EuroBioForum 2013 - Day 1 | Oyvind Melien


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EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany



Personalised medicine in Norway

Dr Øyvind Melien
Senior Advisor at Norwegian Directorate of Health


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EuroBioForum 2013 - Day 1 | Oyvind Melien

  1. 1. Personalised medicinein NorwayØyvind MelienThe Norwegian Directorate of HealthEUROBIOFORUM 2nd Annual ConferenceMay 27 2013 Munich
  2. 2. |EUROBIOFORUM May 27 2013| 2Personalised medicine in Norway• Information• Strategy• Therapy• Research• Industry• Development• Future Challenges
  3. 3. |EUROBIOFORUM May 27 2013| 3InformationConcepts and examples of personalised medicine werepresented in the Norwegian Medicines Handbook from2007; distributed to health personel in Norway (medicaldoctors, pharmacists, students etc).
  4. 4. IndividualizedtreatmentConcomitantmedicationGeneticfactorsDiseasestate/phaseOrganfunctionsAgeBody weightGenderDrugof choice
  5. 5. |EUROBIOFORUM May 27 2013| 5StrategyThe National Strategy for Biotechnology (2011-2020)provides a national platform for a cross-sectionaldevelopment and use of biotechnology within 4 focusareas including the major category:Health, health services, health-related industry• Personalised medicine is examplified in the strategyNational Strategy for BiotechnologyMinistry of Education and Research
  6. 6. |EUROBIOFORUM May 27 2013| 6TherapyPharmacogenetic tests established for certain– Drug-metabolising enzymes (CYP enzymes)– ”Drug targets” (i.e. receptors etc. at which drugs exerttheir effect)
  7. 7. |EUROBIOFORUM May 27 2013| 7Therapy – when to test?1. Always for a few (anticancer) drugs2. Close to routine for a few drugs– Azathioprine/6-MP, irinotecan, warfarin3. Most tests available should probably be reserved forindividual «problem patients»:- Adverse effects/excessive plasma concentration related to dose- Lack of effect or low plasma concentration4. For most drugs no tests available at all Prof. Olav SpigsetSt. Olav Hospital, Norway
  8. 8. Example: targeted therapy in lung cancerPatient with EGF Receptor mutationsAfter 1 month with EGFRinhibitorAfter 1 year with EGFRinhibitorBefore treatmentWith permissionDr. Åslaug HellandOslo University Hospital
  9. 9. |EUROBIOFORUM May 27 2013| 9Example: targeted treatment in lung cancerPatient with ALK translocationWith permissionDr. Åslaug HellandOslo University HospitalMetastasesfrom lung cancerAfter 3 months of targeted therapywith ALK inhibitor
  10. 10. |EUROBIOFORUM May 27 2013| 10ResearchA Publicly-initiated programme for Clinical Trials withinthe cancer field was established in Norway in 2011The National Council for Quality and Prioritization in theHealth Services selected «Cancer treatment tailored tothe individual» as focus area in its first call for theprogramme subsequent to a broad hearing with expertsand clinical researchersThe programme is organized within the Research Councilof Norway
  11. 11. |EUROBIOFORUM May 27 2013| 11ResearchExample:A large scale projectinitiated to examinemutations in eighttypes of cancer:Support from programmes: Including all health regions and Oslo Cancer ClusterPublicly-initiated Clinical TrialsBIOTEK 2021 Breast Lymphoma Leukemia Colon Malignant melanoma Sarcoma Multiple myeloma ProstateNorwegian CancerGenomics ConsortiumHead Ola MyklebostOUS – Norw. Radium Hospital
  12. 12. |EUROBIOFORUM May 27 2013| 12ResearchThe project aims to establish:A national research and innovation platform forpersonalised cancer medicineWork Packages include• WP1. Mutation-based patient stratification• WP2. Target discovery and preclinical validation• WP3. Theragnostic interpretation and clinical trials• WP4. Data sharing and national infrastructure• WP5. ELSA package
  13. 13. CancerGenomics.noAdded values from nationalcollaboration• Population-based data• Standardized genome analysis• Equal patient access nation-wide• Standardized treatment choices• National follow-up of multiple N=1 trials(compassionate use)• National evaluation of mutation frequencies andhealth-economic consequences• Over time accumulation of outcome data ofpersonalized treatments and other therapiesstratified by mutation profiles Prof. Ola MyklebostOUS – Norw. Radium Hospital
  14. 14. |EUROBIOFORUM May 27 2013| 14ResearchThe Research Programme on Biotechnology forInnovation (BIOTEK2021) has provided further funding toresearch on personalised medicine in cancerProgramme within the Research Council of Norway
  15. 15. Individualized cancer treatment based on tumour gene profiles• The National Collaboration Group for Health Research (NSG)recommended that the national Health Service prioritise aneffort on "Individualized cancer treatment based on tumourgene profiles".|EUROBIOFORUM May 27 201315
  16. 16. … the Norwegian approach is wise to take account ofother equally vital considerations such as havingnationally agreed protocols and systems to handleand process new testing and data, as well as effortsto underpin health professional and publiceducation, and provide health economic impact data.…UK Public Health Genetics Foundation
  17. 17. |EUROBIOFORUM May 27 2013| 17IndustryPharmaceutical industry emphasizes how personalisedmedicine may:• Identify patients with potential significant effect oftreatment• Identify patients with minimal or no effect• Support rational health economy and improvetreatment for the patients• Influence study designs and the time for developmentof new products Monica Kjeken,The Association of thePharmaceutical Industry inNorway.In communication
  18. 18. |EUROBIOFORUM May 27 2013| 18Relevant processes in developmentPersonalised medicineSupport to researchDevelop clinical research infrastructureCoordination of BiobanksCoordination of Health registriesNational HTA systemStrategy development
  19. 19. |EUROBIOFORUM May 27 2013| 19Development of clinical research infrastructureInfrastructure and networks for clinical research critical:• Norwegian Clinical Research Network (NORCRIN)established as part of the European network (ECRIN)• Nordic Trial Alliance (NTA) promoted as part of a Nordiccooperation in Health Care, with reference tostatement by the prime ministers (June 2012)• Participation in the OECD Global Science Foruminitiative to facilitate international cooperation in non-commercial clinical trials
  20. 20. |EUROBIOFORUM May 27 2013| 20Health registries and biobanksThe combination of health registries and biobanks inNorway represents a valuable tool for research inpersonalised medicine and validation of new testsHuman Biobanks and Health Data (BIOBANK)A new programme launched by the Research Council ofNorway designed for research on human biologicalmaterial in biobanks, by coupling analysis results withdata from health surveys, health registers and the healthservices
  21. 21. |EUROBIOFORUM May 27 2013| 21Health registriesNorway has a long history of health registries, ex.:• Cancer registry Established in 1951Ongoing national project for coordination of healthregistries in Norway• Example: A pre-project evaluates the potential tocoordinate all drug-related registries in a commonoverarching registry
  22. 22. |EUROBIOFORUM May 27 2013| 22Biobanks• Biobank Norway: a national biobank infrastructure -consortium of Norwegian population-based and clinicalbiobanks involved in international collaborationNine partners National biobanks• Norwegian Women and Cancer (NOWAC) study• Janus Serum Bank (Reserved for Cancer research)HUNT/NTNUNational Institute of Public Health
  23. 23. |EUROBIOFORUM May 27 2013| 23Health Technology AssessmentPotential tool for evaluation of personalised medicineA national system for Health Technology Assessment(HTA) for the specialist health care is introducedTreatment strategies for personalised medicine may infuture be systematically evaluated by means of the HTAmethodology with respect to effect, safety, cost-effectiveness etc. as a basis for potential introduction inthe health care system
  24. 24. |EUROBIOFORUM May 27 2013| 24Strategy DevelopmentThe Ministry of Health in Norway has initiated aninvestigation on personalised medicine which willinclude:• Analysis of the status for personalised medicine atinternational and national level• Development of a strategy for the future• Proposals for efforts to implement personalisedmedicine• Considerations related to ethical, social, economic andhealth implications of implementation• Recommendations
  25. 25. |EUROBIOFORUM May 27 2013| 25Future challenges for personalised medicineCoordination with treatment guidelinesThe challenges and approach for coordination of personalisedmedicine and treatment guidelinesHealth economyEconomic implications and reimbursement with reference tocomplex and dynamic treatment strategies, in many casesrelevant for a limited number of patientsImplementation in clinical practiceComprehensive approach in the need of several supportingsystems, adaptation of information technologies, education,monitoring etc.
  26. 26. Thanks• Karianne Solaas, The Research Council of Norway• Øystein Rønning, The Research Council of Norway• Ola Myklebost, Oslo University Hospital• Åslaug Helland, Oslo University Hospital• Olav Spigset, St Olav Hospital, Trondheim• Kjetil Taskén, Centre for Molecular Medicine Norway• Monica Kjeken, The Association of the Pharmaceutical Industry in Norway|EUROBIOFORUM May 27 201326