Cardiac Output, Venous Return, and Their Regulation
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2013-07-17: Incorporating Personalized Medicine in Community Hospital Systems
1. Incorporating Personalized Medicine in
Community Hospital Systems
Catholic Health Initiativesā
Center for Translational Research
July 17, 2013
2. CHI: 5th Largest Hospital Network in US
Strength in Numbers
Ā§ļ§āÆ 5th largest US network
Ā§ļ§āÆ 86 acute care hospitals in 18 states
Ā§ļ§āÆ 40 LTC facilities
Ā§ļ§āÆ 85,000 employees
Ā§ļ§āÆ 2,900 physicians and midlevel providers
Ā§ļ§āÆ Diverse markets with 90% ranked #1 or #2
Ā§ļ§āÆ $15B in assets, $12B in annual revenue
Ā§ļ§āÆ FY 2012 ā provided $715M+ in charity care
3. Personalized Medicine
Ā§ļ§āÆ What is it?
Ā§ļ§āÆ Personalized medicine is the use of new
methods of molecular analysis to better
manage a patientās disease or predisposition
toward a diseaseā¦ 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. ā Personalized Medicine Coalition
4. CHI Institute for Research
Innovation
Center
Ā for
Ā Clinical
Ā Trials
Ā
-Āā
Ā Clinical
Ā Trial
Ā recruitment
Ā and
Ā
management
Ā across
Ā CHI
Ā
Center
Ā for
Ā Healthcare
Ā
Innova4on
Ā
Ā
(CHCI)
Ā
-Āā
Ā Next
Ā Gen
Ā healthcare
Ā delivery
Ā
-ĀāāÆMul-Āācenter
Ā Bio-ĀāRepository
Ā for
Ā specimen
Ā collecon
Ā across
Ā CHI
Ā network
Ā
-ĀāāÆCLIA
Ā cerļ¬ed
Ā laboratory
Ā for
Ā personalized
Ā medicine
Ā
-ĀāāÆResearch
Ā Laboratory
Ā for
Ā IP
Ā generaon
Ā
Center
Ā for
Ā
Transla4onal
Ā
Research
Ā (CTR)
Ā
Biostascs/Data
Ā Analycs
Ā
-Āā
Ā Electronic
Ā Medical
Ā Record
Ā links
Ā
5. Bio-Repository Network
Ā§ļ§āÆ Responsible for scientiļ¬c oversight of collection process and storage, project
speciļ¬cations
Ā§ļ§āÆ Installation of full time employee at individual sites
across the CHI
Ā§ļ§āÆ Responsible for patient recruitment and sample
processing/storage
Ā§ļ§āÆ Uniform collection procedures
Ā§ļ§āÆ Regulatory Guidance - WIRB protocol approval
Ā§ļ§āÆ Dedicated staff to facilitate sample collection, storage
and shipment
Ā§ļ§āÆ Annotated biospecimens with clinical and
longitudinal data (up to 10 years)
Ā§ļ§āÆ Single software solution for:
qļ±āÆ Chain of custody tracking from consent to
storage
qļ±āÆ Data capture from downstream molecular
analyses
qļ±āÆ Querying capabilities to define cohorts
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8. Physician Engagement
Ā§ļ§āÆ CHI is a community based hospital system
Ā§ļ§āÆ Physician engagement includes:
qļ±āÆ education of local physicians in bio molecular
assays, including next generation sequencing
qļ±āÆ Partnership to investigate clinically relevant
questions from inside the CHI system
qļ±āÆ Proposed projects for grant/venture capital
funding through a variety of mechanisms
9. CHI Discovery Research Network
CTR working with
Physicians in their
communities
Ā§ļ§āÆ Hypothesis-driven
Research
Ā§ļ§āÆ Research Partnering
Ā§ļ§āÆ Education
Discovery
Ā
Research
Ā
Network
Ā
Biospecimen
Ā
Procurement
Ā
Program
Ā
Infrastructure
Ā
Support
Ā
IP
Ā Generaon
Ā
Hypothesis
Ā
Development
Ā
Ā
Translaonal
Ā
Ā
Research
Ā
Ā
Laboratory
Ā
Specimen
Ā
and
Ā
Data
Ā Access
Ā
10. Next Generation Sequencing (NGS)
Ā§ļ§āÆ Current generation of technology allows for
sequencing of the whole genome of a patient,
or a patient tumor sample
Ā§ļ§āÆ Derived from technology used to do the ļ¬rst
human genome sequencing project
Ā§ļ§āÆ That project took years, and millions of dollars
Ā§ļ§āÆ 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
11. Data Tsunami
Ā§ļ§āÆ Data storage and subsequent analysis is rapidly
becoming a bottleneck for most NGS labs
Ā§ļ§āÆ Single gene sequencing produces ļ¬les of 10ās
to 100 KB in size
Ā§ļ§āÆ Exome sequencing produces ~10 GB ļ¬le size
per run
Ā§ļ§āÆ Full genome sequencing produces ļ¬le sizes on
the order of ~100 GB
Ā§ļ§āÆ Accompanying data analysis is time
consuming and requires specialized training
and software
15. Challenges for NGS
Ā§ļ§āÆ Input requirements can be difļ¬cult to meet
with FFPE, especially FNA
Ā§ļ§āÆ Physicians leery of what information they
will get, quantity of information a problem
Ā§ļ§āÆ Clear, concise physician reports required
Ā§ļ§āÆ Current turn around times too long for full
exome sequencing, better for targeted
16. Opportunities for NGS
Ā§ļ§āÆ True implementation of personalized
treatment based on biology not phenotype
or even histology
Ā§ļ§āÆ Preservation of precious tissue by
integrating multiple tests into one assay
Ā§ļ§āÆ Longitudinal examination of a patients
primary, recurrence and resistant disease
Ā§ļ§āÆ Becoming more necessary with additional
targeted therapies and clinical trials
18. Patient Testing
Ā§ļ§āÆ First available test at CTR, for KRAS, codon 12,13,61
Ā§ļ§āÆ Reporting clinical outcome for the use of EGFR
inhibitors (panitumumab, cetuximab)
Ā§ļ§āÆ Predominantly used for colorectal cancers as per
guidelines (National Comprehensive Cancer Network)
Ā§ļ§āÆ 30-35% of patients have KRAS mutation, predictive for
lack of response to EGFR targeting
Ā§ļ§āÆ Cost of EGFR targeting: $30,000 for 8 weeks treatment
Ā§ļ§āÆ FFPE samples, typically from FNA
Ā§ļ§āÆ We also see lung cancer and metastatic samples