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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)
  3. 2015 CDISC Technical Plan

SEND Leadership Team (SLT)

  • Ben Sefing (Industry Leader) (a)
  • open seat (Next Industry Leader) (a)
  • Lou Ann Kramer (CDISC Leader) (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)

  • Ben Sefing (Industry Leader) (a)
  • Lou Ann Kramer (CDISC Leader) (a)
  • Dianna DiRusso (CDISC Project Manager, Foundational Standards) (a,b)
  • Fred Wood (Audrey Walker (Industry Advisor, Past Leader) (a)
  • William Houser (Industry Leader Emeritus)
  • Brian Argo
  • Mary Jo Brucker
  • Jennifer Feldmann
  • Sue DeHaven (PhUSE Liaison)
  • Marc Ellison
  • Stephanie Berry
  • Anthony Fata
  • Robert Friedman
  • Jamie Gilliam
  • Joseph Horvath
  • Christy Kubin
  • Louis Norton
  • Debra Oetzman
  • Dan Potenta
  • Ben Sefing 
  • Erin Tibbs-Slone
  • Michael Wasko Louis Nortonb  (b)
  • Troy Smyrniosb Fred Wood (b)
  • Peggy Zorn
  • Elaine Thompson (FDA representative)
  • open seat (b)
  • FDA CBER Liaisons:
    • Virginia Hussong
    • Lisa Lin
  • FDA CDER Liaisons
    • Jesse Anderson
    Helena Sviglin (FDA representative)
    • Dave Epstein
(
FDA representative)a-
a) = CDISC TLC (Technical Leadership Committee) member
(b
-
) = CDISC (Cross-team) Global Governance Group voting member

SEND Change Control Board (CCB)

Brandy Harter 
  • Jamie Gilliam (Leader)
Jennifer Feldmann
  • William Houser
  • Lou Ann Kramer
  • Louis Norton
  • Debra Oetzman
  • Ben Sefing
  • Audrey Walker
  • Michael Wasko
  • Fred Wood
  • Craig Zwickl
  • Peggy Zorn

    • SEND Sub-teams

    SEND Controlled Terminology: Craig Zwickl 

    Reproductive Toxicology (and Pilot): Mary Joe Brucker

    Safety Pharmacology: Jennifer Feldmann

    SEND IG: Brandy Harter

    FDA CDER Pilot Liaison: Lauren Murphree- Mihalcik
    • FDA Liaison: Patricia Brundage

    Stakeholders

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

    Team Mission andScope

    The CDISC SEND team develops standards that support both the regulatory        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) and it’s their alignment with the SDTM. 

    SEND IG v3.0 was  released in 2011  (available  at: 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.  

    SEND Deliverables

    The published versions of SEND deliverables are available to the public at: https://www.cdisc.org
    /SEND).  This version supports single-dose and repeat- dose general toxicology and carcinogenicity study data.

    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”
    SEND TeamStructureand Operations
    /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 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 two representatives on the CDISC cross-team governance in addition to a long-standing practice of working closely with the CDISC SDS team and CDISC Controlled Terminology. This year, SEND has joined 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 working group: “Nonclinical Roadmap and Impacts on Implementation”.

     

    • SEND Core Team meets

    bi-weekly

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

    sub-teams meet

    Leadership Team Extended (SLTX) -  meets monthly on Wednesdays for 90 minutes (alternating bi-weekly

    on alternating weeks from Core Work-streams

    with Core Team).
    • SEND subteams and CCB meet

    as needed

    biweekly.

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

    2015 Objectives

    • SEND IG v3.1 – approximately 200 comments addressed
    • SEND IG v3.1 production
    • Repro IG v1.0 provisional standard final
    • New study data modeling initiated (e.g. Ocular, Micronucleus)
    • Controlled terminology to maintain the production IG and support development efforts for Safety Pharmacology: modeling for CNS study types
    • Develop appropriate versioning (aligned with CDISC and FDA procedures)
    • Improve Effectiveness, Ease of Use and Transparency of Communications, including adopting CDISC collaboration tools
    • Improve change control by integrating existing SEND Change Control with CDISC comment tracking, archiving, and JIRA

    Stakeholders/Constituency

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

    • Work-streams meet as needed.