Personalised Medicine in European Hospitals

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HOPE, the European Hospital and Healthcare Federation
PwC’s Global Healthcare practice
(http://www.pwc.com/global-health
www.hope.be)
Hospitals and providers have a clear opportunity to adapt to the new healthcare paradigm and provide services that are targeted to the individual patient.

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Personalised Medicine in European Hospitals

  1. 1. www.pwc.com/esPersonalised Medicinein European Hospitals
  2. 2. PwC and the European Hospital and Healthcare Federation (HOPE) have joined forces to identify key elements in the development of Participants personalised medicine in European hospitals. This collaboration will help determine of the current state and the desired future state PwC and HOPE would like to express of personalised medicine practices within European hospitals, and sincere gratitude to the European hospitals that contributed to the will thoughtfully facilitate the creation of a culture of customised development of this paper with their healthcare. knowledge, experience and time. Personalised medicine can be defined as products and services that Special thanks go to the following leverage the science of genomics and proteomics (directly or contributors: indirectly) and capitalise on the trends towards wellness and consumerism to enable tailored approaches to prevention and care. •  aimon Belenes, R Chief Executive Officer, Hospital Clinic de Barcelona (Spain) The dawn of personalised medicine brings not only new advances to our healthcare system today, but also key challenges. This new Alain Bonnin, •  Professor of Medical Parasitology and science has led many participants in the healthcare industry, such Mycology; Director Parasitology as providers, to consider how best to adapt to these challenges and Mycology Laboratory; Director foster a consumer-focused culture. Hospitals have a clear Biological Resource Center Ferdinand opportunity to adapt to the new healthcare paradigm and provide Cabanne – University Hospital of services that are targeted to the individual patient. It is important Dijon (France) to recognise, however, that different hospitals operate and require •  ulia S. Johansen, J different models. Just as doctors will no longer be able to apply the Professor, Senior Consultant, DMSc at same forms of treatment to patients, hospitals will not be able to Herlev Hospital/Copenhagen apply the same approach to addressing the challenges brought on University Hospital at Herlev by personalised medicine. Hospitals and providers have many (Denmark) options for how they respond to the changing market. And as •  orma Penttinen, J evidenced in the interviews we completed with several European Medical Director, Kuopio University hospitals, personalised medicine can be designed and implemented Hospital (Finland) into a hospital model in a variety of ways. •  orut Peterlin, B Head of Clinical Institute of Medical Many European hospitals have already begun to define what Genetics, University Medical Centre personalised medicine means to their hospital and have developed Ljubljana (Slovenia) their strategies for implementation. And as hospitals solidify their •  yörgy Pfliegler, G definition and vision of personalised medicine as well as their Head of Division of Rare Diseases approach for implementation to create a culture of customised Institute of Medicine, Medical and Health Science Center University of healthcare, leading practices will continue to emerge. Debrecen (Hungary)2     Personalised Medicine in European Hospitals
  3. 3. Table of contents The impact of personalised medicine today 4 Part I. Personalised Medicine in European Hospitals 1.  General overview of personalised medicine 7 2.  The pressure to be personalised – Key trends that have changed the healthcare paradigm 8 3.  Next steps for hospitals and providers 11 4. Conclusions 15 Part II. Hospitals in focus List of Participating Hospitals 18 Herlev Hospital / Copenhagen University Hospital at Herlev, Denmark 19 Kuopio University Hospital, Finland 25 University Hospital of Dijon, France 29 Medical and Health Science Center University of Debrecen, Hungary 34 University Medical Centre Ljubljana (UMCL), Slovenia 38 Hospital Clinic de Barcelona, Spain 42 The impact of personalised medicine tomorrow 46 Personalised Medicine in European Hospitals      3
  4. 4. The impact of personalised medicine today Personalised medicine aims to provide • enetic screening is widely used G the timely, precise, personalised for treatment in cancer patients. diagnosis and treatment of patients, Cardiology, neurology, radiology, with a particular emphasis on wellness and the treatment of diabetes are and disease prevention. Although among the key disciplines that personalised medicine has already benefit from the genetics field. been introduced into practice, it is still Advances in genomic and proteomic in its early stages of implementation in science have led to more cost- the European healthcare market. This efficient discoveries, with doctors report outlines the move towards more inclined to use targeted personalised medicine in six European treatments. hospitals — located in Denmark, • tem cell programs and S Finland, France, Hungary, Slovenia treatments are still relatively new. and Spain — compares the path each is Although there are several programs taking, and discusses the following underway, most of the hospitals commonalities: surveyed are not yet applying this field in the clinical setting. • ost of the European hospitals M • elemedicine services are not yet T are focused on initiatives related fully deployed. Devices for to diagnostics and therapeutics. monitoring chronic diseases are The European landscape is working currently being developed and in several ways to develop new implemented in various clinical imaging technology and genetic services, such as cardiology and tools, such as biomarkers and neurology. biochips.4     Personalised Medicine in European Hospitals
  5. 5. • nly a few European hospitals O the life science and medical sectors is focus on nutrition and physical essential in fostering innovation in activities to encourage wellness the field of personalised medicine. and improve the treatment of • he main barriers for the T patients; most do not tackle implementation of personalised prevention as part of their medicine within the European approach. The reason could be that hospital environment are: lack of other factors, such as primary care research funding, lack of strong providers and public health media scientific evidence in some fields, campaigns, already encourage lack of knowledge among doctors, patients to monitor their own health and lack of a clear reimbursement status and maintain a healthier system for related services. lifestyle. • eveloping relationships or D Our study revealed that, although affiliations with other sector Europe is starting the paradigm shift organisations is a usual practice towards personalised medicine, many within the European hospital barriers still need to be addressed. To market. Public and private hospitals keep the process on track, healthcare (EU and US hospitals), public entities professionals and policy makers must such as the National Health Service aim to ensure that personalised (NHS) and laboratories, universities medicine contributes to the and biotech and pharmaceutical improvement of population health with companies, are among the main clear and robust evidence of patient partners to undergo personalised value, and they must remember that the medicine projects. Cooperation shift towards personalised medicine is a between the many stakeholders in process rather than an endpoint. Personalised Medicine in European Hospitals      5
  6. 6. Part I. Personalised Medicinein European Hospitals
  7. 7. 1.  eneral overview of G personalised medicine develop in the future and how the person will respond to a given treatment, enabling the development of a tailored health strategy. • t is preventive; it facilitates a I proactive approach to health and medicine, which shifts the focus from illness to wellness. Personalised medicine is broadly • t is participatory; it empowers I defined by PwC, as “products and patients to make informed choices services that leverage the science of and take responsibility for their own genomics and proteomics (directly or health1”. indirectly) and capitalise on the trends towards wellness and consumerism to The human genome project and enable tailored approaches to dwindling costs in genomic and prevention and care”. This definition proteomic sequencing is creating this encompasses everything from high- “new science” that focuses on the tech diagnostics to low-tech foods, consumer. New science is no longer a technologies that enable storage, and concept of the future; it is here today. analysis and linking of patient and Key trends over the past decade have scientific data. challenged the healthcare environment, payers, pharmaceutical Personalised medicine or the “new and life sciences companies, and science”, also referred to as “P4 providers to become more consumer Medicine” by Dr. Leroy Hood, co- focused in their own right. Providers founder of the Institute for Systems have their own unique set of challenges Biology, encompasses the following that will need to be addressed in order principles: to successfully create a culture of personalised healthcare for the patient. • It is personalised; it is based on an “ Correspondingly, it is important to understanding of how genetic understand the key trends that have variation drives individual pushed healthcare to be more treatment. personalised, the challenges that • t is predictive; it is able to identify I providers face, and how hospitals are what conditions a person might adapting to this new environment. 1   PwC, “The new science of personalized medicine: Translating the promise into practice”, 2009. Personalised Medicine in European Hospitals      7
  8. 8. 2.  he pressure to be personalised – Key trends T that have changed the healthcare paradigm The shift in the healthcare paradigm to model. These trends can be grouped into personalised treatment regimen and personalised medicine did not happen four categories: cost-efficient approach to healthcare. overnight. Over the last decade, By identifying the optimal point of advances in genomics and technology as • enetic trends G intervention for treatment, healthcare well as the patients´ inclination towards • Patient trends providers can improve quality of care care that is consumer focused have • Technology trends and reduce costs by effectively timing contributed to this development. The • Wellness trends treatment intervention and eliminating dawn of personalised medicine brings waste from insufficient or excessive not only new advances to our healthcare Genetic trends — Advances in treatment regimens. system, but also distinct challenges. genomic and proteomic sequencing As genome sequencing costs decline, This new science has led many players have resulted in cost-efficient doctors and patients alike are more in the healthcare industry, such as discoveries that are bending the inclined to seek treatments that are providers, to consider how best to adapt cost curve targeted to the patient’s illness. Today, to these challenges and foster a Advances in genomic and proteomic genome sequencing costs are consumer-focused culture. But before sequencing over the past decade have approximately $20,000 per genome, a the industry can address these led to the development of “targeted” stark contrast to 2001 sequencing costs challenges, it must first understand the diagnostics and therapeutics that of almost $100,000,000 per genome (see trends that have pushed healthcare to leverage knowledge of an individual’s Figure 1). evolve towards a more personalised genetic makeup to create a more Figure 1: Cost per genome from the National Human Genome Research Institute $ 100.000.000 $ 10.000.000 $ 1.000.000 $ 100.000 $ 10.000 $ 1.000 01 02 0 3 0 4 0 4 0 5 0 5 0 6 06 07 t- 07 08 08 09 - 09 0 0 p- p- t- r- t- r- t- r- t- pr- r- ct- r- l r-1 ct-1 se se oc ap oc ap oc ap oc a oc ap o ap ju ap o Source: Wetterstrand KA. DNA Sequencing Costs: Data from the NHGRI Large-Scale Genome Sequencing Program available at: www.genome.gov/sequencingcosts. Accessed 19 April 2011.8     Personalised Medicine in European Hospitals
  9. 9. Patient trends — Accessibility advice available online and more A few key examples of recent progress creates consumer-focused patients/consumers becoming well made in healthcare technology in healthcare educated on health management, Europe are described in Figure 3. Patient empowerment is part of a individuals will expect one-on-one broader trend towards consumer- customised service from physicians. focused healthcare, enabled by easy access to health information that was previously available only to medical Technology trends — Connectivity professionals.2 Not surprisingly, patients fosters treatments in non- are looking to various online resources traditional settings and for medical advice or diagnosis. In fact, encourages the “anytime, global consumers surveyed online by anywhere” mind set PwC said their top information source Connectivity allows for customised on health was online websites (See solutions both inside and outside the Figure 2).3 Social networking sites home. Developments such as telehealth, ranked eighth in this survey. Physicians home health, and web applications and providers are no longer viewed as enable a new paradigm of personalised the primary source for medical care outside the confines of a doctor’s information as online resources create office or clinic. Consumers are becoming educated patients that can now form empowered to predict their own medical their own opinion on how to handle risks, detect diseases, and track/manage their health. Online websites allow their health status overall through patients to feel as if they are in control of genetic testing products for in-home use their health and that advice is targeted — furthering the concept of health to their needs. With more medical management “anytime or anywhere”. Figure 2: Where do you go to find information to make decisions about your healthcare? (Select all that apply) Health website 48% Doctors 43% Through friends or family 30% Magazines or newspapers 27% TV or radio 24% The hospital 22% Government 21% Social networking websites 17% Community services 14% Health clubs (e.g., gymnastic, yoga) 8% Schools 7% 0% 10% 20% 30% 40% 50% 60% Source: PwC’s Health Research Institute Global Consumer Survey. HealthCast 2010. 2   PwC Health Research Institute, “Health Cast: The customization of diagnosis, care and cure”, March 2010. 3   PwC’s Health Research Institute Global Consumer Survey in “HealthCast: The customization of diagnosis, care and cure”, March 2010. Personalised Medicine in European Hospitals      9
  10. 10. Figure 3: Examples of care-anywhere networks through technology Territory Experience The government is making a progressive attempt to mobilise care from the hospital to homes equipped with electronic monitoring France devices. Leading the trend towards home automation, where sensors, central locking systems, radio frequency identification (RFID), ringing- Netherlands mats and cameras are used to monitor patients. P’ASMA is a web-based application that helps patients manage their asthma. The physician registers the patient’s clinical data, asthma Portugal control data and a specific treatment plan. At home, the patient downloads his or her data and receives immediate graphic and written feedback based on the defined treatment plan. The system also delivers automatic messages and alerts online to each patient. Capio Health Care has a daily dialogue with its psychiatric patients via email, for example, by using Montgomery-Åsberg Depression Sweden Rating Scale (MADRS) or comprehensive psychopathological rating scale (CPRS). And for orthopaedic rehabilitation patients, Capio sends their patients animated training programs via email. Toumaz Technology is conducting a clinical trial with the Imperial College Healthcare NHS Trust to test a digital “patch”, a disposable United device with a wireless sensor that sticks to a patient’s chest and can monitor, in real time, vital signs such as temperature, heart rate Kingdom and respiration. Source: PwC Health Research Institute, “Health Cast: The customization of diagnosis, care and cure”, March 2010. Wellness trends — With greater allow them to feel greater ownership in higher quality of service. Patients are focus on the consumer, healthcare the responsibility for their health. researching more on the Internet for is trending from diagnostics to information on healthcare and wellness Today’s trend towards consumerism healthcare coverage. As Figure 4 shows, Personalised medicine encourages attempts to inject something that’s been the share of online health information patients to be more active in the decision missing from health benefits — a seekers has doubled since 2004. making responsibilities of managing their consumer who cares more about cost health, and therefore enables a consumer- and quality. By providing financial focused market. Today, patients can incentives and information to patients, search online for symptoms they are the healthcare system can encourage experiencing; find individuals who may them to assume a greater role in share the same disease state; monitor managing their own healthcare and the their health within the confines of their associated costs, with the intention of own home; or become more enabling patients to make more value- knowledgeable on how to avoid, prevent, driven healthcare decisions. As patients or treat a certain illness. These factors are asked to contribute more towards typically push healthcare decisions and their healthcare coverage costs, they are treatments closer to the consumer and pushing for more information and Figure 4: Individuals from EU-27 using the Internet for seeking health-related information – Percentage of individuals aged 16 to 74. 50 40 33% 34% 28% 30 24% 19% 17% 16% 20 10 0 2004 2005 2006 2007 2008 2009 2010 Source: Eurostat 2010. Note: Health-related information: injury, disease, nutrition, improving health, etc. Within the last three months before the survey.10     Personalised Medicine in European Hospitals
  11. 11. 3.  ext steps for hospitals N and providers proteomics specialists with holistic generation of doctors on personalised knowledge of many different diseases medicine techniques and create and an understanding of gene curricula that are actionable by a interactions, eliminating the need for physician. The European Personalised patients to see a variety of specialists to Medicine Association (EPEMED) is a treat their ailments”.4 To educate the not-for-profit organisation that puts this next generation of physicians and nurses very idea into action. EPEMED brings The steep learning curve must be in the complex issues raised by genomic together key leaders across the met with education and expertise and proteomic science, universities need healthcare industry to discuss Hospitals must adapt to the changing to update their programs. personalised medicine, its key healthcare paradigm and take on the challenges, and best practices. It aims to aggressive learning curve by educating In addition to formalised training, provide a proactive platform for the their healthcare providers on the science conversations with leaders in the field of harmonisation of personalised medicine and clinical application of genomics and personalised medicine across the development and implementation across proteomics. Doctors will no longer be healthcare industry (e.g. government, Europe, focusing on the crucial role of able to apply one approach to a set of provider, payer) and academia could diagnostics, to make personalised patients with a disease state that is offer considerable value. Conversations medicine a reality.5 Key players from the seemingly similar. These patients may and working groups between payers and healthcare industry, regulators, payers have a dozen different gene-based providers, for example, could identify and government have an avenue to variations of the disease, each of which the most efficient reimbursement foster collaboration, learn from one could require a variation of the methods for diagnostic tests. another and improve patient care treatment. With formal schooling or Discussions between physicians and through EPEMED. training programs, “some physicians academics/professors could identify the might be trained as genomics and best approach to educating the next Personalised Medicine in Action: Hospital Spotlight •  he multidisciplinary staff of the Experimental Cancer Therapy Unit at the T Herlev Hospital in Copenhagen, Denmark is trained in handling blood samples for pharmacokinetics pharmadynamics and translational research. •  enetic diagnostics is done at the University of Eastern Finland, Kuopio, G which collaborates closely with the Kuopio University Hospital. Knowledge on monogenic forms of diseases and the potential of modern genetics is part of the course work for medical students. •  he Medical and Health Science Center University of Debrecen in Hungary T trains new doctors to practice personalised medicine. There are PhD courses on the field. •  he University Medical Centre Ljubljana, Slovenia, has a Clinical Institute T of Medical Genetics, which aims to develop tests and counselling as it relates to personalised medicine.   4 PwC, “The new science of personalized medicine: Translating the promise into practice”, 2009.   5 Association European Personalised Medicine, EPEMED, retrieved 4 May 2010, from http://www.epemed.org/index.html. Personalised Medicine in European Hospitals      11
  12. 12. Effective technology is the Due to different needs among interoperable countrywide, due to foundation for personalised specialities, hospitals find it more various restrictions such as technology, medicine difficult to integrate EHR systems, lack of standards or legal frameworks. The foundation for personalised although a few countries have more This lack of standardisation also results medicine will be distributed access to than 50% of their hospitals supported by in challenges for cross-border care in health information, not just for health EHR systems.9 Most installed EHR Europe. professionals.6 With the institution of systems in European countries are not electronic health records (EHRs), genomic, proteomic and personalised medicine data could be shared. Greater sharing of data that is instantaneous Figure 5: could accelerate research efforts In the next five years, which of the following changes, if any, are most likely to dramatically. Results from a PwC survey affect your health system? (multiple response question) demonstrated that a majority of respondents felt that within the next five Merging of information technology healthcare 84 years, “merging of information Relaxation of scope of practice laws that will enable technology and healthcare” will most clinicians to provide more primary care 58 likely affect their health system (See Increased use of virtual health communities 56 Figure 5). Personalised medicine 45 Technology alone, however, will not be sufficient. A great deal of thought will More travel/tourism among patients 45 need to be put into what data will be Relaxation of country restrictions on foreign 44 captured, where it will come from, what medical graduates the appropriate data types and formats More health insurance coverage for travel/tourism 43 will be, and how it should be presented to a physician.7 0 10 20 30 40 50 60 70 80 90 Because medical and academic research Source: PwC’s Health Research Institute Global Health Leaders Survey centres often work in information silos, connecting EHRs is challenging due to differing data standards. Agreement on common data formats and standards will serve to reduce complexity and Personalised Medicine in Action: Hospital Spotlight allow doctors and hospitals to share data among one another.8 •  he Experimental Cancer Therapy Unit, Department of Oncology at HEH, has T access to MRI, CT and PET-scans and a variety of other interventional Although the agreement on common diagnostic radiology and clinical physiological assessments. data and data consistencies is a huge •  enetics offers the possibility to diagnose monogenic diseases accurately at G task that requires time, effort and Kuopio University Hospital. money, there are some promising •  ew imaging technologies, such as 3 Tesla MRI and PETscan, are available at N initiatives from the European the University Hospital of Dijon. perspective such as EUROREC Institute •  he Medical and Health Science Center University of Debrecen uses T (EuroRec). This is an independent telemedicine to remotely monitor cardiology patients with remote ECG not-for-profit organisation that promotes (holter). the use of high-quality Electronic Health •  he University Medical Centre Ljubjana develops and uses their own analysis T Record systems (EHRs) in Europe. software tools for the application of personalised medicine techniques. EuroRec has also developed some tools to exploit its repository and has •  he Hospital Clinic in Barcelona uses remote monitoring devices for cardiac T elaborated (standard) procedures for pathologies and chronic diseases. the certification of eHealth products. 6   PwC, “The new science of personalized medicine: Translating the promise into practice”, 2009. 7  HealthcareLeaders Media in collaboration with PwC, “Breakthroughs: The Impact of Personalized Medicine Today”, 2010. 8  PwC, “The new science of personalized medicine: Translating the promise into practice”, 2009. 9   lectronic Health Record Systems-A Main Pillar in European e-Health Developments for Better Delivery of Care. G. Comyn, Head of Unit “ICT for Health”, DG INFSO, E European Commission, 2007.12     Personalised Medicine in European Hospitals
  13. 13. Changes in the healthcare medical education and clinical care treatment. This has reduced the cost of paradigm create opportunities to makes them well positioned to identify treatment for key populations.11 innovate and bend the cost curve unmet market needs and discover new As the emphasis on wellness grows and targeted therapies. Academic medical Willingness to collaborate will give payers and consumers seek alternative, centres also have access to massive providers the competitive edge less expensive forms of care, hospital amounts of patient data, which While these changes in the healthcare admissions will likely decrease. accelerates the discovery process. paradigm have posed challenges to Providers will be challenged to deliver Moreover, this creates an hospitals and providers, they may have new forms of care in order to maintain unprecedented opportunity to redefine also created opportunities for key consistent revenue. But through the new the research data continuum by participants in the healthcare industry wave of preventative medicine and launching an exchange of data that overall, particularly for non-traditional wellness, hospitals may be able to create goes full circle — from a researcher’s healthcare participants. Personalised new sources of revenue by launching laboratory to a patient’s bedside medicine, specifically, is a highly new services and products focused on back to the researcher’s laboratory complex field, and no one organisation wellness and disease prevention, which again. or industry has the requisite resources, will in turn create greater demand for knowledge and tools needed to molecular tests to determine The introduction of personalised implement solutions in this field. This predispositions and/or therapeutics as medicine at the point of care will require new science not only creates well as the corresponding health a huge change in the way healthcare is opportunities for hospitals and the services required.10 organised. How this might be done is industry to innovate, but also to illustrated by a system in France for the collaborate within or outside their Hospitals linked to universities may treatment of cancer. France’s National industries to create the best possible have brighter prospects, as they are Cancer Institute has set up a network of solutions.12 prepared to take the lead in 28 regional centres, linked with personalised medicine research. Their hospitals, where the tumours of cancer The following are a few examples of the unique combination of academic patients can be rapidly analysed to types of innovation emerging through research, state-of-the-art technology, establish their suitability for drug collaborative relationships: Personalised Medicine in Action: Hospital Spotlight •  everal departments at the Herlev Hospital/Copenhagen University in S Denmark have focused on nutrition and physical activity to improve wellness and treatment of patients. •  he Medical and Health Science Center University of Debrecen in T Hungary has a special nutrition centre where patients receive a personal diet, and they are currently building a wellness centre focused on rheumatologic services. 10   HealthcareLeaders Media in collaboration with PwC, “Breakthroughs: The Impact of Personalized Medicine Today”, 2010. 11  European Perspectives in Personalised Medicine, May 2011. European Commission. 12  PwC, “The new science of personalized medicine: Translating the promise into practice”, 2009. Personalised Medicine in European Hospitals      13
  14. 14. European universities and medical centres for national networks of clinical (EATRIS) is based on translation centres schools form partnerships with research centres and clinical trials units, created by clinics and biomedical research centres abroad to enhance and is able to provide support and research institutions with translational innovation. services to multinational clinical experience. • he University of Minnesota and Mayo T research. Clinic, under the mantle of the • iobanking and Biomolecular Resources B We expect to see complex networks of Minnesota Partnership for Biotechnology Research Infrastructure (BBMRI) forms collaboration to emerge, within and across and Medical Genomics, have formed a an interface between specimens and industries and between the public and strategic research relationship with the data (from patients and European private sectors, as individual organisations Karolinska Institute of Stockholm, populations) and top-level biological and or industries deal with the complex Sweden, the top-rated medical research medical research. During the past three challenges that come with this new focus university in Europe. Leaders of each years, BBMRI has grown into a on personalised medicine.17 As institution signed memoranda of 53-member consortium with over 280 collaborative partnerships develop, it will understanding to commit to the formal associated organisations (largely be important to consider how these ongoing collaboration, called the biobanks) from over 30 countries, complex alliances can be appropriately Frontiers of Biomedical Research.13 making it the largest research managed so that all parties can benefit infrastructure project in Europe. from the innovations that emerge. Pharmaceutical companies have shown • he European Advanced Translational T their commitment to developing Research Infrastructure in Medicine personalised treatments by collaborating with companies in their industry. • rocter Gamble and Inverness Medical P Personalised Medicine in Action: Hospital Spotlight Innovations, a diagnostics company, •  he Herlev Hospital/Copenhagen University Hospital is collaborating with T created a $325 million joint venture to other universities in Denmark, the European Union and the United States for create diagnostics products.14 research purposes and treatment of patients, as well as with the National • erck and AstraZeneca collaborated to M Laboratory for Sustainable Energy and many biotech and pharmaceutical combine two experimental cancer drugs, companies. one from each company, to create a cocktail that could provide better results •  he Kuopio University Hospital in Finland is collaborating with several T than each alone.15 institutions for research purposes, including the National Institutes of Health of the US Department of Health and Human Services, the University of Non-traditional healthcare companies Southern California and the University of Ann Arbor in the United States, and are working together to increase the University of Gothenburg in Sweden. innovation in technology that will •  he University Hospital of Dijon, France, is collaborating with several T monitor the individual’s health. organisations, including other university hospitals, scientific groups and • ntel and General Electric formed an I biotech companies. In particular, the University Hospital of Dijon collaborates alliance to market home-based health. with the Cancer Centre Georges François Leclerc, which develops its own The primary objectives were to enable research programs, some of which are common within the University remote monitoring of patients and lower Hospital of Dijon, INSERM research centre and the biotech company healthcare costs by reducing the number Oncodesign. of necessary hospital visits.16 •  he Medical Health Science Center University of Debrecen, Hungary, is T collaborating with orphan drug companies, such as Genzyme, a laboratory Multicentre networks of clinical testing research on Fabry disease. research in Europe. •  The University Medical Centre Ljubljana, Slovenia, is collaborating with other • he European Clinical Research T universities, companies providing consumables, government and health Infrastructures Network (ECRIN) is insurance companies. based on the connection of coordinating 13  Universityof Minnesota, Mayo Clinic sign research pact with Karolinska. Available at http://www.ahc.umn.edu/media/releases/umayokaro/index.htm. 14  PG “ partners with Inverness in diagnostics venture” Mass High Tech, 18 May 2007. Available at http://www.masshightech.com/stories/2007/05/14/daily43-PG- partners-with-Inverness-in-diagnostics-venture.html. 15  on Winslow, “AstraZeneca, Merck to Test Cancer Drugs in ‘Cocktail’”, Wall Street Journal, 2 June 2009. Available at http://online.wsj.com/article/ R SB124380640803770139.html. 16  Gran Gross, “Intel, GE partner on home health tech”, NetworkWorld, 2 April 2009. Available at http://www.networkworld.com/news/2009/040209-intel-ge-partner- on-home.html. 17  PwC, “The new science of personalized medicine: Translating the promise into practice”, 2009.14     Personalised Medicine in European Hospitals
  15. 15. 4. Conclusions on which treatment(s) should be used when reading genetic data. This includes making better use of modern imaging technologies as well as the more effective use of decision support tools. While many new potential biomarkers are being discovered, the Although a great deal of progress has rate at which these are being qualified been made in genomic and proteomic and validated is slow. research and the field of molecular • niversal standards for managing U genomics, many challenges remain. genomic information in electronic medical records will be necessary to The learning curve poses new implement this technology and ensure challenges for doctors and clinical data is collected and scientists interpreted in a standardised • ecognising which genes or biological R manner.20 mechanisms signify that a patient is predisposed to certain diseases and The least evident challenge is how this in turn translates into often the hardest to overcome knowledge that can be used for • onsumer behaviour, an obstacle that C prevention and treatment strategies may not be apparent, will be key when poses a large learning curve that implementing personalised medicine scientists and doctors will have to and creating a culture that can adapt overcome.18 to these changes.21 • ow we manage our personal health H • iseases need to be reclassified to D and lifestyle are not only difficult reflect new knowledge about human habits to modify but also play a key biology. Many clinical entities role in our susceptibility to disease currently described as single diseases and disease management. Swinging may in fact be more than one disease, the pendulum from treatment to requiring different treatment prevention and from illness to approaches.19 wellness will be essential to implement a consumer-focused Implementation of effective culture. technologies is no easy task • atients need to be educated and P • ey challenges remain in determining K physicians need to be instructed in the the appropriate type and new technologies and methods that sophistication of technology needed allow for a more personalised for doctors to make effective decisions diagnosis of diseases and treatments. 18  PwC, “The new science of personalized medicine: Translating the promise into practice”, 2009. 19  European Perspectives in Personalised Medicine, May 2011. European Commission. 20  PwC, “The new science of personalized medicine: Translating the promise into practice”, 2009. 21  PwC, “The new science of personalized medicine: Translating the promise into practice”, 2009. Personalised Medicine in European Hospitals      15
  16. 16. These challenges will need to be • rovide new health and wellness P addressed at European, national, products and services to the regional and local levels. community. • ork with patients to educate them W With any challenge, however, comes about the need to proactively manage opportunity. The shifting healthcare their own health and commit to paradigm provides hospitals and wellness programs and the benefits healthcare systems around the world that some programs have derived from with an opportunity to adapt to the putting them into practice. changing needs of the patient, treat the • ook to other industries to understand L disease sooner and create cost-cutting how to market directly to patients and measures by instituting alternate forms deliver excellent customer-centric of medicine or treatment. Key services. recommendations are evident as the • ollaborate in research projects to C health industry considers how to boost personalised medicine research respond to the emerging personalised productivity and effectiveness as well medicine market and explore as ensure that proper policy sustainable business models. recommendations are developed to accelerate and support this emerging Recommendations for providers/ market. provider systems are as follows: • ncourage collaboration between E • earn genomics and proteomics to L personalised medicine experts and develop effective prevention and doctors with expertise in the field in treatment plans. the development of new care models.16     Personalised Medicine in European Hospitals
  17. 17. • mplement interoperable electronic I hospitals and providers to respond to the health records to enable the sharing of changing market. Personalised medicine genomic, proteomic, and other health can be set up and implemented into a data related to personalised medicine hospital model in a variety of ways, as among research and healthcare discussed in the interviews with several organisations. European hospitals in Part II of this document. As demonstrated through the It is clear that key challenges exist as the preceding “Hospital Spotlights”, many pressure to be personalised continues to European hospitals have already begun mount. As evidenced through the above to define what personalised medicine recommendations, hospitals and means to their hospital and have providers have a clear opportunity to developed their approach to adapt to the new healthcare paradigm implementation. and provide services that are targeted to the individual patient. It is important to recognise, however, that different hospitals operate and require different hospital models. Just as doctors will no longer be able to apply the same forms of treatment to a group of patients, not all hospitals will be able to apply the same approach to addressing the challenges brought on by personalised medicine. Fortunately, there are many ways for Personalised Medicine in European Hospitals      17
  18. 18. Part II. Hospitals in focus List of Participating Hospitals Herlev Hospital / Copenhagen University Hospital at Herlev, Denmark Kuopio University Hospital, Finland University Hospital of Dijon, France Medical and Health Science Center University of Debrecen, Hungary University Medical Centre Ljubljana (UMCL), Slovenia Hospital Clinic de Barcelona, Spain18     Personalised Medicine in European Hospitals
  19. 19. Copenhagen, Denmark.Herlev Hospital/CopenhagenUniversityHospital at HerlevDenmarkHerlev Hospital (HEH) has for treatment with trastuzumab. Clinical Biochemistry, Pathology,several years focused on research for Several units at HEH provide Radiology and Clinical Physiology.better personalised medicine and technical and logistical support to HEH has several PET/CT, CT, MRIhas included new biomarkers in research in personalised medicine. and ultrasound scanners used inroutine clinical practice, e.g. analysis These units help to improve the projects related to personalisedof KRAS mutation status in patients effectiveness of the logistics medicine, e.g. early evaluation ofwith colorectal cancer before processes and research activities in treatment response to new biologicstreatment with cetuximab and the field of oncology, hematology, for cancer patients.analysis of HER2 protein expression medicine, surgery and gynecology.in patients with breast cancer before The units include Departments of Type of Hospital Public/Academic 425,000 (700,000 in Reference Population certain specialities) Nº Beds 624 Nº Employees 4,141 Nº Physicians 768 Nº Inpatient 131,123 Admissions Nº Day-Hospital 426,379 Admissions Nº Surgery 20,400 Procedures Hospital Annual 3,008 mil DKR Revenues Interview with Julia S. Johansen, Professor, Senior Consultant, DMSc, Herlev Hospital Hospitals in focus     19
  20. 20. Interview with Julia S. Johansen What do you believe to be the key trends related to the What are the top five value propositions that implementation of personalised medicine within the personalised medicine may provide? hospital environment? Feasibility/ Ease of Time Horizon Danish patients and healthy subjects are willing to participate Value Proposition Implementation1 in translational studies concerning improved personalised Better clinical response 1 10 years medicine. The infrastructure and logistics are established for Better survival 1 15 years translational research at HEH. We mainly need further Reduce treatment failures 1 10 years support for hospital staff, researchers and operational costs Reduce side effects 1 10 years for analysis studies in translational research. Decrease cost 1 10 years 1 E ach proposal is rated within a scale 1: high complexity and 5: low complexity How should the health system in your country lay the groundwork for the next steps in personalised What are the main barriers for the implementation of medicine? personalised medicine within the hospital Increase the amount of funding for specific studies related to environment? translational medicine with a main focus on better Lack of research funding for better personalised medicine. personalised medicine. Description of personalised medicine approach in your hospital: Core Activity Diagnostics and Many departments at HEH have a high focus on better diagnostics and therapeutics, e.g. cancer patients are Therapeutics discussed at multidisciplinary team conferences (surgeons, oncologist, pathologists and radiologists). Personalised Medical Care EMR/Clinical Conducted between departments and at multidisciplinary team conferences. Decision Support Disease management is used in several departments, such as oncology, haematology, intensive care, surgery Disease Management and medicine, paediatrics, and gynaecology. Personalised medical care is used in disease management. Telemedicine/Remote Multidisciplinary teleconferences with other hospitals. Patient Monitoring HEH participates in many research projects related to better personalised medicine that is funded by public and private agencies. The Copenhagen General Population Study is located at the Department of Clinical Biochemistry. This is a blood biobank and research study which will follow about 100,000 volunteers, aged 20 years to 100 years, from the Copenhagen area in Denmark. Today more than 60,000 volunteers are included. Initial enrolment Research/Expansion is taking place at HEH, and the participants are followed yearly in the Danish Health registries thereafter. of Science-Base The secretarial office of the Danish CancerBiobank is located at the Molecular Unit, Department of Pathology, HEH. The objective of this biobank nationally is to collect blood and tissues optimal for translational research from patients with primary cancer in order to, for example, improve personalised medicine. The project started in January 2010, which included biological material from 5,281 patients in its first year. There is a connection with the Danish nationwide clinical databases and other national registries. The Experimental Cancer Therapy Unit, Department of Oncology at HEH has been involved in clinical trials for more than 25 years. The department has broad experience with cytostatic drugs, biological and anti-hormonal agents, dendritic cells, and intrahepatic chemotherapy. The Experimental Cancer Therapy Unit was founded in 2004. Its core competency focuses on the planning, preparation and conduct of phase I clinical trials in cancer patients as well as early phase II trials. • he unit offers complete project and clinical trial management systems. T Others • he unit operates with ICH GCP and standards of the pharmaceutical industry, including standard T operating procedures (SOP’s) covering all aspect of clinical trials. • he unit complies with all current legal requirements and the EU Directive on Clinical Trials (Directive T 2001/20/EC Directive 2005/28/EF). • he unit has experience in design and administration of databases and the development of computerised T trial management software.20     Personalised Medicine in European Hospitals
  21. 21. Interview with Julia S. Johansen • he unit has experience in incorporation of health economics and quality-of-life measures. T • he unit has a network of leading scientists and oncologists and collaborates with other phase I units in T Denmark and Europe. A dedicated team, including research nurses, oncologists, and statisticians staffs the unit. The staff members have a comprehensive experience in developing, planning, implementing and running a clinical trial, as wellOthers as conducting data management and statistical analysis. The staff members are trained in handling blood samples for pharmacokinetics, pharmadynamics and translational research. Additionally, tissue sampling may be added to the unit through the collaboration with the Department of Diagnostic Radiology and various surgical departments. Furthermore, the unit has access to MRI, CT and PET-scans, and a variety of other interventional diagnostic radiology and clinical physiological assessments.Nutrition WellnessNutrition/Organic Several departments have focused on nutrition and physical activity to improve wellness and treatment ofCare patients.Complementary N/AAlternative MedicineOthers N/AOther Related Products and ServicesStem Cells N/A The Clinical Research Unit, Department of Oncology, HEH has been involved in clinical trials for more than 25 years. The department has broad experience with cytostatic drugs, biological and anti-hormonal agents, dendritic cells, and intrahepatic chemotherapy. Clinical Research Unit was founded in 1992. The main objective of the unit is to conduct high-quality research to achieve patient benefits. Its core competencies focus on the planning, preparation and performance of phase I–III clinical trials in cancer patients. • he unit offers complete project and clinical trial management systems. T • he unit operates with ICH GCP and standards of the pharmaceutical industry, including standard T operating procedures covering all aspect of clinical trials. • he unit complies with all current legal requirements and the EU Directive on Clinical Trials (Directive T 2001/20/EC Directive 2005/28/EF). • he unit has experience in the design and administration of databases and the development of T computerised trial management software. • he unit has experience in incorporation of health economics and quality-of-life measures. TOthers • he unit has expertise and computing facilities required to coordinate multicentre clinical trials. T • he unit organises educational activities, including training courses and workshops. T • he unit has a network of leading scientists and oncologists, including collaboration with other phase I T units in Denmark and Europe. The unit collaborates closely with the Experimental Cancer Therapy Unit, a dedicated unit for experimental cancer therapy and phase I trials. Furthermore, the unit has easy access to a basic science laboratory and all facilities of a large centre. A dedicated team, including research nurses, oncologists and statisticians staff the unit. The staff members have comprehensive experience in developing, planning, implementing and running a clinical trial, as well as conducting data management and statistical analysis. The staff members are trained to handle blood samples for pharmacokinetics, pharmadynamics and translational research. Additionally, tissue sampling may be added to the unit through the collaboration with the Department of Diagnostic Radiology and various surgical departments. Lastly, the unit has access to MRI, CT and PET-scans, and a variety of other interventional diagnostic radiology and clinical physiological assessments. Hospitals in focus    21
  22. 22. Interview with Julia S. Johansen Where does your hospital stand on the Which service lines, including clinical services as well implementation level of each activity? as non-clinical services, related to personalised medicine are more developed in your hospital? Diagnostics and Therapeutics • linical chemistry: e.g. SNPs, genes, mRNA, microRNA, C 5 protein biomarkers 4 • Pathology: e.g. SNPs, genes, mRNA, microRNA, protein Nutrition / Organic EMR / Clinical Care Decision Support biomarkers 3 • Radiology: CT, MRI, ultrasound 2 • Clinical Physiology: PET/CT 1 0 Policies and programs play an important role as an Other: The Disease accelerator and regulator. What are the key Experimental Management personalised medicine enablers in your hospital environment? Herlev Hospital has for several years focused on research for Research / Telemedicine / better personalised medicine and has rapidly incorporated Expansion of Remote Patient Science-Base Monitoring new biomarkers in routine clinical practice, e.g. analysis of KRAS and BRAF mutation status in patients with colorectal (0: Not applicable; 5: High development). cancer and melanoma before treatment with biologics and analysis of HER2 protein and FISH expression in patients with Do you have relationships or affiliations with other breast cancer before treatment with trastuzumab. sector organisations as it relates to personalised medicine (such as universities, IT companies, HEH participates in many research projects related to better government, biotech, etc.)? How do these personalised medicine funded by the Hospital, and also by, relationships work? e.g. the Danish government, the Danish Cancer Society, the HEH is collaborating with several institutions for research Danish Heart Association, the Danish Rheumatism purposes and treatment of patients. These institutions Association, Biotech Companies like Novo Nordisk, Roche, include: Merck/Serono, Novartis and private foundations. • ther University Hospital in Denmark O • ther universities in Denmark, the European Union, and the O The “Copenhagen General Population Study” is located at the United States Department of Clinical Biochemistry, HEH. This is a blood • he Danish Technical University T biobank and research study which will follow 100,000 • ISØ, National Laboratory for Sustainable Energy R volunteers, aged 20 years to 100 years, from the Copenhagen • any biotech and pharmaceutical companies M area in Denmark. Today more than 60,000 volunteers are included. Initial enrolment is taking place at HEH, and the Have you built a research centre that encompasses participants are followed yearly in the Danish Health personalised medicine? registries thereafter. Some of the expenses (e.g. salaries to The Clinical Research Unit, Department of Oncology, has a technicians and doctors, biomarker analysis) for this unique close collaboration with the Experimental Cancer Therapy biobank are paid by HEH. Unit, a dedicated unit for experimental cancer therapy and phase I trials. Furthermore, the unit has easy access to a basic The secretarial office of the “Danish CancerBiobank” is science laboratory and all facilities of a large centre. located at the Molecular Unit, Department of Pathology, HEH. The objective of this biobank is to nationally collect blood and The units have access to MRI, CT and PET-scans, and a variety tissues optimal for translational research from patients with of other interventional diagnostic radiology and clinical primary cancer in order to, for example, improve personalised physiological assessments. medicine. The project started in January 2010, and during the first year, biological material from 5,281 patients was Current status report on the integration of included. There is a connection with the Danish nationwide personalised medicine into actual clinical practice clinical databases and other national registries. Some of the within your hospital: expenses (e.g. salaries to technicians and doctors) for this Several tests for personalised medicine are used in daily unique biobank are paid by HEH. clinical practice (e.g. KRAS mutations, HER2 expression, molecular profiling in haematological disease). Several units at HEH provide technical and logistic support to research in personalised medicine and help to improve the22     Personalised Medicine in European Hospitals
  23. 23. Interview with Julia S. Johanseneffectiveness of logistics processes and research activities inthe field of oncology, haematology, internal medicine, surgeryand gynaecology. The units include Departments of ClinicalBiochemistry, Pathology, Radiology and Clinical Physiology.HEH has several PET/CT, CT, MRI and ultrasound scannersused in projects related to personalised medicine, e.g. earlyevaluation of treatment response to new biologics for cancerpatients. Technicians at the Department of ClinicalBiochemistry take many project-related blood samples fromhealthy subjects and patients included in different projects,without cost, at the same time as routine blood samples arecollected. This is also a benefit for the patients (they will nothave to give blood twice) with various types of diseasesincluded in different clinical studies (including biomarkersstudies of treatment response to, for example, biologicaltreatment of patients with cancer and inflammatory diseases).What are the operational challenges you haveexperienced in your hospital as it relates tointegrating personalised medicine? Dimension ChallengesArchitecture and Equipment Too little spaceServices Offered –Clinical Activity –Organisational Structure –IT Bad/slow in many areasFinancial Limited financial supportResearch Development –Academic/Teaching activity –How does personalised medicine impact on qualitymeasures in your hospital?• etter survival B• ewer side effects F• horter hospitalization S With any new technology or new initiative, there is an• ost C adoption curve before the initial investment pays off.• atients are more satisfied P Where do you stand with personalised medicine on that curve?Can you describe the basic infrastructure New technologies of initiatives for personalised medicine are(technologies and tools) for the application of typically adopted as soon as they are introduced.personalised medicine that exists in your hospitaltoday? Did personalised medicine impact the roles andSeveral units at HEH provide technical and logistical support responsibilities of your healthcare providers?to research in personalised medicine. These units help to Yes, very much. In recent years, the cost of new medicine, i.e.improve the effectiveness of the logistics processes and biologics like adalimumab and infliximab (for patients withresearch activities in the field of oncology, haematology, rheumatoid arthritis); trastuzumab (for patients with breastmedicine, surgery and gynaecology. The units include the cancer); rituximab (for patients with lymphoma) andDepartments of Clinical Biochemistry, Pathology, Radiology bevacizumab, cetuximab and panitumumab (for patients withand Clinical Physiology. HEH has several PET/CT, CT, MRI colorectal cancer) have increased dramatically during the lastand ultrasound scanners used in projects related to five to ten years. Unfortunately, less than 30% of the patientspersonalised medicine. Early evaluation of treatment response will benefit from the treatment since it is very expensive andto new biologics for cancer patients is one example. has severe side effects. The healthcare providers know very Hospitals in focus   

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