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
Overall Goals Improve outcomes –Disease care –Health care Reduce costs
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
How? Because Health-care trumps Disease-care –Create a healthier population –Shift more responsibility for care to the individual –Reduce overall healthcare costs?
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
As the train is leaving the station… Does California Government have a role In the Personalized Health Rush?
If so, what? What priorities? How to create a recommended plan?
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
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
CCST proposal to BTH –Create 3 pH Task Forces Macroeconomics Regulatory HIT How to create a plan?
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
Health Information Technology Examine infrastructure goals in pH context Make recommendations (PSAB) to enable –Validating biomarkers –Tracking individual information & materials –Archiving and sharing
Task Force Leaders Macroeconomics: Richard Levy Regulation: William D. Young –Kathy Hibbs HIT: Ramesh Rao