Transformation to Value-Based Personalized Healthcare: Cancer as a Model<br />William S. Dalton, PhD, MDPresident, CEO & C...
Total Cancer Care: A Personalized Approach to a Patient’s Health Journey<br />Populations at Risk<br />Intervention<br />D...
The Necessary Components<br />Clinically  annotated bio-repository for tumor and normal specimens<br />Partnership among r...
The Approach for Cancer<br />The Total Cancer Care Protocol<br /><ul><li>Can we follow you throughout your lifetime?
Can we study your tumor using molecular technology?
Can we recontact you? </li></li></ul><li>Electronic Consenting System<br />Consists of IRB Approved:<br /><ul><li>Introduc...
Consent Video by PI
Informed Consent
Signature Capture
Demographics Survey</li></ul>Wireless touch- screen tablet<br />Connects via secure interface and forwards HIPAA-compliant...
Partners in the Fight Against Cancer<br />
Nexus Biostore<br /><ul><li>Four unit capacity of 2.4 Million samples
Stores samples in a -80°C environment
Handles samples in a -20°C environment
Retrieves samples using NEXUS proprietary ‘Cool Transition’ technology
Flexibility to accommodate a wide variety of samples, vessels and labware
Automated 24/7 monitoring system in place
Automated Inventory functionality provides real-time inventory tracking of stored biospecimens</li></li></ul><li>As of Aug...
M2Gen Offices, Bio-repository 100,000 sqft in Tampa, FL<br />
The Approach<br />Improved<br />Medical <br />Practice<br />Create a delivery system that will integrate new technologies ...
Four Portals to Total Cancer Care™<br />Researcher View<br />Next Generation Health and Research Informatics Platform<br /...
 Molecular Profiling
 Comparative Effectiveness</li></ul>Patient View<br /><ul><li> Personal Health Record
 Longitudinal Follow-up
 Personalized Search</li></ul>Administrators View<br /><ul><li> Operational Dashboards
 Quality & Safety Reporting
 Meaningful Use
 Decision Support
 Clinical Pathways
 Clinical Trial Matching
 Access for Affiliate Network</li></ul>Clinician View<br />
The HRI Platform Defined<br />An integrated information platform that will create real-time relationships and associations...
Core <br />Data Aggregation andStorage<br />Source Systems<br />Some representative examples of business level data domain...
 HRI Demonstration   <br />
Number of patients in the HRI today & growing<br />
Patient data available – drill down capabilities to 5 levels of detailed data elements.<br />
Tissue specimen data available – drill down capabilities to 5 levels of detailed data elements.<br />
The Need for Linked Queries<br />Patient 1<br />Patient 2<br />1-1-2009<br />Lung Upper Lobe<br />1-1-2010<br />Lung <br /...
Venn Diagrams<br />
Four Portals to Total Cancer Care™<br />Researcher View<br />Next Generation Health and Research Informatics Platform<br /...
 Molecular Profiling
 Comparative Effectiveness</li></ul>Patient View<br /><ul><li> Personal Health Record
 Longitudinal Follow-up
 Personalized Search</li></ul>Administrators View<br /><ul><li> Operational Dashboards
 Quality & Safety Reporting
 Meaningful Use
 Decision Support
 Clinical Pathways
 Clinical Trial Matching
 Access for Affiliate Network</li></ul>Clinician View<br />
Stakeholders as Partners<br />Researcher View<br />Total Cancer Care Multi-Dimensional Data Warehouse<br />
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  • Dalton presentation

    1. 1. Transformation to Value-Based Personalized Healthcare: Cancer as a Model<br />William S. Dalton, PhD, MDPresident, CEO & Center DirectorMoffitt Cancer Center & Research InstituteTampa, Florida<br />
    2. 2. Total Cancer Care: A Personalized Approach to a Patient’s Health Journey<br />Populations at Risk<br />Intervention<br />Diagnosis<br />Survivorship<br />Prognosis<br />Relapsed Disease<br />Treatment<br />– Behavioral Research<br />– Psychosocial & Palliative Care<br />– Family Needs<br />– Health Outcomes<br />– Risk Factors<br />– Genetics<br />– Early Detection<br />– Health Disparities<br />– Recurrence Therapy<br />– Drug Discovery<br />– Adaptive Trial Design<br />– Prevention<br />– Lifestyle/Nutrition<br />– Education<br />– Genomics/Proteomics<br />– Imaging Modalities<br />– Nanotechnology<br />– Primary Therapy <br /> • Multimodality<br /> • Target Based<br />– Post Therapy <br /> • Surveillance<br />– Clinical Trials Matching<br />– Molecular Oncology<br />– Biomarker Analysis<br />(http://www.hhs.gov/myhealthcare/news/phc_2008_report.pdf; pg 243) <br />
    3. 3. The Necessary Components<br />Clinically annotated bio-repository for tumor and normal specimens<br />Partnership among researchers, clinicians, regulators, policy makers, and patients to design an integrated information network system<br />
    4. 4. The Approach for Cancer<br />The Total Cancer Care Protocol<br /><ul><li>Can we follow you throughout your lifetime?
    5. 5. Can we study your tumor using molecular technology?
    6. 6. Can we recontact you? </li></li></ul><li>Electronic Consenting System<br />Consists of IRB Approved:<br /><ul><li>Introductory Video
    7. 7. Consent Video by PI
    8. 8. Informed Consent
    9. 9. Signature Capture
    10. 10. Demographics Survey</li></ul>Wireless touch- screen tablet<br />Connects via secure interface and forwards HIPAA-compliant information to database<br />
    11. 11. Partners in the Fight Against Cancer<br />
    12. 12. Nexus Biostore<br /><ul><li>Four unit capacity of 2.4 Million samples
    13. 13. Stores samples in a -80°C environment
    14. 14. Handles samples in a -20°C environment
    15. 15. Retrieves samples using NEXUS proprietary ‘Cool Transition’ technology
    16. 16. Flexibility to accommodate a wide variety of samples, vessels and labware
    17. 17. Automated 24/7 monitoring system in place
    18. 18. Automated Inventory functionality provides real-time inventory tracking of stored biospecimens</li></li></ul><li>As of August 16, 2011<br />Total Cancer Care To Date<br />Patients Consented<br />78,615<br />Tumors Collected <br />28,146<br />Tumors Profiled<br />14,604<br />8<br />8<br />8<br />Confidential and Proprietary<br />
    19. 19. M2Gen Offices, Bio-repository 100,000 sqft in Tampa, FL<br />
    20. 20. The Approach<br />Improved<br />Medical <br />Practice<br />Create a delivery system that will integrate new technologies into the standard of care and develop evidence-based guidelines for the treatment of cancer. <br />
    21. 21. Four Portals to Total Cancer Care™<br />Researcher View<br />Next Generation Health and Research Informatics Platform<br /><ul><li> Cohort Identification
    22. 22. Molecular Profiling
    23. 23. Comparative Effectiveness</li></ul>Patient View<br /><ul><li> Personal Health Record
    24. 24. Longitudinal Follow-up
    25. 25. Personalized Search</li></ul>Administrators View<br /><ul><li> Operational Dashboards
    26. 26. Quality & Safety Reporting
    27. 27. Meaningful Use
    28. 28. Decision Support
    29. 29. Clinical Pathways
    30. 30. Clinical Trial Matching
    31. 31. Access for Affiliate Network</li></ul>Clinician View<br />
    32. 32. The HRI Platform Defined<br />An 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. <br />
    33. 33. Core <br />Data Aggregation andStorage<br />Source Systems<br />Some representative examples of business level data domains<br />Patient Cohort Examples<br />Demographics<br />Cancer Stage<br />Diagnosis<br />Treatment<br />Labs<br />Drugs<br />Integrated Data Warehouse<br />Data Factory Implementation<br />Data <br />Mapping<br />Data <br />Sourcing<br />Data <br />Profiling<br />Data <br />Modeling<br />Data Linkage<br />HRI Solution: Conceptual Architecture<br />Front End<br />Information Delivery<br />Newly Diagnosed, Primary Pancreatic, having CEL File <br />Cancer Registry<br />LabVantage<br />Capstone<br />Primary Breast Cancer, Survival Time >30 months, Disease Stage 1-4, Diagnosed with Type 2 Diabetes, currently on Metaformin <br />Female with myelodysplastic syndrome, currently taking vidaza as Ist course chemotherapy, initially diagnosed in 2007-2008<br />CEL Files<br />Galvanon<br />3M<br />
    34. 34. HRI Demonstration   <br />
    35. 35. Number of patients in the HRI today & growing<br />
    36. 36. Patient data available – drill down capabilities to 5 levels of detailed data elements.<br />
    37. 37. Tissue specimen data available – drill down capabilities to 5 levels of detailed data elements.<br />
    38. 38. The Need for Linked Queries<br />Patient 1<br />Patient 2<br />1-1-2009<br />Lung Upper Lobe<br />1-1-2010<br />Lung <br />Upper Lobe<br />1-1-2010<br />Adenocarcinoma<br />NOS<br />LINK<br />6-30-2010<br />Adenocarcinoma<br />NOS<br />6-30-2010<br />Skin Trunk<br />
    39. 39. Venn Diagrams<br />
    40. 40. Four Portals to Total Cancer Care™<br />Researcher View<br />Next Generation Health and Research Informatics Platform<br /><ul><li> Cohort Identification
    41. 41. Molecular Profiling
    42. 42. Comparative Effectiveness</li></ul>Patient View<br /><ul><li> Personal Health Record
    43. 43. Longitudinal Follow-up
    44. 44. Personalized Search</li></ul>Administrators View<br /><ul><li> Operational Dashboards
    45. 45. Quality & Safety Reporting
    46. 46. Meaningful Use
    47. 47. Decision Support
    48. 48. Clinical Pathways
    49. 49. Clinical Trial Matching
    50. 50. Access for Affiliate Network</li></ul>Clinician View<br />
    51. 51. Stakeholders as Partners<br />Researcher View<br />Total Cancer Care Multi-Dimensional Data Warehouse<br />
    52. 52. How is Moffitt Benefiting from the RIE?<br />Using the TCC Database to match patients to clinical trials<br />Right treatment for the right patient using molecular markers for patient selection<br />Development of Comparative Effectiveness Research Infrastructure<br />What works best for whom<br />Integration of molecular, clinical, biospecimen and patient self-report data<br />Gene expression data, Exome sequencing data, SNP/CNV data for new diagnostics, prognostic response and new drug discovery<br />
    53. 53. Radiochemotherapy<br />Validation of a Predictive Model of Clinical Response to Concurrent Radiochemotherapy<br />Javier Torres-Roca, MD<br />(R21 CA135620) <br />Eschrich SA, et al., Int J Radiat Oncol Biol Phys, 2009<br /><ul><li>TCC database: validation of clinical response</li></ul>Figure 1<br />Defining the pathway scale by mathematical modeling<br />A linear regression algorithm is used to model the pathway/network scale in the radiosensitivity continuum. Biological variables (ras status, p53 status and TO) known to influence radiosensitivity along with gene expression are included in the model<br />
    54. 54. High-Throughput Sequencing<br />Exome Sequencing<br />361 breast and ovary biospecimens sequenced at BGI<br />Whole exome sequencing (Agilent SureSelect 38MB kit )<br />Raw and analyzed data currently available<br />4,000 samples being sequenced at BGI<br />~1,400 genes<br />500 lung, 400 kidney, 300 colon<br />150 each: uterus, pancreas, ovary, endometrium<br />100 each: heme malignancies, melanoma, breast<br />50 each: stomach, esphagus, liver, cervix, soft tissue, rectum, anus<br />650 undecided<br />Whole genome sequencing: Melanoma<br />13 match pairs at Wash U Genome Inst.<br />
    55. 55. Melanoma Comprehensive <br />Research Center<br />Melanoma whole genome sequencing<br /><ul><li>15 melanomas and matched normal pairs chosen from TCC bio-repository
    56. 56. Linked to TCC gene expression array and clinical follow-up databases
    57. 57. Completed in only 2 months
    58. 58. Further analysis by MCC Cancer Informatics Core
    59. 59. Funded by MCC and a gift from Donald A. Adam</li></li></ul><li>Immunology<br />Classification into high and low NF-kB<br />Correlation of NF-kB Signature<br />with Ras Signature<br />Ras Signature<br />r=0.692 (p<0.001)<br />NF-kB and K-ras Signatures in lung cancer<br />Amer Beg, PhD<br />Initial Study:<br />400 Lung Patients<br />TCC database validating signatures<br />P50 CA121182<br />
    60. 60. Cancer Epidemiology<br />Insulin-Like Growth Factor Axis & Colon Cancer Outcomes<br />300 Patient Cohort Study<br />Erin Siegel, PhD<br />Outcomes:<br /><ul><li>Treatment Toxicity & response
    61. 61. Quality of Life & symptoms
    62. 62. Recurrence & survival</li></ul>Recruitment at Surgery<br /><ul><li>Tumor Tissue
    63. 63. Gene expression Profile
    64. 64. Pre-surgery blood
    65. 65. New Patient Questionnaire
    66. 66. Physical Activity
    67. 67. Anthropometrics
    68. 68. Quality of Life (QOL)</li></ul>Treatment Information<br />Follow-up<br />3M<br />12M<br />6M<br />Toxicity & QOL<br /><ul><li>Blood draws
    69. 69. Anthropometrics
    70. 70. Questionnaires (health behaviors, symptoms & QOL)</li></ul>*Green = utilizing TCC infrastructure<br />State of Florida, 09BN-13<br />
    71. 71. Health Outcomes & Behavior<br />Patient Centered Outcomes Research (PCOR)<br />David Fenstermacher, PhD<br /><ul><li>New information infrastructure to support PCOR or Comparative Effectiveness Research (CER)
    72. 72. Metadata-driven data model
    73. 73. Natural language processing algorithms
    74. 74. Developed novel data dictionary and metadata tools
    75. 75. Generated additional descriptive tool to understand differences in patient response and validation for exponential failure.
    76. 76. CER analyses to guide developing CER infrastructure
    77. 77. 3 CER studies on myelodysplastic syndrome completed(Alan List, et al., submitted in Blood)</li></ul>UC2 CA148332 (NCI Grand Opportunity grant)<br />
    78. 78. Clinical Trial Matching<br />Using TCC Warehouse to Accrue Patients Jonathan R. Strosberg, MD<br />Phase 2 trial of single agent Roche gamma secretase inhibitor in metastatic CRC (PI, Jonathan Strosberg, MD) <br /><ul><li>Trial (NCI 8537) supported by CTEP N01 contract
    79. 79. Re-contacted Moffitt TCC patients using general eligibility criteria
    80. 80. Enrolled 37 patients in 4 months
    81. 81. Time from LOI submission to last patient treated just over 10 months
    82. 82. OEWG/IOM expectation for N01 trial activation is 210 days</li></li></ul><li>Four Portals to Total Cancer Care™<br />Next Generation Health and Research Informatics Platform<br />Patient View<br /><ul><li> Personal Health Record
    83. 83. Longitudinal Follow-up
    84. 84. Personalized Search</li></li></ul><li>
    85. 85.
    86. 86.
    87. 87.
    88. 88.
    89. 89.
    90. 90. Four Portals to Total Cancer Care™<br />Next Generation Health and Research Informatics Platform<br /><ul><li> Decision Support
    91. 91. Clinical Pathways
    92. 92. Clinical Trial Matching
    93. 93. Access for Affiliate Network</li></ul>Clinician View<br />
    94. 94. Clinical Pathways: Decision Support<br /><ul><li>Decision support tools available at point-of-care that leverage:
    95. 95. Clinical outcomes studies
    96. 96. Comparative effectiveness data
    97. 97. Comprehensive disease models
    98. 98. Evidence-based clinical pathways</li></li></ul><li>Clinical Pathways<br />
    99. 99. Pathways Approach<br />Clinical Priorities in Pathway development<br />Efficacy<br />Toxicity<br />Cost<br />Comprehensive Clinical Coverage<br />
    100. 100. Fixing Clinical Trials? <br />
    101. 101. Current Clinical Trial Challenges<br /><ul><li>Trial activation too slow
    102. 102. Trial accrual too slow
    103. 103. Patients do not want to leave home
    104. 104. 80% of cancer care delivered locally
    105. 105. Novel investigational trials performed in Academic Medical Centers
    106. 106. Trials are searching for patients</li></li></ul><li>Current Clinical Trial Challenges<br /><ul><li>Cancer patients enrolled: 2-3 % in community and 10-12 % in cancer centers
    107. 107. Early phase trials’ response rates too low
    108. 108. Early enrollers on Phase I trials are under-treated
    109. 109. Small incremental benefits in large later phase trials
    110. 110. Regulatory burden is increasing</li></li></ul><li>Clinical Trials Vision<br /><ul><li>Develop a consortium network for clinical trials (practices and hospitals)
    111. 111. Obtain molecular data from patients’ tumors
    112. 112. Maintain real-time clinical data on patients
    113. 113. Match drugs to patients using molecular and clinical data
    114. 114. Faster and smaller trials with increased response rates</li></li></ul><li>Paradigm Shift<br />TODAY<br />Trials searching for patients<br />TOMORROW<br />Trials designed for and directed to patients<br />
    115. 115. 344<br /> 275<br />220<br />209<br />167<br />134<br />107<br /> 42<br /> 30<br />Molecular Mapping to Produce Dynamic Pool of Trial-Ready Patients<br />(Many Mapped to Pre-Selectively Enroll a Few)<br />Newly Diagnosed Metastatic/Locally-Advanced Patients<br />Assumptions Reducing Sample Size<br /><ul><li>Starting sample sizeY
    116. 116. Availability of biopsy* (-20%)
    117. 117. Adequacy of biopsy (-20%)
    118. 118. Assay failure (-5%)
    119. 119. Death/Morbid/Toxicity (-20%)
    120. 120. Temporal Readiness within 1 yr of the Bx (TTP < 1yr) (-20%)
    121. 121. Performance Status or inadequate Labs (-20%)
    122. 122. Prevalence of Mutation (-60%)
    123. 123. Pt/MD Choice of Rx (-30%)</li></ul>One Tumor Type<br />Diminishing<br /># of Patients<br />Potential “Positive” Factors:<br /><ul><li>Could also limit to specific diseases (such as colon, lung, breast, pancreas) to ensure proper final mix</li></ul>* Could allow primary biopsies for brain, prostate, pancreas, ovary, bladder, pancreas where distant metastases hard to access;<br />* Could also assume physicians might consider a “diagnostic” Bx in a situation when otherwise they might pass<br />Trial-Ready<br />
    124. 124. Ultimate Goal of New Trials<br />To incorporate molecular characteristics <br />of the tumor, as well as the patient’s genetic <br />background, into an individualized treatment <br />plan to maximize clinical benefit to the <br />patient from specific anti-tumor agents. <br />
    125. 125. Biomarker-driven trials at Moffitt<br /><ul><li>Phase 3 RRM1/ERCC1 directed chemo in advanced NSCLC (completed)
    126. 126. Phase 2 R115777 in elderly AML with specific 2-gene ratio (active)
    127. 127. Phase 2 Notch inhibitor in mCRC (completed)
    128. 128. Planned TCC consortium trials
    129. 129. CY 2011 Pharma Trials </li></li></ul><li>Designing a New Research & Healthcare Network Model<br />Hospitals & Healthcare Networks<br />Offices & Clinics<br />Insurers<br />Research<br />Information<br />Exchanges<br />Personal <br />Health <br />Records<br />Researchers Centers<br />& Networks<br />Genomic Data &<br />Annotation<br />Services<br />Patients<br />Researchers<br />Dalton, Fenstermacher, et al, Clin Cancer Res; 16 (24) December 15, 2010<br />
    130. 130. Rapid Learning Information System for Cancer Care & Research<br />
    131. 131. Thank You<br />

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