EuroBioForum 2013 - Day 1 | Greame Boyle


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



2b or not 2b – delivering Smart Clinical Trails

Graeme Boyle
Interim Director Stratified Medicine Scotland & Senior Programme Manager at Health Science Scotland


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EuroBioForum 2013 - Day 1 | Greame Boyle

  1. 1. 2B or not 2BThe case for Smart Clinical TrialsGraeme Boyle, Stratified Medicine ScotlandEuroBioForum, Munich, May 27, 2013
  2. 2. Health Science Scotland
  3. 3. Lost in Translation?BasicresearchPrototypediscoveryPreclinDev.EarlytrialsLate trialsHTA,HRSUse inNHSTMRCHealth Science Scotland1st gap in translation 2nd gap in translationHTA: health technology assessmentHSR: health services researchAdapted from Cooksey report Chart 7.1, page 105SMC/SHTG/MHRASULSA/SINAPSENRS/PCC
  4. 4. Scotland - World ClassTherapeutic Areas – e.g.• CV – Metabolic• Oncology• Inflammatory/Immune• Stem Cell/Regenerative MedicineInfrastructure – e.g.• NRS/CRF• BioBanks• Health Informatics• Stratified Medicine
  5. 5. Issue 1 – Collaborative ResearchAdapted from Tufts Center Report
  6. 6. Stratified Medicine Scotland - InnovationCentre“The right treatment, to the right patient,at the right cost………”
  7. 7. Stratified Medicine = better outcomesIt will allow us to offer• The right drug• To the right patient• For the right disease• At the right time• With the right dose• Targeted treatment based ongenetic profile• Develop diagnostic markersfor disease• Reduce the costs ofclinical trials through bettercohort selectionReduction in drugtoxicityFaster and cheaper tobring drugs to marketTargeted drug designEarlier illnessdetection & preventionDetermine diseasevariants
  8. 8. Scotland’s USPGeneticsProvider Informatics
  9. 9. Exemplar Programme 2: Heart disease & diabetesExemplar Programme 3: RhA & respiratoryExemplar Programme 1: OncologyCompanyATissue/Bio-repositories/DatasetsBiomedical Informatics/e HealthImagingGenomic/”omic’ medicineInnovation Centre Business PlatformThe ModelCompanyBCompanyC
  10. 10. Stratify patientsPatient sample sentto CRO forgenotypingDrug Trials Get SmarterMutation A EnrolledRejected (TreatmentDelayed)Clinical Trialagent targetsmutation ANGS PanelTrial BTrial ATrial DTrial CMutation BMutation AMutation DMutation CNo MutationEnrollment through centralizedtesting (old)Enrollment through care-embedded testing (future)Patients withdiseaseOLDNEWModified from
  11. 11. Long Term VisionTo transform management of chronic disease globally byaccelerating biomedical research, high quality health careprovision and economic growth.Key Segment:Molecular DiagnosticsPrecisetherapyrequiresprecisediagnosticsThewaywelookat diseaseischanging AssemblingthenecessarytechnologiestoleadRespondersPatient populationsMammography MolecularBiopsyToolsTumor+IHCStainGenesequencingMolecular pathologyImaging Molecular DiagnosticsAlzheimer’s Disease Age matched control[18F]AH110690 PETImaging90 –120 min summationAlzheimer’s Disease Age matched control[18F]AH110690 PETImaging90 –120 min summationOperations&commercializationMolecular imagingagents&equipmentTechnology&contentEnablingworkflowinvivodiagnosticsGRCMolecularPathologyDigitalPathologyClarient...tobea leader inthenext diagnosticfrontierToxicimpactNoimpactABGenomic profile of tumourActionable mutationsKRAS(G12D)p16/CDKN2A(loss)TP53(V274F)Modified from
  12. 12. Issue 2 – Creating Economic ValueSMENew andexistingResearchPartnerEnd User of IParisingNew EntrantsSupply ChainPartnerTechnologySolutionProvider
  13. 13. Characteristics of Scotland• Population 5M• Rural and inner city• Stable population• Collaboration – Aberdeen, Edinburgh, Dundee,Glasgow, St Andrews• Single coherent health care provider• Unique patient identifier
  14. 14. Collecting data from cradle to grave …MaternityBIRTHDEATHNeonatal Record SMR11Child health surveillanceImmunisationGP consultationsDental SMR13Out patients SMR00 Hospital Admissions SMR01Mental Health SMR04Prescribing ScreeningCommunity care SMR50Cancer registrations SMR06Cancer registry
  15. 15. NRS WNRS NENRS SENRS EBiorepository NetworkStrategic national collections• Rheumatoid arthritis• Renal cancer• Type 1 diabetes• Generation Scotland/ SHHSNational/ local planned collections• Generic consent• Strategy driven• Future focusBespoke collections• Specific consent• Project based• Investigator ‘owned’Infrastructure development• Inventory management system• Patient record linkage• Enhanced storage capacity• Facilitated rapid accessPathology archive
  16. 16. Issue 2: European Biorepository Network
  17. 17. Imagingphenotype(PACS)laboratoryphenotype(SCI store)Storage Area NetworkMortality(GROS)Hospital episodes(SMR: ISD)Identification(CHI)PrescribingNHS Data storesPrimary Care?Dumb terminalsSAFE HAVENSecure storagepower protectioncamera surveillanceNHS staffIntegrated datasetsAccredited accessHealth Informatics Centres
  18. 18. Issue 3:Connecting Health Informatics
  19. 19. Issue 4 – Information Commons
  20. 20. The Opportunity – WindowActively Working but 1-2 years offMatured capabilityPotential but no plans to develop Unlikely to provide access due to policy or technical UnknownReadiness to implement electronicHealth Records – Stratified MedicineGSK recognises Scotland’s current leadership in electronic Public HealthRecords … this IC will provide the opportunity to secure that positionthrough its application to Clinical Trials to stratify patient groups..Patrick Vallance, President Pharmaceutical R&D, GSK
  21. 21. European Markets for StratifiedMedicineSource:Advancing Access to Personalized Medicine: A Comparative Assessment of EuropeanReimbursement Systems – Personalised Medicine Coalition
  22. 22. Issue 5: Developing skills• Modern apprenticeship• Further education levelThe Stratified Medicine Scotland consortium has identifiedthe key training needs required to support the exploitationof stratified medicine by Scottish industry.• Graduate level (Health science/informatics)• Post Graduate (Health science/informatics)• Entrepreneurship• Senior level/industry exchange (GSK, P Vallance)• Industry/Academia mentoring
  23. 23. Issue 6: Ethics and Public Engagement
  24. 24. Challenges & Opportunities• Collaborative Research• Economic Impact• Biorepository linkages• Informatics• Skills Development• Public Engagement &EthicsModified from ESF: Personalised Medicine for the European Citizen
  25. 25. Danke schönThank YouMercitakkDank umulțumescСпасибоGrazie& Tapadh Leibh