Gene Express Jaima Presentation September 04, 2008 Chiba


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Presentation at Japan Analytical Instruments Association conference, Chiba, 10/2008

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Gene Express Jaima Presentation September 04, 2008 Chiba

  1. 1. Molecular Diagnostics and Personalized Medicine: Challenges and Opportunities David S. Lester, Ph.D. Executive VP, Corporate Development
  2. 2. Wikipedia Definition “ Personalized medicine is the concept that information about an patient's genotype or gene expression profile could be used to tailor medical care to an individual's needs. Such information could be used to help stratify disease status, select between different medications and/or tailor their dosage, provide a specific therapy for an individual's disease, or initiate a preventative measure that is particularly suited to that patient at the time of administration.”
  3. 3. The Two Components of Personalized Medicine Pharmaceuticals + Molecular Diagnostics = Personalized Medicine
  4. 4. Existing Business Models <ul><li>Pharma: High Volume + High Margins (due to high attrition rate and high cost of development). </li></ul><ul><li>MDx: High Volume + Low Margins (relative low cost of development and relatively low attrition) </li></ul>
  5. 5. The Discovery to Delivery Chain for Diagnostics; Gene Express, Inc. Discovery CLIA assay Standardization & Validation Commercialization Delivery/ Clinical Practice + $50B Market Academic Labs Technology Platforms (ABI, Beckmann, Ventana, Agilent, etc.) Monogram, Roche Genomic Health, Navigenics Roche, Abbott, Siemens, Philips, etc. LabCorp, Quest CROs SUPPLY DELIVERY
  6. 6. Speed to Market vs. traditional IP approach <ul><li>Traditional IP approach – results in companies that have single test, “one trick ponies”. Very high risk. </li></ul><ul><li>Speed to Market approach – biomedical imaging approach. Closer to the software model. </li></ul>
  7. 7. Examples of challenges in the present system <ul><li>Standardization – bcr-abl CML as an example </li></ul>
  8. 8. bcr-abl in clinical practice <ul><li>Three phases : </li></ul><ul><li>Chronic lasts 3-5 years </li></ul><ul><li>Accelerated 4-6 months </li></ul><ul><li>Blast crisis 2-3 months </li></ul><ul><li>5,000 new cases a year </li></ul><ul><li>20% of leukemias </li></ul><ul><li>IRIS trial (2003) indicated that treatment with imatinib could reduce BCR-ABL gene transcripts by 3 logs and this was associated with a significant inhibition of disease progression </li></ul>
  9. 9. bcr-abl Molecular Assay Defined by initial creation of translocation between Chromosomes 9 and 22 BCR-ABL Fusion Gene is necessary and sufficient to cause CML Mughal and Goldman 2006 Deininger et al. Blood 96:3343 2000
  10. 10. bcr-abl Molecular Assay <ul><li>1993 - competitive PCR </li></ul><ul><li>2000 - RQ-PCR </li></ul><ul><li>2005 - clear need for standardization - Bethesda Conference </li></ul><ul><li>2005 to present - continuing efforts to improve the quantitative RT-PCR assay, IS committee </li></ul><ul><li>In response to the IRIS trial and success of Imatinib: </li></ul><ul><li>Problem in US: </li></ul><ul><li>- 156 Labs </li></ul><ul><li>- 41 different methods </li></ul><ul><li>- 6 different control genes </li></ul><ul><li>- No harmonization of results </li></ul>
  11. 11. Conclusions of AMP Survey to 39 laboratories “ Our study emphasizes the need for optimization of real time qRT-PCR before offering clinical testing and the need for widely available standards that can be used for calibration.” Zhang et al. J. Mol Diagn. 9:421,2007
  12. 12. <ul><li>Impact for MDx – allows development of kits and propagation of glucose strip diagnostic model. This means high volume and rapid global deployment. </li></ul><ul><li>Impact for Pharma – allows launch strategy, globalization, of drug with a highly reproducible diagnostic assay. </li></ul>Impacts of Standardization of Assays
  13. 13. Examples of challenges in the present system 2. The question of reimbursement
  14. 14. Examples of challenges in the present system 2. The question of reimbursement Adapted from presentation by Bruce Quinn Senior Health Policy Analyst, Foley Hoag LLP
  15. 15. The Realities of Reimbursement - Medicare
  16. 16. Examples of Cost of Development of an MDx
  17. 17. You get what you pay for!
  18. 18. Some suggested changes – must come through govt. reforms
  19. 19. Conclusions
  20. 20. Thank You! David Lester, Executive VP [email_address]