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

1. Janus Update
Armando Oliva, M.D.
Deputy Director for Bioinformatics
Office of Critical Path Programs
armando.oliva@fda.hhs.gov
March 10, 2009

2. The views expressed in this presentation are
those of the speaker and not necessarily
those of the Food and Drug Administration
…

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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