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Wang Webinar Nov 2015 - LinkedIn

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Wang Webinar Nov 2015 - LinkedIn

  1. 1. Copyright © 2015 Jian Wang, PhD CEO Next Generation Biobanking Webinar recording: https://youtu.be/wvsyL9PUZRg
  2. 2. Copyright © 2015
  3. 3. Copyright © 2015 Biobanking Used to be Simple…
  4. 4. Copyright © 2015
  5. 5. Copyright © 2015 HIGH QUALITY HIGHLY ANNOTATED CONSENTED PATIENT LINKED SAMPLE
  6. 6. Copyright © 2015 The Critical Biobanking Challenges Biobanks Expectation of driving the science Externalization & Collaboration Increased regulatory scrutiny
  7. 7. Copyright © 2015 Data Management & Exploration Operational Biobanking Virtual Biobanking; Clinical Trial Sample / Consent Tracking
  8. 8. Copyright © 2015 Sponsor Clinical Trial Sample / Consent Tracking Site Central Lab Site Site Testing Lab Testing Lab StorageTesting Lab
  9. 9. Copyright © 2015 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
  10. 10. Copyright © 2015 Support Virtual Biobank
  11. 11. Copyright © 2015 Conceptual Framework Plan Reality Consent Analysis request Destruction workflow Operational reporting Sample/consent reconciliation …
  12. 12. Copyright © 2015 https://image-store.slidesharecdn.com/2eb15037-d07b-4f31-b93d-043a157b5814-original.jpeg
  13. 13. Copyright © 2015 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
  14. 14. Copyright © 2015 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, …
  15. 15. Copyright © 2015 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
  16. 16. Copyright © 2015 Operational Biobank
  17. 17. Copyright © 2015 Research BioBank 1B PathologySample A597 (text-onlylabel) Sample Inventory & Operations
  18. 18. Copyright © 2015 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
  19. 19. Copyright © 2015 ExplorationAcquisition AnalysisAnalysis Data Harmonization, Reporting & Exploration
  20. 20. Copyright © 2015 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
  21. 21. Copyright © 2015 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
  22. 22. Copyright © 2015 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)
  23. 23. Copyright © 2015 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)
  24. 24. Copyright © 2015 Example (Mock) Reconciliation Report
  25. 25. Copyright © 2015 For Further Information 25 Contact: Jian Wang, Ph.D. CEO BioFortis, Inc. 10320 Little Patuxent Parkway, Suite 410 Columbia, MD 21044 jwang@biofortis.com

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