FDA/CDER SEND PilotFDA/CDER SEND Pilot
Lauren Murphree Mihalcik, Ph.D.Co-chair, IT Subcommittee, PTCC
OND CDER FDAOND, CDER, FDA
November 12, 2009CDISC InterchangeCDISC Interchange
Disclaimer
This presentation represents my own personal views and not those of the FDApersonal views and not those of the FDA
or U.S. government.
First FDA SEND Pilot• FDA involved in SEND since 2002• Original pilot began in 2003• SEND IG 2 3• SEND IG 2.3• Simulated study data• 1st iteration of ToxVision
Developed under a CRADA with PharmQuest– Developed under a CRADA with PharmQuest
Outcome of First Pilot• 9 companies participated• 12 datasets submitted• Reviewers were able to view and evaluate• Reviewers were able to view and evaluate
data • Recommendations for further changes to
SEND and ToxVisionSEND and ToxVision• Continuous FDA engagement with SEND
tteam
Current Pilot• Who is involved?
– Eight companies– NCTR: housing data and ToxVisionNCTR: housing data and ToxVision– CDER
• IT Subcommittee of the Pharmicology/Toxicology• IT Subcommittee of the Pharmicology/Toxicology Coordinating Committee
• Representatives from OC/OCP• Representatives from OC/OCP• Support from the CSC
Current Pilot• What are we testing?
The entire process of standardized nonclinical– The entire process of standardized nonclinical data submission
S b i i lid ti i l i• Submission → validation → reviewer access → analysis– New version of the SEND IG
• New domains including BW gain, PK, tumor findings– Redesigned ToxVision
• Along with SEND validator, built on an Orchestra platform with semantic data exchange services
ToxVision
View and export data without paper cuts or crooked scansView and export data without paper cuts or crooked scans
Pilot Details-Logistics• New or previously submitted data
– SEND and PDFSEND and PDF• Through FDA gateway:
– Dataset to NCTR for Validation – PDF to electronic document room
• SEND dataset available toS ll il t itt– Small pilot committee
– Assigned regulatory reviewer (optional)
Pilot Details: Responsibilities• Normal decision making, based on PDF in
review divisionreview division • Subset of the pilot committee evaluates dataset:
C i t b t SEND d PDF– Consistency between SEND and PDF – Utility of ToxVision and suggested improvements
Possible utility of other analysis tools– Possible utility of other analysis tools• Technical (not regulatory) feedback to sponsor
on the dataset from the pilot committee ason the dataset from the pilot committee as requested
• Formal report at the end of the pilot• Formal report at the end of the pilot
Progress so far• FDA training for pilot committee reviewers
on use of ToxVision• Several iterations of ToxVisionSeveral iterations of ToxVision
improvements based on FDA reviewer feedbackfeedback
• Some recently submitted• Looking forward to more!
Future of SEND at FDA• FDA is planning to transition from the
traditional paper/PDF formats to a true electronic data format for submission of nonclinical animal data for regulatory review
• Goal: to expand SEND across all FDA• Goal: to expand SEND across all FDA centers
AcknowledgementsITSC Members & Paul Brown (FDA)Lilliam Rosario (FDA)Lou Ann Kramer (Lilly)Lou Ann Kramer (Lilly)Shree Nath (PointCross)
CDISC / SENDStandard for Exchange of
Nonclinical DataNonclinical Data
CDISC Interchange, November 2009Baltimore
Strength through collaboration.
A l f d i ll b i CDISC b i h
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As a catalyst for productive collaboration, CDISC brings together individuals spanning the healthcare continuum to develop
global, open, consensus-based medical research data standards.
SEND TeamCurrent Participation
• 99 individuals 20+ organizations supportive99 individuals, 20+ organizations supportive• 30+ individuals very active, 11 companies & FDA S bt• Subteams:
• Reproductive and Developmental ToxS f t Ph l• Safety Pharmacology
• Controlled Terminology T i l D i• Trial Design
• FindingsSEND IG / CCB• SEND IG / CCBInterested? [email protected] ‐or‐ cdisc.org
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CDISC (Clinical Data Interchange Standards Consortium)
CDISC SDS CDISC BRIDG … Etc.CDISC AdAM
(Clinical Data Interchange Standards Consortium)
CDISC SEND CDISC SDS CDISC BRIDG … Etc.CDISC AdAM
Submission Data StandardsProduct: SDTM IG
Biomedical Research
Integrated Domain GroupProduct: BRIDG Domain
Analysis Dataset Modeling TeamProduct: ADaM
Lead: Lou Ann Kramer,Lilly
Core Team
Standard for Exchange of Nonclinical DataProduct: SEND IG
model y
RFDA
SENDIGControlled Safety Trial FindingsRepro CDER Pilot SENDIG Terminology
Lead: Mary Jo
Lead: Mary
FDA Contact:Paul Brown, CDER
Lead: Peggy
Sa etyPharm
Co-Leads:Mary
Design
Lead: Allen
Findings
Lead: Audrey
Brucker, Merck
Cauley, Lilly
FDA CDER SME: Lauren Murphree-Milhalcik
CDISC/SEND Contact:
Zorn, Thomson-Reuters
Jeanne Kallman,CovanceWherly
Glover,Covance
Walker,CharlesRiverLabs
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CDISC/SEND Contact:Lou Ann Kramer,Lilly
Hoffman, Elan
20-May-20093
CDISC / SENDCDISC / SEND Lower CostsLower CostsCDISC / SEND CDISC / SEND Lower CostsLower CostsBetter ToolsBetter Tools
SStandardtandardSubmissions to FDA SStandard tandard for for
EExchangexchange
Submissions to FDA• Review a study
BUT ALSO EExchange xchange of of li i lli i l
BUT ALSO….
• Data Mining Across Compounds NNonclinical onclinical DDataata
Data Mining Across Compounds• Industry Collaborative Efforts
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SEND RequirementsSEND RequirementsSEND RequirementsSEND Requirements
Submission
FDA Data FDA Data W hW hOperational Warehouse Warehouse (JANUS)(JANUS)
One Standard One Standard
Built from Clinical StandardBuilt from Clinical Standard (SDTM(SDTM))
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