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Jian Wang, PhD
CEO
Next Generation Biobanking
Webinar recording:
https://youtu.be/wvsyL9PUZRg

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Biobanking Used to be Simple…

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HIGH QUALITY
HIGHLY ANNOTATED
CONSENTED
PATIENT LINKED
SAMPLE

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The Critical Biobanking Challenges
Biobanks
Expectation of
driving the
science
Externalization
&
Collaboration
Increased
regulatory
scrutiny

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Data Management
& Exploration
Operational
Biobanking
Virtual
Biobanking;
Clinical Trial
Sample /
Consent
Tracking

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Sponsor
Clinical Trial Sample
/ Consent Tracking
Site
Central Lab
Site
Site
Testing Lab
Testing Lab
StorageTesting Lab

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Site Sponsor
Vendor/ CRO
Sample
Shipment
Consent Deviation /
Sample Destruction
(e.g. patient withdraw)
Sample
Destruction
(patient withdraw
or sponsor policy)
Patient Consent
Trial Setup &
Sample Logistics
Sample Collection
Specification
Sample
Inventory
Consent
Reconciliation
consent
patients &
acquire samples
Sample Tracking Use Case
Sample
Shipment

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Support Virtual Biobank

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Conceptual Framework
Plan
Reality Consent
Analysis request
Destruction workflow
Operational reporting
Sample/consent reconciliation
…

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https://image-store.slidesharecdn.com/2eb15037-d07b-4f31-b93d-043a157b5814-original.jpeg

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Typical Process
• Study Planning
• Patients, visits, consents, …
• Sample collection, routing, …
• Patient Enrollment
• Actual patients
• “Expected” samples for patients
• Patient Consent
• Consent on samples
• Consent reconciliation
• Sample Intake
• Receive samples
• Store samples

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Typical Process
• Sample Reconciliation
• Reconciliation per study plan
• Data harmonization across all players in the ecosystem
• Sample Request
• Request samples for research use
• With proper approval processes
• Request Fulfillment
• Actually fulfill the sample request
• Potentially across multiple facilities
• Sample Destruction
• End of life, Consent withdraw, …

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Example Data Sources
•Study Protocol& Lab Manual: Sample collection/routingplans
•Informed Consent Document: Consent parameters
•IxRS: Subject Info, SID
•EDC: Visit, Subject Consent
•Central Lab (or site): First data on samples, derivative samples,
shipment/receiving,patient info
•Testing lab: derivative samples, shipment/receiving
•Storage: derivative samples, shipment/receiving,future use

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Operational Biobank

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Research BioBank 1B
PathologySample A597
(text-onlylabel)
Sample Inventory & Operations

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Platform Advantage
Operational
• Biobanking workflows
• Access Controls
• Annotations
• More…
Decision Support
• Scientificinsights
• Ad hoc query
• Hypotheses
• Reporting
Uniqueout-of-the boxintegration of the operational with decision
support

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ExplorationAcquisition AnalysisAnalysis
Data Harmonization, Reporting & Exploration

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Qiagram Enables Data Exploration
Data Managers
Query datadirectly
by themselves
Researchers
SELECT DISTINCT PATIENT_ID, SAMPLE_ID,
SAMPLE_NAME
FROM SAMPLE_INVENTORY S
INNER JOIN PATIENTS P ON S.PATIENT_ID = P.PATIENT_ID
INNER JOIN DIAGNOSIS D ON S.PATIENT_ID =
D.PATIENT_ID
INNER JOIN MEDICATIONS M ON S.PATIENT_ID =
M.PATIENT_ID
INNER JOIN BIOMARKERS B ON S.PATIENT_ID =
B.PATIENT_ID
WHERE
D.DIAGNOSIS_NAME = ‘LUNG CANCER’ AND
M.MEDICATION_GENERIC_NAME = ‘CETUXIMAB’ AND
B.BIOMARKER_NAME = ‘EGFR’ AND
B.OBSERVATION = 1
ORDER BY PATIENT_ID, SAMPLE_NAME
Both now speak
the same language

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Clinical Trial Sample Tracking – Can You
Answer These Questions?
Study-specific reports (on-going studies):
1. Planned sample collection report
2. Actual sample collection report
3. Reconciliation of planned vs. actual sample collection
• What samples are missing (or late) for a given visit?
• Which patients have complete set of samples collected for a
given (set of) visits and sample types?
4. Anticipated upcoming sample collections(based on Subject
enrollment and sample collection plan)
5. Sample allowable use (consent) report

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Clinical Trial Sample Tracking – Can You
Answer These Questions?
6. Sample Chain of Custody (CoC) report
• Sample location
• Sample status
• Reconciliation of sample location with routing plan
• Expected vs actual timing of CoC events
7. Study Closeout Report
• Number of samples collected,reconciled: Do we have all the
samples for all the patients in the study?
• Subject participation rate (for optional collections)

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Clinical Trial Sample Tracking – Can You
Answer These Questions?
Cross-Study Reports:
1. Sample collection performance metrics
• By Facility across studies
• By Country
• By Study
• By Therapeutic area
2. Sample expiration report (based on consent and other parameters)

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Example (Mock) Reconciliation Report

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For Further Information
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Contact:
Jian Wang, Ph.D.
CEO
BioFortis, Inc.
10320 Little Patuxent Parkway, Suite 410
Columbia, MD 21044
jwang@biofortis.com