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Personalized Health Care
Through Basic, Translational and
      Applied Research
   A Case for Improved Care, Lower Costs and
    Transformation from Disease to Wellness

                Clay Marsh, MD
Vision for Ohio State University

• It is Ohio State's time to be the university
  of the American dream, an institution
  worthy of the public trust and the front
  door to the future.
   – Gordon Gee, President, The Ohio State
     University
Create the
   Future of
  Medicine to
   Improve
   People’s
Lives Through
 Personalized
 Health Care
                Harvard
                Business
                Review |
                October 2007 |
                hbr.org
What is the goal of Personalized
  Health Care at Ohio State
          University?
Improve People’s Lives
by Transforming Disease-
 Based Care to Wellness
P4 Medicine
•   Predictive:
    – Probabilistic health
      history--DNA
      sequence
•   Personalized:
    – Unique individual
      human genetic
      variation mandates
      individual treatment
•   Preventive:
    – Focus on wellness
•   Participatory:
    – Patient understands
      and participates in
      medical choices
•   Precise:
    – Deep
      understanding of
      health and disease
                                       Wellness and Risk Management
What is the Compelling Argument
to Change the Way Health Care is
        Delivered to You?
National Health Care Trends
• Health Care - one of the top three issues of
  American concern along with Iraq war,
  economy/jobs in 2008

• In 2005, total health care spending represented
  16% ($2.5 Trillion) of the GDP and is projected to
  increase to 20% ($4 Trillion) of the GDP by 2015

• Chronic Diseases like heart disease, asthma,
  cancer, diabetes are primarily responsible for the
  rise in health care spending


                        Sources: pollingreport.com, National Coalition on Health Care, CDC
Health Care Expenditures as % of GDP
Between 2001 and 2016, health spending is projected to grow 2.5% per
 year faster than GDP, so that by 2016 it may constitute 20% of GDP.

                  $14,000                                                                                     20.0%

                                                                                                16.0%
                  $12,000                                                            15.9%

                                                                    13.7%   13.8%                             15.0%
                  $10,000
                                                            12.3%
In Billions ($)




                   $8,000                           10.4%




                                                                                                                      Percent
                                          9.1%                                                                10.0%
                                   8.1%
                   $6,000   7.2%

                   $4,000
                                                                                                              5.0%

                   $2,000


                     $-                                                                                       0.0%
                            1970   1975    1980      1985   1990    1995      2000       2005       2006

                                     National health exp.   GDP      Health Exp as % of DGP


                                                                      SOURCE: CMS, Office of the Actuary, National Health Statistics Group.
USA outspent other developed countries in
              health care
Higher Spending Does Not Necessarily
        Lead to Higher Quality




                        Source: Baicker and Chandra (Health Affairs 2004)
Life Expectancy
  While much higher than developing countries, US life
  expectancy is lower than most developed countries.

                                                                      81.5

                                           79.7        79.9
      80                          79.4
                          78.5
                  78.1
           77.1
Age




      75




      70
           U.S.   U.K.   Germany France   Canada       Italy         Japan

                                                   Source: OECD, 2004 & Health Affairs 2002; 21(4): 99
% Finding Difficulty in Receiving Care
More than 1 in 4 in the population finds accessing care
             difficult in the United States.

                                      30   28
 % finding it difficult to get care




                                      25
                                                   21
                                      20
                                                               15          15                 15
                                      15


                                      10


                                       5


                                       0
                                           U.S.   Canada   New Zealand   Australia           U.K.



                                                                                     Commonwealth Fund Survey, 1998
Trends in Health Care – Chronic Disease




  •   By 2025, nearly 49% of U.S. population will have one chronic disease
  •   Those with chronic diseases account for 81% of hospital admissions;
      91% of all prescriptions filled; and 76% of all physician visits
  •   CDC estimates that chronic disease management represents 75% of all
      healthcare spending and responsible for 70% of deaths

                                                        Sources: CDC, fightchronicdisease.org
Limitation of Standard Drug Treatment
Drugs prescribed for patients are effective in fewer than

     Reate of Efficacy with Standard Therapy (%)
               60% of treated patients
                                                   100
                                                     90
                                                     80
                                                     70
                                                                                                                       60             60          62
                                                     60                                                     57
                                                                                    48            50
                                                     50
                                                     40
                                                                         30
                                                     30        25
                                                     20
                                                     10
                                                        0
                                                                       e




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                                                                                    The rape utic Are a
                                                                                          Source: Brian B. Spear, Margo Heath-Chiozzi, and Jeffrey Huff, “Clinical Application of
                                                                                                                Pharmacogenetics,” Trends in Molecular Medicine (May 2001).
Summary:
      The need for transformation
• Total health care spending was $2.5 trillion in 2008,
  representing 16% of the GDP, like to reach $4 trillion by
  2016
• 75-90% were spent on managing and treating chronic
  illnesses that are preventable and effectively managed
• On a per-person basis, our health care costs are 50%
  higher than the second most costly nation
• USA outspent other developed countries in health care but
  quality of care does not follow.
• The U.S. healthcare ranked by the WHO 37/191 countries
  in performance
• Drugs prescribed for patients are effective in fewer than
  60% of treated patients but costs of development is
  skyrocketed.
What Makes Each One of Us
Unique and What Defines Health?
Patient Phenotype




    home.honolulu.hawaii.edu/~pine/variation3.jpg
http://genomics.energy.gov/
The Human Genome Project
• A 13-year project coordinated by the U.S.
  Department of Energy and the NIH

• The total number of genes estimated at 30,000

• 99.9% nucleotide bases are exactly the same in
  all people

• Functions unknown for over 50% of discovered
  genes
Source: Human Genome Project Information
   http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml
NY Times Magazine:
   My Genome, My Self




          Steven Pinker, Jan 7, 2009
Complex Relationships Determine
      Health and Disease
              • Complex interactions of
                genes and proteins
                explain differences
                between people
              • Complex Interactions of
                proteins in networks and
                our environment are
                critical in determining
                health and disease
              • What field has tools that
                we need to understand
                the organization of these
                complex interactions?
Systems Biology
• Emergent field that aims at
  systems understanding of
  biological systems.
   – Systems view focuses at
     understanding:
      • The complexity of the
        system
      • The networks activated in
        the system
      • The control methods of
        the system
                                    www.sysbio.de/figs/sysbio8.gif
      • Key nodes in the system
Systems Biology Opportunity in Clinical Medicine
 Identify Networks and Key Regulatory Nodes Controlling Networks




              http://mcdb.colorado.edu/courses/3280/lectures/class16-2.html
PLoS One
How Will Personalized Medicine
     Look in the Future?
The Future
What Does the COM Contribute to
   Research at Ohio State?
• $34.1 M over 5 years
• CTSA is an outcome
  of the Roadmap for
  Research from NIH
NIHIdeas
  People
Resources
Leadership
NIH Roadmap for Medical Research

                 New Pathways
                  to Discovery




                      NIH


Research Teams               Re-engineering the
 of the Future          Clinical Research Enterprise


                                           Source: NIH
                                         Roadmap Project
NIH Roadmap Strategy
          Interdisciplinary Research
          Pioneer Award
          Nanomedicine                          Training
                               Public Private   National Clinical Research
                               Partnerships     Associates


          Bench                Bedside                 Practice
Building Blocks                 Clinical         Integrated Research
Pathways                        Research         Networks
Molecular Libraries             Informatics      Clinical outcomes
Bioinformatics and
                      Translational
   Computational
                      Research
   Biology
Structural Biology    Initiatives                      Source: NIH Roadmap Project
Nanomedicine
Molecular
                                    Libraries     Building Blocks,
          Re-engineering the
                                   and Imaging   Biological Pathways
           Clinical Research
                                                    and Networks
               Enterprise
Clinical
Enterprise
                                                    Structural
    Public-Private
                                                     Biology
    Partnerships               Implementation
                                   Groups


                                                    Bioinformatics and
                                                   Computational Biology
     High-risk
     Research
                     Interdisciplinary
                         Research         Nanomedicine
                                                          New Pathways
Research Teams                                            to Discovery
                                                         Source: NIH Roadmap Project
How Has the Stimulus Package
Affected Research in the COM and
         Medical Center?
American Recovery and Reinvestment Act 2009
ARRA Stimulus Funding Proposal by Type
                 OSUMC
                        As of 6/2/09

                  $4,949,092
    $11,923,253                                   Challenge
                                                  Supplement
                               $74,640,044        Aut ism
                                                  Shared Inst r
$63,091,300                                       APRC *
                                                  RC2 GO Grant
                                                  P30 Core Ct r
     $450,812
                                                  Revision
     $5,734,402            $33,199,437

              $2,911,697

                                             Source: COM Office of
                     Total $200M                   Research
How Does Personalized Medicine
Align with the Research Mission?
Personalized Health Care


               DISEASE TO WELLNESS
      Translation             Application/       Dissemination
                            Implementation           Practice to
       Experimental            Health Care       Population Health
     Therapeutics and        Delivery; Health      Impact; Social
    Devices; Preclinical    Care Effectiveness    Networking Tools
      to Clinical (T2)             (T3)          and Solutions (T4)


                           DISCOVERY
          Systems Biology/Systems Medicine
Genomics/Proteomics; Genetics; Informatics; Modeling (T1)
BHAG for Personalized Health
         Care planning at Ohio State
• We will develop and execute a demonstration
  project in personalized health care by 2010 to
  deliver care in a cost-effective, convenient, high
  quality and precision-based approach starting with
  our health plan and create the social epidemic to
  lead to its acceptance and desirability.

• We will develop a personalized health care model
  that will meet our blue ocean strategy and…
  –   Create Precision Medicine to improve quality
  –   Lower the cost of health care
  –   Increase patient access and customer satisfaction
  –   Move health care from the doctor’s office to the patient’s
      home on demand
Tools
Applied Research and Systems Biology

• Emergent field that aims at
  systems understanding of
  biological systems.
   – Systems view focuses at
     understanding:
      • The complexity of the
        system
      • The networks activated in
        the system
      • The control methods of
        the system                  www.sysbio.de/figs/sysbio8.gif
      • Key nodes in the system
PHR and Portability




Microsoft HealthVault
Telemedicine
Social Networking
Systems and Process Focus

                                                Make your car last
                                                 200,000 miles
                                            GOOD BETS        BAD BETS
                                            Honda Civic      BMW 7-Series
                                            Honda CR-V       Infiniti QX56
                                            Honda Element    Jaguar S-Type
                                            Lexus ES         Jaguar X-Type
                                            Lexus LS         Mercedes-Benz M-
                                                             Class (V8)
                                            Toyota 4Runner   Mercedes-Benz SL
                                            Toyota           Nissan Armada
                                            Highlander
                                            Toyota Land      Nissan Titan
                                            Cruiser
                                            Toyota Prius     Volkswagen Touareg
                                            Toyota RAV4      Volvo XC90 (6-cyl.)
Decoding the DNA of the Toyota Production
System, Harvard Business Review, 1999                                        October 2007
FROM




                                           TO




*Number of ICU beds is subject to change

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Personalized Healthcare and Research

  • 1. Personalized Health Care Through Basic, Translational and Applied Research A Case for Improved Care, Lower Costs and Transformation from Disease to Wellness Clay Marsh, MD
  • 2.
  • 3. Vision for Ohio State University • It is Ohio State's time to be the university of the American dream, an institution worthy of the public trust and the front door to the future. – Gordon Gee, President, The Ohio State University
  • 4. Create the Future of Medicine to Improve People’s Lives Through Personalized Health Care Harvard Business Review | October 2007 | hbr.org
  • 5. What is the goal of Personalized Health Care at Ohio State University?
  • 6. Improve People’s Lives by Transforming Disease- Based Care to Wellness
  • 7. P4 Medicine • Predictive: – Probabilistic health history--DNA sequence • Personalized: – Unique individual human genetic variation mandates individual treatment • Preventive: – Focus on wellness • Participatory: – Patient understands and participates in medical choices • Precise: – Deep understanding of health and disease Wellness and Risk Management
  • 8. What is the Compelling Argument to Change the Way Health Care is Delivered to You?
  • 9. National Health Care Trends • Health Care - one of the top three issues of American concern along with Iraq war, economy/jobs in 2008 • In 2005, total health care spending represented 16% ($2.5 Trillion) of the GDP and is projected to increase to 20% ($4 Trillion) of the GDP by 2015 • Chronic Diseases like heart disease, asthma, cancer, diabetes are primarily responsible for the rise in health care spending Sources: pollingreport.com, National Coalition on Health Care, CDC
  • 10. Health Care Expenditures as % of GDP Between 2001 and 2016, health spending is projected to grow 2.5% per year faster than GDP, so that by 2016 it may constitute 20% of GDP. $14,000 20.0% 16.0% $12,000 15.9% 13.7% 13.8% 15.0% $10,000 12.3% In Billions ($) $8,000 10.4% Percent 9.1% 10.0% 8.1% $6,000 7.2% $4,000 5.0% $2,000 $- 0.0% 1970 1975 1980 1985 1990 1995 2000 2005 2006 National health exp. GDP Health Exp as % of DGP SOURCE: CMS, Office of the Actuary, National Health Statistics Group.
  • 11. USA outspent other developed countries in health care
  • 12. Higher Spending Does Not Necessarily Lead to Higher Quality Source: Baicker and Chandra (Health Affairs 2004)
  • 13. Life Expectancy While much higher than developing countries, US life expectancy is lower than most developed countries. 81.5 79.7 79.9 80 79.4 78.5 78.1 77.1 Age 75 70 U.S. U.K. Germany France Canada Italy Japan Source: OECD, 2004 & Health Affairs 2002; 21(4): 99
  • 14. % Finding Difficulty in Receiving Care More than 1 in 4 in the population finds accessing care difficult in the United States. 30 28 % finding it difficult to get care 25 21 20 15 15 15 15 10 5 0 U.S. Canada New Zealand Australia U.K. Commonwealth Fund Survey, 1998
  • 15. Trends in Health Care – Chronic Disease • By 2025, nearly 49% of U.S. population will have one chronic disease • Those with chronic diseases account for 81% of hospital admissions; 91% of all prescriptions filled; and 76% of all physician visits • CDC estimates that chronic disease management represents 75% of all healthcare spending and responsible for 70% of deaths Sources: CDC, fightchronicdisease.org
  • 16. Limitation of Standard Drug Treatment Drugs prescribed for patients are effective in fewer than Reate of Efficacy with Standard Therapy (%) 60% of treated patients 100 90 80 70 60 60 62 60 57 48 50 50 40 30 30 25 20 10 0 e s s ) as s ia i ti es on es a si hr m hm se yp ro si et t th ar di s po lt b st y re ia al rh d 's A eo ep D oi r( er ar st at D ce m ac O um ei an di h he C ar lz A R C The rape utic Are a Source: Brian B. Spear, Margo Heath-Chiozzi, and Jeffrey Huff, “Clinical Application of Pharmacogenetics,” Trends in Molecular Medicine (May 2001).
  • 17. Summary: The need for transformation • Total health care spending was $2.5 trillion in 2008, representing 16% of the GDP, like to reach $4 trillion by 2016 • 75-90% were spent on managing and treating chronic illnesses that are preventable and effectively managed • On a per-person basis, our health care costs are 50% higher than the second most costly nation • USA outspent other developed countries in health care but quality of care does not follow. • The U.S. healthcare ranked by the WHO 37/191 countries in performance • Drugs prescribed for patients are effective in fewer than 60% of treated patients but costs of development is skyrocketed.
  • 18. What Makes Each One of Us Unique and What Defines Health?
  • 19. Patient Phenotype home.honolulu.hawaii.edu/~pine/variation3.jpg
  • 21. The Human Genome Project • A 13-year project coordinated by the U.S. Department of Energy and the NIH • The total number of genes estimated at 30,000 • 99.9% nucleotide bases are exactly the same in all people • Functions unknown for over 50% of discovered genes Source: Human Genome Project Information http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml
  • 22. NY Times Magazine: My Genome, My Self Steven Pinker, Jan 7, 2009
  • 23. Complex Relationships Determine Health and Disease • Complex interactions of genes and proteins explain differences between people • Complex Interactions of proteins in networks and our environment are critical in determining health and disease • What field has tools that we need to understand the organization of these complex interactions?
  • 24. Systems Biology • Emergent field that aims at systems understanding of biological systems. – Systems view focuses at understanding: • The complexity of the system • The networks activated in the system • The control methods of the system www.sysbio.de/figs/sysbio8.gif • Key nodes in the system
  • 25. Systems Biology Opportunity in Clinical Medicine Identify Networks and Key Regulatory Nodes Controlling Networks http://mcdb.colorado.edu/courses/3280/lectures/class16-2.html
  • 27. How Will Personalized Medicine Look in the Future?
  • 28.
  • 29.
  • 30.
  • 31.
  • 32.
  • 33.
  • 34.
  • 35.
  • 37. What Does the COM Contribute to Research at Ohio State?
  • 38.
  • 39.
  • 40. • $34.1 M over 5 years • CTSA is an outcome of the Roadmap for Research from NIH
  • 42. NIH Roadmap for Medical Research New Pathways to Discovery NIH Research Teams Re-engineering the of the Future Clinical Research Enterprise Source: NIH Roadmap Project
  • 43. NIH Roadmap Strategy Interdisciplinary Research Pioneer Award Nanomedicine Training Public Private National Clinical Research Partnerships Associates Bench Bedside Practice Building Blocks Clinical Integrated Research Pathways Research Networks Molecular Libraries Informatics Clinical outcomes Bioinformatics and Translational Computational Research Biology Structural Biology Initiatives Source: NIH Roadmap Project Nanomedicine
  • 44. Molecular Libraries Building Blocks, Re-engineering the and Imaging Biological Pathways Clinical Research and Networks Enterprise Clinical Enterprise Structural Public-Private Biology Partnerships Implementation Groups Bioinformatics and Computational Biology High-risk Research Interdisciplinary Research Nanomedicine New Pathways Research Teams to Discovery Source: NIH Roadmap Project
  • 45. How Has the Stimulus Package Affected Research in the COM and Medical Center?
  • 46. American Recovery and Reinvestment Act 2009
  • 47.
  • 48. ARRA Stimulus Funding Proposal by Type OSUMC As of 6/2/09 $4,949,092 $11,923,253 Challenge Supplement $74,640,044 Aut ism Shared Inst r $63,091,300 APRC * RC2 GO Grant P30 Core Ct r $450,812 Revision $5,734,402 $33,199,437 $2,911,697 Source: COM Office of Total $200M Research
  • 49. How Does Personalized Medicine Align with the Research Mission?
  • 50. Personalized Health Care DISEASE TO WELLNESS Translation Application/ Dissemination Implementation Practice to Experimental Health Care Population Health Therapeutics and Delivery; Health Impact; Social Devices; Preclinical Care Effectiveness Networking Tools to Clinical (T2) (T3) and Solutions (T4) DISCOVERY Systems Biology/Systems Medicine Genomics/Proteomics; Genetics; Informatics; Modeling (T1)
  • 51. BHAG for Personalized Health Care planning at Ohio State • We will develop and execute a demonstration project in personalized health care by 2010 to deliver care in a cost-effective, convenient, high quality and precision-based approach starting with our health plan and create the social epidemic to lead to its acceptance and desirability. • We will develop a personalized health care model that will meet our blue ocean strategy and… – Create Precision Medicine to improve quality – Lower the cost of health care – Increase patient access and customer satisfaction – Move health care from the doctor’s office to the patient’s home on demand
  • 52. Tools
  • 53. Applied Research and Systems Biology • Emergent field that aims at systems understanding of biological systems. – Systems view focuses at understanding: • The complexity of the system • The networks activated in the system • The control methods of the system www.sysbio.de/figs/sysbio8.gif • Key nodes in the system
  • 57. Systems and Process Focus Make your car last 200,000 miles GOOD BETS BAD BETS Honda Civic BMW 7-Series Honda CR-V Infiniti QX56 Honda Element Jaguar S-Type Lexus ES Jaguar X-Type Lexus LS Mercedes-Benz M- Class (V8) Toyota 4Runner Mercedes-Benz SL Toyota Nissan Armada Highlander Toyota Land Nissan Titan Cruiser Toyota Prius Volkswagen Touareg Toyota RAV4 Volvo XC90 (6-cyl.) Decoding the DNA of the Toyota Production System, Harvard Business Review, 1999 October 2007
  • 58.
  • 59. FROM TO *Number of ICU beds is subject to change

Notas do Editor

  1. Predictive:Probabilistic health history--DNA sequenceBiannual multi-parameter blood protein measurementsBiannual blood cell measurements--dynamicIn vivo and single cell molecular imagingPersonalized:Unique individual human genetic variation mandates individual treatmentPatient is his or her own controlPerturb blood cells for dynamic measurementsGo directly to patient and skip doctor--patient will have all medical informationPreventive:Strategies for re-engineering the behavior of disease- perturbed networks with drugsVaccinesFocus on wellnessParticipatoryPatient understands and participates in medical choicesSource: Leroy Hood, presentation at NIH. http://www.itl.nist.gov/Healthcare/conf/presentations/LH%20NIST%209-24-07.pdf.
  2. Source: pollingreport.com. In a variety of national polls, when asked what are important issues facing America today, healthcare ranks as one of top 3 “very important” issues.Source: National Coalition on Health Care (health care spending). Rising cost of coverage, reason for decline in coverage.Source: CDC (chronic disease)<number>
  3. <number>
  4. <number>
  5. <number>
  6. <number>
  7. Closing Slide
  8. SourcePoisal Ja Fau - Truffer, C, S Truffer C Fau - Smith, A Smith S Fau - Sisko et al.: Health spending projections through 2016: modest changes obscure part D's impact. Health Affairs 26, w242-w253 (2007).Tom Daschle: New facts on U.S. health care:U.S. ranks poorly with other wealthy nations http://www.americanprogress.org/issues/2007/11/daschle_health.htmlThe World Health Report 2000. World Health Organization (2000).Brian B. Spear, Margo Heath-Chiozzi, and Jeffrey Huff, “Clinical Application of Pharmacogenetics,” Trends in Molecular Medicine (May 2001).
  9. Personalized health care is enabled by having a lifetime transportable medical record that follows the patient everywhere to ensure they receive the safest and most effective care based on their history.The most personalized medicine will occur when each of us has a transportable version of our fully sequenced genomes available to optimize care for the diseases we are likely to develop – John Halamka, CIO of Harvard Medical SchoolMicrosoft HealthVault vs. Google HealthBoth systems share the same objective of creating an online tool for patients to store personal medical records, get information, find doctors, make medical appointments, communicate online, manage medications, share information with providers and more. Both put users in control over what goes into the record and who has access to it. Both are free Web-based services, meaning you can access the records without cost from any computer. The services are described as being as secure as online banking.
  10. *Number of ICU beds is subject to change