SEND Leadership Team (SLT)
SEND Leadership Team Extended (SLTX)
a- CDISC TLC (Technical Leadership Committee) member
b- CDISC (Cross-team) Global Governance Group voting member
SEND Change Control Board (CCB)
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 Implementation Guides (IGs) 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.
The SEND deliverables are available to the public at: www.cdisc.org/SEND.SEND Change Control Board(CCB)
SEND Subteams (leader)
SEND Controlled Terminology: Craig Zwickl
SEND Conformance Rules: Christy Kubin
SEND CCB: Jamie Gilliam
SEND for CBER: Lisa Lin, Sue DeHaven
Cell Phenotyping (Cross-CDISC team): Craig Zwickl, Erin Muhlbradt
Dermal / Ocular Toxicity : Brian Argo
Exposure : Debra Oetzman, Wenxian Wang
Genotoxicity (Gene Tox) : Michael Wasko
Immunogenicity Specimen Assessments: Robert Friedman, Alex Kistner, Anthony Fata
Pharmacokinetic Concentrations & Parameters: Marc Ellison
Safety Pharmacology: Christy Kubin
Developmental & Reproductive Toxicology : Mary Jo Brucker
Macro and Microscopic: Daniel Potenta, Joseph Horvath, Ben Sefing
Tumor Combinations: Charlotte Keenan
Tumor Findings: Daniel Potenta
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
The SEND Team maintains representatives on the many CDISC cross-team initiatives. SEND also maintains 2 - 3 seats on the CDISC governance.
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.
• Core Team membership comprises all SEND members, with well over one hundred active members currently.
• Work-Streams, 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.
William Houser, Lou Ann Kramer, Christy Kubin, Louis Norton, Debra Oetzman, Ben Sefing, Audrey Walker, Mike Wasko, Fred Wood, Craig Zwickl
• SEND Core Team meets monthly on Wednesdays for 90 minutes. Active members meet face-to-face at the FDA two times each year.
• SEND Leadership Team Extended (SLTX) - meets monthly on Wednesdays for 90 minutes (alternating bi-weekly with Core Team).
• SEND subteams and CCB meet biweekly.
• Work-streams meet as needed.