EuroBioForum 2013 2nd Annual Conference 27-28 May 2013 - Hilton Munich City, Munich, Germany http://www.eurobioforum.eu/2013 ======================================= # NATIONAL PERSPECTIVES # Germany: Personalized Medicine at the German Federal Ministry of Education and Research (BMBF) Karin Effertz Scientific Officer at Federal Ministry for Education and Research ======================================= http://www.eurobioforum.eu

1. Personalized Medicine at the
German Federal Ministry of Education and Research (BMBF)
• Future Project of the High Tech Strategy 2020 of the BMBF (2010)
• Action Field of the Health Research Framework Programm (2010)
• Action Plan for Personalized Medicine (2013)
• International Strategic Activities of the BMBF in Personalized Medicine
Dr. Karin Effertz, Personalized Medicine at the BMBF, Eurobioforum Munich 2013

2. The Action Plan for Personalized Medicine:
A new Way for Research and Care
Definition (Excerpt, BMBF)
• Personalized Medicine identifies biological factors that influence the
probalbility to develop a disease, its progression and healing as well as the
effectiveness of therapies in a specific, and thereby unique, manner at
the level of the individual patient.
• Successes are expected primarily for stratification strategies
• Better understanding of the function of factors and their complex
interactions opens options for custom- tailored prevention strategies and
therapies, to reduce side effects and thereby to more effiecient
therapeutic regimen
Dr. Karin Effertz, Personalized Medicine at the BMBF, Eurobioforum Munich 2013

3. The Action Plan for Personalized Medicine:
A new Way for Research and Care
• Perspective: A more in-depth understanding of health and disease
promises better healing success rates
– Patients: Custom-tailored therapies for a more specified care
– Health Care System: Efficient and sustainable use of ressources
– Health Economy: Promotion of new products and procedures
– Society: Increased awareness of health relevant actions
Dr. Karin Effertz, Personalized Medicine at
the BMBF, Eurobioforum Munich 2013

4. Programm: Foci of BMBF Funding
• Aims of funding
– Better runderstandíng of individual factors that impact disease development and
progression
– Clinical validation of results and development of new therapies and products
– Lowering of barriers between research/clinics/industry
Strategies
Funding of basic and applied biomedical research
Special focus on systems medicine
biomarker validation
design of clinical studies
partnering between academia, clinics and companies
international cooperation
ethical aspects in personalized medicine
Dr. Karin Effertz, Personalized Medicine at the BMBF, Eurobioforum Munich 2013

5. The Action Plan for Personalized Medicine:
A new Way for Research and Care
• If PM is successful, we expect…
– Faster and more precise diagnostics (biomarker–based) as well as more 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
– More investments in individualized medicine in the health economy
– Better under standing within the whole society for individualized medicine (FORSA-
survey)
– Faster market access for products and services related to personalized medicine
Dr. Karin Effertz, Personalized Medicine at the BMBF, Eurobioforum Munich 2013

6. Programm: Foci of BMBF Funding
• Measures
– Identification: better understanding of diseases
– Validation and Implementation: Verficaction of results and translation
to clinical practice and transfer to the health economy
– Discussion: Analysis of consequences for society as a whole
– Budget: up to 100 Mio. € from 2013-2016
Dr. Karin Effertz, „Personalized Medicine at the BMBF“, Eurobioforum Munich 2013

7. The Action Plan for Personalized Medicine:
A new Way for Research and Care
• Launched end of April 2014 by Minister Prof. Wanka together with 3 calls:
1) Innovations for Personalized Medicine:
• Funding of projects, that aim at the development of new products and processes for
diognosis and therapy considering biomarker- based stratification
• Modules: diagnostics and therapy
• 3 Phases: Forum for innovations, preparatory phase, realisation phase
2) Demonstrators for Personalized Medicine:
• Showcases,that demonstrate immediate usefulness and applicability of results
from basic biomedical research for PM.
• Use of systems-medicine approaches for prevention, diagnosis and therapy of diseases
• A special focus is on data analysis and integration as well as modelling.
•
3) Ethical, social and regulatory aspects in Systems Medicine
• Budget: Up to 100 Mio. € for 3 years
Dr. Karin Effertz, Personalized Medicine at
the BMBF, Eurobioforum Munich 2013

8. Measures:
Better understanding of diseases
The research and funding concept e:Med
• „Paving the way for Systems Medicine“
• Systems Medicine uses systems approaches in research and care to
illuminate complex physiological and pathological processes and therby to
create a basis for innovative therapies and preventve measures
• 5 Modules
1) Research Consortia for Systems Medicine (call closed, 11 Consortia)
2) Demonstrators for Individualized Medicine (Call open till August)
3) Young Researchers (in preparation)
4) Future and Crosscutting Fields
5) Internationalization
Dr. Karin Effertz, Personalized Medicine at
the BMBF, Eurobioforum Munich 2013

9. International Activities in Personalized Medicine
• CSA Systems Medicine „CASyM“
– Objective: Complementing and Coordination of Systems Medicine
across Europe, Strategy paper on Systems medicine. The road map
is driven by clinical needs: It aims to identify areas where a systems
approach will address clinical questions and solve clinical
problems.
• Key components of this strategy are:
• Engagement of all relevant stakeholders
• Development of multidisciplinary training concepts
• Assessment of methodological and technological challenges
• Strengthening innovation activities
• Professional dissemination concepts
• Analysis of instruments for the implementation of research programs
• Creating and shaping a sustainable European community of Systems Medicine
• Coordinating Systems Medicine across Europe
– Team: 22 partners, scientists, funders
– Time: 2012-2016
Dr. Karin Effertz, Personalized Medicine at
the BMBF, Eurobioforum Munich 2013

10. International Activities in Personalized Medicine
• CSA PerMed (Idea was born at the Eurobioforum 2012 in
Brussels)
• Objective:.
• overcoming barriers for innovation, such as fragmented activities, lack of communication or
generic solutions in different fields of PM.
• Need governance strategies at the European and global level are to be developed as PM
challenges the way in which healthcare systems worldwide are set up.
• A plethora of initiatives already exist (European Science Foundation (ESF) Forward
• Look, the Manifesto of the European Alliance for Personalised Medicine (EAPM), the European Best
Practice Guidelines of the Public Health Genomics European Network (PHGEN), the Roche report on
Personalized Medicine or the report of the European Hospital and Healthcare Federation (HOPE))
• Umbrella Initiative of European and national decision-makers and funding bodies
Team: 18 international partners from funding bodies, ministries,
universities
Time: Start planned in 2013
Dr. Karin Effertz, Personalized Medicine at the BMBF, Eurobioforum Munich 2013

11. • Priorities for PM
Identification: Better understanding of disease, better biomarker (signatures),
integration of BiG DATA
Discussion: More responsibility for the individual?
Health Care System: Data management vs. Data protection
–
Dr. Karin Effertz, Personalized Medicine at
the BMBF, Eurobioforum Munich 2013