Towards the Implementation of Personalised
Medicine in Europe: the Strategic Research
and Innovation Agenda (SRIA)Tallinn, 26 October 2015
Erica Hackenitz
The Netherlands Organisation for Health Research and Development
(ZonMw)
For CSA PerMed
Why are our health interventions still not so
successful?
Only 15% are evidence-based
Patients react different on the same intervention
• Diseases are due to genome-environmental
interactions. Examples: cancer, CVDs, obesity, addiction
• There is no „one size fits all“
We need more targeted, “personalised“ interventions
A paradigm shift is needed
• From common complex diseases to “multiple rare diseases”
• From diseases to “diseasomes”
• From risk factor to “risk pattern”
• From clinical utility to “personal utility”
(A.Brand, 2008)
• “Some countries have already developed their national
strategy on PM while others have only started” (Inventory EC
DG Research 2015)
• A range of activities are ongoing in different countries and
consortia in Europe
• Joint forces will be necessary for the implementation of PM
State-of-the-Art
AIMS:
• To step up coordination efforts between European key
stakeholders already active in the field of PM
• To prepare a strategic research and innovation agenda
(SRIA)
EC: Coordination & Support Action (CSA) PerMed
• Research and Health Ministries
• Funding Bodies
• Research Institutes
• Industry and SMEs
• Foundations and Societies
• Connected to important other
European initiatives related
Personalized Medicine (e.g.
EuroBioForum, ESF, EAPM, CASyM,
EPEMED)
Who?
Ministry of
Social
Affairs
(MoSA-
Estonia)
Cooperating
partner
18 Partners, 9 cooperating partners
Evaluation of
Personalised Medicine
(PM) Reports (over
20)
Interviews with
PM Stakeholders
(around 40)
PerMed Partners
(27)
Further input
From a.o. Publications
and Meetings on PM
Workshop 1, Berlin~ 90 participants
• Basic Research & New Technologies
• Translational Research
• Regulation, Reimbursement & Market
access
• Health System in General
• PM in Europe & Canada
• HTA and Citizens perspective
Workshop 2, Gastein, EHFG Forum 4 ~ 120 participants
• Patient involvement
• General Practitioner (GP)
• Hospitals
• Legal & Ethical aspects
• Regulatory aspects
• Rare Diseases (example)
• Nutrition & life style (example)
SRIA Recommendations to:
• European Commission
• Member States
• Research Communities
• Industry
• Funding and Regulatory Bodies
• Providers
How?
• 5 Challenges
• 35 Recommendations
Strategic Research and Innovation Agenda
SRIA - Challenges
• Challenge 1 – Developing Awareness and Empowerment
• Challenge 2 – Integrating Big Data and ICT Solutions
• Challenge 3 – Translating Basic to Clinical Research and Beyond
• Challenge 4 – Bringing Innovation to the Market
• Challenge 5 – Shaping Sustainable Health Care
I. Provide further evidence for the benefit delivered by PM to health
systems.
II. Develop and promote models for individual responsibility, ownership
and sharing of personal health data.
III. Develop mobile health applications to maximize engagement of
patients with their treatment pathways and track the safety and
effectiveness of these interventions.
IV. Understand how the changes related to PM will impact public health
and ensure they translate directly to benefits for individual citizens and
society.
1. Developing Awareness and Empowerment(excerpt)
I. Promote strategies to make sense of ‘big data’.
II. Develop and encourage the fast uptake of technologies for data
capture, storage, management and processing.
III. Support translational research infrastructures and enforce data
harmonisation fostered by specific ICT infrastructures designed to the
health data.
IV. Support analytical methods and modelling approaches to develop new
disease models, e.g. ‘Computerised Twins’ or a ‘Virtual Patient’.
2. Integrating Big Data and ICT Solutions(excerpt)
I. Develop methods to better integrate and evaluate the information
provided by genomic, epigenetic, transcriptomic, proteomic,
metabolomic and microbiome analyses.
II. Support research in preclinical models to validate hypotheses resulting
from molecular analyses of patient samples and treatment outcomes.
III. Promote collaborative pre-competitive and trans-disciplinary research
in all disease areas to gain trustworthy and objective information.
IV. Instigate a European-wide biomarker evaluation and validation process.
3. Translating Basic to Clinical Research and Beyond(excerpt)
I. Formalise a risk-based approach for the evaluation of PM.
II. Optimise individual drug therapies and poly-pharmacy especially in the
case of multi-morbidity.
III. Support research on an adequate regulatory and legal framework for
PM.
IV. Encourage a systematic early dialogue between innovators, patients
and decision-makers throughout all regulatory steps to provide
guidance and clarity.
4. Bringing Innovation to the Market(excerpt)
I. Support health economics research of PM to support decision makers.
II. Develop prospective surveillance systems for personal health data that
facilitate accurate and on-going assessment of highly dynamic health
information across the life course.
III. Develop training programmes on PM for health professionals.
IV. Encourage a citizen-driven framework for the adoption of electronic
health records.
V. Develop a framework for pricing and reimbursement for PM that
ensures equitable access for all patients – regardless of economic or
geographic status – and is sustainable for health systems.
5. Shaping Sustainable Health Care(excerpt)
Published and launched in June
2015 in Brussels.
• There will be a need to include more communication and training
modules, more outreach activities, and more non-research cross-sectoral
projects to complement ‘classical’ basic and translational research
activities.
• Funding needs to provide incentives to include specialists from a wide
range of areas such as: Big data, information and communication
technologies, data sharing and integration, public health, ethical, legal
and social aspects, regulatory affairs, industry
Towards PM ImplementationThe challenge for research funders and decision-makers will be to fund
research beyond the classical funding schemes
DG Research has organized several workshops with MS to join forces for PM
research in Europe.
Towards a
European
roadmap for
Personalised
Medicine
“European Personalised Medicine
Consortium” (EPMC)
The basis for
the EPMC
initiative of
the
European
Commission
Each Challenge Group is composed of Experts
and lead by a Facilitator from one of the Member States..
ESTONIA?
Possible Structure EPMC
Shaping Europe’s Vision for Personalised Medicine
Thank you very much for your attention
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