WG6 Endpoint Predictivity 28 June 2012 Meeting Minutes

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When: 11:00AM (EDT) , 28Jun2012
Place: Teleconference/Webconference
Facilitator: Paul Cornwell
Scribe: Paul Cornwell
Attendance: Jon Kimball, Jeremy Wally, Shree Nath, Joelle Ibanes, Paul Cornwell, Dave Seyler, Tim Gartner, Troy Smyrnios, Martha Lee, Bradley, Richard Khan-Malek, Jane Reed
Agenda:

  • Introduction of new members (Kimball, Kansy, Ibanes)
  • Commitment from FDA (Kropp or Cornwell)
  • Use cases brainstorming


General discussion

  • Jon Kimball and Joelle Ibanes introduced themselves. Manfred Kansy was not in attendance.
  • Discussed that Tim Kropp had indicated that the FDA would provide some resources for this project. Once the team identifies the use cases and the analysis, the FDA may be able to conduct some of the analysis using FDA tools and data. Of course, the content of the results would be limited by data disclosure limitations. Expect that Tim will be at next meeting to discuss this commitment.
  • There was some brief discussion regarding the goal of the team. That included whether our goal was to "predict" adverse events in clinical trial / early clinical development or post-marketing adverse events.
  • The team discussed the Use Cases that the team would like to pursue, discussing the list compiled from team members prior to the meeting. We discussed the method of choosing / prioritizing these use cases, including (1) picking the Use Cases first and then finding the data/resources vs. (2) inventorying the available data and then designing use cases that could be answered from the data. We decided to do a hybrid of both in parallel. We will continue to identify Use Cases (regardless of the required resources) while also compiling an inventory of available data. We expect that the FDA likely is the best source of nonclinical and clinical data.
  • It was noted that in order to understand preclinical false positives and false negatives, we would likely need contributions of data from pharma (or whoever owns the data). Our team currently only includes representatives from three pharma. companies (Sanofi, Roche, Lilly). The team was encouraged to contact colleagues at other companies to broaden pharma. industry participation.


Follow up

  • Questions for Tim Kropp:
    • More details about exactly what would be available
    • How many people would work on this analysis and how much time could they spend?
  • At the next meeting, we will narrow down our list to a prioritized list of 3-5 use cases. Before the next meeting, team members are asked to pick their favorites and narrow as needed.
  • Team members need to continue to contribute to the list of historical and on-going efforts in this area. This will help in prioritizing use cases by making it clearer what data is and is not available.

Last revision by Pacorn,07/16/2012