Page History

SEND Leadership Team (SLT)

• Audrey Walker 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
• 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) (a
• 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 Friedman
• Jamie Gilliam
• Matthew HayesJoseph Horvath
• Christy Kubin
• Louis Norton (b)Norton
• Debra Oetzman
• Dan Potenta
• Ben SefingTroy 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 LinElaine Thompson

• FDA CDER Liaisons
  • Michelle DieterJesse Anderson
  • Dave Epstein
  • Kevin Snyder
  • Helena Sviglin

(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 Subteams (leader)

SEND Controlled Terminology: Craig Zwickl 

SEND Conformance Rules: Christy Kubin

SEND CCB: Jamie Gilliam

Dermal / Ocular Toxicity : Brian Argo

Reproductive Toxicology : Mary Jo Brucker

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 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. 

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.  

SEND Deliverables

Production releases of the SEND standard:

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

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

Stakeholders

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

Collaborations

The SEND Team maintains representatives on the many 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 team is working closely with the CDISC SHARE effort.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

• Core Full Team membership is open to all interested parties with approximately seventy-five comprises all SEND members, with well over one hundred active members currently.
• Subteams are formed to manage long-term subject areas.
• Change Control Board (CCB) assesses and recommends action on changes requested regarding production SEND 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 for the team, with representation at the CDISC TLC and the CDISC GGG (Global Governance Group).

• Work-Streams are , when needed, are for all tasks that are not within the scope of the listed subteams and expected to have a clear start and end (ie, shorter term need). 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.
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