Download PGRx: An Interactive Software System for Integrating Clinical

PGRx: An Interactive Software System for
Integrating Clinical Genotyping with Prescription
Drug Safety Assurance.
Michael D. Kane, Ph.D.
Assistant Professor of Computer and Information Technology
Lead Genomic Scientist, Bindley Bioscience Center
Purdue University
Experience: Preclinical R&D Pharmaceutical Industry,
VP of R&D in Genomics-Biotechnology Industry.
Expertise: Genomics Technology, Bioinformatics, Pharmacology.
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Emerging Landscape of Clinical Genotyping
Enabling Opportunities
Human Genome is Complete
Genotyping Technologies are “Everywhere”
Confirmed Links between Allelic Variants and Clinical Outcomes is Growing
Hindrances to Implementation
Consumers have Reservations About the Use of Their DNA
Limited knowledge about Genomics in Healthcare Professional Practices
Cost-Benefit for Disease Prognostics is Uncertain
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Costs of Adverse Drug Responses (ADR)
 According to a survey published in the Journal of American
Pharmacists Association in 2001, the cost of drug-related mortality
and morbidity in the US was estimated at over $175 billion in 2000.
 ADRs represents approximately 10% of all health care costs in the
US.
 It is estimated that adverse drug reactions are the cause of over
200,000 deaths each year and is among the top 10 causes of
death in the US.
 McKesson is the world’s largest distributor of drugs and the largest
healthcare software and IT company, a Fortune 18 company with $93
billion in revenues in 2007.
THIS IS WHERE THE OPPORTUNITIES EXIST TO INTEGRATE
CLINICAL GENOTYPING WITHIN HEALTHCARE
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What does the PGRx System Do?
Utilizes patient-specific genotyping to predict and prevent
adverse drug responses.
Supports the prescription drug process from physician to
pharmacist to consumer.
The system behaves similar to a “Drug-drug interaction”
system, but can be described as a “Gene-drug interaction”
system with detailed training components.
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Why Pharmacy & Drug Safety?
•
Based on Known Monogenic Traits
– Phase-1 oxidative enzymes with known SNPs
– Characterization of In vitro (& In vivo?) effects of
SNPs is relatively simple
•
Immediate Impact on Point-of-Care Therapeutics
– Response to SNP data is easily “translated” to
patient drug choice and dosing options
– Addresses adverse idiopathic drug responses
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Why Pharmacy & Drug Safety?
• Relatively Limited Ethical and Information Security
Concerns
– Knowledge of a patient's predisposition to altered
drug clearance is a financial benefit to consumer,
HMO, pharma, etc.
– Patient-specific CYP-SNP data is amenable to “low
security” web-based access supporting “travel
incident” justification.
• Utilizes Established Information Management Logistics
– “Drug-Drug” interactions management augmented
with “Gene-Drug” interaction risk.
- New Warfarin Label includes SNP-Clearance Data
(8/16/07)
– Roche (Affymetrix) AmpliChip for 2D6 genotyping
(12/23/04) approved by FDA
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PGRx is both Operational and Educational
• The software system integrates patient-specific
genotypic and physiological information to predict the
risk of ADRs.
• ADRs include:
– Inadvertent overdosing due to poor metabolism.
– Inadvertent under-dosing due to increased metab.
– Inadvertent under-dosing due to decreased pro-drug
bioactivation due to poor metab.
• The software includes a “mock” patient population that
represents all clinically relevant genetic alleles relevant
to drug metabolism.
• The software includes all FDA approved drugs and
formulations.
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PGRx is both Operational and Educational
(continued)
• The software system includes detailed training components about
each allelic variant (specific DNA changes, effects on
protein/enzyme, etc.)
• The software system includes the ability to alter physiological
variables in the “mock” population to allow the user to better
understand the relationship between a patients physical status
relevant to drug clearance variables (age, weight, volume of
distribution, etc.) with allelic variations and ADR risk.
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Implementation & Users
The practicing pharmacist will likely be
the first operational and educational
user of the PGRx system, followed by
physicians.
The value proposition for the PGRx
system lies in partnerships with
established healthcare software
companies, particularly those who
support prescription drug dispensing.
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CONTACT INFO:
Michael D. Kane, Ph.D.
Department of Computer and Information Technology,
Lead Genomic Scientist, Bindley Bioscience Center,
Purdue University,
West Lafayette, IN 47907-2021
(765) 494-2564
[email protected]
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