Personalized Medicine: Current and Future Perspectives Personalized Medicine: Current and Future Perspectives

Personalized Medicine: Current and Future Perspectives Patricia Deverka, MD, MBe Duke University, Institute for Genome Sciences and Policy Rick J. Carlson, JD University of Washington

Background ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Personalized Medicine ,[object Object],[object Object],[object Object],[object Object],[object Object]

What Is It? ,[object Object],[object Object],[object Object],*Kathyrn Phillips, UCSF

Personalized Medicine: Vision vs. Reality ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Tools Needed for Prediction and Personalized Care Disease Burden Time Cost 1/reversibility Decision Support Tools: Baseline Risk Preclinical Progression Disease Initiation and Progression Assess Risk Refine Assessment Predict/Diagnose Monitor Progression Predict Events Inform Therapeutics Sources of New Biomarkers: Stable Genomics: Single Nucleotide Polymorphisms (SNPs) Haplotype Mapping Gene Sequencing Dynamic Genomics: Gene Expression Proteomics Metabolomics Molecular Imaging Therapeutic Decision Support Typical Current Intervention Earliest Clinical Detection Earliest Molecular Detection Initiating Events Baseline Risk

Prospective Health Care Risk Assessment and Decision Support Tools Personal Lifestyle Plan Disease Management Risk Modification Disease Burden Time Low Risk High Risk Early Chronic Cost 1/reversibility Personalized Health Plan Late Chronic Participating Population

What are some examples? Dosing of warfarin VKOR/CYP2C9 Guide prescribing/ adjust dose of ~25% of commonly used drugs CYP2D6/CYP2D19 Avoid use of chemotherapy in breast CA patients with low risk of recurrence Transcriptional profile – 21 genes Breast and ovarian cancer inherited risk, prophylactic tamoxifen and surgery BRCA1/2 Select Herceptin (trastuzumab) for breast cancer Her-2/neu receptor Application Biomarker

The Leading Edge: Pharmacogenomics (PGx ) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Key distinctions between PGx testing and traditional genetic testing ,[object Object],[object Object],[object Object],[object Object],[object Object]

Private Payers ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Payer perspective: what will be the impact of pharmacogenomics on total healthcare costs? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Providers, Physicians ,[object Object],[object Object],[object Object],[object Object]

Developers of Bio-Pharmaceutical Products and Services ,[object Object],[object Object],[object Object],[object Object]

Government ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Consumers ,[object Object],[object Object],[object Object],[object Object],[object Object]

Emerging ethical, legal, policy ( ELP) issues

ELP concerns in clinical research ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

PGx research requires creation of biorepositories linking genotypic and phenotypic information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

ELP issues in clinical practice ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Rapid and unmanaged introduction of genetic tests into marketplace ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

When might direct consumer access to PGx testing be permissible? ,[object Object],[object Object],[object Object],[object Object],[object Object]

What Are the Major Policy Issues? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

What Does it Mean for You? ,[object Object],[object Object],[object Object]

PM requires coordination across multiple stakeholders Producers Consumers PGX Diagnostic Companies Government & Universities Biopharmaceutical Co’s Genetics Companies (data miners, technology co’s, etc. Patients and HC consumers Healthcare Professionals Managed Care Payers Ethicists, Legislators

Personalized Medicine: Current and Future Perspectives Personalized Medicine: Current and Future Perspectives

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Personalized Medicine: Current and Future Perspectives Personalized Medicine: Current and Future Perspectives