EAPM - 2nd European Alliance for Personalised Medicine Congress 26 - 28 NOVEMBER 2018
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2018 EAPM M I L A N Table of Contents Invitation to Participate................................................................................................................................ 4 About the Venue............................................................................................................................................. 4 About EAPM 2018............................................................................................................................................6 About Milan.........................................................................................................................................................7 Local Organiser Scientific Committee - LOSC..................................................................................8 Programme.........................................................................................................................................................9 Plenary - Presidential Sessions Overview.......................................................................................... 12 Key Dates........................................................................................................................................................... 13 Tracks Overview............................................................................................................................................. 14 Who will attend?............................................................................................................................................ 18 3
2018 EAPM M I L A N Invitation to participate Milan Congress on the right track for EAPM Aims and Objectives personalised medicine The European Alliance for Personalised The European Alliance for Personalised Medicine (EAPM) is a Brussels-based Medicine (EAPM) will hold its second annual organisation consisting of patients, academics, Congress at the end of November, this time in healthcare professionals, researchers, industry the Italian city of Milan. representatives and more, from 40 different stakeholder groups. The event will take place in the Lombardy capital from 27-30 November at the MiCo - Its goal is the integration of personalised Milano Congressi - five minutes from the centre medicine into Europe’s healthcare systems. of the city. The Alliance meets regularly with legislators/ regulators to explain the stakeholder The prestigious gathering will complement the first perspective from a consensus-based platform. annual Congress (held in Belfast last November). The Alliance aims to: The event in Northern Ireland’s capital saw 650 delegates plus more than 200 speakers. Establish a leadership position in These were drawn largely from patients personalised medicine representatives (22%), policy makers/politicians Position personalised medicine within the (35%), 30% of attendees and speakers had broader context of personalised Healthcare research and/or scientific backgrounds and industry representatives accounted for around l Help to ensure the understanding of 15% of those present. personalised healthcare by patients, professionals and policymakers These statistics were largely mirrored by the exhibitors at the Congress and the Help shape EU policy discussions and create aforementioned percentages are expected to be incentives for personalised medicine echoed in Milan. Help shape a favourable reimbursement As happened in Belfast, EAPM is working environment for personalised medicines and closely with a much-esteemed local organising companion diagnostics committee, who are working hard ‘on the ground’ Bring together healthcare planners, medical to make the Congress a great success. We are professionals, research organisations, NGOs, especially delighted to be working with Lombardy industry any other stakeholders in the Region, Italian National Institute of Health, continuum Humanitas Hospital and University of Milan. Ensure a multi-disciplinary approach Among the most successful elements in Belfast were the daily newsletters and the non-stop Promote ‘outreaching’ to regulatory Twitter content, highlighting the main events authorities, EU politicians, national of the day and previewing many of the sessions politicians and EU/national media upcoming. This strategy will be used again in Develop a comprehensive and collaborative Milan giving the Congress plus its sponsors and approach to achieve coordination speakers the highest profile possible. The venue Launched in 2002 and doubled in size in 2005, the Featuring two plenary rooms, one with seating for current extension places MiCo - Milano Congressi 4,000 and the other for 2,000 and an Auditorium among the largest conference facilities in Europe that seats 1,500, it is the ideal venue for large-scale and worldwide. Designed by Mario Bellini, it’s able to performances and for international conferences accommodate up to 18,000 people in 70 or so fully requiring a large number of rooms. In the same way, appointed conference rooms with permanent control the exhibition halls offer 54,000 sq.m of exhibition booth. space and can also be set up as extra plenary rooms accommodating more than 5,000 people. 4
2018 EAPM M I L A N Top topics Interaction is key… The themes and tracks at Milan will see There will be more than 35 networking Congress debate, among other things, opportunities throughout the week of the diagnostics and medical devices and Congress, and EAPM is in partnership with translational research. These will run alongside a major organisation in order to develop the sessions covering personalised medicine in content and structure around each theme, hospitals and a look at the work of various which will run as separate tracks. regions across the EU in the personalised One of the over-arching aims, as ever, is to medicine field. The latter track will run across also allow for interaction between the different three days. disease and policy areas, allow delegates to gain Also featured will be a two-day track covering a greater depth of knowledge into barriers in many aspects of men’s health, including the field of personalised medicine. awareness raising, plus sessions dealing with On top of this, Congress will offer up valuable hospitals and specifically patients. evidence and stakeholder opinion on which To complement the Alliance’s annual summer policy makers can base their decision making on school for healthcare professionals (HCPs), such how better to integrate personalised medicine as general practitioners, a three-day ‘winter into the EU’s healthcare services. school’ will also be a feature of the Congress. The event will provide a large and effective This is specific to the education of HCPs in that ‘space’ to allow for such the meeting of minds if personalised medicine is to be in line with the and expertise and will act as a vital one- EU and Member State principle of universal and stop-shop for top-level discussion and the equal access to high-quality healthcare, then formulation of real action plans. clearly it must be made available to many more citizens than is currently the case. In the region of 850 delegates are expected to attend, with a focus on regional representations Also featured at the Congress will be coverage (including Member State and regional agencies, of our proposed and very ambitious Million such as medical authorities, regional HTA European Genomes Alliance (MEGA) over two agencies, notified bodies and data authorities). days, as well as aspects of artificial intelligence. Other topics will see a focus on diabetes, EU-, national- and regional-level politicians will patient perspectives, access and early diagnosis. be present to complement the regional focus on research and innovations in health. They will The role of SMEs in modern-day medicine will be joined by experts from scientific centres, also come under the Congress spotlight at the scientific hospitals and research centres. November event in a track that covers two days. Also attending will be legislators and This track-based Congress system allows policymakers in the form of MEPs and separate stakeholders in different arenas to Commission officials, given that a key aim of concentrate on their fields. But, of course, the Congress is to set the agenda for European these diverse groups also allow for necessary healthcare during the coming years. cross-fertilisation, interaction and sharing of ideas. For more information on the agenda, click here The Congress will also play host to nine Presidential sessions across the week. Like the first edition and several Presidency conferences, the Milan Congress will bring together leading experts in the arena drawn from patient groups, payers, healthcare professionals plus industry, science, academic and research representatives. 5
2018 About EAPM 2018 EAPM M I L A N More than 1000 Life Sciences thought fit-for-purpose and reflect the swiftly changing world of medicine, are vital. Hence our continued leaders will convene at the second annual EAPM Congress, to be held at the MiCo - Milano interaction with MEPs, Commissioners and Congressi - in Milan this November 27-30. Member State health leaders. As it did last year in Belfast, the annual EAPM also aims to showcase developments and event will bring together key audiences who new ideas at Congress. For example, development contribute to the vast programme content and of major initiatives in genomics and personalised vital knowledge exchange. medicine is a global trend with significant investments being committed, for example by the Don’t miss the opportunity to join large governments of the US and China. numbers of industry professionals, government regulators, patients, academia, and exhibitors to In Europe the most comprehensive initiatives, drive insights to action. encompassing clinical implementation, research and enterprise, are being seen in countries such More than ever this year, a focus will be on as the UK (100,000 Genomes Project) and the upcoming European Parliament elections France (Médecine Génomique 2025). and the installation of a new College of Commissioners, tasked with devising and It is important that Europe remains competitive implementing regulatory frameworks in all in this field given the resulting health and areas, including certain aspects of health. economic benefits and EAPM’s plans for a Million European Genomes Alliance (MEGA) More than 700 MEPS will be elected next would be synergistic with the national aims, summer and the Commission will also have a projects and activity of participating Member new president as Jean-Claude Juncker steps States and provide structures and a network down. that can move research to clinical practice and One of the goals of Congress is to engage commercial enterprise, putting these countries politicians and lawmakers in the fast-growing at the forefront of personalised medicine field of personalised medicine, and deliver globally. political asks through our consensus-based MEGA is part of just one of many tracks to be process. covered in Milan including innovation, education, Europe needs to grasp the fact that health modern hospitals, funding, guidelines and more. equals wealth and that investment in research Click here for more information on the agenda. and innovation, alongside laws and rules that are Why you should attend Milan will see a multi-stakeholder driven Congress with patients at the centre The EAPM Congress is a neutral organisation providing thought leadership content and a global platform for healthcare product development and knowledge exchange designed to drive change and improve outcomes. It’s an opportunity to learn more the scientific, research and policy development in personalised medicine, its huge potential and how it can change the lives of millions of patients for the better Attendees have the chance to hear the opinions of experts first hand and engage with European, national and regional pliticians, as well as respond to and pose questions on the day Also, those present will have the chance to understand how an integrated, coherent, cost-effective and cohesive health strategy will impact on systems and the standard of care in individual Member States Congress is a valuable opportunity to see into the minds of other stakeholders, understand their issues and find out what they really feel they need from you And it represents an excellent chance to network with (and be interviewed by) health journalists. Also, to meet industry leaders, cutting-edge scientists and all other personalised medicine stakeholders from across the EU Click here to register. 6
2018 More on Milan EAPM M I L A N On top of this, the city is home to two of Europe’s most successful football teams, AC Milan and Internazionale (Inter Milan), who share the famous San Siro stadium. The MiCo venue features welcoming conference halls and well linked spaces. It is within easy reach of the city’s finest attractions, such as Leonardo’s Last Supper, which is less than five EAPM is delighted to have the famous and minutes’ walk away. elegant city host the Congress. Among other things, Milan is renowned for healthcare, The ‘old own’ is just one Metro stop away: along research, the arts, commerce, with the Duomo and the Sforza Castle. design, education, entertainment, Milan is the powerhouse of Italy: it fashion, finance, and tourism. It is produces 10% of the country’s GNP; home to Italy’s Stock 25% of domestic research, it Exchange as well as is home to 10 universities the headquarters of and every year it attracts large national and over 4 million tourists. international banks. The Romans called it Given its prowess “Mediolanum” due to its in healthcare, Milan position at the centre of the will act as the main communication routes of perfect venue for the time. Today, it is still one the personalised of Europe’s most accessible medicine Congress. and welcoming cities: Personalised 200 destinations linked medicine is, of by 364,000 flights a year, course, in the news 380 hotels with over 21,000 more-and-more often guest rooms. An immense these days, with its goal of giving system that comprises not only the right treatment to the right manufacturing, but also services, culture, patient at the right time. entertainment, art, cinema, television, NGOs, fashion, sport and research. Milan has ancient Milan has the third-largest economy in origins; it was the capital of the Western Roman respect of European cities and is considered Empire and boasts a unique, world-famous one of the ‘Four Motors for Europe’. It acted artistic heritage, of which the best known is as the de facto capital of the Western Roman Leonardo da Vinci’s Last Supper. Today the Empire from 286 to 402 AD. international centre of fashion and design, and Modern day Milan is considered the fashion a shopper’s paradise, Milan is a vibrant, trendy and design capital of the world hosting city, brimming with things to do and with a several international events and fairs, not least constantly changing scenario of clubs, bars among them the Milan Fashion Week and the and restaurants. All this against a truly enviable Milan Furniture Fair. backdrop, Lombardy: dotted with charming cities of art, it is the region with the greatest The city receives around eight million expanse of natural parks and magnificent lakes – overseas visitors each year. These tourists such as Lake Como – surrounded by mountains are attracted by Milan’s museums and art that attract numerous hikers and skiers. Without galleries, hosting some of the most important forgetting the rich flavours of Lombardy’s collections in the world, including important internationally renowned foods and wines. All works by Leonardo da Vinci and other this just over two hours from Venice, Florence famous names. and Genoa. 7
2018 EAPM M I L A N Local Organiser Scientific Committee - LOSC David Byrne, Co-Chair, European Alliance for Personalised Medicine Gordon McVie, Co-Chair, European Alliance for Personalised Medicine Denis Horgan, Executive Director, European Alliance for Personalised Medicine Local Committee Walter Ricciardi Paolo Casali Italian National Institute of Health (Istituto Head of the Adult Mesenchymal Tumour Superiore della Sanità); Institute of Public Medical Oncology Unit, Istituto Nazionale Health, Università Cattolica del Sacro Cuore, Tumori, Milan Rome, Italy Monica di Luca Giulia Veronesi Full Professor, Department of Pharmacological Robotic Thoracic Surgery, Humanitas Research and Biomolecular Sciences, University of Milan Hospital Marina Gerini Filippo de Braud General Director, Fondazione Regionale per la Professor, Medical Oncology, University of Milan Ricerca Biomedica Gennaro Ciliberto Ivana Cattaneo Scientific Director, IRCCS, Instituto Nazionale Public Affairs Director, Novartis Oncology Tumori “Regina Elena, Rome, Italy Europe Gabriella Pravettoni Francesco de Lorenzo Professor of Cognitive and Decision Making President, European Cancer Patient Coalition Psychology, University of Milan Stefania Vallone Mario Pazzagli President, Lung Cancer Europe (Luce) Professor, Dept. Clinical Physiopathology, O.U. Clinical Biochemistry, University of Florence Giovanni La Via Member of the European Parliament Giovanni Codacci Pisanelli Assistant Professor in Medical Oncology, Paolo Marchetti University of Rome “La Sapienza” Full Professor of Medical Oncology, Sapienza University, Rome Fedro Peccatori Director of the Fertility and Procreation Unit, Division of Gynecologic Oncology, Department of Gynecology, European Institute of Oncology, Milan 8
2018 Programme EAPM M I L A N Day 1 Access Education Diagnostics/ Men’s Genomics/ and Regional – Winter Medical Health School Devices MEGA Early Diagnosis 09:00 - 10:15 Parallel Session Role of Putting the Opening Regulatory Perspectives Are Current Coordinating Spotlight Session: Framework on Genomics Frameworks Support On Men and Objectives of for Useful to Action Men’s Health the Winter Companion Capture the Through Summer Diagnostics Value of P.M. Funding School: and Medical Technolo- Mechanisms Diagnosis Devices gies? Are and Decision other Making Frameworks/ Frameworks Methodolo- for Family gies Physicians Required? and General Practitioners 10:15 - 10:45 Networking and Exhibition 10:45 - 12:00 Parallel Session Structural Men’s Session I: Reimburse- What can Value from Funds to Health as an Shared Ment and Genomics the Economic support Investment Diagnosis Financing do Now? Perspective Infrastruc- and Decision- Framework tures for the Making: for Personalised Patient/ Diagnostics – Healthcare Physician Medical Era Communica- Devices tion Opening Plenary Presidential Session – 12:15 - 13:15 “Forward as one – Europe as a Global Player” 13:15 - 14:15 Lunch and Networking and Exhibition Presidential Session – “Advancing Europe’s Healthcare – Patients & 14:15 - 15:30 Economy” 15:30 - 16:00 Networking and Exhibition 16:00 - 17:15 Parallel Session Private Accessing Session II: Value of Implementa- Value from Investment to Health Emerging Diagnostic tion of Organiza- Drive Forward Services Screening & Information Genomics tional Healthcare Diagnostic (Vodi) from into Perspective Tools to Concept to Healthcare Context Facilitate Reality Systems Matters Early Diagnosis of Disease 17:30 - 18:30 Presidential Session - “New Research in Personalised Medicine” 19:00 - 20:30 Welcome Reception - “60 years of the Rome Treaties” 9
2018 EAPM M I L A N Day 2 Education Genomics/ Regional Hospital – Winter SMEs Diabetes MEGA School 08:00 - 08:30 Networking and Exhibition 08:30 - 09:45 Parallel Session Regional Guidelines Session III: SMEs Million Ensure New Innovation For The Individualizing Executive European TID Therapies in Nordic Implementa- Clinical Workshop Genomic are Safe and Countries tion of PM In Decisions – Session I: Alliance Effective the Clinical For Elderly Go/No Go: (MEGA) – Setting Patients Framework Bringing with Multiple to Prioritize Innovation Chronic Market Entry into Conditions Healthcare systems Parallel Session 10:00 - 11:15 Regional The Role of Session IV: SMEs Why Should Promote Innovation Data Sharing Pathways for Executive the EU Take a Access to TID in Central Within and Diagnosing Workshop – Lead? Therapies and European Among Rare Diseases Session II: EU Technologies Countries Hospitals Commercial Funding Opportuni- ties for SMEs Presidential Session - 11:30 - 12:45 “Facilitating access for todays diseases” 12:45 - 14:00 Lunch and Networking and Exhibition 14:00 - 15:15 Parallel Session Regional Value Based Session V: SMEs Pillars to Protections Innovation in Indicators to Digital Tools Executive Realize for Pre- East Europe Measure the to Connect Workshop – MEGA existing Countries Impact of with Patients Session III: Conditions Research into Pharma Clinical Data Collabora- tions: What are the tradeoffs? 15:30 - 16:45 Parallel Session Regional New Session SMEs Public- Evaluation of Innovation in Opportunities VI: Poly- Executive Private New Therapies Mediterra- for Healthcare pharmacy: Workshop Collaboration nean Member Communica- Prioritizing – Session States tion Medical IV: Early Treatments Dialogues: Engaging EU Regulatory Agencies Presidential Session – Dialogue with CEOs: 17:15 - 18:45 “From Here to 2025: Personalised Medicine and Healthcare for an Immediate Future” 10 20:30 - 22:30 Presidency Dinner
2018 EAPM M I L A N Day 3 Education Artificial Translational Regional Patient – Winter SMEs Intelligence Research School 08:00 - 08:30 Networking and Exhibition 08:30 - 09:45 Parallel Session Access Biomarkers Session VII: SMEs Artificial Prevention Accelerated Health Redefining Executive Intelligence: – Reducing Initiative Literacy the Role Workshop – Here & Now Harmful of Family Session V: Impact Physicians Early of Future Through Use Dialogues: Diseases of EHR’s Engaging Local and Artificial Reimburse- Intelligence ment Agencies 10:00 - 11:15 Parallel Session Better and Ensuring Session VIII: SMEs Frameworks Profiling – Common that Patient Tools to Executive to Empower Opportunities Guidelines Preferences Individualize Workshop – the to be Seized on Various are Valued Clinical Session VI: Healthcare Diseases when Decisions for Case Study: Is Community Assessing HCP’s in the Localization new Era of Co- Scalable? Treatments mordities & Survivorship 11:30 - 12:45 Presidential Session – “Interfacing with Public Policy Makers” 12:45 - 14:00 Lunch and Networking and Exhibition 14:00 - 15:15 Parallel Session Recent Improving Session SMEs Public Policy Therapeutics Advances in Health IX: Recent Executive Considera- – Matching Rare Disease Literacy of Advances in Workshop – tions Conditions Era Immuno- Personalised Session VII: with Oncology Medicine Case Study: Treatments Therapy Market- Specific Idiosyncrasies that SMEs Forget to ask About? 15:30 - 16:45 Closing Presidential Session - “Who is to do What?” 11
2018 EAPM M I L A N Plenary - Presidential Sessions Overview Opening Plenary Presidential Session – modernisation. Individual responsibility in risk “Forward as one – Europe as a Global Player” reduction and cost sharing/insurance is foreseen to develop. The medical structures and citizen Whether it is post-Brexit growth in the UK involvement will also need development to or resilience in China, improved healthcare optimise the best use of the new possibilities. supports economic activity. Focus on research into new medicines and A healthier Europe will mean citizens spending cutting-edge treatments is key and this will less and less time in hospitals under expensive already in the shorter run create jobs – whether treatment regimes, often at a direct cost to they be in research itself, education, design and the taxpayer, and it will also mean that people manufacture of in-vitro products or within the receiving the right treatment at the right time pharmaceutical industry. are more able to stay in the workplace, thus generating wealth rather than whittling it away. A shift towards preventative medicine will Research Frontiers in Personalised reduce costs still further. A focus on research Medicine - from Local to Global into new medicines and cutting-edge Europe’s and the international research treatments will also create jobs – whether they landscape remains too fragmented. A lack of be in research itself, education, design and critical mass in many research centres means manufacture of in-vitro products or within the not enough patients, biological materials, pharmaceutical industry. technological resources or competences. If Europe is in the vanguard of developing Wider collaboration and better infrastructure new ways of keeping citizens healthy, it will would help: technical platforms for genomics inevitably attract investment from outside of the and other specialty disciplines, screening bloc. facilities for new pharmaceutical agents, The road to better health must have biobanks for tissues and biofluids, quality- personalised medicine as its destination. This assured patient registries... innovative method of treating patients utilises So too would better resources, for prospective research, data and up-to-the-minute technology validation of biomarkers that may be predictive to provide better diagnostics and follow-up for for treatment, networks on biostatistics, citizens than is currently the case. epidemiology and outcomes research. With the backing of the European Union, This session will present the leading Europe can work towards building a healthy and developments in the area from the oncology, wealthy Europe, one worthy of its stated goals neurology and diabetes. for generations to come. Presidential Session – “Advancing Europe’s Presidential Session - Facilitating access Healthcare – Patients & Economy” for today’s diseases European Union governments and healthcare Personalised healthcare will need to start with providers have been seeking to maximise the prevention to be truly successful and individual, value for money that they can obtain from the it will move from disease management to acquisition of new treatments for patients. health management which will change the cost structures and prevent loss of quality life and Consequently, there is a large awareness generate wealth. of the limits that can be placed on patients with regards to having to make financial In order to be effective in personalised medicine, contributions to their healthcare needs. Payers and specifically prevention, the way therapy is are now increasingly likely to deny or severely approved and subsidised will need significant 12
Key Dates 2018 Call for Abstracts - March 19th, 2018 EAPM Open Registration - March 19th, 2018 M I L A N Opening of EAPM Annual Personalised Medicine Congress, Nov. 26th, 2018 restrict the use of advanced therapies when Innovative approaches treatment guidelines, there is no clear or exceptional economic value and to training and education, will equip for the broader population as they seek to cut healthcare professionals with new skills and costs and decrease public spending and debt. knowledge, and overcome reticence by clear demonstration of advantages among those Current models have been based on medicines hesitant to adopt new approaches. designed to treat an entire patient population, and the economic value of a specific medicine And radical changes in thinking at the highest has traditionally been analysed through a policy level in relation to public health generally comparison with other treatment alternatives or will enhance the measurement of value for palliative care. health interventions and adapt payment systems accordingly. All of this will require This session will examine different strands of agreement on standards, and improvements to this issue. regulatory pathways, as well as an appropriate regulatory and medical framework. Presidential Session – Dialogue with CEOs: “From Here to 2025: Personalised Medicine Closing Presidential Session and Healthcare for an Immediate Future” The evidence of the merits of personalised A massive improvement in the health of medicine is already ample. The potential is Europe’s citizens is within reach – but making huge. The benefits are there for the taking for it happen faces challenges that are as much patients, citizens and society, and will bring new political as technical. levels of satisfaction to professionals working in Scientists, technologists, physicians and health the health domain. economists have devised innovative pathways Why, then, is its development and exploitation to boost the health status of individuals and so slow, particularly in Europe? to make healthcare systems more sustainable. Advanced personalised health is no longer a Personalised medicine is the test-case for how science-fiction vision. It is a tangible possibility. far health systems are capable of a rational and reasoned response to opportunity. It is What is needed now to turn vision into reality also a test-case for how far the supporters is a clearer understanding among Europe’s of personalised medicine are able and willing policymaker and decision-takers about what is at to come together in a joint effort to drive the stake: about the gains that can be made with the process that can induce constructive change. right actions, and equally about the opportunities that might be squandered with the wrong ones. In some areas, the EU has had a strongly supportive role in healthcare. The resulting This session will feature leading politicians and coordination, to develop science, to translate CEOs. innovation, to systemise marketing authorisation requirements for medicines and to facilitate quality testing and trials has shown a positive Presidential Session – “Interfacing with aspect of the EU, and should serve as Public Policy Makers” inspiration and encouragement for more joined- up approaches to tackle new challenges. The innovative quality of personalised care demands links to other areas of innovation - If the will to work together on personalised notably in the use of data, bio-banking, next medicine can be found, a new horizon for health generation sequencing, screening, advanced in Europe can be reached. The journey can imaging, biomarkers and more sophisticated reach its destination by 2025. But the benefits analytics, sharpening the impact of R&D and early can accrue as from today. diagnostics, all linked to the digitisation of health. 13
2018 EAPM M I L A N Tracks Overview Regional track: From innovation to in evaluating the risk and benefits of therapies implementation recommended by other specialists. This program will address the critical role that GP/ Today’s approach to personalised healthcare FPs play in advancing personalised medicine remains sub-optimal. The opportunities are and how different healthcare systems should obvious: physicians increasingly identify the facilitate the role of these physicians. root causes of disease and match patients to the therapy that can target a specific type of disease or genetic mutation, with diagnostic Men’s Health in the EU: A tests and tools increasingly driving treatment Personalised Approach decision-making. Men’s health is complex and multifaceted, The understanding of disease advances all the and it moves well beyond those male-specific time, with breakthroughs in treatment options conditions resulting from men’s differing biology in many non-communicable conditions ranging with women. Patterns emerging show a marked from neurological to cardiovascular to diabetes differences between the health of men and to respiratory - and to rare haematological women, and at the same time large disparities diseases, as well as in cancer, where some 250- in health outcomes within male populations in 300 identified types and subtypes can now be each Member State. identified and targeted. The extent and depth of the problem of But there are serious delays in introducing premature mortality is one of the most striking innovation into healthcare systems. Therefore, and worrying findings, especially as it involves during this track, personalised health experts nearly the whole spectrum of health conditions. will present their shared vision on the role, structure and responsibilities of integrating Men’s greater risk of developing and dying healthcare into EU healthcare systems at both from nearly all cancers that, biologically, should regional and national level. affect men and women equally; the high rate of premature deaths from cardio-vascular disease; the increased risk from the major communicable Winter School: Diagnosis and Decision diseases; and the vulnerability of men to Making Frameworks for Family accidents, are but some of the life-limiting Physicians and General Practitioners factors impacting on men. With the emergence of personalized medicine, patients are increasingly being treated with Medical Devices and Diagnostics novel treatments by specialist. Due to this changing paradigm, the role of the family The recently adopted EU Council Conclusions physician/general practitioner is evolving to on Personalised Medicine for Patients1 refer make them critical in screening and diagnosing to personalised medicine as “a medical patients to ensure that they can benefit model using characterisation of individuals’ from the latest treatments. These shifts are phenotypes and genotypes (e.g. molecular necessitating that FP/GPs stay updated on the profiling, medical imaging, lifestyle data) for latest advances across medicine to allow them tailoring the right therapeutic strategy for to advocate for their patients and address the the right person at the right time, and/or to many questions asked by Internet-informed determine the predisposition to disease and/or patients. Considering that many newly available to deliver timely and targeted prevention.” treatments are more effective when diseases are In this respect, personalised medicine has the diagnosed and treated early, it is advantageous potential to optimise the timely delivery and that these physicians diagnose their patients dosing of treatments so that patients can early to improve outcomes. Also, the FP/GPs receive the most benefit for the least amount of often act as a trusted advisor to their patients 14
2018 EAPM M I L A N risk and harm, minimising both the unnecessary laws. Other faculty will include representatives side effects of potentially toxic treatments such from large pharmaceutical companies, patient as chemotherapy and the delays associated organizations, venture capitalists, and other with the “trial-and-error” process that many Senior leaders from leading SMEs. patients endure to obtain the correct diagnosis and treatment for their condition. Despite their widely recognised promise, the use Genomics Track: From Innovation To of diagnostics in clinical practice across Europe Implementation is still limited. Healthcare systems in Europe are Next Generation Sequencing technologies not designed to support personalised medicine provide physicians with the ability to make approaches and related innovative diagnostic educated diagnoses based on a patient’s technologies. This is reflected in a lack of genome which will lead to better health appropriate patient access and pathways for outcomes for rare inherited diseases and cancer. reimbursing molecular diagnostics. The technology is out there, but stakeholders This track will present a policy framework for need to collaborate much better, invest more in integrating diagnostics into healthcare systems. research and innovation, and deliver again and again the message that patients are at the heart of their own healthcare. SME Executive Workshop: Prioritization, Funding and Access Genomics is driving precision medicine, which across European markets is in turn driving massive changes in disease diagnosis and treatment. With its strong Target Audience: Senior level managers from tradition of universal healthcare the European SMEs* - Pharmaceutical, Diagnostic, and Digital Union is in a unique position to reap the Healthcare companies. resulting quality and costs improvements; this track will be an opportunity build a plan for Personalised Healthcare Executives often genomics in European healthcare. face critical decision junctions on whether to pursue opportunities outside their home markets or develop new product offerings to Hospitals of the Future in the Age of support the next wave of growth in the face Personalised Medicine of limited resources. As most healthcare – related products especially therapeutics are University hospitals play an important role as commercialized globally, these executives front-runners in and catalysts for innovation, are questioned by their boards and potential as well as promoting best practices and customers on their plans to commercial contributing to the development of strong local, products across Europe and whether they plan regional and national economies. to commercialize directly or with a partner. The overall aim of University Hospital This session will provide these senior leaders Association Europe (UHAE) members is to play essential frameworks to prioritize opportunities an active role in shaping the future of healthcare across various European markets and to better in the EU, sharing best practices for patient understand the EU Personalized Healthcare benefit and maximising efforts to drive high- landscape. The participants will learn about quality research. unique opportunities to gain additional funding Personalised medicine is an integral part and accelerate market access under special of UHAE approach to improve patient care EU programs. Also, these executives will whilst ensuring the sustainability of healthcare have opportunity to ask questions to market systems. By placing patients at the heart of the access and regulatory experts on topics such system, healthcare services will increasingly as the new IVD directive and data privacy deliver the right intervention to the right person 15
2018 EAPM M I L A N at the right time, improving the outcomes But exactly how will AI and robotics define for patients and cutting down unnecessary modern-day healthcare? treatments. During this session, UHAE representatives will present their shared vision on the role, structure Defining Value In Personalized and responsibilities of the hospitals of the Medicine, Sides And Domains future. The conclusions from this work are the That Define Value From A Holistic result of an extensive multi-stakeholder expert Perspective. consultation among UHAE members which was Personalised medicine approaches, although presented to the European Commission’s DG well-known in the past and applied as required SANTE in June 2018. by health professionals, have experienced dramatic changes in their way they address the conditions and pathologies. Mostly, it has Finding The Policy Balance For been due to the launch and application of new Diabetes Patients technologies and solutions, such as genetics, Type 1 diabetes is a disease continuum with improvement in the recording of clinical, specific pre-symptomatic stages with defined environmental and life style data and capacity risk of progression to symptomatic disease. of the systems to integrate all these data and provide individual diagnostic and prognostic Prognostic biomarkers have been developed for profiles for individual patients. disease staging and for stratification of subjects that address the heterogeneity in rate of disease This promising landscape is obviously progression. Using biomarkers for stratification generating a non-deniable change to the way of subjects at different stages of type 1 diabetes health professionals diagnose, treat and follow- will enable smaller and shorter intervention up patients and it is clearly impacting the clinical trials with greater effect size. management of individual patients. Addressing the heterogeneity of the disease will Having said this, it is noticeably that it has also allow precision medicine-based approaches to an impact on health care systems’ organization, prevention and interception of pre-symptomatic budget and outcomes. The issue at this stage stages and treatment and cure of symptomatic is to determine to which extent existing disease. frameworks to capture value of technologies can be directly applied to Personalised medicine solutions. Artificial Intelligence Track: From Innovation To Implementation Patient Track: From Innovation To While continual advances in medicine have Implementation paved the way for more effective treatments, increasing pressure on healthcare systems is In this modern world of medicine, in which many reinforcing the need for improved efficiencies. stakeholders are pushing for co-decision on treatments between patients and their doctors, Expenses and labour issues are taking their the relationship between the two has never toll on healthcare quality and accessibility been more important. worldwide. The increasing prevalence of Artificial Intelligence (AI) in the sector is poised EAPM is of the opinion that patients should be to disrupt healthcare systems on a global scale. placed at the centre of their own healthcare decisions. and empowering the patient is a AI is a collective term for computer systems fundamental pillar of personalised medicine. that can sense their environment, think, learn, and take action. The emergence and increasing While modern medicine, including genetics- use of AI and robotics will have a significant based technologies, screening programmes, impact on healthcare systems around the world. imaging, innovative medicines and more, are 16
2018 EAPM M I L A N allowing doctors to target medicines much the barriers that currently exist more effectively, Europe has issues of bringing - Empowerment: Providing the infrastructure innovation into healthcare systems not helped and tools to deliver a PM-enhanced by an ageing population. health system landscape that empowers Even if there is treatment available it can still be translation of discovery science into new difficult to get a targeted therapy. We already diagnostic, therapeutic and preventative know that a patient’s lifestyle and working approaches situation will, in ideal circumstances, play a major part in any treatments if the doctor/ patient relationship is operating at optimum levels. And it is certainly key that the patient is proactive in asking questions. This session will deal with the different paradigms. Translational Research Track: Realising the vision of Translational Research In cancer, targeted approaches such as the use of Tyrosine Kinase Inhibitors (TKI) in Chronic Myeloid Leukemia (CML) and Monoclonal Antibodies (MOAb) in erb-B2 positive breast cancer, have led to practice-changing clinical management in these diseases, while the establishment of a national molecular diagnostics platform by L’Institute International du Cancer (L’INCa) in France has underpinned precise stratification of patients for innovative personalised medicine therapies. In Cystic Fibrosis, the use of a companion diagnostic which recognises a particular disease-causing mutation in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, allows selection of patients for successful therapy with a treatment that targets this specific mutation. Such approaches are also shaping the development of new preventative and therapeutic methods in cardiovascular and infectious disease. However, despite the significant advances that have been made, the undoubted potential can only be realised by a harmonised research agenda that enables efficient and effective translation of scientific innovation. Two critical pillars will underpin activities: - Awareness: Understanding the potential for PM to deliver improved outcomes for European citizens, the challenges that it presents to traditional health systems and 17
2018 Who will attend? EAPM M I L A N More than 1000 delegates (plus over 200 speakers) are expected to attend including: • National and regional representatives (medical authorities, regional HTAs, notified bodies and data authorities) • Legislators and policymakers (MEPs, EU Commission experts, national and regional politicians) • Research experts (Scientific centres, hospitals and research centres) • Health economic systems experts (National and regional health ministers and representatives from payer/reimbursement authorities) • The voice of the patient (Patient groups and experts advocating giving the right treatment to the right patient at the right time) 18
2018 EAPM M I L A N Contact: Denis Horgan EAPM Executive Director Avenue de l’Armee/Legerlaan 10, 1040 Brussels Tel: + 32 472 535 104 www.euapm.eu 19
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