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March 2009 DIA Janus Update
 

March 2009 DIA Janus Update

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Update on FDA\'s Janus Initiative, presented at the March 2009 DIA Meeting in Philadelphia

Update on FDA\'s Janus Initiative, presented at the March 2009 DIA Meeting in Philadelphia

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    March 2009 DIA Janus Update March 2009 DIA Janus Update Presentation Transcript

    • Janus Update Armando Oliva, M.D. Deputy Director for Bioinformatics Office of Critical Path Programs armando.oliva@fda.hhs.gov March 10, 2009
    • The views expressed in this presentation are those of the speaker and not necessarily those of the Food and Drug Administration …
    • What is Janus? • FDA’s Enterprise Program to improve management of structured scientific data – Clinical study data – Nonclinical study data – Pharmacogenomic (and other –omic) data – Product quality and manufacturing data – Post-market surveillance data
    • What will Janus do? • Implementing data standards - Move towards a single information model: the HL7 Reference Information Model (RIM) • Improving access: multiple interoperable data warehouses • Support and improve analytic tools
    • Janus Activity - Governance • Sept. 2008: – Janus approved by Bioinformatics Board as Agency- wide initiative – Previously Center-specific activities • Uncoordinated • Under-resourced • January 2009: – FDA Management Council approved Janus funding from FY08 supplemental appropriations
    • Janus Architecture Exchange Layer HL7 Messages (XML) RIM Database Source Layer (Data Warehouse) Janus Database SPL Database Database Layer (Materialized Views) (Materialized view) (Materialized view) Views) Data Mart & CDISC SDTM CDISC SEND CDISC ADaM FAERS Databases Special Purpose (Materialized Views) (Analysis Views) (Materialized Views) (Analysis Views) (Materialized Views) (Analysis Views) (Materialized Views) (Analysis Views) Layer FAERS COTS SAS JReview WebSDM WebVDME Analysis Layer Package (Software Application) (Software Application) (Software Application (Software Application) (Software Application) (Software Application) Results Layer Results
    • Janus Architecture Management Data Exchange Layer HL7 Messages (XML) Common EDR RIM Database RIM Database Source Layer (Data Warehouse) Clinical Nonclinical Harmonized Product Information Database Database Database n Database (SPL) Database Layer (NCI) (NCTR) Inventory Data Mart & CDISC SDTM CDISC SEND CDISC ADaM FAERS Database MedWatch+ (Analysis Views) (Analysis Views) (Analysis Views) Data Mart n (Analysis Views) Special Purpose Layer FAERS FAERS COTS Analysis SAS JReview Array Track Package WebVDME Analysis (Software Application) (Software Application) (Software Application) (Software Application) (Software Application) Software n Layer Analysis Results Layer Results
    • Janus Architecture • Flexible, Modular, and Extensible • Leverages the HL7 RIM for healthcare information to promote interoperability both within and outside FDA • Open architecture and standards allow multiple plug-and-play solutions • Initial focus: – Clinical study data – Nonclinical study data – Pharmacogenomic data – Product Labeling, Registration, Listing data – Post-marketing AE data • Additional interoperable databases, data marts, and tools can be added to accommodate additional scientific data streams
    • Now/Near Future SDTM XPT SEND XPT Exchange Layer HL7 ICSR XML Source Layer (planned) Clinical Nonclinical Database Database Database Layer (NCI Janus 1.x) (NCTR Janus 1.x) Data Mart & CDISC SDTM CDISC SEND FAERS Database (Analysis Views) (Analysis Views) (Analysis Views) Special Purpose Layer FAERS COTS Analysis WebSDM JReview Array Track ToxVision Package (Software Application) (Software Application) (Software Application) (Software Application) (Software Application) Layer Results Layer Results
    • Phase 1: Pre-market human study data SEND XPT SDTM XPT Exchange Layer HL7 Messages (CDISC-HL7 XML) HL7 ICSR XML RIM Database Source Layer (Data Warehouse) (planned) Clinical Nonclinical Database Database Database Layer (NCI Janus 2.0) (NCTR Janus 1.x) Data Mart & CDISC SDTM CDISC SEND CDISC ADaM FAERS Database (Analysis Views) (Analysis Views) (Analysis Views) (Analysis Views) Special Purpose Layer FAERS COTS Analysis WebSDM JReview Array Track ToxVision Package (Software Application) (Software Application) (Software Application) (Software Application) (Software Application) Layer Results Layer Results
    • Phase 2: Pre-market animal study data SEND XPT Exchange Layer HL7 Messages (CDISC-HL7 XML) HL7 ICSR XML RIM Database Source Layer (Data Warehouse) (planned) Clinical Nonclinical Database Database Database Layer (NCI Janus 2.0) (NCTR Janus 2.0) Data Mart & CDISC SDTM CDISC SEND CDISC ADaM FAERS Database (Analysis Views) (Analysis Views) (Analysis Views) (Analysis Views) Special Purpose Layer FAERS COTS Analysis WebSDM JReview Array Track ToxVision Package (Software Application) (Software Application) (Software Application) (Software Application) (Software Application) Layer Results Layer Results
    • Phase 3: Post-market data HL7 Messages Exchange Layer (CDISC-HL7; ICSR XML) HL7 ICSR XML RIM Database Source Layer (Data Warehouse) Clinical Nonclinical Database Database Database Layer (NCI Janus 2.0) (NCTR Janus 2.0) Data Mart & CDISC SDTM CDISC SEND CDISC ADaM FAERS Database (Analysis Views) (Analysis Views) (Analysis Views) (Analysis Views) Special Purpose Layer FAERS COTS Analysis WebSDM JReview Array Track ToxVision Package (Software Application) (Software Application) (Software Application) (Software Application) (Software Application) Layer Results Layer Results
    • Phase 4: Structured Product Information HL7 Messages (already started) Exchange Layer (CDISC-HL7; ICSR; SPL XML) RIM Database Source Layer (Data Warehouse) Clinical Nonclinical Product Information Database Database Database (SPL) Database Layer (Janus 2.0) (NCTR Janus 2.0) Data Mart & CDISC SDTM CDISC SEND CDISC ADaM FAERS Database (Analysis Views) (Analysis Views) (Analysis Views) (Analysis Views) Special Purpose Layer FAERS COTS Analysis WebSDM JReview Array Track ToxVision Package (Software Application) (Software Application) (Software Application) (Software Application) (Software Application) Layer Results Layer Results
    • Janus Activities for 2009 • Long-term planning – Assess/incorporate all Centers’ needs into long-term Agency roadmap / strategic plan for Janus • Support ongoing pilots – Janus Phase 3 pilot for clinical data • Move NCI Janus 1.x at NCI to production for SDTM submissions – Phase 2 SEND pilot for nonclinical data • Test SEND and NCTR Janus 1.x for animal toxicology data • Test CDISC-HL7 messages – RIM database for study data