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The Revolution – Personalized Medicine – What It Means for Pathologists and Patients

The Revolution – Personalized Medicine – What It Means for Pathologists and Patients . Mara G. Aspinall CAP 2008 San Diego, California September 2008. Personalized Medicine - The Revolution . What is it? Why now? When will it be real? Call to Action for Pathologists .

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The Revolution – Personalized Medicine – What It Means for Pathologists and Patients

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  1. The Revolution – Personalized Medicine – What It Means for Pathologists and Patients Mara G. Aspinall CAP 2008 San Diego, California September 2008

  2. Personalized Medicine- The Revolution • What is it? • Why now? • When will it be real? • Call to Action for Pathologists

  3. The Personalized Medicine Timeline Fear Value Acceptance

  4. The Personalized Medicine Timeline Fear Pathologists: Reduces My Market - Traditional Tissue analysis will dwindle - Treating Physicians will work around me - New Technology will change the profession - Many Tests will cost my lab a lot of money

  5. Pathologist Fear? New Sample TypesBeyond Tissue • Molecular Blood Tests • Breath Tests • Urine Tests

  6. Pathologist Fear? Disruptive Technology Needed • Currently, 17 % of Burkitt Lymphoma are incorrectly diagnosed as Diffuse Large B Cell Lymphoma Classic Burkitt Lymphoma Atypical Burkitt Lymphoma Diffuse Large B Cell Lymphoma Source: Louis Staudt, MD, PhD. National Cancer Institute

  7. Why Now? Disruptive Technology Needed Patients’ Actual Disease Diagnosis Treatment Classic Burkitt Lymphoma Cure Rate Atypical Burkitt Lymphoma Cure Rate Burkitt Lymphoma Burkitt Lymphoma Intensive Chemotherapy 80 % 60 % Burkitt Lymphoma Diffuse Large B Cell Lymphoma CHOP Regimen 15 % 0 %

  8. Pathologist Fear? New Technology Trumps Morphology Diffuse Large B-cell Lymphoma Burkitt Lymphoma Classic Atypical Louis Staudt, MD, PhD, National Cancer Institute

  9. Pathologist Fear?Molecular Tests are Exploding IVD-MIA Tests 200 200 100 Number 6-10 0 In-Development Today Source: In Development – Coalition for 21st Century Medicine Survey 2007

  10. Call to Action Need to Capture the Future Present Future Morphology Tests Molecular Tests Stable Base of Technology Many New Technologies – including Microarrays Tissue Samples Multiple Sample Types Single Gene Tests Multi Gene / Multi Technology Tests Timeframe Controlled by Pathologist Point of Care Diagnosis Desired (IVD kits more available) Pathologist Initiates & Interprets Diagnosis Molecular Lab Provides Diagnosis directly to Treating Physician

  11. Call to Action Pathologists Need to : - Own Personalized Medicine - Source of expertise on all tests available - Independent of Specimen Type - Interpreter and consolidator of all test results - Educator of all other physicians on diagnosis Pathologists able to move market from Fear to Acceptance

  12. Moving From Fear To Acceptance • Physician Education • Data Ownership • Policy Reform Aspinall and Hamermesh, Harvard Business Review, Oct 2007

  13. Physician Education Lifecycle “Tests are not used appropriately to reach the most precise and relevant diagnosis” “Biomarkers are slowly gaining acceptance in trials, but still the majority of trials look only at final endpoint without meaningful diagnosis data on differential response.”

  14. Percent of Respondents Receiving Training in Genetic Testing During Medical School Practicing Physician Views on Genetic Testing 100 85 77 80 71 “I feel comfortable with my 18 % knowledge of available genetic tests” “I have a standard for deciding 28 % when patients need to be informed about the option of genetic testing” 60 38 40 20 0 1990-1999 1980-1989 1970-1979 1940-1969 Year of Graduation Tremendous Educational Needs Laurie Demmer MD, et al.,University Of Massachusetts Medical School, Department of Pediatrics and Office of Ethics

  15. Move From Fear to Acceptance • Physician Education – PATHOLOGIST LEAD • Pathologist as “Go To” person for all test information • Pathologist publishing more PM practice guidelines – tests and technologies • Engage formal medical education process from school to fellowship to focus on the importance of diagnosis

  16. Move From Fear to Acceptance • Data Ownership – PATHOLOGIST LEAD • Pathologist designing and publishing more clinical trials on appropriate use of Personalized Medicine and all diagnostics • Pathologist leading in the build of the Electronic Medical Record • Pathologists embrace new technologies

  17. Move From Fear to Acceptance • Policies Needed – PATHOLOGIST LEAD • Reform Reimbursement - based on value rather than activity • Create regulatory options that encourage diagnostic and drug combinations

  18. Call to Action • Opportunities… • Expand scope of practice • Increase impact on patient treatment • Institutional Knowledge Coordinator • Results … • Leadership in Personalized Medicine • - It is here to stay • Embrace the Era of Diagnostics • - Best way to improve patient outcomes

  19. Acknowledgements • Genzyme • Personalized Medicine Coalition • David Turnquist and Boston College

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