PERSONALIZED MEDICINE

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PERSONALIZED MEDICINE
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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

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Overall Goals

• Improve outcomes
• Disease care
• Health care
• Reduce costs

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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

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How?

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

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personalized MEDICINE
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pH
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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

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

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

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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

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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

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How to create a plan?

• CCST proposal to BTH
• Create 3 pH Task Forces
• Macroeconomics
• Regulatory
• HIT

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Macroeconomics

• Propose pilot studies to determine
• Economic impact on healthcare in California
• Retrospective
• Prospective
• Opportunities for largest savings

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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

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Health Information Technology

• Examine infrastructure goals in pH context
• Make recommendations (PSAB) to enable
• Validating biomarkers
• Tracking individual information materials
• Archiving and sharing

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Task Force Leaders

• Macroeconomics Richard Levy
• Regulation William D. Young
• Kathy Hibbs
• HIT Ramesh Rao

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Next Step?

• Complete the Funding

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-Steven E. Brenner