
Dean of Education Faculty of Medicine, Health and Life Sciences, Queen’s University Belfast

What have a church in Barcelona and the health of the EU’s citizenry got in common? Not much, at first glance, but you may be surprised.

Work on the famous La Sagrada Familia Basilica in the capital of Catalonia has entered its final stage and is on track to be (virtually) completed in another ten years.

The year 2026 will mark the centenary of visionary architect Antoni Gaudi’s death, and the by-then-finished central tower of 172.5 metres will make it the tallest cathedral in Europe, beating the tower of Ulm, in the federal German state of Baden-Württember, at 162 metres.

The plan has been to raise six huge towers in Barcelona, and the central ‘Tower of Jesus Christ,’ the tallest of the six, will take the popular tourist attraction into the record books.

But Gaudi left a huge legacy. He knew his towering and beautiful church would not be complete before his death, but still he began to build it, knowing that one day it would be finished for the benefit of the generations that followed.

In a similar fashion, science has led to major advances in the understanding of the role of genomics in diseases, in the discovery of biomarkers, in the development of new statistical methods and in the invention of dynamic tools for collecting real-world effectiveness and safety data. The opportunity exists to move beyond the current symptom-based approach to diseases.

But to create effective new methods of diagnosis, treatment and prevention, scientificevidence must be translated into patient access. The current R&D and regulatory processes are ill-adapted, and need adapting to a new understanding of disease biology. Promoting innovation will require organisational change to move more efficiently from science to R&D, with greater certainty from product development to product authorisation, and more rapidly from authorisation to patient access.

Such altruism is not always the norm, and it is the responsibility of policy- and lawmakers to always invest in the future in whatever way possible, by boosting research and development, and in this case letting patients share their data in a speedy, safe and efficient manner, rather than impeding the process with out-of-date or cumbersome legislation.

29 November

Presidential Session – 09.00 – 10.45


Big Data Saves Lives

Session Organiser: Mark Lawler
Dean of Education Faculty of Medicine, Health and Life Sciences, Queen’s University Belfast;
Denis Horgan
Executive Director, EAPM
In respect of personalised medicine, Big Data represents the vast and continuously growing amount of health information (including biomedical and environmental) and its usage to drive innovation in translational research and health outcomes tailored to the individual. Using these data to first understand the cause of disease, the medical profession can then develop new drugs and therapies to find the cure, as well as other health interventions targeting the individual. The personalised, individual approach requires advanced technologies and processes to collect, manage and analyse the information and, even more importantly, to contextualise it, integrate it, interpret it and provide rapid and precise decision support in a clinical and public health context.

Not only does Big Data offer the potential to revolutionise the effectiveness of health interventions, it may also help ensure the more effective management of resources in what are increasingly cash-strapped public healthcare systems. Over the coming decades, the financial sustainability of health systems will become more and more challenging as the population ages. The number of over 65s in Europe will increase by 75% by 2060. Alongside this ageing population there is likely to be an associated rise in chronic illness which will lead to spending on health and social care reaching unsustainable levels unless we are able both to increase the quality of health outcomes and the efficiency of healthcare resources. Big Data, in theory, offers the potential to do both. It is widely acknowledged that ‘value-based’ approaches to the management of care are an ideal way forward. Big Data will be a key enabler of this. And in future, physicians and health managers should have real-time, real-world evidence on what works and what doesn’t for each patient. Moreover, other trends, such as mHealth, will bring the benefits of Big Data much closer to the citizen. That should lead to more informed individuals, and more rational and less wasteful decision-making.

Getting a Data Strategy for Personalised Medicine right in Europe would yield multiple benefits. Not only would it accelerate the development of more effective treatments and potentially help with the management of healthcare resources as described above, it would also act as a foundation for private sector investment and jobs in R&D in Europe. Global developments in approaches to Big Data in healthcare are of major importance to the future of several industries including startups and SMEs on ICTs, pharmaceuticals, medical devices and others. A coherent strategy for Big Data would, for example, have a direct effect on the attractiveness of a given health system for the placement of clinical trials. The European Union should see Big Data as a strategic investment that could drive industrial competitiveness.

This session will examine these element through a debate and panel discussion


Presidential Session – 13.00 – 14.15


Research Frontiers in Personalised Medicine

Session Organiser: Denis Horgan
Executive Director, EAPM
Europe’s and the international research landscape remains too fragmented. A lack of critical mass in many research centres means not enough patients, biological materials, technological resources or competences. Wider collaboration and better infrastructure would help: technical platforms for genomics and other specialty disciplines, screening facilities for new pharmaceutical agents, biobanks for tissues and biofluids, quality-assured patient registries…

So too would better resources, for prospective validation of biomarkers that may be predictive for treatment, networks on biostatistics, epidemiology and outcomes research. Integration along the research continuum would make it easier to bridge basic/preclinical research and clinical research in early translational research. In late translational research, clinical results could be more closely linked to innovations in the health care systems, incorporating outcomes research more systematically, and profiting from the broader human perspective that patients’ experience and expertise can bring.

The session will present the leading developments in the area from the oncology, neurology and diabetes.


Presidential Session – 16.30 – 18.00


Public-private partnerships and personalised medicines research

Session Organiser: Pierre Meulien
Executive Director, IMI
The challenges to be overcome in developing personalised medicine are numerous and difficult. They include the wide heterogeneity of disease, a lack of predictive biomarkers, clinical designs and regulatory processes that are outdated, the determination among public authorities to contain healthcare spending, and the inadequate incentives for companies.

While biomedical research is already delivering personalised medicines and benefiting patients in areas such as cancer, and it is becoming increasingly clear that a personalised approach to treatment is needed in many other disease areas. However, identifying the different and distinct diseases that are currently considered to be one disease and developing the appropriate tests to diagnose them and the treatments to tackle them requires a large scale research and innovation effort involving all key players in the drug development process.

Only a shift in mindset among the stakeholder communities can overcome these challenges. Identifying the different and distinct diseases that are currently considered to be one disease and developing the appropriate tests to diagnose them and the treatments to tackle them requires a large-scale research and innovation effort involving all key players in the drug development process. Public-private partnerships are a valuable model for driving personalised medicines research forward, as they bring together experts from academia, research centres, the pharmaceutical industry, small and medium sized enterprises, hospitals, regulators, and patient groups. For this reason, public-private partnerships (PPPs) represent a suitable model for driving forward personalised medicines research, as they bring together experts from academia, research centres, the pharmaceutical industry, small and medium sized enterprises (SMEs), hospitals, regulators, and patient groups.

The Innovative Medicines Initiative (IMI), as the largest public-private partnership of its type, is an example of how a neutral broker can promote that shift. By bringing together both private industry and the public sector – in the form of the European Commission – it is able to foster large-scale industry collaboration and engagement with the scientific community. It can catalyse open innovation. It can facilitate intellectual property agreements. It ensures the excellence of the partnerships and projects established. And it promotes the active involvement of patients, regulators and payers. The outcomes are an increased probability of success and earlier patient access. Public-private partnerships contribute to move personalised medicine forward by addressing key scientific challenges, developing tools to translate scientific advances into regulatory guidelines, considering new pathways to accelerate patient access to innovative therapies.

In practice, this means that new research findings benefit from the expertise and input of, and can be rapidly exploited by, all key groups. In addition, PPPs very often involve all partners pooling data (including companies’ historical or legacy data) to create immense databases that offer new opportunities for research.

30 November

Presidential Session – 09.00 – 10.45


Health Economics and Decision Making in Personalised Medicine

Session Organiser: Professor Richard Sullivan
Director of the Institute of Cancer Policy and KHP Integrated Cancer Centre, Kings College London
In a tough economic environment, European Union governments and healthcare providers have been seeking to maximise the value for money that they can obtain from the acquisition of new treatments for patients. Consequently, there is also a large awareness of the limits that can be placed on patients with regards to having to make financial contributions to their healthcare needs. Payers are now increasingly likely to deny or severely restrict the use of advanced therapies when there is no clear or exceptional economic value for the broader population as they seek to cut costs and decrease public spending and debt.

Current models have been based on medicines designed to treat an entire patient population, and the economic value of a specific medicine has traditionally been analysed through a comparison with other treatment alternatives or palliative care. These comparisons are made through the collection of data taken during randomised controlled trials across a broad patient population. In the past, there have been efforts to specifically select sub-groups of patients based on certain conditions, such as age, sex, or likeliness to contract a certain disease, but importantly, these were not constituted with firm scientific evidence or statistically well-sampled within the clinical data, lacking in particular crucial information regarding the molecular and individual patient level.
This session will examine different strands of this issue.


Presidential Session – 13.00 – 14.15


Regulating the future – Balance of patient safety and facilitating innovation (EMA-FDA)

Session Organiser: TBC

The field of regulatory affairs in the European Union and the US is by its very nature a complex one. Perhaps nowhere more complex than in the arena of health – and certainly extremely complicated when it comes to legislating for the exciting advances and growing expectations being brought about by personalised medicine. The issues and rules surrounding, for example, in vitro devices and data protection are labyrinthine. Yet they need to be addressed swiftly and effectively if we are to be able to give the right treatment to the right patient at the right time while, at the same time, offering every European equal access to the best treatment available.
This is a major problem in many areas of health generally, and PM in particular, covering everything from education to information sharing, and from authorities deciding patient access to the need for one, clear voice to communicate with legislators and much more. It is also a fact that much legislation tends to be reactive rather than proactive.

Again, with better collaboration between all involved stakeholders, including the EMA and FDA, it will be possible to foresee potential problems that could occur down the line, rather than acting in an ad-hoc manner if and when these problems do occur. In the fast-moving area of PM with its cutting-edge science it is already, and will become more, vital that stakeholders collaborate openly and effectively. This should ensure that regulations and legislation covering, for example the new, smaller clinical trials required to make PM work effectively, the huge practical and ethical issues surrounding Big Data and data protection, and the necessary standards for biobank samples and in vitro devices are common, understood and enforced across the EU.
This session will look at the different threads of this issue through a high level discussion constituted by representatives from the EMA-FDA around thematic areas.


Closing Presidential Session – 16.30 – 18.00


Keeping the Promise and Preparing for the Future

Session Organiser: Mark Lawler
Dean of Education Faculty of Medicine, Health and Life Sciences, Queen’s University Belfast;
Denis Horgan
Executive Director, EAPM

As we try to look forward in terms of personalised medicine there is certainly a long way to go to fully integrate it into healthcare systems across Europe.

For example, as discussed elsewhere in the Congress, stakeholders need to leave their silos and cooperate, both within countries and across borders. Fortunately, there are clear signs that this is happening more and more.
New technologies can only help, and sensible data protection legislation that safeguards the rights of individuals, while also allowing for the necessary use of vital data in medical research, will be a key driver of long-term success in this area.

The European Alliance for Personalised Medicine, in its STEPs campaign, set out the following key goals:
STEP 1: Ensuring a regulatory environment that allows early patient access to novel and efficacious personalised medicine
STEP 2: Increasing R&D for personalised medicine, while also recognising its value
STEP 3: Improving the education and training of health care professionals
STEP 4: Supporting new approaches to reimbursement and HTA, required for patient access to personalised medicine

The above aims reflect the current barriers to full integration of personalised medicine, not least of which is patient access.
It is clear that Europe’s health policies need to recognise and tackle the inherent health system vulnerabilities faced, specifically, by smaller countries and in the regions of the larger ones. The Alliance therefore introduced its SMART approach.
‘SMART’ stands for Smaller Member states And Regions Together and already the idea has been a great success, involving medicines bodies, national health ministers and cross-sectional stakeholders, all working to move personalised medicine to the next level of integration.

SMART aims to establish the direction required to facilitate an environment for personalised medicine at national level. This includes (but is not exclusive to):

Harmonisation of research between Member States
Implementation of EU regulatory instruments at the national level (data protection, clinical trials and the future in-vitro diagnostics)
Better and common guidelines on various diseases
Patient empowerment and health literacy
National Cancer Plans/biomarkers

Now is the time for all stakeholders to work together to ensure that the full potential of personalised medicine is realised, for the benefit of current generations and the many that will follow.

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