1. PERSONALIZED MEDICINE

2. What is Personalized Medicine? Information-based healthcare –Person-by-person: high content, resolution & fidelity –Ushered in by the sequencing of human genomes –Enhanced by new biological knowledge –Right drug, right patient, right dose, right time –But NOT limited to management of therapy

3. Overall Goals Improve outcomes –Disease care –Health care Reduce costs

4. How? Disease care –Target medicines precisely (pharmacogenomics) –Administer medicines safely (toxicogenomics) Health care –Predict disease susceptibility Prevent disease –Detect early onset of disease Preempt disease progression

5. How? Because Health-care trumps Disease-care –Create a healthier population –Shift more responsibility for care to the individual –Reduce overall healthcare costs?

6. personalized MEDICINE HEALTH

7. pH

8. What are potential disadvantages? Greater costs of diagnostics/biomarkers Smaller patient markets for therapeutics Need to track individual health information Necessity for accelerated HIT Diagnoses without treatments Re-education of healthcare professionals Distraction from other $ saving opportunities

9. As the train is leaving the station… Does California Government have a role In the Personalized Health Rush?

10. If so, what? What priorities? How to create a recommended plan?

11. If so, what? Support economic development of industries –Fierce competition from other states Engender public trust Promote thoughtful policy and legislation –Avoid duplicative & restrictive regulation Promote HIT and data sharing Encourage continued innovation Foster education & training

12. What priorities? Economics & reimbursement –Short-term vs. long-term perspective –Micro-economics vs. macro-economics Regulation & Policy development –Privacy & Non-discrimination –Redundancies & confusions –Unintended consequences Health Information Technology –Encouraging innovation –Educating & training –Integration and implementation

13. CCST proposal to BTH –Create 3 pH Task Forces Macroeconomics Regulatory HIT How to create a plan?

15. Macroeconomics Propose pilot studies to determine –Economic impact on healthcare in California Retrospective Prospective –Opportunities for largest savings

17. Regulation Propose guiding principles –Consistency & clarity of Federal vs. State laws –Rational adjudication Recommend specific regulatory modifications –Enable tracking individual outcomes –Promote disease prevention –Mitigate impediments to innovation

18. Health Information Technology Examine infrastructure goals in pH context Make recommendations (PSAB) to enable –Validating biomarkers –Tracking individual information & materials –Archiving and sharing

19. Task Force Leaders Macroeconomics: Richard Levy Regulation: William D. Young –Kathy Hibbs HIT: Ramesh Rao

20. Next Step? Complete the Funding

21. - Steven E. Brenner