- The document discusses the Total Cancer Care (TCC) approach at Moffitt Cancer Center, which aims to provide personalized cancer care through comprehensive data collection and analysis. - TCC collects extensive clinical, genomic, treatment and outcomes data from over 78,000 consented patients to power research studies and clinical trials matching. Molecular profiling has been conducted on over 14,000 tumor samples. - The TCC data is housed in a large integrated database and used by researchers for studies in areas like radiochemotherapy response, exome sequencing, immunology biomarkers, and cancer epidemiology. - The database also helps clinicians identify eligible patients for clinical trials and develop evidence-based treatment pathways. The goal is to transform cancer

1. Transformation to Value-Based Personalized Healthcare: Cancer as a ModelWilliam S. Dalton, PhD, MDPresident, CEO & Center DirectorMoffitt Cancer Center & Research InstituteTampa, Florida

2. Total Cancer Care: A Personalized Approach to a Patient’s Health JourneyPopulations at RiskInterventionDiagnosisSurvivorshipPrognosisRelapsed DiseaseTreatment– Behavioral Research– Psychosocial & Palliative Care– Family Needs– Health Outcomes– Risk Factors– Genetics– Early Detection– Health Disparities– Recurrence Therapy– Drug Discovery– Adaptive Trial Design– Prevention– Lifestyle/Nutrition– Education– Genomics/Proteomics– Imaging Modalities– Nanotechnology– Primary Therapy • Multimodality • Target Based– Post Therapy • Surveillance– Clinical Trials Matching– Molecular Oncology– Biomarker Analysis(http://www.hhs.gov/myhealthcare/news/phc_2008_report.pdf; pg 243)

3. The Necessary ComponentsClinically annotated bio-repository for tumor and normal specimensPartnership among researchers, clinicians, regulators, policy makers, and patients to design an integrated information network system

4. The Approach for CancerThe Total Cancer Care ProtocolCan we follow you throughout your lifetime?

5. Can we study your tumor using molecular technology?

6. Can we recontact you? Electronic Consenting SystemConsists of IRB Approved:Introductory Video

7. Consent Video by PI

8. Informed Consent

9. Signature Capture

10. Demographics SurveyWireless touch- screen tabletConnects via secure interface and forwards HIPAA-compliant information to database

11. Partners in the Fight Against Cancer

12. Nexus BiostoreFour unit capacity of 2.4 Million samples

13. Stores samples in a -80°C environment

14. Handles samples in a -20°C environment

15. Retrieves samples using NEXUS proprietary ‘Cool Transition’ technology

16. Flexibility to accommodate a wide variety of samples, vessels and labware

17. Automated 24/7 monitoring system in place

18. Automated Inventory functionality provides real-time inventory tracking of stored biospecimensAs of August 16, 2011Total Cancer Care To DatePatients Consented78,615Tumors Collected 28,146Tumors Profiled14,604888Confidential and Proprietary

19. M2Gen Offices, Bio-repository 100,000 sqft in Tampa, FL

20. The ApproachImprovedMedical PracticeCreate a delivery system that will integrate new technologies into the standard of care and develop evidence-based guidelines for the treatment of cancer.

21. Four Portals to Total Cancer Care™Researcher ViewNext Generation Health and Research Informatics Platform Cohort Identification

22. Molecular Profiling

23. Comparative EffectivenessPatient View Personal Health Record

24. Longitudinal Follow-up

25. Personalized SearchAdministrators View Operational Dashboards

26. Quality & Safety Reporting

27. Meaningful Use

28. Decision Support

29. Clinical Pathways

30. Clinical Trial Matching

31. Access for Affiliate NetworkClinician View

32. The HRI Platform DefinedAn integrated information platform that will create real-time relationships and associations from disparate data sources needed to create new knowledge for improved patient treatments, outcomes and prevention.

33. Core Data Aggregation andStorageSource SystemsSome representative examples of business level data domainsPatient Cohort ExamplesDemographicsCancer StageDiagnosisTreatmentLabsDrugsIntegrated Data WarehouseData Factory ImplementationData MappingData SourcingData ProfilingData ModelingData LinkageHRI Solution: Conceptual ArchitectureFront EndInformation DeliveryNewly Diagnosed, Primary Pancreatic, having CEL File Cancer RegistryLabVantageCapstonePrimary Breast Cancer, Survival Time >30 months, Disease Stage 1-4, Diagnosed with Type 2 Diabetes, currently on Metaformin Female with myelodysplastic syndrome, currently taking vidaza as Ist course chemotherapy, initially diagnosed in 2007-2008CEL FilesGalvanon3M

34. HRI Demonstration

35. Number of patients in the HRI today & growing

36. Patient data available – drill down capabilities to 5 levels of detailed data elements.

37. Tissue specimen data available – drill down capabilities to 5 levels of detailed data elements.

38. The Need for Linked QueriesPatient 1Patient 21-1-2009Lung Upper Lobe1-1-2010Lung Upper Lobe1-1-2010AdenocarcinomaNOSLINK6-30-2010AdenocarcinomaNOS6-30-2010Skin Trunk

39. Venn Diagrams

40. Four Portals to Total Cancer Care™Researcher ViewNext Generation Health and Research Informatics Platform Cohort Identification

41. Molecular Profiling

42. Comparative EffectivenessPatient View Personal Health Record

43. Longitudinal Follow-up

44. Personalized SearchAdministrators View Operational Dashboards

45. Quality & Safety Reporting

46. Meaningful Use

47. Decision Support

48. Clinical Pathways

49. Clinical Trial Matching

50. Access for Affiliate NetworkClinician View

51. Stakeholders as PartnersResearcher ViewTotal Cancer Care Multi-Dimensional Data Warehouse