Nonclinical Working Group Minutes 20Dec2013

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When: 20 Dec 2013
Place: Teleconference
Facilitator: R. Dorsam and S. DeHaven
Scribe: S. DeHaven
Attendance: Alain Nanzer; Alan Brown; Ben Sefing; Bob Dorsam; Cheryl Sloan; Gitte Frausing; Isaac Hatzell; Ken Olivier; Linda Hunt; Mike Harwood; Mike Wasko; Paul Brown; Peggy Zorn; Shifu Zhao; SN; Steve Denham; Jyotsna Kasturi; Rick Thompson; Maria Francomarco; G Randolf Carolyn McGary; Troy Smirnios; Debra Oetzman; Maureen Rossi ; Joe Horvath; Lauren Mihalcik; Susan DeHaven


  1. Update from projects
  2. Preparation for Computational Sciences Symposium 2014
  3. Ideas for WG and Project Team activities (break-outs, panel discussions, development of plan for 2015...)
  4. Presentation of achievements (posters, presentations, deliverables,...)
  5. Schedule of WG activities until then



The Nonclinical Working Group holds quarterly meetings for the full WG membership, to update all on the progress of projects: accomplishments, activities and challenges. In addition, opportunities for collaboration with other working groups are discussed and planning for next Computational Sciences Symposium.

This meeting was held to get updates from each team in the WG, to talk about PhUSE 2014 meeting, and to discuss a potential topic of collaboration (Emerging Technologies)

General discussion

Project Updates from each team:

Standards Roadmap Team: finished effort on the e-Paper (posted on Wiki). New project is “How to Design a Custom Domain” which the group will bring to PhUSE 2014 for comment by the WG. A suggestion was made to informally point standards development organization (SEND) to information about priorities in nonclinical data.

SEND Implementation: This group is aiming to publicize their Wiki as a standards information resource. CDISC Newsletter, Wikipedia, FDA Standards are considered as outlets. Bob will contact others WG members who have reached out to various groups so that the team can achieve wide distribution.

Historical Controls: the team has a rough draft manuscript that they aim to have submitted by March 2014 to Therapeutic Innovation and Regulatory Science (formerly Drug Information Journal.)

NICE: (Nonclinical InterConnectivity for Endpoint prediction) Data Interconnectivity group has had a paper accepted to Therapeutic Innovation and Regulatory Science. The NICE group is re-calibrating and may aim for a broader approach to endpoint predictivity, though the details will be the subject of discussion in the next months. The group will not focus on specific scientific questions that require data.

ISend: (Interorganizational SEND) Continuing with real-world applications of datasets coming from across organizations. The group expects to present a poster at the upcoming PhUSE 2014 meeting

SDRG: (Study Data Reviewers Guide) Is considering how the clinical study data reviewer’s guide might apply to nonclinical datasets. The group is considering where the guide fits in the review process in relation to define file. The group is on course for making recommendations about the nonclinical SDRG (and if the clinical template fits) for the PhUSE 2014 meeting.

PhUSE 2014 meeting preparation – Our theme: Translation and Collaboration

  • Nonclinical WG is looking for opportunities to reach out to other groups and possibly translate their ideas and work to the nonclinical arena.
  • We should be looking for these opportunities now. Two ways of gathering information on other groups were offered:
  • Collect all poster abstracts for the PhUSE meeting and distribute them before the meeting so that people can get ideas about areas of collaboration

Follow up

  • Teams should prepare projects for deliverables for 2014 meeting.
  • In January, refer to Dashboard for PhUSE for info about other WGs deliverables
  • All teams should send their deliverables list to Bob or Sue for posting on the PhUSE WG dashboard
  • The next Nonclinical Quarterly meeting is planned for February 2014
  • Monthly Core Team meetings will be held January, Feb, and March 2014 for development of PhUSE 2014 meeting agenda

Last revision by SusanDeHaven,01/5/2014