Report
2nd Annual Conference 2013
A collaborative approach
to Personalised Medicine
27-28 May 2013, Hilton Munich City, Munich, Germany
EuroBioForum is funded by the European Commission (DG Research & Innovation),
7th Framework Programme. Grant Agreement Number: HEALTH-F4-2010-261453.
Duration: 1 January 2011 – 31 December 2014
EuroBioForum | 2nd Annual Conference 2013 | Report
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Content
page number
1. Introduction
3
2. Conference Agenda
4
3. Overview of keynotes and presentations
6
4. Summary of presentations and discussions
7
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1. Introduction
The EuroBioForum Annual Conferences are focussed on Personalised Medicine and offer a forum to
exchange views on the state of affairs in policy development and deployment, and on the challenges
with respect to policies, implementation strategies and required investments.
Personalised Medicine needs involvement of all stakeholders: how can we address the challenges to
find solutions? The complexity of diseases and the biology of humans is calling for a different
approach. But the question is whether the present focus on Personalised Medicine is the solution.
What are the perspectives in policy making and funding of Personalised Medicine? How can the
aforementioned issues be addressed? How to tackle the future challenges in Personalised Medicine?
Objectives:

Provide insight into national and regional policies, funding instrumentation and strategic
research & innovation agendas in Personalised Medicine.

Facilitate participants to meet other ‘key players’ in the field of Personalised Medicine and to
learn from each others’ experiences.

Explore specific topics for possible coordination and cooperation.

Encourage joint public-public and/or public-private partnerships.
The 1st EuroBioForum Annual Conference 2012 was held in Brussels on 18 April 2012 and addressed
the role of national funders, bioclusters and regions in Personalised Medicine. Around 60 participants
from 14 countries attended the conference.

www.eurobioforum.eu/2012
The 2nd EuroBioForum Annual Conference 2013 was held in Munich on 27 and 28 May 2013 with a
focus on exploring potential areas for transnational and transregional collaboration in Personalised
Medicine. The conference was co-hosted by BioM, the management organisation for the Munich
Biotech Cluster m4.
About 70 representatives of national governments, funding agencies and bioregions participated in
the conference. Participants came from 17 different countries, including Canada and Russia.
During both conference days 14 presentations were delivered by national and regional governments
and funders, picturing the state of play on Personalised Medicine in their countries/regions. In
addition, keynote presentations addressed cross-cutting topics such as health economics, social
media and the challenge of education and training.

www.eurobioforum.eu/2013
The 3rd EuroBioForum Annual Conference 2014 will be held in Tallinn, Estonia on 22 and 23
September 2014.

www.eurobioforum.eu/2014
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EuroBioForum 2013 photos are also available on: www.flickr.com/EuroBioForum
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2. Conference Agenda
The presentations during the conference were structured along the following lines:

Day 1: National perspectives (including Canada and Russia) and keynotes on market
perspectives and health economics.

Day 2: Regional perspectives, including Canadian provinces, and keynotes on education &
training and social media & web technology.
Day 1: Monday 27 May 2013
13.00 Welcome by Wouter Spek, Managing Director of EuroBioForum
13.10 Keynote presentation by Horst Domdey, Managing Director of BioM, Munich
(co-host of EuroBioForum 2nd Annual Conference 2013)
13.25 Video message by Ruxandra Draghia-Akli, Director of Directorate Health at
DG Research and Innovation, European Commission
NATIONAL PERSPECTIVES
13.45 Canada: Pierre Meulien, President and CEO of Genome Canada
Étienne Richer, Assistant Director CIHR Institute of Genetics
14.10 Norway: Øyvind Melien, Senior Advisor at the Norwegian Directorate of Health
14.35 Switzerland: Anne Eckhardt, Consultant on behalf of the Swiss Academies of Arts
and Sciences
15.30 Germany: Karin Effertz, Scientific Officer at the German Federal Ministry of
Education and Research
15.55 Belgium: Wolfgang Eberle, Programme Manager Life Science Technologies at Imec
16.20 Russia: Sergey Suchkov, Professor in Medicine and Immunology at the Moscow State
Medical & Dental University & I.M. Sechenov Moscow Medical Academy
16.45 Scotland: Graeme Boyle, Interim Director Stratified Medicine Scotland & Senior
Programme Manager at Health Science Scotland
MARKET PERSPECTIVES
17.15 Keynote presentation by Emmanuelle Benzimra, General Delegate of EPEMED,
The European Personalised Medicine Association
17.40 Keynote presentation by Katherine Payne, Professor of Health Economics,
Health Sciences – Economics, University of Manchester
Member of the EuroBioForum Strategic Advisory Board
18.00 Wrap-up by Eero Vuorio, Chair of the EuroBioForum Strategic Advisory Board
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Day 2: Tuesday 28 May 2013
09.00 Welcome-back by Wouter Spek, Managing Director of EuroBioForum
09.05 Keynote presentation on the challenges of Education & Training by Jami Taylor,
Senior Director Global Access Policy at Janssen, the Pharmaceutical Companies of
Johnson & Johnson, Vice-chair of the Education Committee of EPEMED
09.30 Keynote presentation on Social Media & Web technology by Pelagiya Dragomirova,
Communication Advisor at Publimarket / EuroBioForum
REGIONAL PERSPECTIVES
10.00 Eurobiomed, France
Franck Molina, President of EDCA (European Diagnostic Clusters Alliance), Chair
of the diagnostics group of Eurobiomed, Director of SysDiag
10.25 Ontario Genomics Institute, Canada
Mark Poznansky, President and CEO
11.10 Genome British Columbia, Canada
Rachael Ritchie, Director Business Development
11.35 Genome Quebec, Canada
Marc LePage, President and CEO
12.00 Rotterdam Delta, The Netherlands
Menno Kok, Advisor Research Strategies of Erasmus Medical Center and
sector manager of Medical Delta
12.25 Bioindustry Park / bioPmed – Piemonte Innovation Cluster, Italy
Alberto Baldi, Business Development & Technology Transfer
12.50 Overall conclusions, follow-up and closure by
Wouter Spek, Managing Director of EuroBioForum
14.00 Satellite meeting – Transregional partnerships in Personalised Medicine
(closed set-up)
During the conference the EuroBioForum Partnering Hub served as a successful vehicle to lay the
foundation for transnational and transregional collaborations and partnerships.
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3. Overview of keynotes and presentations
KEYNOTES
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page number
EuroBioForum
European Commission
Market Access
Health Economics
Education & Training
Social Media
7
8
21
22
25
26
COUNTRIES
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Canada
Norway
Switzerland
Germany
Belgium
Russia
Scotland
10
12
14
16
17
18
19
REGIONS / BIOCLUSTERS

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BioM (DE)
Eurobiomed (FR)
Ontario Genomics (CA)
Genome BC (CA)
Genome Québec (CA)
Medical Delta (NL)
Piemonte (IT)
8
27
28
30
32
33
34
All presentations and video messages can be viewed or downloaded from EBF’s website
www.eurobioforum.eu/2260/output-eurobioforum-2013.
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4. Summary of presentations and discussions
Day 1
KEYNOTES
The conference was opened by Wouter Spek, Managing Director of EuroBioForum, followed by
keynote presentations by Horst Domdey, Managing Director of BioM in Munich and Ruxandra
Draghia-Akli, Director Directorate Health at DG Research & Innovation, European Commission.
Wouter Spek
EuroBioForum
Welcome

Spek opened the conference with a recent cover of TIME Magazine: “Angelina Jolie’s double
mastectomy puts genetic testing in the spotlight;…about calculating risk, cost and peace of
mind”. Illustrating that Personalised Medicine is becoming reality and will soon be part of our
daily life.

He looked back at the past year and gave a resume of EBF’s achievements since the 1st
EuroBioForum Annual Conference in April 2012 in Brussels. In the process of “scout –
connect – activate”, EBF has established its Observatory and is shifting now to the
connect/activate stage. He mentioned new initiatives in Education & Training, Big Data and
transregional collaboration, as well as two studies carried out by EBF on biomarkers research
in Europe and the impact of social media on personalised (participatory) medicine.
As a follow-up of a special satellite meeting during the 1st EBF conference, a working group of
funding organisations and other stakeholders has been established to prepare for a CSA
proposal as a precursor for a future ERA-Net on Personalised Medicine. The proposal
entitled: Personalized Medicine 2020 and beyond – Preparing Europe for leading the global
way (PerMed), was approved by the Commission in April 2013 (duration 24 months). The
consortium consists of 30 organisations and is coordinated by DLR/DE.


Spek stressed the necessity of collaboration (convergence) between health and ICT research:
without data no personalised medicine. He referred to a short analysis of recommendations
mentioned in the numerous reports in the recent past. He concluded that hardly any
progress has been made in turning these recommendations into action. He also referred to
the biomarker controversy: about 150000 biomarkers are claimed, but only a 100 are used
on a routine basis in the clinic; biomarker research accounts for about 1 billion euro annually.

Finally he challenged the audience to express during the conference their priorities for action
and future partnerships.

A special word of welcome was for the Canadian delegation, representing the federal
government and three of the big provinces in Canada. They will participate in the Satellite
meeting on transregional partnerships to be held right after the conference. Interested
regions are welcome.
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Horst Domdey
BioM, Munich
The Munich Biotech Cluster m4 Approach towards Personalised Medicine

As co-host of the conference Domdey welcomed the participants in the capital of Bavaria and
looked forward to the next German elections. He gave an overview of the Munich Biotech
Cluster m4, which is running a € 100 M programme fully dedicated to personalised medicine.
The cluster comprises big pharma companies, (university) hospitals and biotechnology startups. The programme involves scouting (identification of (bio)pharmaceutical research
projects with a high innovation potential), a regional pre-seed programme for innovative
research projects in the field of biomarkers and drug development, professional mentoring
and assisted incubation.

He gave an example of a successful start-up, Corimmun, which was acquired by Jansen-Cilag
in June 2012. The company developed a drug to prevent heart failure, which is now being
tested in a phase II clinical trial; it is administered to a subgroup of heart failure patients who
have been stratified by a specific diagnostic test.

The healthcare of the future will be based on Leroy Hood’s principles (P4 Medicine):
predictive, preventive, personalised and participatory. Domdey mentions the following
challenges for the years to come:
Health Economics: provide evidence for future sustainable cost savings in health care
Alternative individualised treatments: e.g. to prolong life expectance
Biomarkers: validation, open data sharing, open registries, market place (e-Bay),
multiple markers system approach (beyond biomarkers).
IT: data, infrastructures.
Ruxandra Draghia-Akli
Directorate Health at DG Research & Innovation, European Commission

The video message is the reflection of an interview taken by the EBF-team just before the
conference and structured along the following questions:

Do you think Europe has made some progress in the past year in the area of Pmed?
Yes. The recommendations of the Personalised Medicine Conference in 2011 and the Forum
have been taken up in the Commission proposal for Horizon 2020. Issues as health and
disease are relevant for Pmed, the goal being to move from medicine today (more
phenotypical) to molecular medicine which is the basis for stratified and then personalised
medicine. Another issue that has been incorporated is the design of clinical trials and a much
better approach to address groups of individuals rather than diseases. But the biggest part in
front of us is the implementation to the patient.



More and more countries in Europe are putting Pmed on the agenda. Wouldn’t it be the time
for a more coordinated approach, initiated by the Commission?
An ERA-Net or Joint Programming seems at this stage premature in the absence of definite
plans of the Member States. If this would be the case, the Commission will support initiatives
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such as ERA-Nets or joint programming, if they are based on concrete plans and obviously in
alignment with the work already been done and in progress by the Commission (H2020).

How are you looking at the various initiatives, their positioning and interrelationships?
(EuroBioForum, CSA PerMed, CA Systems Medicine, other Commission initiatives)
All these initiatives are very complementary and are addressing various aspects of Pmed. For
instance the Rare Diseases Consortium (IRDiRC) in which field resources and expertise are
scarce. With 33 committed members a strategic research agenda is being drafted now
addressing different aspects of Pmed. Also part of this universe of initiatives are the epi-,
cancer- and metagenomics consortia, all moving towards Pmed. As is the public-private
partnership IMI (Innovative Medicine Initiative) with 37 projects ongoing.

What are your thoughts on ‘Participatory Medicine’, e.g. The role of the patient?
Do you think that internet and social media will catalyse the implementation of Pmed?
Patients play an essential role in the new way of performing clinical trials and gathering
information. The Commission is catalysing the involvement of patients at all levels, in
advisory groups for programmes and topics (H2020), all the way down to the implementation
of projects; investigators are encouraged to involve patients in their projects, particularly in
clinical trial design. In IRDiRC, large patient organisations are member of the executive board
and actively participating in shaping the policies of the consortium.

Nowadays a lot of attention is geared to the ‘technology’ side of Pmed, but at the end of the
chain, innovation is not readily fully accepted. What in your view needs to be done to involve
the payers in this respect?
Decisions for payment are taken at the individual Member State level. So, it is difficult to
involve the payers. Initially, Pmed was thought to be extremely expensive, but the INCA
programme in France shows the opposite; the breast cancer screening programme with a
cost of 1.5 to 2 million euro resulted in proven cost savings of 30 million euro (savings of
expensive drugs, less treatment of adverse effects, less sick leave). Involve payers by starting
a systematic dialogue, and shift the discussion from “Pmed is going to be very expensive” to
the question “where is the balance”.

How and to what degree will Horizon 2020 contribute to Pmed?
Horizon 2020 is very much about Pmed. If we want to understand health and diseases and
change the definition of diseases, we have to go through the entire business cycle and
change the way we have done business for very many years. H2020 is all about Pmed, from
very basic understanding of diseases to healthcare and healthcare systems, and how we are
going to deal with these changes both in the population, in expectations and in technology,
but also in diagnosis, prevention and cure.

What is your message to our conference participants?
The biggest challenge is the implementation. So, I would encourage the participants to look
for successful models, such as the cancer screening programme in France. Put forward this
economic modelling and look at what are the benefits for the patient. And bring the evidence
that would convince politicians, tax payers and ministers of finance. That is the way to move
forward.
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NATIONAL PERSPECTIVES
Étienne Richer
CIHR Institute of Genetics, Canada
Personalized Medicine: A Canadian Collaborative Perspective

The CIHR (The Canadian Institutes of Health Research) is the Federal Funding Agency for
health research in Canada. The agency works in association together with Genome Canada.
Its mission is to transform health research in Canada, with an annual budget of $ 1 billion.
CIHR consists of 13 virtual institutes and has linkages with researchers from more than 50
countries.

Pmed is defined as “the tailoring of preventative, diagnostic or therapeutic interventions to
the characteristics of an individual or population”. The incentive is that such targeted
interventions could ultimately lead to the optimization of the healthcare system and reduced
costs.

The objective of CIHR’s Personalized Medicine Initiative is to enhance health outcomes
through patient stratification approaches by integrating evidence-based medicine and
precision diagnostics into clinical practice, covering two themes: 1) develop and translate
discoveries and 2) supporting policy and practice. This is done by building a National
Framework through the following activities:
Generating Evidence (funding, cancer consortium, rare disease consortium)
Addressing the Regulatory and Policy Challenge (federal and provincial, IRDiRC)
Developing a National infrastructure and services (i.a. clinical trials network)
Creating Outreach (stakeholders community, public awareness, international
cooperation)
Building tools for the analysis and management of Data.

The following examples under the Evidence funding scheme are mentioned:

2010: Advancing Technology Innovation through Discovery Program ($ 6.5 M)
The Canadian Pediatric Cancer Genome Consortium
Finding of Rare Disease Genes in Canada (FORGE)
2012: Genomics and Personalized Health ($ 142 M) – 17 teams funded
Large Scale Research Projects
Large Scale GE3LS Projects (Economic, Environmental, Ethical, Legal and Social research)
2012: Multidisciplinary Research Teams ($ 29 M) – 13 teams funded
Childhood Cancer – Late Effects of Treatment
Emerging Team Grant – Rare Diseases
2012: Bioinformatics and Computational Biology ($ 11 M)
Small-Scale Innovative Projects
Large-Scale Applied Projects




Under the Outreach activity CIHR is worldwide participating in many international Pmedrelated projects and consortia.

As top priority for the implementation of Pmed Richer mentioned:
“Develop an innovative clinical trial design framework / specialized support unit”.
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Pierre Meulien
Genome Canada
The Canadian Environment in Personalized Medicine

Genome Canada is the largest federal funder of genomic sciences and, with investments
reaching more than $ 2 billion over 12 years, has developed a national infrastructure which
includes 6 Regional Genomics Centres and 5 Science and Technology Innovation Centres. Its
research focus is in 7 key economic sectors: Agriculture, Energy, Environment, Fisheries,
Forestry, Health and Mining.

Canada has strong clinical networks across the country and has - for some diseases - among
the best outcomes in the world. However, Canada’s ability to move the latest technology into
healthcare delivery is low and the way technology is assessed across the country is very
heterogeneous. New technologies are often seen as just an added cost and economic
analyses performed are not convincing enough for the payers.

Sequencing genomes is truly disruptive and is perturbing the status quo as reflected by the
many questions being asked: what can my genome tell me about my health status and future
health, who owns the genome data, who has access to it and how will it be used? If we want
genomics to be part of personal health records, a massive change to an already stressed
system is required.

So the question is how do we translate, taking into consideration a lot of complex issues:
How good is the technology? (clinical validation)
When do we decide that “now is the time for transfer”?
Is it easy to adapt existing clinical laboratory structures?
Who will be making these decisions? (and based on what criteria?)
Technology assessment based on sound economics and clinical benefit?
Who will pay?
How can behavioural change be accelerated?
To answer these questions we need pilots/demonstrators to show that the technology can
deliver real value to patients and that integrating the technology within the healthcare
system will be cost effective.

As an example Meulien referred to the Large-Scale Applied Research Project Competition
under the 2012 Genomics and Personalized Health program (total budget ~ $ 150 M,
including matching), partnered with the Canadian Institutes of Health Research (CIHR). 17
projects, including 20 companies, have been recently (26 March 2013) selected, all
addressing the abovementioned questions. The projects cover various diseases.
Prerequisites for a successful Integration of Genomics into the Healthcare System are:
- Develop receptor capacity for technology pull (capacity for clinical and translational
research).
- Involve the private sector.
- Educate and train healthcare professionals to be proficient users of the technology.
- Ensure information systems are modern and harmonize e-patient records.
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-
Role of patients and advocacy groups in demanding evidence based medicine.
Robust technology assessments focused on improvement on clinical outcomes and
economic benefit analyses.
More balance between prevention and treatment.
Legislation to “encourage” behaviour change in the younger population.

Talking about a collaborative approach to personalised medicine, Canada could offer
partnership, case studies including economic rationale and the Canadian model of health
delivery (publically funded- provincial- central regulation). On the other hand, Canada is
looking for knowledge about what other jurisdictions are doing:
- How e-health records and genomics data can be integrated
- How data from large cohort studies can be interrogated (new international platform
being considered?).

Meulien concludes his presentation with the following top 3 recommendations:
1. We need many demonstrations (to payers) that Pmed offers sustainable value (this will
be the only way to generate “pull” in the system).
2. We need to “solve” the health informatics conundrum.
3. We need to move genomics to the clinical space in a more “urgent” manner.
Starting up things is the only way: demonstrators, case studies, to show policy makers the
real value of Pmed.
Øyvind Melien
The Norwegian Directorate of Health
Personalised Medicine in Norway

Personalised medicine was first introduced in 2007 in the Norwegian Medicines Handbook,
that was widely distributed among medical doctors, pharmacists, students, etc.). Now, it is
part of the National Strategy for Biotechnology (2011-2020), at the same time recognising
that Pmed raises new ethical and societal questions asking for a dynamic regulatory
framework.

In 2011 the Publicly-initiated Clinical Trials Programme was established. Focus area for the
first call was “Cancer treatment tailored to the individual”. The programme is managed by
the Research Council of Norway (RCN). Under this scheme the Norwegian Cancer Genomics
Consortium (see http//:cancergenomics.no) is running a two-phase large scale project to
examine mutations in eight types of cancer and to establish a national research and
innovation platform for personalised cancer medicine. The project is co-financed by BIOTEK
2021, the Research Programme on Biotechnology for Innovation, also managed by the RCN.
The National Collaboration Group for Health Research (NSG) recommended that the national
Health Service prioritise an effort on “Individualized cancer treatment based on tumour gene
profiling”.
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
Key in the Norwegian health (research) policy is collaboration. Through collaboration the
following added values are aimed for:
- Population-based data
- Standardised genome analysis
- Equal patient access nation-wide
- Standardised treatment choices
- National follow-up of multiple N=1 trials (compassionate use)
- National evaluation of mutation frequencies and health-economics consequences
- Over time accumulation of outcome data of personalised treatments and other therapies
stratified by mutation profiles.

In this respect, reference is made to a comment in Nature, GenomeWeb: “…the Norwegian
approach is wise to take account of equally vital considerations such as having nationally
agreed protocols and systems to handle and process new testing and data, as well as efforts
to underpin health professionals and public education, and provide health economic impact
data”.

The national strategy is supported by The Association of the Pharmaceutical industry in
Norway.

In concreto, the following processes are currently under development in Norway:
1. Development of a clinical research infrastructure
- Norwegian Clinical Research Network (NORCRIN), as part of ESFRI-ECRIN.
- Nordic Trial Alliance (NTA), part of a Nordic cooperation in Health Care.
- Participation in the OECD Global Science Forum for non-commercial clinical trials.
2. Coordination of Health registries
- A pre-project evaluates the potential to coordinate all drug-related registries in a
common overarching registry.
3. Coordination of Biobanks
- Biobank Norway: a consortium of Norwegian population-based and clinical biobanks.
- A new programme of the RCN deals with research on human biological material in
biobanks, by coupling analysis results with data from health surveys, health registries
and the health services.
4. Development of a Health Technology Assessment (HTA) system
- To evaluate treatment strategies for personalised medicine with respect to effect,
safety, cost-effectiveness etc.
5. Strategy development, initiated by the Ministry of Health
- A report is to be expected in the summer of 2014, including: an analysis of the status
of Pmed at national and international level; a strategy for the future; proposals for
efforts to implement Pmed; considerations related to ethical, social, economic and
health implications of implementation; recommendations.

Melien mentions the following top 3 challenges for the future:
1. Coordination of treatment guidelines.
2. Health economics: economic implications and reimbursement, with reference to
complex and dynamic treatment strategies, in many cases relevant for a limited number
of patients.
3. Implementation in clinical practice: approach to fulfil the need of supporting systems,
adaption of IT, education, monitoring, etc.
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Anne Eckhardt
Swiss Academy of Medical Sciences / TA-SWISS
Personalised Medicine in Switzerland

Dr. Eckhardt is project manager of an extensive study on Pmed which started end of 2013 by
TA-SWISS, a Centre of Excellence for Technology Assessment of the Swiss Academies of Arts
and Sciences. The study is supported by the Swiss Federal Office of Public Health FOPH, the
Swiss Academy of Medical Sciences SAMS and the National Advisory Commission on
Biomedical Ethics NEK-CNE. Results are expected end 2013/ begin 2014. The study will cover
1) biomedical and clinical aspects (current status and future, assessment in the context of
e.g. informatics, imaging and genetics), 2) actors (the role of patients, physicians,
universities, industry and government), 3) social and ethical aspects, 4) economic aspects
and healthcare system, and 5) legal aspects. The study will provide input for a revision of the
Swiss Federal Law on genetic testing on human beings.

In September 2012 a position paper was issued by SAMS titled “The potential and limits of
personalized medicine”, outlining a number of measures to be taken:
1. Remedying deficiencies in knowledge of physicians, i.a. in epidemiology, medical genetics
and medical statistics.
2. Strengthening medical genetics (genetic analysis and counselling) in basic medical
education.
3. Specialist training and continuing education programmes for physicians in their own
speciality.
4. Giving greater weight to family history in medical education and training, and developing
guidelines for analysis and use.
5. Preventing unwelcome developments and creating transparency, e.g. freely accessible
Pmed-related services must be subjected to scientific review.

In addition, the position paper concludes that, - to meet patient needs -, it is crucial that data
collection and processing techniques associated with Pmed are integrated into the personal
relationship between physician and patient.

Dr. Eckhardt presents an overview of the present situation:
Public perception
In Switzerland personalised medicine is perceived as an ambitious concept, but the response
in politics and media is modest so far. Sceptical voices prevail (e.g. marketing instrument of
the pharmaceutical industry) and the debate concentrates on special aspects like genetic
testing; there is a tendency to open the market for genetic testing, beyond medical purposes
only.
Research
Most research is privately financed. Although an explicit national programme on Pmed is
non-existing, there are many individual projects. But a need for complementing research is
growing: legal aspects, bioinformatics, communication, etc.
Medical practice
Well established in centres of excellence, mainly located in university hospitals, but the
concept of Pmed is still vague. The boundaries between ‘healthy’ and ‘ill’ are vanishing.
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E-Health
The federal administration has established a strategy for E-Health, with central importance of
standardised electronic medical files within a federalist healthcare structure. There is a niche
for private services, but standardisation is urgently needed.
Internet and Social Media
The use of these new media raises many questions but offers also opportunities. How to deal
with data collection, which type of data and the integration in electronic files; open source
versus data protection and the conflict between private and public.
Legal challenges
There are many challenges, such as a ban for direct to consumer genetic testing, different
regulations for the dealing with genetic biomarkers and other biomarkers, and licensing of
drugs tailor-made for blockbusters.
Economic aspects
Switzerland has a strong pharmaceutical and medtech industry. Here is a need for innovative
concepts and alternatives for the blockbuster model. In addition, there is an interest in
limiting costs for clinical studies, and in new services for new customers. The consequences
for political economy are still open.

In its position paper of September 2012, the Swiss Academy of Medical Sciences clearly put
forward that there is a need for action:
- Information and education for physicians and patients
- Label for physicians with special competence
- Improvements in medical genetics and the use of case history
- Evaluation of direct to consumer services.

However, looking at the present situation in Switzerland, we are not yet well prepared for a
real breakthrough of personalised medicine, according to Eckhardt. Also taken into account
the concept of solidarity: obligatory health insurance, solidarity in society and the balance
between individual capacities and individual needs. Potential solutions should anyway be
accepted by patients and politicians.

Eckhardt mentions two recommendations for the implementation of Personalised Medicine:
1. Use technology assessment as a catalyst
2. Intensify the political and societal debate
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Karin Effertz
German Federal Ministry of Education and Research
Personalised Medicine at the German Federal Ministry of Education and Research
(BMBF)

As part of the € 5.5 billion Federal Government’s Health Research Framework, an Action Plan
for Personalised Medicine was launched in April 2014 with a budget of € 100 million for a
period of 3 years. The plan addresses and involves the following actors:
- Patients: Custom-tailored therapies for a more specific care
- Health Care System: Efficient and sustainable use of resources
- Health Economy: Promotion and transfer of new products/ procedures to the health
economy
- Society: Increased awareness of health relevant actions

The Action Plan for Personalised Medicine, subtitled ‘A new Way for Research and Care’, is
linked to the primary objective to establish a systems medicine approach in Germany.
Reference is made to the BMBF report “Paving the Way for Systems Medicine” – The e:Med
research and funding concept, that was published in October 2012.

Under the Action Plan for Personalised Medicine 3 calls for projects were launched in April
2013:
1. Innovation for Personalised Medicine
- Aiming at the development of new products and processes for diagnosis and
therapy, considering biomarker-based stratification.
2. Demonstrators for Personalised Medicine
- Showcases that demonstrate the immediate usefulness and application of basic
biomedical research.
- Use of systems medicine approaches for prevention, diagnosis and therapy.
- Special focus on data analysis and integration as well as modelling.
3. Ethical, social and regulatory aspects in Systems Medicine.

A call for Young Researchers is in preparation. Other topics are ‘Future-oriented and
crosscutting measures’ and ‘Internationalisation’.

Regarding internationalisation, BMBF is involved in two Personalised Medicine-related
European consortia:
- CSA Systems Medicine (CASyM) – 2012-2016
- CSA PerMed – 2013-2014

The BMBF strategy and policy measures as to Pmed are based on the following expectations:
- Faster and more precise diagnostics (biomarker-based) as well as efficient treatments
with less side effects.
- Ineffective therapies to be avoided.
- Better (interactive) integration of diagnostics and therapy as well as integration of data
from research and clinics.
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-
More investments in individualized medicine in the health economy.
Better understanding within the whole society for individualized medicine (FORZAsurvey).
Faster market access for products and services related to Pmed.

As priorities for Pmed are mentioned:
- Better understanding of diseases, better biomarkers and integration of big data.
- As to the healthcare system: data management vs data protection
- Discussion about more responsibility for the individual.

The idea was put forward to bring all European Pmed activities under one umbrella.
Wolfgang Eberle
Imec, Life Science Technologies, BE
A healthy life for each of us

Imec plays an import role in the Belgium innovation landscape by putting different disciplines
together in one place to accelerate life science research/technology/innovation and to crossfertilize applied technology and basic research. As an example, Eberle refers to NERF
(Neuroelectronics Research Flanders), a joint basic research initiative to unravel the neuronal
circuitry of the human brain. The project will i.a. generate technologies for medical
applications such as diagnostics and treatment of nervous system disorders. Supported by
the Flemish Government, NERF has been set-up by Imec, VIB (Flanders’ leading life science
institute) and the Leuven University.

To accelerate the translation of innovation in human healthcare into novel clinical
applications, the Flemish Government has recently created - in collaboration with the
universities/university hospitals and the healthcare industry in Flanders - the Center for
Medical Innovation (CMI). One of the first initiatives of the center in 2010 was the creation of
a virtual centralised biobank, that is interconnected through a central IT backbone, allowing
for inter-university and industry translational projects based on a significantly broadened and
quality data base.

In the area of Pmed the Flemish Government has two programmes running, one focussing on
Applied biomedical research (TBM), the other on Transformational medical research (TGO).
Both programmes are managed by IWT, the Flemish Agency for Innovation by Science and
Technolgy.

As examples of international cooperation are mentioned: Nanotechnology for Health (NfH),
Health Axis Europe and KIC Health.
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
In conclusion Eberle summarizes what is needed for a successful development of Pmed:
1.
Development of suitable technologies to manage disease complexity, treatment
complexity and cost efficiency.
2.
Development of ways to involve all stakeholders in order to multiply excellence by
interaction, to increase the chance to bring R&D results to the market and patients, and
to identify incentives to keep R&D innovation ongoing.
Development of methods and policies supporting longer term strategies for new
structured alliances and gap funding.
3.
Sergey Suchkov
Moscow State Medical & Dental University & I.M. Sechenov Moscow Medical
Academy
Predictive, Preventive and Personalised Medicine (PPPM) a new paradigm of public
healthcare services

Prof. Suchkov is the Russian representative and member of the Advisory Board of EPMA, the
European Association for Predictive, Preventive and Personalised Medicine.

PPPM is a medical model being tailored to the individual and dictates a construction of
algorithms to diagnose, to predict and to prevent in time! In the near future, “…omics-based
genotyping and phenotyping will be used for creation of the unified databanks necessary for
personalising health monitoring. Blood, liquor-, and tissue-derived information might be
combined with the individual's medical records, family history, and data from imaging and
laboratory tests to develop personalised and effective treatments”. So, two key objectives of
PPPM are:
1. detection of subclinical abnormalities with a selection of suitable pharmacotherapeutic
targets for drug-based prevention;
2. drug-based correction of the abnormalities detected under preventive measures.
The chronic autoimmune diseases Type 1 Diabetes and MS are mentioned as illustration, as
well as the initiation and progression of cancer tumors.

According to Suchkov, a system approach to the formation of an innovative infrastructure
regarding predictive and preventive algorithms is an ultimate approach that will contribute
to the modernization of the world healthcare services drastically. Individuals to be under
regular monitoring that helps to detect pathological shifts at subclinical stages of a disease
have a higher life expectancy and are able-bodied up to 8–15 years more than those under
traditional treatment. This means that the society saves more than US$20,000–40,000 per
person annually.
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
In Russia there is no structured approach towards Pmed and related research. Specific
strategies, policies or programmes are non-existing. There is a lack of political and financial
support, so cross-border collaboration is crucial to catch up with the global developments in
Pmed. On translational medicine and PPPM Suchkov collaborates with the Lancaster
University in UK (students workshops on PPPM) and several organisations in the USA: NIH, La
Jolla Institute for Allergy and Immunology, Johns Hopkins University School of Medicine,
University of Pennsylvania School of Medicine, Autoimmunity Research Foundation (CA),
Waters Corporation, Harbor Therapeutics (CA) and ResearchDx (CA).

As main hurdles for the advancement of PPPM Suchkov mentions:
- lack of robust validated biomarkers
- economic barriers, such as poorly aligned incentives
- operational issues in public healthcare systems
The operational issues can often be largely resolved within a particular stakeholder group,
but correcting the incentive structure and modifying the relationships between stakeholders
is more complex.

Although year to date translational research, biomarker-based studies and careful patient
segmentation in clinical trials have led to successes such as new biomarker-based drugs
(companion diagnostics), a lot of questions remain unanswered: who should be screened
(general population vs specific groups) and when (age), which biomarkers should be
screened for, and how and to whom to communicate the screening results? And at the same
time taking privacy and data protection issues into consideration.

For achieving tangible results Suchkov has three recommendations:
1.
2.
3.
Focus on the most advanced areas of medical research, define subareas to identify
existing teams with the best outcome and set-up international teams in pre-selected
topics.
Set-up an international multidisciplinary team to develop education/training
programmes for students, researchers, clinicians and biotechnologists to secure a future
basis for progress.
Develop a series of different models of Centers for Medical and allied Health Services
addressing PPPM.
Graeme Boyle
Health Science Scotland, Stratified Medicine Scotland Innovation Centre
2B or not 2B; The case for Smart Clinical Trials

Health Science Scotland (HSS) is a partnership of the government, the medical universities
and the National Health Service (NHS) to promote excellence in the field of clinical and
translational medicine. The partnership is chaired by the Chief Scientist for the Scottish
Government Health Directorate and supported by Scottish Enterprise, the main economic
development agency for Scotland.
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
Stratified Medicine Scotland Innovation Centre is created by HHS and brings together experts
from academia, industry and the NHS to implement a biomedical informatics service to aid
clinical and translational research and enable stratified medicine. The main industry partners
are Aridhia (informatics), Life Technologies (genetics) and big pharma (GSK, AstraZeneca and
Novartis). The immediate aim of the Centre is to enable precision targeting of population
subsets in order to demonstrate the benefit of stratification in clinical trials.

Under the heading ‘Lost in Translation?’ Boyle identifies two gaps, one between basic
research to early trials, and the second between late trials to the actual use in the health
system. He mentiones six issues (challenges and opportunities) that can contribute to filling
these gaps and lead to a successful implementation of personalised medicine:
- Collaborative Research
- Creating Economic Value
- Connecting Health Informatics
- Information Commons
- Skill Development
- Ethics and Public Engagement
Collaborative Research
In the Scottish research model all actors (academia, clinical centres and companies) work
together within specific programmes (e.g. oncology, heart disease & diabetes, RhA &
respiratory), making use of common datasets (e.g. tissue/bio-repositories, electronic health
records) and tools (e.g. ‘omics’, imaging).
As to the funding of collaborative research Boyle sees a shift from unrestricted grants and
fee-for-service to corporate venture capital funds and academic drug discovery centres, to
risk-sharing and competitive grants in the future. Except the government, also charities play
an important role in funding.
Collaboration will accellerate biomedical research, high quality healthcare provision and
economic growth, which will finally lead to the transformation of the management of chronic
diseases globally.
Creating Economic Value
Scotland has about 600 biotech companies. They play an important role as research partner,
technology solution provider, supply chain partner and as end user of IP.
As to the European market potential for stratified medicine, Boyle refers to a report of the
Personalized Medicine Coalition of October 2011: “Advancing Access to Personalized
Medicine: A comparative Assessment of European Reimbursement Systems”.
Connecting Health Informatics
Scotland has 70 years of data of it 5 million population and is in the process of developing a
country-wide infrastructure: a biorepository network consisting of four regional nodes, which
will contain all national tissue collections and a pathology archive; an inventory management
system, patient record linkage and rapid access are under development. It is the intention to
link the network to a future European Biorepository Network.
Patient data are available in many separate NHS Data stores: prescribing, mortality, hospital
episodes, identification, laboratory phenotype and imaging phenotype. Integration of these
stores into one safe Storage Area Network is under development.
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To improve patient care and public health, a total of ₤19M is being invested by the UK
Government and charity funders in four e-health research centres. The University of Dundee
has been elected to host one of these centres, which will combine clinical, social and
research data to investigate serious conditions, including diabetes, cancer and cardiovascular
disease.
Information Commons
Scotland is recognised by industry as a current leader in electronic health records, providing
the opportunity to implement clinical trials to stratified patient groups. Combining data from
Clinical Medicine (diagnosis, treatment and health outcome) and Biomedical Research, and
sharing these data in a common Knowledge Network will finally lead to a new taxonomy of
diseases and improved diagnosis/treatment.
Skill Development
The Stratified Medicine Scotland consortium has identified the key training needs required to
support the exploitation of stratified medicine by Scottish industry: modern apprenticeship
and further education level, at graduate and post graduate level (health science/informatics),
entrepreneurship, senior-level/industry exchange, and industry/academia mentoring.
Ethics and Public Engagement
Systematic data collection and sharing mechanisms should be anchored in clear and
workable legal and ethical frameworks. Boyle mentions the Angelina Jolie case as a
contribution to public engagement and awareness.

Main recommendation of Boyle is: shorten clinical trials, by smart research and proper
regulations.
MARKET PERSPECTIVES
Emmanuelle Benzimra
EPEMED, European Personalised Medicine Association
Navigating the Challenges of Personalised Medicine Access in Europe

EPEMED is an independent, broad and inclusive not-for-profit organisation founded in 2009
and bringing together forces in personalised medicine in the EU. It serves as a central point
of communication for the different parties involved in progressing personalised medicine,
addressing issues in personalised medicine that confront the industry, regulators, payers &
insurers as well as governments in Europe. Members include clinicians, diagnostics &
pharmaceutical companies, service providers as well as patient advocacy groups. EPEMED is
aiming to provide a platform for the harmonisation of personalised medicine development
and implementation across Europe, focusing on the role of diagnostics, to make personalised
medicine a reality.

This presentation is about biomarkers and why they don’t reach the market. The
development of biomarkers in relation to Pmed has accelerated in the last decade. But
despite promising market forecasts and current development efforts, only a small number of
companion diagnostics (CDx: disease related biomarker + effective drug) have reached the
market. According to EPEMED this low market access is mainly due regulatory hurdles, such
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as evaluation/validation, coding, pricing and reimbursement. But also appropriate
partnership models and commercialisation business models are complicating factors.


In spite of many EU-wide initiatives to create opportunities for Pmed – to be mentioned FP7
Health, Horizon 2020, IMI, EMA/revised IVD directive, Biobanks, and several European
associations –, there are only very few value-based reimbursement initiatives for innovative
diagnostics. This is due to the wide heterogeneity in Europe in terms of regulation and
reimbursement: differences in centralised and decentralised systems in the individual
countries and differences in HTA (Health Technology Assessment) systems between and
within countries.

Together with La Charité Institute for Social Medicine, Epidemiology and Health Economics,
Universitätsmedizin Berlin, EPEMED is presently performing a 15 months “European Market
Access Study”. The aim of the study is to devise recommendations how to shape a postapproval environment that facilitates broad and equitable access to (companion)diagnostics.
Preliminary findings will be presented on 28/29 October 2013 in Luxembourg during the
Health Economics Personalised Medicine Symposium.
EPEMED’s recommendations for bringing Personalised Medicine to the market are:
1.
A European wide coordination initiative should be started among health technology
bodies to harmonize their processes and to reimburse all types of diagnostics, including
Pmed products, in order to ensure that promising research results have a chance to
reach the market. In other words: reimbursement allows innovation.
2.
Competences at payers level should be improved in order to ensure that submitted
dossiers are understood and evaluated in a fair and knowledgeable manner.
3.
A more unified and coordinated accreditation procedure should be established for
European clinical testing laboratories, enabling to break the actual national
protectionism.
4.
A more focused and coordinated effort should be established to make use of patient
registries, patient biological samples and patient outcome data in a targeted Pmed
development programme with results published in a timely manner.
Katherine Payne
Health Economics, Health Sciences – Economics, University of Manchester
Market Access for Personalised Medicine – Recommendations for Europe

How to find the solution to offer good value for money in the trajectory from theoretical
concept to clinical application of personalised medicines? And all of this in a context of a
poor economic climate, an emphasis on effective use of health budgets, a diversity of
healthcare systems, and decision makers that want a sufficiently robust evidence base to
reassure them they are spending the resources in the best way possible.

The main hurdles, from market access to patient benefit, are regulations and
reimbursement. In the case of companion diagnostics these hurdles are more complex
compared to medicines, because their specifics (processes and evidentiary requirements) are
completely different.
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In addition there are different levels of decision making:
- national (centralised)
- provider (hospital or primary care)
- patient-clinician level
And finally, there are different evidence requirements likely to be considered to be useful
and sufficient to inform introduction of a personalised medicine.

Health Technology Assessments (HTAs) can potentially be used to inform clinical guidelines
or reimbursement decisions for local, regional or national use. However, there is a
substantial variation across Europe in:
- - the process of funding and producing HTAs
- - the technical details used in the evaluation methods
- - the intended use of the HTA reports.
In some jurisdictions HTAs have a more formal legal status and are used by national decision
makers working for healthcare third parties payer organisations.

An economic evaluation could provide a framework for measuring added value:
Inputs > Process of health care (current practice versus pharmacogenetic test) > Outputs.
Examples of Inputs are the costs for medicines, managing side effects, tests and lab, staff,
monitoring etc. Outputs are: % cases cured, life years gained and quality adjusted life years
(QALYs). Some examples of model-based economic evaluation are presented.

The main organisation in UK dealing with health economics in relation to Pmed (companion
diagnostic: is the medicine cost effective?, is the diagnostic cost effective?), is NICE, the
National Institute for Health and Care Excellence. NICE is a Non Departmental Public Body,
operationally independent of government, but accountable to the Department of Health.
NICE provides national guidance and advise to the NHS, local authorities, charities and
everyone with a responsibility for commissioning or providing healthcare, public health or
social care services.

Payne presents the following recommendations, grouped under short, medium and
medium/long term:
short term
1. To understand the current use of HTA to inform reimbursement and payer decisions for
companion diagnostic medicines across Europe.
2. To identify and create a database of existing reimbursement and payer systems for
diagnostics and medicines across Europe.
3. To identify how companion diagnostics are priced and/or charged for at the provider
level across Europe.
4. To understand the extent of variation in technologies and processes for the conduct of
companion diagnostic testing within and across European countries.
medium term
1. To understand how existing reimbursement and payer systems for diagnostics and
medicines across Europe must be re-aligned to facilitate market entry.
2. To produce guidance on the technicalities of the design and conduct of the HTA process
specific to companion diagnostic medicines.
3. To understand the implications of moving from single companion diagnostics to
multiple/profiles for evidence requirements and service provision.
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4. To describe and quantify gaps in the evidence base and the added value of future
research to reduce current uncertainties to support the introduction of companion
diagnostics.
medium/long term
1. To identify incentives to encourage manufacturers to invest in the production of a robust
evidence base to support the clinical & cost effectiveness of companion diagnostic
medicines.
2. To identify and target national funding for research to understand the added value of
technologies.
3. To align the use of HTA for the reimbursement of companion diagnostics in line with
existing practice for medicines.
4. To produce clear and explicit guidance on the evidence decision makers, working at
national and local providers levels, would like to support the reimbursement of
companion medicine diagnostics.

Acknowledgements for contribution go to Value in Health, The Journal of the International
Society for Pharmacoeconomics and Outcome Research, and to Lieven Annemans, Ghent
University.
Day 1 is closed by Eero Vuorio, Director of Biocenter Finland, University of Helsinki, and Chairman of
the Strategic Advisory Board of EuroBioForum. He thanks the speakers for their excellent
presentations. He concludes that personalised medicine cannot denied any longer and that some
European countries have strategies in place or working on it. The main barrier is that we are
confronted in Europe with 27 different healthcare and regulatory systems. This is only to be solved
by cooperation between countries, but public healthcare departments have little tradition to work
cross-border. Which is not the case in the research community. So you could say that the Pmed
strategy development in Europe is in the hands of scientists and researchers instead of governments.
Vuorio urges governments to awake and stand-up. Pmed is already there and will become more
sooner than later a reality, one way or the other. As example, he refers to Norway where
government took the initiative to take action in close participation with all stakeholders.
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Day 2
KEYNOTES
The meeting is opened by Wouter Spek giving a short wrap-up of the previous day that was
dedicated to country initiatives. Today’s meeting will be focused on regions and their role in the
implementation of Pmed. But first two keynotes on education & training and the potential role of
social media.
Jami Taylor
Janssen Diagnostics, Johnson & Johnson, Vice-chair of the Education
Committee of EPEMED
Personalised medicine; education &training: macro challenges and the path forward

There are three challenges that complicate personalised medicine education & training
today:
1. Knowledge gaps are not clearly identified
2. The guiding lexicon is not yet standardised
3. The technology is advancing rapidly

Meeting the challenges of Pmed education and training will first require a clearer
understanding of where the gaps in knowledge lie, the extent of those gaps and their
associated implications. Additionally, a complicating factor is the lack of a clear common
definition of Pmed. Terms used to describe this trend in medicine have not yet been
standardised or fully clarified: e.g. personalised medicine, individualised medicine, precision
medicine, stratified medicine, P4 medicine, targeted therapy. Pmed confounds familiar
categories, and as such will continue to drive a new vocabulary in medicine aiming to capture
the phenomena it enables, e.g. therapeutics + diagnostics > theranostics? And finally,
technology is advancing so rapidly that what we teach today will be obsolete by the time
Pmed is in common practice.

As to the path forward and options for considerations, Taylor presents the following three
sets of recommendations:
Assessing and managing the knowledge gaps
- Conduct a series of Pmed knowledge audits among stakeholders, using a range of tools.
- Analyse the information collected and identify the needs.
- Develop a Pmed education strategy based on the audits’ findings.
- Refine continually, based on built-in feedback mechanisms, new information and new
insights.
Stakeholders to be involved: practicing clinicians, medical school students, patients & patient
advocacy groups, and medical societies & guideline committees.
Managing a lexicon in flux
- Allow for a multiplicity of terms while striving for some standardisation.
- Be open to introducing new terms as the technology evolves and older terms prove
inadequate.
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-
As a community, push for clarity as new terms are introduced; test new terms vigorously
within and beyond the community to determine which best illuminate the concepts at
hand.
Keeping pace with the technology
- Create resources to help stakeholders keep pace with advances.
- Draw from best practices used in other high-tech fields.
- Convey more powerfully and consistently the larger vision of Pmed and its
transformative potential… A vision for all patients, everywhere…

An important message to doctors is to learn how to communicate to the patient. Patients
who stand-up and take their own decisions will cause a forthcoming complexity.
Pelagiya Dragomirova
EuroBioForum /Publimarket
The social media boost – intruder or trigger?

The potential and impact of real-time on-line communication in relation to Pmed is not yet
very well understood, but it is clear that the rise of social media will cause a shift towards
more and better informed patients and finally to “participatory’ medicine with a global
reach.

It is expected that in 2015 75% of the world population has access to internet. And the usage
of social media is growing fast, as illustrated by the following figures (visitors per month):
- Facebook 7012.9 M visitors per month
- Twitter
182.0 M
- Pinterest 104.4 M
- LinkedIn
85.7 M
- Google + 61.0 M

On the basis of Leroy Hood’s P4 Medicine model (predictive, preventive, personalised,
participatory) Dragomirova gives some examples of websites and portals dedicated to Pmed:
Predictive
A Dutch healthcare insurance company (Agis) is offering direct communication via Twitter,
Facebook and a Forum. In terms of numbers of messages Twitter [@Agisweb] is the most
popular (53%) with more than 6000 followers, followed by Facebook (17%) and the Forum
(16%).
Preventive
Livestrong.com offers diet, nutrition and fitness tips for a healthier lifestyle. The site has
14000 followers. Also Pinterest is mentioned as a useful social network site.
Personalised
PatientsLikeMe is a patient network that improves lives and a real-time research platform
that advances medicine. On PatientsLikeMe’s network, people connect with others who have
the same disease or condition and track and share their own experiences.
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In the process, they generate data about the real-world nature of disease that help
researchers, pharmaceutical companies, regulators, providers and nonprofits develop more
effective products, services and care. The network has more than 220000 members.
Participatory
Reference is made to Agendia, a developer of genomics-based diagnostic tools for
oncologists, with a special focus on breast cancer and colon cancer. For breast cancer
patients the company developed the SYMPHONY Personalised Breast Cancer Genomics
Profile, that helps determine the best treatment for specific tumor types. Agendia is
represented on Facebook, Twitter and Facebook, offering a wide range of on-line
communication, information sharing and discussion services. In this way Agendia tries to
serve as a bridge between patients and doctors, and to help reduce health illiteracy.

It is concluded that social media will serve in the near future more and more as tools to
interact, share, integrate and influence, at all levels of all stakeholders.

The presentation is concluded with a video about youth perspectives on the future of
healthcare with a view on doctors, hospitals, medicines, insurance companies, pharmacies,
etc.
REGIONAL PERSPECTIVES
Franck Molina
European Diagnostic Clusters Alliance - EDCA, Eurobiomed/EuroMediag (FR),
SysDiag (FR)
Private Public collaboration to boost open innovation

Molina is president of EDCA, chairman of Euromediag – a working group of the Southern
French Health cluster Eurobiomed – and director of SysDiag, a public-private laboratory
established by CNRS and Bio-Rad in 2007.

SysDiag’s mission is to understand the bases of chronic and multifactorial diseases, to
identify new biomarkers and to provide innovative solutions for clinicians. Its focus is on
translational medicine and transfer to industry. The SysDiag model is based on public-private
collaboration and interdisciplinary.

Eurobiomed (Biocluster Méditerranée) is one of the seven big French health clusters,
comprising 400 companies, 4 science & technology parks, 4 universities, over 6000 academic
researchers and 3000 industrial researchers. Its aims are to develop and federate a network
of healthcare stakeholders, to provide development support for companies and to foster the
implementation of R&D collaborative projects.

Euromediag is one of the working groups of Eurobiomed, dedicated to smart-specialisation in
medical diagnosis. The group is a member of EDCA, the European Diagnostic Clusters
Alliance, together with:
- Bio Wales (UK)
- Biocat (ES)
- BioWin Liege (BE)
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-
LifeScience Klaster Krakow (PL)
Lyonbiopole (FR)
Nexxus Scotland (UK)
Oxfordshire Biosience Network
Uppsala Bio (SE)
ZMWB Berlin-Brandenburg (DE)

EDCA is characterized by open innovation, combining more than 350 SMEs, various
technology platforms, and scientific, clinical and regulation expertise. By sharing expertise,
modifying regulatory constraints, dropping healthcare costs and easing access to the market,
the Alliance is aimed at reshaping the diagnostic practices and market for the benefit of
patients and society as a whole, by exploring and deploying new clinical practices (needs,
prescription, decision, treatment, monitoring).

Molina points at the present weird situation that diagnostic tests represent less than 5% of
hospital cost and about 1.6% of all health costs, whereas their results influence up to 60-70%
of medical decisions. But changes are on the rise leading to more convergence of diagnosis
and therapy, and further to personalised medicine and theranostics: e.g. new roles of
biomarkers in molecular assay development, integration of IT, new interfaces between
biology and electronics (imaging, biosensors) and new Point-of-Care technologies and home
monitoring/testing. Lots of new technologies make genetics no longer the central point of
Pmed. So, successful implementation of Pmed is about multidisciplinary collaboration and
sharing cultures.

Molina formulates the following needs to boost open innovation in healthcare research:
-
-
Interdisciplinary partnerships - with SMEs growth opportunities - to target the individual
or close to the patient market, mainly inspired by patient demand or new clinical
practices.
Large public-private consortia (including pharma) to target the specialised laboratory
assay market, mainly inspired by clinician demand.
International pioneer projects able to induce European “Patient Leadership” by market
reshaping (new clinical practices).
Early and dynamic interaction between innovation and regulation.
Mark Poznansky
Ontario Genomics Institute, Canada
Ontario’s Perspective on Personalized Medicine: Innovative Research, Innovative
Translation

The Ontario Genomics Institute is one of the six regional genome centres in Canada. The
institute is a not-for-profit corporation supported by the federal and provincial governments.
Its mission is to use world-class research to create strategic genomics resources and
accelerate Ontario’s development of a globally-competitive life sciences sector. The institute
develops, funds and manages genomics projects which are carried out by Ontario’s public
and private institutions in the life sciences. Besides research programme management,
business development and outreach (awareness and public dialogue) are important activities
to fulfill the mission.
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
Ontario has a population of 13.5M and health expenditures of $71.8B. The total amount
spent on health-related R&D is $1.9B per year, including Federal, Provincial, Health Charities
and Privat funding. Total available budget for human genomics research in Ontario is $320M
per year: $190M/yr in federal funding (Genome Canada, CIHR, others) and $130+M in
provincial funding (various institutions).

Personalised medicine is a key part of the health sciences agenda and Ontario’s
infrastructure.
Poznansky mentions some unique initiatives:
Mount Sinai Hospital: Rheumatoid Arthritis Pilot Study
1) to discover genes via targeted and whole sequencing that confer risk for RA and modulate
outcome/drug response, and 2) to develop informatics solution to collect, store and mine
clinical data, to integrate clinical and genomics data and to apply genomics data in the clinic
to improve healthcare delivery.
CAMH (Centre for Addiction and Mental Health): IMPACT Study on Individualized Medicine:
Pharcogenetic Assessment and Clinical Treatment
Assessment of rapid PGx in primary care setting (depression, schizophrenia); based on panel
of SNP markers (liver enzymes, drug target); expansion to > 250 primary care physicians;
20000 patients.
CHEO (Children’s Hospital of Eastern Ontario): Enhanced CARE for RARE
This project is building on the success of the Finding of Rare Disease Genes in Canada (FORGE
Canada) project, in which over 100 genetic mutations underlying rare disorders in children
were identified. Disorders are individually rare but effect ~3% of population. The Enhanced
CARE for RARE Genetic Diseases in Canada project will expand the search for causitive
mutations in rare disorders and identify therapeutics using genome-wide analysis as a
diagnostic tool in small patient groups.
SickKids: Autism Spectum Disorders: Genomes to Outcomes
SickKids is Canada’s largest hospital-based child health research institute. ASD affects one in
88 children, with a cost of $1B/yr. The project is part of the international Autism Sequencing
Consortium, investigating 10.000 genomes of ASD patients and their families. Objective of
the project is to identify remaining diagnostic risk factors, to set-up clinical guidelines and to
come to early, objective diagnosis.
Despite its excellent science and research system, including health bioinformatics research
and infrastructure support (e.g. Canada Health Infoway), Canada fails when it comes to
implementation, innovation and commercialisation.

Poznansky mentions the following challenges of implementing personalised medicine:
-
Integrated infrastructure to support the type of data that will be generated and need to
be shared.
Resources to provide clinical validation.
Privacy policy to address public concerns over data storage and release.
Education about this emerging field (both for the public and health professionals).
Regulatory and reimbursement policies that can accommodate these new technologies.
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To this purpose Ontario has put in place various support and service organisations such as:
- MaRS Discovery District, a large-scale innovation centre to build the next generation
growth companies. MaRS originally stands for Medical and Related Services, but today
the centre is covering a broader range of innovative sectors.
- MaRS Innovation: commercialisation agent for IP
- MaRS EXCITE (Excellence in Clinical Innovation and Technology Evaluation): helps
companies to accellerate adoption and market penetration.
- ICES (Institute for Clinical Evaluative Services): 20 year repository of population-based
health information on an individual patient basis and a unique linkage between research
and clinical data.
- OICR (Ontario Institute for Cancer research): Facilitating the adoption of pensonalised
medicine for cancer.
- Ontario Brain Institute: Founded in 2010 with two imperatives: 1) integrated discovery
(science+commercialisation+real-world outcomes) and 2) integrated data via Brain-CODE
(Centre for Ontario Data Exploration) in an open-access informatics platform.
- Clinical Trials Ontario: Streamlining multicentre trials, attracting clinical trial investment
and engaging the public.

Despite a wealth of patients, investigators and platforms towards the objectives of
personalised medicine, Poznansky still has a lot of questions, e.g.:
- Where do we sit on the path from science to implementation?
- Are we ready; do we have the data?
- Will personalised genome sequencing really become a driver of healthcare?
- What are the most suitable models for implementation?
- Reimbursement?

He concludes his presentation with the following top 3 recommendations:
1. Integrate data
2. Collect data
3. Share data
Rachael Ritchie
Genome British Columbia, Canada
Genome BC: Regional Perspectives on Personalized Medicine in British Columbia,
Canada

Genome British Columbia is a non-profit research organisation that invests in and manages
large-scale genomics and proteomics research projects and enabling technologies focused on
areas of strategic importance such as human health, forestry, fisheries, bioenergy, mining,
agriculture and the environment.

BC has a population of 4.6M (cf. Ontario 13.5M) and a healthcare budget of $15.1B (cf.
Ontario $71.8B). The annual amount spent on health-related R&D is $180M (cf. Ontario
$1.9B).
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
Genome BC has initiated its third strategic plan (2010-2015), including plans for a $340M
research programme. Investment sources: 45% Federal, 25% Provincial and 30%
International, Industry and Institutional. Genome BC covers the full research funding
continuum, from discovery > applied > translational > commercialisation.

To support Personalised Medicine in BC two programmes have been initiated:
1. Personalized Medicine Program (PMP) [Genome BC]:
Larger-scale projects (budget up to $3M) with outcomes ready for clinical use and/or
uptake into the health system within 3 years of launch, demonstrating the support of the
payer and the potential cost-effectiveness. Similar to the Welcome Trust “Health
Innovation Challenge Fund”.
2. Genomics and Personalized Health (GPH) [Genome Canada]:
In partnership with CIHR (Canadian Institutes of Health Research. Outcomes should be
concrete deliverables for clinical utility and/or practical applicability. Project budget is
$10M.

Some examples are of Pmed projects in BC are:
-

Regarding R&D in Pmed, Ritchie notices that we are still doing more research (80%) than
development (20%), instead of e.g. 50 vs 50%. The transition to development is not easy and
the shift to impact is even more difficult. She mentions the following lessons learned:
-

Genomics Applied to the Management of High-risk AML/Myelodysplastic syndromes
($3M).
Implementation of a Pharmacogenetic ADR Prevention Program in BC ($4M).
Clinical Implementation of Diagnostic Biomarker Assays in Heart and Kidney
Transplantation ($2.6M).
Stratifying and Targeting Pediatric Medulloblastoma Through Genomics ($9.9M).
Personalized Treatment of Lymphoid Cancer: BC as Model Province ($10M).
Viral and Human Genetic Predictors of Response to HIV Therapies ($4.9M).
Reducing Stroke Burden with Hospital-Ready Biomarker Test for Rapid TIA Triage
($9.8M).
Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD
Management ($7.2M).
Success in translation varies by disease area.
Difficulty achieving milestones (e.g. ending research and achieving clinical validation).
Insufficient data provided to demonstrate achievement of milestones.
Stratification reduces effective population sample sizes, making replication difficult.
The pathway to translation envisioned may not be realistic.
Existing or emerging competition may limit potential for translational success; need to
figure out win-win-win.
Despite a solid publicly funded R&D infrastructure, a single payer system, a single medical
school with strong ties to many communities and healthcare organisations, a critical mass of
researchers, physicians and healthcare providers, a centralised system of care in key disease
areas, a strong record in supporting excellence in health research and many innovative
organisations such as Genome Canada Science and Technology Innovation Centres, BC
Cancer Agency, BC Centre for Disease Control and the Center for Drug Research and
Discovery, Genome BC is looking for international partnerships and collaboration and groups
that can articulate what they need to get a win-win.
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
Ritchie concludes her presentation with the following top 3 recommendations:
1. Arrange for bigger cohorts
2. More attention for biostatistics/bioinformatics
3. End-user buy-in
Marc LePage
Genome Québec, Canada
Personalized Medicine: Opportunities in Québec

Genome Québec is helping to accelerate the discovery of new applications for genomics in
strategic areas such as human health. The funds invested by Genome Québec are provided
by the Québec Ministry of Higher Education, Research, Science and Technology, the
Government of Canada through Genome Canada, and private partners. Québec has a
population of about 8M.

Genome Québec is managing the operations of the McGill University and Genome Québec
Innovation Centre. The Centre has developed in the past years a world-renowned expertise
in complex genetic disorders such as cardiac disease, asthma and Type 2 Diabetes. The
Centre provides sequencing and genotyping services to users in 23 countries, mostly in
Europe. Annual revenues are $12M. The Centre is involved in a major Canada/EU
collaboration project (COGS; Collaborative Oncological Gene-environment Study), one of the
largest genotype projects globally.

Together with the Montreal Heart Institute, Genome Québec founded the Centre of
Excellence in Personalized Medicine (2008-2014) to contribute actively to the development
of personalized medicine in Canada through educational initiatives and by financing
public/private partnership innovative projects in cutting edge technology platforms.

A big asset is CARTaGENE/Genizon, a Québec population based biobank with 22000
genotyped donors to facilitate the screening of compatible blood. A second donor
recruitment phase has been started in 2012. The overall objective from a public health
perspective is to develop personalized medicine and public policy initiatives targeting highrisk groups.

LePage gives an overview of the Genome Québec project portfolio in Pmed:
-
Personalized medicine in the treatment of epilepsy ($10.8M)
Biomarkers for paediatric glioblastoma through genomics and epigenomics ($5.1M)
Personalized cancer immunotherapy ($13.5M)
Inflammatory bowel disease Genomic Medicine Consortium [iGenoMed] ($9.9M)
Personalized genomics for prenatal aneuploidy screening using maternal blood
[PEGASUS] ($10.5M)
Innovative chemo-genomic tools to improve clinical outcome in acute myeloid leukemia
($11.3M)
Personalized risk stratification for the prevention and early detection of breast cancer
($11.4M)
Personalized medicine strategies for molecular diagnostics and targeted therapeutics of
cardiovascular diseases ($9.4M).
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Genome Québec is much open to international collaboration. It has a lot to offer, but there still is an
urgent need (read: topics for collaboration) for:
- Successful models and approaches for translational strategies
- Collaborators and cohorts
- Lessons learned on clinical genomics
- Genomics and prevention (healthy lifestyle habits…)

LePage concludes his presentation with an impressive 4-minutes video on Pmed – Solutions
are in our genes – in tribute of Québec’s research community as well as their patients,
expressing their gratitude for having been part of its piloting Pmed projects.
Menno Kok
Erasmus University Medical Center, Rotterdam, The Netherlands
What’s keeping medicine…from becoming personalized?

Erasmus MC is partner in Medical Delta, a research driven life sciences and medical
technology cluster in the western part of the Netherlands (Delft-Leiden-Rotterdam),
combining forces of three universities and two university medical centres. Medical Delta is
the largest cluster of life sciences companies (about 600) in the Netherlands, including 40
medical technology related start-ups in the last three years.

Erasmus MC is covering all medical disciplines: basic research, clinical research,
epidemiology, healthcare technology, and translational research as overarching binding
factor. Because all disciplines are physically located under one roof, multidisciplinary is
common practice.

All strategic research is performed in international collaborations. At national level Erasmus
MC is partner in the String of Pearls Initiative, a cooperation between the eight university
medical centres in the Netherlands (since 2007). The objective of the initiative is to set up an
infrastructure for collecting clinical data and biomaterial in NL with a focus on 8 (to be
extended to 13) disease areas. To create further mass the consortium is looking for roll-out
possibilities at international level.

The main activities of Erasmus MC relate to cancer, cardiovascular, medical and bioinformatics, imaging, -omics and health technology assessments (HTA), always using the
patient as a starting point. Personalised medicine is a cornerstone in that it generates and
uses all the relevant information available on the individual patient to make informed
choices between treatment options and fine-tune these subsequently.

On the road from Personalised Medicine to Personalised Health the following main hurdles
should be considered:
- at research level:
evidence base
- at implementation level:
reimbursement models
- at execution level:
acceptance and adherence
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
Because empirical (genetic) data will change the way individuals perceive themselves, and
the responsibility for good health will shift from government to the individual (selfmanagement), patient-centred medicine will require patient-centred decision making, health
literacy, trusted information sources, and a better communication to start with.

Kok draws up the following top 3 recommendations:
1. Innovation in clinical trials (including age-related approaches: young children/elderly
people).
2. Develop point of care devices and technologies.
3. Promote personalised health.
Alberto Baldi
Piemonte Innovation Cluster / bioPmed, Italy
bioPmed, a step beyond personalised medicine

The Piemonte Innovation Cluster bioPmed was created in 2009 and is dedicated to bio- and
medical technologies. The initiative is managed by Bioindustry Park Silvano Fumero, the local
science & technology park close to Turin, that since its creation in 1998 worked as system
integrator for the development of Life Sciences in the Region. For the sake of clarity it is
noticed that Piemonte, in terms of population, is almost as big as Scotland.

The bioPmed cluster comprises a community of around 390 companies, 3 universities and
different research centers, foundations and associations active in Life Sciences fields. The
cluster has 80+ core members. bioPmed is one of the founders of the national cluster ALISEI
(Advanced Life SciEnces in Italy), involving 13 different regional clusters.

Convergence of technologies is the leading principle in bioPmed’s shared smart approach,
which is inspired by the following strategic perspective:
-
-

While the current, almost “traditional”, concept of Personalised Medicine stands for the
customisation of healthcare for patient subgroups through medical decisions, practices
and products, the future will be probably the development of a Personalised Healthcare
with a solution-driven approach, bringing together the necessary industry sectors.
This shall not only involve therapeutics and diagnostics research & development, but also
include other technological approaches for the lifelong management of health and
healthcare, like e-Health (patient care using IT solutions and devices), medical
technologies, new materials, electronics and mechatronics, but also the involvement of
“traditional” low-medium tech sectors such as agro-food, cosmetics and textiles.
To support the internationalisation of SMEs bioPmed is involved in many international
networks and projects. Collaborations have been established with Toscana Life Science (IT),
BioAlps (CH), MVA (DK), One Nucleus (UK), Stockholm Science City (SE), Wroclaw Center (PL)
and the BioNegev Cluster (IL). Together with ERAI (Entreprise Rhône-Alpes International, FR),
Lyonbiopole (FR), Biocat (ES) and BioM (DE), bioPmed takes part in bioXclusters, an
international platform based on a shared vision. The main objectives of bioXclusters is to
develop a common and joint internationalisation strategy for the four life sciences clusters,
EuroBioForum | 2nd Annual Conference 2013 | Report
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in order to reinforce the competitiveness of European SMEs outside Europe and to reinforce
the visibility of the four clusters and European competences worldwide. Pilot actions have
been started in four target markets: Brazil, China, India and US.

Using bioXclusters as a starting platform to involve other European health clusters, the four
clusters together with Health Science Scotland, are in the process to build a strong European
Alliance on Personalised Healthcare. A proposal for a European Strategic Cluster Partnership
(ESCP) with a global vision is in preparation; future target markets are Korea, Japan and
North Africa.

For achieving tangible results, Baldi’s top 3 recommendations are:
-
Try to think big and on the long term
Life Long health management should be the paradigm
Work on the integration of healthcare systems at European level,

using a solution-oriented approach, based on integration of multiple technological domains,
combined with an international vision and development strategy, based on partnerships and
complementarities.

Baldi draws attention to BIO-Europe Spring, that will be organised in Turin on March 10-12
2014.
Day 2 and the conference is closed by Wouter Spek. He thanks the speakers and the audience, in
particular the Canadian delegation, for their participation and valuable contributions. He promises
that EuroBioForum will take further steps in specific areas such as health economics, trans-border
collaboration, communication and education & training, to push the implementation of Pmed
forward.
He announced that the 3rd EBF conference will be held in Tallinn, Estonia, in September 2014.
EuroBioForum | 2nd Annual Conference 2013 | Report
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Video messages
Our 2013 participants shared their ideas on video.
Marc LePage | Watch the video
Katherine Payne | Watch the video
Dr Pierre Meulien | Watch the video
Rudi Balling | Watch the video
Dr Ruxandra Draghia-Akli | Watch the video
Graeme Boyle| Watch the video
Dr Mark Poznansky | Watch the video
Dr Anne Eckhardt | Watch the video
The youth perspective on the future of healthcare | Watch the video
All presentations and video messages can be viewed or downloaded from EBF’s website
www.eurobioforum.eu/2260/output-eurobioforum-2013.
EuroBioForum | 2nd Annual Conference 2013 | Report
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Contact
Project office EuroBioForum:
c/o Publimarket,
Nieuwe Uitleg 29
2514 BR The Hague
The Netherlands
t: +31 70 356 1534
[email protected]
www.eurobioforum.eu
© 2013 EuroBioForum. All rights reserved.
EuroBioForum | 2nd Annual Conference 2013 | Report
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