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Seven Steps to the Sample Life: Best Practices for Clinical Trial Sample Data Management
Mark A Collins, Ph.DDirector of Marketing
Molecular Medicine Triconference Feb 10-12, San Francisco
Booth #413
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WHY?
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“Companies that have access to millions of highly annotated biospecimens with clear consent, traceability and tools to rapidly mine for desired profiles will have an edge in biomarker-based discovery, segmenting patients for clinical trials and developing companion diagnostic /theranostic applications”
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How do we get there?
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Thousands of trials
Tens of Thousands of patients
Millions of samples
Millions of data points (and growing)
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Increasing externalization
Global trials
Complex consent landscape
Large amounts of complex data
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Traditional sample management operations
consents
externalization
clinical
molecular
science
future use
regulatory
Virtual biobanks
knowledgebase
Next generation sample management[where the industry is heading)
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Dr Steven Bova, MD.Johns Hopkins
Revolutionizing the understanding of prostate cancer to guide personalized therapy
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• 30,000 samples• 150,000 pathology slides• 1000’s of genes• 100’s patient visits • 33 patients• 14 years
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One system for sample and sample data management
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Biobanking for the personalized medicine era
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The Next Generation Biobanking informatics platform
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Living the 7-Steps(getting with the program).
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1 Understand the whole (data) picture
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Collect and Harmonize Data.
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• 1000’s of trials• 1000’s of subjects• 100’s of trial sites• Millions of samples• Billions of data points
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Does sample data management feel like this..
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Multiple, disparate data sources
SEP
22
Need to harmonize and aggregate the data & provide access
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Harmonization of disparate data
A hub of harmonized information linking patient, specimen, consent, clinical and molecular data
SEP
22
Powered by
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Overcome Information bottlenecks
Right data, Right People, Right Time
Powered by
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2 Know that “no” really means no
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Comprehensive Consent Tracking.
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Real time dashboards of consent information
Powered by
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3 Knowledge is Power
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Specimen “immortality”.
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Generating Scientific Insights
Knowledgebase of harmonized information
Clear consent
Powerful, ad hoc query tools
Generate scientific insights
Powered by
Long after the specimen is exhausted we can still mine the data
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Can you easily ask your biobank?
Patient Profile
DCIS
T size>1cm, ER+, HER2/neu+, Node negative
Radiation therapy
BRCA1 mutation 185delAG
HOXB7 gene overexpression
Tissue banked for immunohistochemistry?
What is the incidence of breast cancer recurrence in patients with the following profile?
Type of Data
Clinical
Genotype
Gene Expression
Sample Management
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Patient Profile
DCIS
T size>1cm, ER+, HER2/neu+, Node negative
Radiation therapy
BRCA1 mutation 185delAG
HOXB7 gene overexpression
Tissue banked for immunohistochemistry?
Scientific Insights
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4 Network, Network, Network
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Support the Distributed Research & Trial Ecosystem.
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Unlike Dr. No – we don’t do research on an isolated island anymore…
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Support for externalization
Labmatrix offers, secure access & role based security to ensure all collaborators have appropriate access
Powered by
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5 Trust but verify
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Ensure compliance with robust chain-of-custody and audit trails.
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Enhanced Security & Compliance
360o consent tracking, chain of custody and audit trials
Powered by
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6 Do Sweat the small things
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Day-to-day operational management.
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Operational Workflows
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Operational Workflows
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Operational Workflows
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Operational Workflows
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7 Reduce Waste
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Track site collection rates.
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Reconciliation
Design
Expectation Reality
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Operational Tracking
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Operational Tracking
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Labmatrix 7 Steps Scorecard• Reduction in time to release samples – days to
hours• Improved compliance• >40% reduction in costs from sample over-
collection• >30% reduction in costs for sample
procurement• Improved ability to respond to unplanned events
in-trial• Greater confidence in data• Holistic view of the trial – “sample EDC”• Scientific insights & hypothes generation
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THANKYOU.
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