Personlig medicin i Danmark en kort og ufuldstændig status

1. Personlig medicin i Danmarken kort og ufuldstændig status Prof. Torben Ørntoft Molekylær Medicinsk Afd Aarhus Universitetshospital

2. Instructions from the Boss • Political initiatives   • Research council activities incl. funding schemes • Initiatives from other actors/agencies • University initiatives • Legislative changes • Participation in international research and research infrastructure initiatives with focus on personalised medicine • You may use max 20 min.

3. Political initiatives   • Research council activities incl. funding schemes • Initiatives from other actors/agencies • University initiatives • Legislative changes • Participation in international research and research infrastructure initiatives with focus on personalised medicine • You may use max 20 min.

4. Political initiatives   • Finance act 2016, 5 mill DKK for a Pre-analysis • Professional implications, staffingetc • Technical issues • Ethical and legal issues • Economicalissues • Contribute - an overview of state of the art in PM in Dk and internationally - Suggest scenarios for a PM program in Denmark

5. Organisering af arbejdet med foranalysen

6. Referencegruppens sammensætning • Dansk Biotek (deltager ikke) • Dansk Data Arkiv • Danske Bioanalytikere • Danske Patienter • Danske Regioner • Danske Sygeplejeråd • Danish e-InfrastructureCooperation, DeIC • Dansk Industri • Den Nationale Videnskabsetiske Komité, DNVK • Danmarks Tekniske Universitet • Erhvervs- og Vækstministeriet • Finansministeriet • Forbrugerrådet Tænk • Genome Denmark • Innovationsfonden • Justitsministeriet • Københavns Universitet • Lægemiddelindustriforeningen, LIF • Lægevidenskabelige Selskaber, LVS • Lægeforeningen • Lægemiddelstyrelsen • Region Hovedstaden • Region Midtjylland • Region Nordjylland • Region Sjælland • Region Syddanmark • Statens Serum Institut • Styregruppen for Regionernes Bio- og Genombank • Sundhedsdatastyrelsen • Sundhedsstyrelsen • Sundheds- og Ældreministeriet • Syddansk Universitet • Uddannelses- og Forskningsministeriet • Aalborg Universitet • Aarhus Universitet

7. 4) Referencegruppens definition af personlig medicin ”I denne rapport er der fokus på personlig medicin som anvendelsen af især genetisk men også anden molekylærbiologisk kortlægning mm. for at få indsigt i sundhed og sygdom til brug for vurdering af risiko, forebyggelse, diagnostik og behandling af sygdom, tilpasset den enkeltes særlige, biologiske forhold.”

8. 8 tracks in PM.dk strategy • Governancestructureestablished • Ethical, legal and data safetyissuessolved • Information and dialog with citizens of DK • Bio-and genome banks, sequencing, data handling and link to registries • Implement. in health system, trainingstaff • Datamanagement, data analysis, IT • Academic and clinical research • Innovation and commercialexploitaiton

9. Mulige scenarier for et dansk program for personlig medicin National satsning og strategi (scenarie 2) • Governancestructure, with welldefinedgoals and successcriteria • A coordinatedeffort as a national unitedstrategy for the whole country • A large program implemented over a relatively short period of years Minimumsmodel (scenarie 1). Ingen samlet national satsning (0-scenarie)

10. Active scenario • National Danish Genome Center • Related to Health Ministry and Danish Hosp. regions • Information sharing • Clinicalinfrastructure • Research infrastructure • Knowledge sharinginfrastructure • National workinggroups

11. Political initiatives   • Research council activities incl. funding schemes • Initiatives from other actors/agencies • University initiatives • Legislative changes • Participation in international research and research infrastructure initiatives with focus on personalised medicine • You may use max 20 min.

12. Research council activities incl. funding schemesInitiatives from other actors/agencies • The Danish Free Research councildoes not makespecifiedcalls (untillnow!) – in the future it can do and is renamed a research Fund • Other public funds mergedinto the Innovation Fund DK • This has mainfocus on industry – verylittle on strategichealth research –but maychange? • Part of ERA net in EU for PerMed and will support calls of strategicimportance for DK (STAR) • Part of IC Per Med in EU with local Danish support of selectedcalls • Industry and growthrelated funds for start-ups etc • Danish regions and hospitals - Severalminor support schemes, strategic

13. Otherfoundations • Private foundations (Novo-Nordic/ Lundbeck) • May specifycalls for PerMed with requirement of national projects and national storage of data • Patient organisations (Cancer and Heart etc) • Oftenspecifycalls • Somecallsvery large

14. Political initiatives   • Research council activities incl. funding schemes • Initiatives from other actors/agencies • University initiatives • Legislative changes • Participation in international research and research infrastructure initiatives with focus on personalised medicine • You may use max 20 min.

15. University/Hospitals initiatives • University and Region collaborate on research in DK • Bioinformaticeducation at severaluniversities in DK • Universities support infrastructure: • HP computing • Bioinformatictraining • Biobanking • Seq.cingcore centers • Hospitals support infrastructure • Biobanking • Sequencers with low TAT (Turn-around-time) • Quality assurance of all procedursaccording to ISO15189 • Interpretation of mutations

16. Political initiatives   • Research council activities incl. funding schemes • Initiatives from other actors/agencies • University initiatives • Legislative changes • Participation in international research and research infrastructure initiatives with focus on personalised medicine • You may use max 20 min.

17. Workinggroup on ethics and legal issues • Sundheds – og Ældreministeriet • Danske Regioner • Regionernes biobankssekretariat • Styrelsen for Patientsikkerhed • Lægemiddelstyrelsen (agency) • Statens Serum Institut • Sundhedsdatastyrelsen • Sekretariatet for Det Nationale Videnskabsetiske Komitésystem og Det Etiske Råd • Justitsministeriet • Uddannelses – og Forskningsministeriet • Danske Patienter • Repræsentant for forskere – udpeget af sundhedsdekanerne i fællesskab • Repræsentant for klinikere – udpeget af regionerne i fællesskab • Lægeforeningen/Lægevidenskabelige selskaber

18. Legislative changes • Workinggrouptasks • Fundament for genomicanalysis and biobanking • EU personal data act interpreted in a pragmaticway • Enablecrossanalysis of genomes and registries • Citizen Rights and insight • Enablingactivecitizen participation

19. Political initiatives   • Research council activities incl. funding schemes • Initiatives from other actors/agencies • University initiatives • Legislative changes • Participation in international research and research infrastructure initiatives with focus on personalised medicine • You may use max 20 min.

20. Participation in international research and research infrastructure initiatives with focus on personalised medicine • IC PerMed in EU • ERA net on PerMed • Horizon 2020 proposals • ICGCmed (US/UK driven) participate in workinggroups • NIH grants for large projects (e.g. in psychiatry) • Others?

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