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.

Overview• Background on previous pilot• Current pilot outline• Progress so far• Progress so far

Motivation forMotivation for SEND

This data is not searchable

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

• How we see th d tthe data

Screen shots used with permission of PointCross

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

1

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? lkramer@lilly.com ‐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 

44

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))

55

Strength through collaboration.

A t l t f d ti ll b ti CDISC b i t th As a catalyst for productive collaboration, CDISC brings together individuals spanning the healthcare continuum to develop

global, open, consensus-based medical research data standards.

6