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  1. SEND Home on the CDISC Website
  2. SEND Home on the CDISC Wiki (Access may be restricted to SEND Team Members)

SEND Leadership Team (SLT)

  • TBD Ben Sefing (Incoming Industry Leader) (a)
  • William Houser open seat (Next Industry Leader) (a)
  • Lou Ann Kramer (Past CDISC Leader) (a)Chris Gemma (CDISC Liaison) (a
  • Dianna DiRusso (CDISC Project Manager, Foundational Standards) (a,b)
  • Audrey Walker, (Industry Advisor, Past Leader) (a)
  • William Houser (Industry Leader Emeritus)

SEND Leadership Team Extended (SLTX)

  • William Houser Ben Sefing (Industry Leader) (a)
  • Lou Ann Kramer (Past CDISC Leader) (a)Chris Gemma (CDISC Liaison
  • Dianna DiRusso (CDISC Project Manager, Foundational Standards) (a,b)
  • Audrey Walker (Industry Advisor, Past Leader) (a)
  • William Houser (Industry Leader Emeritus)
  • Brian ArgoKathryn Brown
  • Mary Jo Brucker
  • Sue DeHaven (PhUSE Liaison)
  • Marc Ellison
  • Stephanie Berry
  • Anthony Fata
  • Robert FriedmanGitte Frausing
  • Jamie Gilliam
  • Mattew HayesJoseph Horvath
  • Christy Kubin
  • Louis Norton (b)Norton
  • Debra Oetzman
  • Dan Potenta
  • Ben Sefing
  • Troy Smyrnios (b)
  • Sefing 
  • Erin Tibbs-Slone
  • Audrey Walker Michael Wasko (b)Michael Wasko
  • Fred Wood (b and Past Leader)
  • Craig Zwicklopen seat (b)
  • FDA CBER Liaisons:
    • Virginia Hussong
    • Lisa Lin
    • Elaine Thompson
  • FDA CDER Liaisons
    • Crystal AllardJesse Anderson
    • Dave Epstein
    • Kevin Snyder
    • Helena Sviglin
    • Kendra Worthy
a-
(a) = CDISC TLC (Technical Leadership Committee) member
(b
-
) = CDISC (Cross-team) Global Governance Group voting member

SEND Change Control Board (CCB)

  • Jamie Gilliam (Leader)
  • William Houser
  • Lou Ann Kramer
  • Louis Norton
  • Debra Oetzman
  • Ben Sefing
  • Audrey Walker
  • Michael Wasko
  • Fred Wood
  • FDA Liaison: Patricia Brundage

SEND Sub-teams (leader)

SEND Controlled Terminology: Craig Zwickl 

Reproductive Toxicology (and Pilot): Mary Jo Brucker

SEND Conformation Rules: Christy Kubin

SEND IG/CCB: Jamie Gilliam

FDA CDER Pilot Liaisons: Elaine Thompson, Helena Sviglin, and David Epstein

PhUSE Liaison: Susan DeHaven

Stakeholders

• Regulatory Authorities
• Pharmaceutical Sponsors
• Nonclinical Research Scientists & Pathologists
• Contract Research Organizations
• Independent Consultants
• Information Technology Tool Developers
• Service Providers

The above deliverables are available to the public at: www.cdisc.org/SEND. 
SEND TeamStructureand Operations

SEND is one of the required standards for data submission to the FDA. Details on the requirements for the FDA are specified in the FDA’s Data Standards Catalog for IND, NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.  

Team Mission andScope

The CDISC SEND team develops standards that support both the regulatory submission of nonclinical data as well as the operational use and exchange of nonclinical data throughout the industry.

This team is responsible for overall development and maintenance of the production SEND IG Implementation Guides (Implementation GuideIGs) versions and their alignment with the SDTM. 

Production releases of the SEND standard:

Standard & VersionSupplemental Materials

SENDIG v3.0, rel. 17June2011 (supports single- and repeat- dose general toxicology and carcinogenicity study data)

Confirmed Data Endpoints for SENDIG v3.0 Data Exchange
(CoDEx 1.0 for SEND v3.0), rel. 16Aug2017

SENDIG v3.1, rel. 07July2016 (supports single- and repeat- dose general toxicology and carcinogenicity study data)

SEND Deliverables

The published versions of SEND deliverables are available to the public at: https://www.cdisc.org/standards/foundational/send

Upcoming Releases:

  • SENDIG-DART v1.2 is to guide the implementation of toxicology studies that use juvenile animals, includes a new domain for Developmental Milestones (DP), and is targeted for June/July 2023
  • SENDIG-GeneTox v1.0 is the first release to guide the implementation of genetic toxicology in vivo data, includes a new domain for Genetic toxicology in vivo (GV), and is targeted for June/July 2023
  • SENDIG v4.0 is a major release, includes significant new functionality for many use cases, multiple domains new to SEND (CP, IS, NV, OE, SK), and is targeted for Q1 2025

SEND Subteams (leader)

SEND Controlled Terminology: Erin Tibbs-Slone 

SEND Conformance Rules: Christy Kubin

SEND CCB: Jamie Gilliam

Dermal / Ocular Toxicity : Brian Argo

Exposure : Wenxian Wang

Genotoxicity (Gene Tox) : Michael Wasko

Immunogenicity Specimen Assessments: Robert Friedman, Alex Kistner, Anthony Fata

Pharmacokinetic Concentrations & Parameters: Stephanie Berry

Safety Pharmacology: Christy Kubin

Trial Domain enhancements: Anthony Fata, Brandy Harter

Developmental & Reproductive Toxicology : Marc Ellison

Macro and Microscopic: Rachel Harper, Matt Hayes

Tumor Combinations: Charlotte Keenan

For more details on SEND initiatives, please see the SEND Home Wiki page at: SEND Home


Collaborations

The SEND Team maintains representatives on the many CDISC cross-team initiatives.  SEND also maintains 2 - 3 seats on the CDISC governance.  

The SEND team partners with the INHAND organization for pathology-related terminology (http://www.toxpath.org/inhand.asp).

SEND also has a strong presence on the FDA/PhUSE Computational Sciences Symposium (CSS) (http://www.phuse.eu/css), including several leadership positions and significant overlap in membership with the Nonclinical Topics working group.

Operating Model

• Full Team membership comprises all SEND members, with well over one hundred active members currently.
• Subteams are

• Core Team membership is open to all interested parties with over eighty-five members currently.
• Sub-teams

formed to manage long-term subject areas.
• Change Control Board (CCB) assesses and recommends action on changes requested regarding

the

production SEND

IG

deliverables.
•SEND Leadership Team (SLT) - sets direction for the team and is responsible to CDISC leadership for the SEND Team; consists of past, current, and future team leaders.
•SEND Leadership Team - Extended (SLTX) assists in setting direction, with representation

from

at the CDISC TLC and the CDISC GGG (Global Governance Group).

• Work-Streams

initiated by the SLT and CCB

, when needed, are for all tasks that are not within the scope of the

aforementioned sub-teams

listed subteams and expected to have a clear start and end (ie, shorter term need).

SEND Work-Stream Leadersand Cross-teamIntegrators

Work-streams are initiated by the CCB or SEND leadership.

• Leadership Mentors - To develop new leaders on the SEND team, an experienced SLTX member will co-lead or mentor a newer leader for any new Work-Streams. All Subteams and Work-streams are governed by the SLTX and all work is reviewed by the Core Team.
• Business Integrators - are individuals who have demonstrated expertise with alignment across all domains and are often needed to review key concepts early in their development. They typically have an understanding of the CDISC and SEND strategy and approaches to certain concepts and designs and will look at impact beyond a domain, across domains and even across multiple "child" IGs.  Such individuals will often be needed in specific sessions at F2F weeks. This includes the following individuals:

When a task, issue or group of issues is identified for a Work-Stream, by the SEND CCB, an experienced SEND member leads or mentors a newer leader for the Work-Stream and reports back to the CCB and Core Team until the topics reach closure.

Jennifer Feldmann, Gitte Frausing, Brandy Harter,

William Houser, Lou Ann Kramer, Christy Kubin, Louis Norton, Debra Oetzman,

Troy Smyrnios

Ben Sefing, Audrey Walker, Mike Wasko, Fred Wood,

Peggy Zorn

Craig Zwickl

Collaborations and

Meetings

The SEND Team maintains representatives on the CDISC cross-team governance in addition to a long-standing practice of working closely with the CDISC SDS, Controlled Terminology, and XML Technologies teams. With the release of SENDIG-DART v1.1,the SEND is working closely with the CDISC SHARE effort.

The SEND team partners with the INHAND organization for pathology-related terminology (http://www.toxpath.org/inhand.asp). SEND also has a strong presence on the FDA/PhUSE Computational Sciences Symposium (CSS) (http://www.phuse.eu/css), including several leadership positions and significant overlap in membership with the Nonclinical Topics working group.

• SEND Core Team meets monthly on Wednesdays for 90 minutes. Active members meet face-to-face at the FDA two times each year.
• SEND

sub-teams

Leadership Team Extended (SLTX) -  meets monthly on Wednesdays for 90 minutes (alternating bi-weekly with Core Team).
• SEND subteams and CCB meet

bi-weekly

biweekly.
• Work-streams meet as needed

.• FDA/PhUSE CSS Working Group sub-teams meet regularly via teleconference

.

Stakeholders/Constituency

• Regulatory Authorities
• Pharmaceutical Sponsors
• Nonclinical Research Scientists & Pathologists
• Contract Research Organizations
• Independent Consultants
• Information Technology Tool Developers
• Service Providers

SEND datasets are accepted now and will be required in future FDA Submissions per the following guidances:
•“Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act” - parent guidance
•“Providing Regulatory Submissions in Electronic Format – Standardized Study Data”
•“Study Data Technical Conformance Guide”