Nonclinical Core Team Minutes 15 July 2016

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When: 15 Jul 2016
Place: Teleconference
Facilitator: S. DeHaven
Scribe: S. DeHaven
Attendance: Bob Dorsam, Fred Wood, Kevin Snyder, Phil Drew, Laura Kaufman, Gitte Frausing, Bill Houser, Patty Brundage, Dave Epstein, Mike Wasko, Kathy Brown, Sue DeHaven, Maria Francomacaro


  • Update from EU PhUSE meeting
  • PhUSE Steering update
  • Round table of project issues, updates
  • WIKI changes

General discussion

1. Gitte Frausing provided a nice summary of the Nonclinical portion of the EU CS Meeting. Key points were:

  • Significant Regulatory participation, including deep presentations from FDA (Lilliam Rosario) and PMDA (Yuki Ando) + attendance by European Regulatory agency rep (which felt new). A small discussion on EU interest ensued and it seems there is a slow, but building activity in EU national approaches.
  • 2 CRO and 1 Pharma presented Industry perspectives
  • Forward Looking topics beyond the regulatory implementation of SEND were presented in one breakout. Examples of strong interest in leveraging SEND model for warehousing and visualization.
  • An overview of the nonclinical PhUSE projects was presented to attendees, so they can become familiar with our content.
  • Lou Ann presented what’s in the pipeline from CDISC.
  • Overall, though limited in participation by small venue, it was a valuable meeting and the output presentations are great – find them on our WIKI thanks to Philippe Marc:
  • For the future, though this may not be an annual meeting, the door is open and communication paths are available to have continued contact and collaborative relationship with our European colleagues.

2. Steering News:

  • Investigating Endpoints Biomarker white paper was reviewed by the CS Steering Committee with positive results. Committee commented the paper is excellent and approved it to be published for public review. This is done here. In addition, the Optimizing Data Standards WG will be alerted (Barry Nelson) to determine if a clinical followup can be done. All felt best approach would be to collaborate with this group on both the followup on the biomarkers recommendation in the white paper and also and next project for this team to pursue similar activity for ADA data. CDISC SEND Team (via Lou Ann Kramer) has been alerted of recommendations. All agreed there is more and valuable work that can be done by extending this project. Mike Wasko will follow up with project team for public review, proposal for another paper and connection with ODS team.

3. Project Updates:

  • The Data Consistency project reported they have identified 15 scenarios of possible inconsistencies between SEND and Report. Question raised whether this should be shared with FDA’s Fit for Use pilot. Bob Dorsam suggested this would probably be helpful and will alert Dave Epstein (who had left the meeting early.) Also suggested that outcomes from Fit for Use pilot could inform the Data Consistency team. Overall, transparency and bidirection communication was suggested. FDA will be providing feedback to individual Sponsors on their own FFU submission, and Sponsors are planning to provide that feedback in a generic way, to everyone. SEND Core Team supporting this effort. This will also help to identify if there are outcomes from FFU that impact other projects in our WG.
  • Nonclinical Scripts Assessment project will be presenting to CS Steering end of July, in order to get their advice on various concerns raised regarding the development and publication of scripts for SEND in an opensource way by the project team participants, which include FDA. PhUSE CS has been down this road before on various topics and are expected to be able to provide guidance which can help team to clarify the scope and goals of the project, and enable the team to progress.

4. WIKI Updates: New Nonclinical WIKI Page is now created; 2016 Posters added with Links; Updated Nonclinical WG Core Team list with email contacts; Old page is updated to direct to new page 5. Postmeeting note: New text developed for PhUSE CS Dashboard on PhUSE Website. Content derived from project team wiki pages.

Follow up

  • Post Biomarkers White Paper for Public Review (inform Scott Bahlavooni of team's preference on how to provide comments and who to name as contact on PhUSE Deliverable for Review page.) - Mike Wasko
  • Contact Optimizing the Use of Data Standards team regarding collaboration between Clinical and Nonclinical for Endpoint Modeling (Biomarkers and ADA specifically)

Last revision by SusanDeHaven,07/18/2016