Can We Transform Healthcare in the Public Interest Now?

1. Can We Transform Healthcare in the Public Interest Now? ScienceDriven January, 2012

2. Agenda: Use What We Already Have for Prospective Health Now • DEFINE • Model and Assessments based on Knowledge Exchange between Patient/Family & Multidisciplinary Care Team • DESIGN • Framework for New Service Development for Personalized Healthcare Delivery • DELIVER • Higher value, more efficient KNOWLEDGE EXCHANGE • On Target: Save Lives and Let the “Rising Star” Clinicians Thrive • On Time: Get Research Breakthroughs to Patients Sooner • On Budget: Avoid and Defer Costs

3. Define a Model for New ServiceDevelopment in a For-Mission Enterprise Academic HealthcareProcess How this Process Maps to Missions * Emerging * “Clinical” and “laboratory” refer to the locations where research takes place

4. Similarity to New Product Development in a For-ProfitEnterprise • In an enterprise, need a balance of people. ALL are needed. Academic HealthcareProcess New ProductDevelopment* • Each innovates differently Inventor Adapter Practitioner discovers re-purposes identifies unmet need *See Steven Wheelwright and Kim Clark “Revolutionizing Product Development” (1992)

5. Distinction of New Service Developmentin a For-Mission Enterprise • Excellent Science Cycle Drives Healthcare Transformation To renew cycle, need:1. ResourcesNote: Cycle does not violate laws of thermodynamics. 2. Flexible, appropriate performance assessments 3. Renewable support for clinician-investigators • Clinical Innovation • Biologically Inspired Translation • PersonalizedHealth Care

6. Define Flexible, AppropriatePerformance Assessments To allocate limited life-saving resources that transform healthcare in the public interest

7. Multiple Stakeholders: Challenge for Implementing Prospective Health in the Clinic Each stakeholder has its own, appropriate interests and priorities Stakeholders may contribute to prospective health, but will not have clinical adoption as their primary goal. How will this be solved? New clinical services must put patient/family & multi. care team back at the center of healthcare.

8. Historically, trade sustains self-renewing societies Middle Kingdom • Trade involves more than goods and commerce • Translation of language • Acceptance of culture • Exchange of knowledge EGYPT Old Kingdom New ROME Kingdom Republic Empire BRITAIN 1st 2nd 3000 BC 2000 BC 1000 BC 0 1000 AD 2000 AD

9. Knowledge Exchange: Unit Operation of Real-world Healthcare URGENT NEED: Renew and refocus healthcare on Knowledge EXCHANGE Patient /Family Multidisciplinary Care Team GOAL: Sustainable, high-performance KNOWLEDGE EXCHANGE

10. The Generality of Knowledge Exchange As a unit operation, Knowledge Exchange between Service Teams and Service User is of broad generality for development of mission-driven services • For HEALTH, renew and refocus on knowledge exchange between multi teams of health coaches/mentors/advocates/advisors and healthy people/their families. • For EDUCATION, renew & refocus on knowledge exchange between teachers and students/families. • For LEARNING, renew & refocus on knowledge exchange among learners/do-ers. • For FAMILIES, renew and refocus on knowledge exchange between parents and daughters/sons.

11. We become what we measure • For product manufacturing, measure 3 dimensions • “On target,on time,on budget” Faster, better, cheaper • For services with knowledge exchange as unit operation: • Performance = f (Value,Efficiency) + Observation • Value = QualityEfficiency = Unit Operation = Knowledge ExchangeCostUnit Time Time • For dynamic R&D, “on target” is captured in Observation

12. Numbers Don’t Tell the Whole Story • Observation = Summary of unmet need, lesson learned, next experiment, or suggested improvement • Like a comment in chart or lab notebook • Knowledge waiting to be exchanged • Most important measure for R&D dashboard

13. Simple Assessments for Experiments in New Service Development Patient/Family Multi. CareTeam Novel Measures Reported by assess relative change in Value = QualityEfficiency = Knowledge ExchangeCostTime provideObservations for ongoing evaluation

14. Agenda: Use What We Already Have for Prospective Health Now • DEFINE • Model and Assessments based on Knowledge Exchange between Patient/Family & Multidisciplinary Care Team • DESIGN • Framework for New Service Development to Deliver Personalized Healthcare • DELIVER • Higher value, more efficient KNOWLEDGE EXCHANGE • On Target: Save Lives and Let the “Rising Star” Clinicians Thrive • On Time: Get Research Breakthroughs to Patients Sooner • On Budget: Avoid and Defer Costs

15. per·son·al·izedmed·i·cine * The application of genomic and molecular data to: • - better target the delivery of health care • - facilitate the discovery and clinical testing of new products • -help determine a person’s predisposition to a particular disease or condition * From bipartisan “Genomics & Personalized Medicine Act of 2007” co-sponsored by Burr (R-NC) and Obama (D-IL)

16. Both Retrospective AND Prospective Clinical Innovation Is Needed * Pathology of cancer cells (traitors) and infectious diseases (invaders), as well as immune and metabolic responses to both, are sufficiently understood for meaningful interpretation of prospective studies.

17. Personalized Medicine System applied to Patients diagnosed with Cancer * Note: Outside healthcare, risks to life and health are empirically estimated (see links in http://law.vanderbilt.edu/faculty/faculty-personal-sites/w-kip-viscusi/biography/index.aspx )

18. Connecting the Dots for a Prototype ofPersonalized Healthcare Delivery 1. Engaging the Patient 2. Systems Diagnosis 3. Therapy Decision Support 4. Benefit-CostAnalysis 5. MolecularActuarial = Informatics Infrastructure = Human Experience

19. Agenda: Use What We Already Have to Deliver Personalized Healthcare Now • DEFINE • Model and Assessments based on Knowledge Exchange between Patient/Family & Multidisciplinary Care Team • DESIGN • Framework for New Service Development to Deliver Personalized Healthcare • DELIVER • Higher value, more efficient KNOWLEDGE EXCHANGE • On Target: Save Lives and Let the “Rising Star” Clinicians Thrive • On Time: Get Research Breakthroughs to Patients Sooner • On Budget: Avoid and Defer Costs

20. One Starting Point: Systems Diagnosis Informs Personalized Therapy Decision Support • Clinical Pathway for Systems Diagnosis • Use companion biomarkers as prototypes • Working Prototype of Therapy Decision Support at the Point of Care • Disseminate best practice of knowledge exchange between patient/family and multidisciplinary care team 1. Engaging the Patient 2. Systems Diagnosis 3. Therapy Decision Support 4. Benefit-Cost Analysis 5. MolecularActuarial

21. Real-World Unwarranted Variation ( • Patient JM (reported in WSJ, May 2010)with abdominal pain; scan reveals gastrointestinal tumor; liver metastases Example of Current Care • 1. Surgery (1st hospital) to remove GI tumor and colon • 2. Chronic meds for digestive symptoms • 3. Patient seeks opinions for months • 4. Surgery (2nd hospital): Liver too damaged for aggressive resection • 5. Meds to manage infection • 6-9. Radiology (3rd hospital): Chemo delivered to liver; 4 invasive treatments • Cost to date: $600,000 • Community oncology team & patient/family exchange knowledge. • Tumor biopsy sent out for Systems Diagnosis. • 3. Interpretive report yields personalized diagnosis • 4. Multidisciplinary therapy decision support yields personalized therapy plan • 5. Short-course radiation treatment sensitizes tumor to pathway inhibitor • 6. Surgery to remove tumor remaining after treatment • Cost to date: $100,000 Personalized Medicine Example of Current Care Personalized Medicine ScienceDriven

22. Potential Economic Value: Personalized Dx & Personalized Tx • Rough Extrapolation of Case Study • Cost Reduction from Personalizing Treatment of One Patient Diagnosed with GI Cancer $500,000 • Annual New Cases of GI Cancer in US 270,000 $500,000  270,000 = $135 billion annually

23. Why Now? • “. . . an innovation that reduced overall cancer death rates by only 1% would be worth almost $500 billion or about 6% of GDP. Reducing age-specific death rates from a single category of cancer such as breast or digestive cancer by 10% would have a similar value.” • -- Kevin M. Murphy & Robert Topel (1999) “The Economic Value of Medical Research” Current Care • Treatment with chemotherapy. • Overall 5 yr survival rate <10%. • Female Asian Never-Smokersclinical diagnosis • of non-small cell lung cancer • 1. Molecular tests of tumor biopsy reveal ALK mutation in personalized diagnosis. • 2. As part of personalized therapy plan, team & patient/family share decision to enroll in clinical trial of ALK pathway inhibitor • 3. 65% of patients enrolled in trial respond to ALK pathway inhibitor. • Value of lives saved estimated at >$100B per year Personalized Medicine

24. Personalized Therapy Decision Support at the Point-of-Care Proposed Interactive Screen (used by Patient/Family and Multidisciplinary Team)

25. Personalized Therapy Decision Support at the Point-of-Service: Benefits

26. What it Will Take to Finish Prototype (or Who Will Pay to Transform Healthcare in the Public Interest?) AGILE “SWAT” TEAMS collaborate to connect existing solutions DE-IDENTIFIED STRATEGIC PHILANTHROPY is most likely funding mechanism. OBJECTIVE: WORKING PROTOTYPE 1 yr after funding received Prototype provides real-world basis for business plan: 21st century FFRDC ScienceDriven * All FTEs are real people, not position descriptions

27. --Institute of Medicine Member & HHMI Investigator “A well run system with average practitionersdelivers better healthcare thana poorly run system with outstanding practitioners.” ScienceDriven

28. Unwarranted Variation • Rates of common surgical procedures among Medicare patients for 306 referral regions Mulley A G BMJ 2009;339:bmj.b4073

29. Regional Informatics • Imagine a rural farmer who visits a community oncologist. . . • MidSoutheHealth Alliance • Primary care physicians for 900,000 Memphis residents have an e-Health record system that lets them see what Vanderbilt physicians see, at lower cost • Turnkey, portable infrastructure for cost-effective health information exchange • Established by Vanderbilt Center for Better Health in 2004 • http://www.markfrisse.com/presentations/2008-11-10-amia.pdf

30. Navigating the Interface of Clinical Research and Routine Patient Care

31. Some Guiding Principles • Do no harm. • There are no villains. • Play to strengths. • Learn by doing. • Use what we’ve got. • Better together. • Hope over fear.