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European perspectives in
         personalised medicine


Ruxandra Draghia-Akli, Director for Health Research
Directorate-General for Research and Innovation
European Commission


                     dna hcraeseR
                     noitavonnI
Not here to preach to the choir…

• We are here to explore
  how we can make music
  together
• We are here to listen and
  learn from each other
• EU level coordination can
  help in the implementation
  of personalised medicine




                              dna hcrayciloP
                                      eseR P
                              noitavonnI
Personalised medicine: the time for
  action is now
• Rapidly emerging area with
  high potential for Europe
• Raising questions along the
  full innovation cycle
• Potentially great benefits
  for patients
• Potentially large economic
  impact across public and
  private sectors


                               dna hcrayciloP
                                       eseR P
                               noitavonnI
EC stocktaking exercise: personalised
  medicine workshops and conference
• Vision for Europe 2020: identify bottlenecks for
  implementation and research needs at European level
• 2010: Preparatory workshops (-omics, biomarkers, clinical
  trials/regulatory, uptake)
• 2011: European Perspectives in Personalised Medicine
  conference




                          dna hcrayciloP
                                  eseR P
                           noitavonnI
noitavonnI
                                   dna hcrayciloP
                                           eseR P
                                                           snoitalupop
     llams ro/dna deifitarts rof seigolodohtem lairt lacinilc detpadA     •
                       seipareht gnitsixe ni srekramoib fo esu retteB     •
       srekramoib fo sepyt lla fo noitadilav lacinilc dna noitacifilauQ   •
                           srekramoib fo noitadilav dna noitacifitnedi
            rof seigolodohtem dna sehcaorppa wen fo tnempoleveD           •
            • Translating knowledge to medical applications
                     serutangis xelpmoc erolpxe ot smhtirogla levon
   fo tnempoleved dna seliforp ralucelom htiw atad lacinilc gnikniL •
serudecorp lacitylana dna noitcelloc elpmas dna atad rof sdradnatS •
       sgnittes lacinilc ni esu rof sloot hcraeser wen fo snoitatpadA •
    • Generating knowledge and developing the right tools
        key challenges for research (1/2)
        Outcome of our stock taking exercise:
noitavonnI
                               dna hcrayciloP
                                       eseR P
                    sehcaorppa enicidem desilanosrep no seiduts
  cimonoce-ocamrahp rehto dna ssenevitceffe tsoc evitarapmoC •
                tnemssessA ygolonhceT htlaeH rof seigolodohteM •
                  smetsys erac htlaeh ni sehcaorppa desilanosrep
 fo ytilibaiv cimonoce eht no dna stneitap rof tcapmi no seidutS •
      • Understanding the economic impacts and aspects
alucirruc gniniart dna noitacude ni egdelwonk wen fo noitargetnI •
                                                    sredlohekats
   dna senilpicsid tnereffid neewteb noissucsid dna noitaroballoC •
    • Breaking barriers and speaking the same language
     key challenges for research (2/2)
     Outcome of our stock taking exercise:
Current EC health research activities

   • Around €1 billion to
     collaborative research
     enabling the development
     of personalised medicine
     approaches
                        JRC (EC)
                 Euratom
                          1.8
       Capacities     4.1
                     4.3
                                   Cooperation
       People      4.7
                                   32.3
                    7. 5
           Ideas

Total FP7 budget: € 54.6 billion
Health Priority in Cooperation: € 6.1 billion   dna hcrayciloP
                                                        eseR P
                                                 noitavonnI
Personalised medicine: our current
  research focus (period 2010 – 2012)
• Technologies for patient stratification/personalised
  medicine
• Genome based biomarkers for patient stratification and
  pharmacogenomic strategies
• Human epigenomics
• Validation of –omics based biomarkers
• Rare diseases as a model for personalised medicine
• Clinical bioinformatics
• Statistical methods for collection and analysis of
  – omics data
• New methodologies for Health Technology Assessment


                               dna hcrayciloP
                                       eseR P
                               noitavonnI
Examples of EU-funded research



                          CAGEKID
METAHIT
                          Cancer Genomics of the     European Research
Metagenomics of the
                          Kidney                     initiative to develop Imaging
Human Intestinal Tract
                                                     Probes for early In-vivo
                                                     Diagnosis and Evaluation of
                                                     response to therapeutic
                                                     substances




                TRANSBIG                                 European Network for
    MINDACT- Microarray In Node negative                 Genetic and Genomic
      Disease may Avoid ChemoTherapy                         Epidemiology

                                    dna hcrayciloP
                                            eseR P
                                     noitavonnI
International Rare Diseases Research Consortium
                    (IRDiRC)

            Ambitious 2020 goals

           200 New Therapies


           Diagnosis For Most Rare Diseases

           23 committed members
           EU investment over € 430 million
                     dna hcrayciloP
                             eseR P
                     noitavonnI
IMI: enabling personalised medicine
 approaches – 3 project examples
      U-BIOPRED: Unbiased BIOmarkers in
      PREDiction of respiratory disease
      outcomes



     PROactive: physical activity as a crucial
     patient reported outcome in COPD



DIRECT: DIabetes REsearCh on
patient straTification

                   dna hcrayciloP
                           eseR P
                   noitavonnI
gro.NOITADNUOF-GNUL-NAEPORUE.DERPOIBU.www
                   -Clinical data from a large group of
                    asthma patients and healthy people
                   - “-omics” technology
                   - Animal and laboratory models
                   - Human challenge models
                               Systems biology


                   Handprint of characteristics that can be
                         observed (“phenotypes”)
Thorax, 23.11.10      to better classify severe asthma




                                        dna hcrayciloP
                                                eseR P
                                         noitavonnI
Horizon 2020: The next framework
  programme for research and innovation
• Europe needs cutting edge
  research and innovation
• Essential to ensure
  competitiveness, growth
  and jobs
• Vital to tackle pressing
  societal challenges
• 3% of GDP invested in
  R&D: headline target of
  Europe 2020


                             dna hcrayciloP
                                     eseR P
                             noitavonnI
noitavonnI
                                                            dna hcrayciloP
                                                                    eseR P
                                                                                                        esaesid gnitaerT      •
                                                                                           noitciderp dna tnemeganam
                                                                           esaesid gnivorpmi rof enicidem ocilis-ni gnisU     •
                      .sehcaorppa dna seigolonhcet
     evitavonni dna ,ecitcarp tseb fo noitanimessid                                • Improving diagnosis
      dna gnikam noisiced desab ecnedive hguorht
      seitilauqeni gnicuder dna smetsys erachtlaeh                                 seniccav evitneverp retteb gnipoleveD      •
      fo ssenevitceffe dna ycneiciffe eht gnisimitpO    •
                          erac detargetni gnitomorP     •                      • Understanding disease
                                               htlaeh
 fo tnemeganam-fles rof tnemrewopme laudividnI          •                       ssenderaperp dna ecnallievrus gnivorpmI       •
    gnivil detsissa dna tnednepedni ,gniega evitcA      •                                                    ytilibitpecsus
                sdeen yrotaluger dna gnikam ycilop                              esaesid fo tnemssessa eht gnivorpmi dna
troppus ot sdohtem dna sloot cifitneics gnivorpmI       •                     semmargorp gnineercs evitceffe gnipoleveD       •
                           atad htlaeh fo esu retteB    •                                             ;noitneverp esaesid
                                                                                dna noitomorp htlaeh gnivorpmi ,)srotcaf
                         snoitca noitavonni elbalacs                         detaler etamilc dna latnemnorivne gnidulcni(
    dna ecitcarp lacinilc ot egdelwonk gnirrefsnarT     •                       htlaeh fo stnanimreted eht gnidnatsrednU      •
      Wellbeing Challenge – proposal ~ €8.5bn
      Health, Demographic Change and
      Horizon 2020:
Some key questions for discussion
• How can bioclusters/bioregions support the rapid uptake of
  personalised medicine?
• How can bioclusters/bioregions help proving the value of
  personalised medicine approaches in healthcare?
• What incentives could be developed to stimulate innovation
  in personalised medicine approaches?
• How can rapid integration of innovative
  technologies/approaches be assured while ensuring quality
  and safety for patients?



                           dna hcrayciloP
                                   eseR P
                           noitavonnI
More information including workshop and conference reports




Visit us online: http://ec.europa.eu/research/health
                         dna hcrayciloP
                                 eseR
                         noitavonnI
                                      P
noitavonnI
             dna hcrayciloP
                     eseR P
Thank you for your attention

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European Perspectives in Personalised Medicine

  • 1. European perspectives in personalised medicine Ruxandra Draghia-Akli, Director for Health Research Directorate-General for Research and Innovation European Commission dna hcraeseR noitavonnI
  • 2. Not here to preach to the choir… • We are here to explore how we can make music together • We are here to listen and learn from each other • EU level coordination can help in the implementation of personalised medicine dna hcrayciloP eseR P noitavonnI
  • 3. Personalised medicine: the time for action is now • Rapidly emerging area with high potential for Europe • Raising questions along the full innovation cycle • Potentially great benefits for patients • Potentially large economic impact across public and private sectors dna hcrayciloP eseR P noitavonnI
  • 4. EC stocktaking exercise: personalised medicine workshops and conference • Vision for Europe 2020: identify bottlenecks for implementation and research needs at European level • 2010: Preparatory workshops (-omics, biomarkers, clinical trials/regulatory, uptake) • 2011: European Perspectives in Personalised Medicine conference dna hcrayciloP eseR P noitavonnI
  • 5. noitavonnI dna hcrayciloP eseR P snoitalupop llams ro/dna deifitarts rof seigolodohtem lairt lacinilc detpadA • seipareht gnitsixe ni srekramoib fo esu retteB • srekramoib fo sepyt lla fo noitadilav lacinilc dna noitacifilauQ • srekramoib fo noitadilav dna noitacifitnedi rof seigolodohtem dna sehcaorppa wen fo tnempoleveD • • Translating knowledge to medical applications serutangis xelpmoc erolpxe ot smhtirogla levon fo tnempoleved dna seliforp ralucelom htiw atad lacinilc gnikniL • serudecorp lacitylana dna noitcelloc elpmas dna atad rof sdradnatS • sgnittes lacinilc ni esu rof sloot hcraeser wen fo snoitatpadA • • Generating knowledge and developing the right tools key challenges for research (1/2) Outcome of our stock taking exercise:
  • 6. noitavonnI dna hcrayciloP eseR P sehcaorppa enicidem desilanosrep no seiduts cimonoce-ocamrahp rehto dna ssenevitceffe tsoc evitarapmoC • tnemssessA ygolonhceT htlaeH rof seigolodohteM • smetsys erac htlaeh ni sehcaorppa desilanosrep fo ytilibaiv cimonoce eht no dna stneitap rof tcapmi no seidutS • • Understanding the economic impacts and aspects alucirruc gniniart dna noitacude ni egdelwonk wen fo noitargetnI • sredlohekats dna senilpicsid tnereffid neewteb noissucsid dna noitaroballoC • • Breaking barriers and speaking the same language key challenges for research (2/2) Outcome of our stock taking exercise:
  • 7. Current EC health research activities • Around €1 billion to collaborative research enabling the development of personalised medicine approaches JRC (EC) Euratom 1.8 Capacities 4.1 4.3 Cooperation People 4.7 32.3 7. 5 Ideas Total FP7 budget: € 54.6 billion Health Priority in Cooperation: € 6.1 billion dna hcrayciloP eseR P noitavonnI
  • 8. Personalised medicine: our current research focus (period 2010 – 2012) • Technologies for patient stratification/personalised medicine • Genome based biomarkers for patient stratification and pharmacogenomic strategies • Human epigenomics • Validation of –omics based biomarkers • Rare diseases as a model for personalised medicine • Clinical bioinformatics • Statistical methods for collection and analysis of – omics data • New methodologies for Health Technology Assessment dna hcrayciloP eseR P noitavonnI
  • 9. Examples of EU-funded research CAGEKID METAHIT Cancer Genomics of the European Research Metagenomics of the Kidney initiative to develop Imaging Human Intestinal Tract Probes for early In-vivo Diagnosis and Evaluation of response to therapeutic substances TRANSBIG European Network for MINDACT- Microarray In Node negative Genetic and Genomic Disease may Avoid ChemoTherapy Epidemiology dna hcrayciloP eseR P noitavonnI
  • 10. International Rare Diseases Research Consortium (IRDiRC) Ambitious 2020 goals 200 New Therapies Diagnosis For Most Rare Diseases 23 committed members EU investment over € 430 million dna hcrayciloP eseR P noitavonnI
  • 11. IMI: enabling personalised medicine approaches – 3 project examples U-BIOPRED: Unbiased BIOmarkers in PREDiction of respiratory disease outcomes PROactive: physical activity as a crucial patient reported outcome in COPD DIRECT: DIabetes REsearCh on patient straTification dna hcrayciloP eseR P noitavonnI
  • 12. gro.NOITADNUOF-GNUL-NAEPORUE.DERPOIBU.www -Clinical data from a large group of asthma patients and healthy people - “-omics” technology - Animal and laboratory models - Human challenge models Systems biology Handprint of characteristics that can be observed (“phenotypes”) Thorax, 23.11.10 to better classify severe asthma dna hcrayciloP eseR P noitavonnI
  • 13. Horizon 2020: The next framework programme for research and innovation • Europe needs cutting edge research and innovation • Essential to ensure competitiveness, growth and jobs • Vital to tackle pressing societal challenges • 3% of GDP invested in R&D: headline target of Europe 2020 dna hcrayciloP eseR P noitavonnI
  • 14. noitavonnI dna hcrayciloP eseR P esaesid gnitaerT • noitciderp dna tnemeganam esaesid gnivorpmi rof enicidem ocilis-ni gnisU • .sehcaorppa dna seigolonhcet evitavonni dna ,ecitcarp tseb fo noitanimessid • Improving diagnosis dna gnikam noisiced desab ecnedive hguorht seitilauqeni gnicuder dna smetsys erachtlaeh seniccav evitneverp retteb gnipoleveD • fo ssenevitceffe dna ycneiciffe eht gnisimitpO • erac detargetni gnitomorP • • Understanding disease htlaeh fo tnemeganam-fles rof tnemrewopme laudividnI • ssenderaperp dna ecnallievrus gnivorpmI • gnivil detsissa dna tnednepedni ,gniega evitcA • ytilibitpecsus sdeen yrotaluger dna gnikam ycilop esaesid fo tnemssessa eht gnivorpmi dna troppus ot sdohtem dna sloot cifitneics gnivorpmI • semmargorp gnineercs evitceffe gnipoleveD • atad htlaeh fo esu retteB • ;noitneverp esaesid dna noitomorp htlaeh gnivorpmi ,)srotcaf snoitca noitavonni elbalacs detaler etamilc dna latnemnorivne gnidulcni( dna ecitcarp lacinilc ot egdelwonk gnirrefsnarT • htlaeh fo stnanimreted eht gnidnatsrednU • Wellbeing Challenge – proposal ~ €8.5bn Health, Demographic Change and Horizon 2020:
  • 15. Some key questions for discussion • How can bioclusters/bioregions support the rapid uptake of personalised medicine? • How can bioclusters/bioregions help proving the value of personalised medicine approaches in healthcare? • What incentives could be developed to stimulate innovation in personalised medicine approaches? • How can rapid integration of innovative technologies/approaches be assured while ensuring quality and safety for patients? dna hcrayciloP eseR P noitavonnI
  • 16. More information including workshop and conference reports Visit us online: http://ec.europa.eu/research/health dna hcrayciloP eseR noitavonnI P
  • 17. noitavonnI dna hcrayciloP eseR P Thank you for your attention