Copyright © 2016 Covance. All Rights Reserved

SEND

A New, Digital Way to Exchange Nonclinical Data …and so much more

…into a standardized, electronic dataset

What Is SEND?

SEND = STANDARD FOR EXCHANGE OF NONCLINICAL DATA

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SEND

Presents your nonclinical data in a standard format to fulfill regulatory eCTD submission requirement

Packages nonclinical study

data points …

CURRENT STATE SEND STATE

What Led To SEND? A Surprising Finding.

► Consult several different tables individually

► Search through hundreds of pages of data

► Use the digital SEND dataset plus a visualization tool

► View data on one screen to organize and analyze data

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Who Developed SEND and Why?

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Pharma

CROs

Software solution vendors

WHY

► Set controlled terminology ► Standardize format ► Enhance data review ► Eliminate data entry by agency ► Enable data warehousing, analysis

and visualization

WHO

Covance is active in the SEND Consortium and FDA/PhUSE Working Group 6

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When Do I Need To Be Ready For SEND?

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2015 2016 2017 2018 2019 2020 2021

Final guidance

was issued

New NDA and BLA studies must

comply

Original IND studies

must comply

Defined as protocol finalization

Starts with General Toxicology

and Carcinogenicity Studies

With other study types to come….

Source: Providing Regulatory Submissions In Electronic Format —Standardized Study Data Guidance for Industry, FDA, CDER, CBER, Dec. 2014

SENDIG x.x Safety Pharm − CNS DART − FEE − PPND Genetic Toxicology Dermal/Ocular Dataset XML format

BEYOND SENDIG 3.1* Safety Pharm (issued 07 Jul 2016)

– Cardiovascular – Respiratory

SENDIG DART 1.0* DART (issued 17 Aug 2016)

− EFD Study Data Reviewer’s Guide, SDRG (v1.0 issued 03 Mar 2016–not a regulatory requirement)

NEXT

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How Will SEND Requirements Expand Overtime?

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SENDIG 3.0 General Toxicology

−GLP −Non-GLP −Single Dose −Multiple Dose

Carcinogenicity

BEGINNING DEC 17

…And pharmacology will come later

NOT EVERYTHING WILL BE REQUIRED ON DAY 1 (DEC 17, 2016)

*SENDIG 3.1 and SENDIG DART 1.0 have been released by CDISC. The effective date is TBD pending announcement by the FDA via Federal Register Notice that these standards have been accepted into the data standards catalog

What Do I Need To Be SEND-Ready?

THE BASIC REQUIREMENTS TO ACCEPT SEND

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DATA ANALYSIS DATA STORAGE ACCEPT SUBMIT* You need the ability to accept or handle

large files

You need software to view and use your

SEND dataset

You need the ability to submit SEND datasets

You need a storage solution for warehousing

large files

*In Oct 2016, the FDA indicated legacy studies (those started prior to 17 Dec 2016) included in an NDA will require a TS (trial summary) domain in .xpt format with one entry for study start date

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Who Needs to Collaborate for Successful SEND Implementation?

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Regulatory Procurement IT Study Teams

Understand submission requirements

Vendor selection

Software validation and implementation

Nonclinical data production, scientists and operations

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IT TAKES A MULTI-DISCIPLINARY TEAM

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How Does SEND Arrive?

► A zip file arrives via FTP site or Covance StudyTracker®

► Data types are presented in separate “domains” (i.e.: Body Weight (BW) data in BW domain)

► Multiple domains make one dataset per study

► The domains are in .xpt format (readable by SAS Viewer)

► Each dataset has a “define” file explaining certain details

ARRIVES AS A COPY OF DATA PRESENTED IN FINAL STUDY REPORT

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Did you know: A standard SEND dataset for an 8-week rat toxicology study (4 week treatment/4 week recovery) will be ~ 50,000 data points, 8.7MB file size, with a 7MB final report.

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SEND – It’s Not Only An FDA Requirement, You Can Benefit In Many Ways…

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Data warehousing

Data visualization

Statistical analysis

Historical control data

STANDARDIZATION

Covance is Delivering SEND to Clients Today!

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40+ clients

750+ studies

1500+ deliveries

125B+ data points

Get started with SEND today

SEND – Are You Ready?

Or, contact Covance today!

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Need help? Here are more resources.

► “Data-Driven Decisions” blog (link here)

► “Are you SEND Ready” webinar (link here)

► “SEND – What Can I Expect?” webinar (link here)

► “The Tale of a Real-life SEND Test Submission” blog (link here)

► SEND web page (link here)

► FDA guidelines (link here)