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Incorporating Personalized Medicine in Community Hospital Systems ��� Catholic Health Initiatives’���Center for Translational Research July 17, 2013
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CHI: 5th Largest Hospital Network in US
Strength in Numbers § 5th largest US network § 86 acute care hospitals in 18 states § 40 LTC facilities § 85,000 employees § 2,900 physicians and midlevel providers § Diverse markets with 90% ranked #1 or #2 § $15B in assets, $12B in annual revenue § FY 2012 – provided $715M+ in charity care
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Personalized Medicine
§ What is it? § Personalized medicine is the use of new
methods of molecular analysis to better manage a patient’s disease or predisposition toward a disease… approaches may include genetic screening programs that more precisely diagnose diseases and their sub-types, or help physicians select the type and dose of medication best suited to a certain group of patients. – Personalized Medicine Coalition
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CHI Institute for Research & Innovation
Center for Clinical Trials -‐ Clinical Trial recruitment and
management across CHI
Center for Healthcare Innova4on (CHCI)
-‐ Next Gen healthcare delivery
-‐ Mul<-‐center Bio-‐Repository for specimen collec<on across CHI network -‐ CLIA cer<fied laboratory for personalized medicine -‐ Research Laboratory for IP genera<on
Center for Transla4onal Research (CTR)
Biosta<s<cs/Data Analy<cs -‐ Electronic Medical Record links
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Bio-Repository Network
§ Responsible for scientific oversight of collection process and storage, project specifications
§ Installation of full time employee at individual sites across the CHI
§ Responsible for patient recruitment and sample processing/storage
§ Uniform collection procedures § Regulatory Guidance - WIRB protocol approval § Dedicated staff to facilitate sample collection, storage
and shipment § Annotated biospecimens with clinical and
longitudinal data (up to 10 years) § Single software solution for:
q Chain of custody tracking from consent to storage
q Data capture from downstream molecular analyses
q Querying capabilities to define cohorts
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Best Practices: Biospecimen Collection Overview
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Cloud-based Informatics: Network Strength
Data Warehouse
CCR CTR
Research Data
Analysis
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Physician Engagement
§ CHI is a community based hospital system § Physician engagement includes:
q education of local physicians in bio molecular assays, including next generation sequencing
q Partnership to investigate clinically relevant questions from inside the CHI system
q Proposed projects for grant/venture capital funding through a variety of mechanisms
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CHI Discovery Research Network
CTR working with Physicians in their communities § Hypothesis-driven
Research § Research Partnering § Education
Discovery Research Network
Biospecimen Procurement
Program Infrastructure
Support
IP Genera<on
Hypothesis Development
Transla<onal Research Laboratory
Specimen and
Data Access
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Next Generation Sequencing (NGS)
§ Current generation of technology allows for sequencing of the whole genome of a patient, or a patient tumor sample
§ Derived from technology used to do the first human genome sequencing project
§ That project took years, and millions of dollars § Current turn around time is 6 to 8 weeks for an
entire genome to be sequenced, turn around times continue to decrease as do costs
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Data Tsunami
§ Data storage and subsequent analysis is rapidly becoming a bottleneck for most NGS labs
§ Single gene sequencing produces files of 10’s to 100 KB in size
§ Exome sequencing produces ~10 GB file size per run
§ Full genome sequencing produces file sizes on the order of ~100 GB
§ Accompanying data analysis is time consuming and requires specialized training and software
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Personalized Report
§ Personalized report generated from the exome sequencing of our patient
§ Can be tailored to individual physician preferences
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Clinical Trial #1 Eligibility
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Patients Like Me
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Challenges for NGS
§ Input requirements can be difficult to meet with FFPE, especially FNA
§ Physicians leery of what information they will get, quantity of information a problem
§ Clear, concise physician reports required § Current turn around times too long for full
exome sequencing, better for targeted
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Opportunities for NGS
§ True implementation of personalized treatment based on biology not phenotype or even histology
§ Preservation of precious tissue by integrating multiple tests into one assay
§ Longitudinal examination of a patients primary, recurrence and resistant disease
§ Becoming more necessary with additional targeted therapies and clinical trials
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Therapies targeting the EGFR pathway
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EGFR = Epidermal Growth Factor Receptor
Selected QIAGEN partners:
therascreen KRAS test
BKM120
Afatinib
Zelboraf
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Patient Testing
§ First available test at CTR, for KRAS, codon 12,13,61 § Reporting clinical outcome for the use of EGFR
inhibitors (panitumumab, cetuximab) § Predominantly used for colorectal cancers as per
guidelines (National Comprehensive Cancer Network) § 30-35% of patients have KRAS mutation, predictive for
lack of response to EGFR targeting § Cost of EGFR targeting: $30,000 for 8 weeks treatment § FFPE samples, typically from FNA § We also see lung cancer and metastatic samples
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Thank you.