NICE Minutes 2013-09-30

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When: 11:00AM , 30Sept2013
Place: Webconference
Facilitator: Paul Cornwell / Alan Brown
Scribe: Alan Brown
Attendance: Paul Brown, Paul Cornwell, Alan Brown, Jyotsna Kasturi, Joelle Ibanes, Paul Bradley, Jon Kimball

Agenda

  1. New name for combined working group.
  2. Develop a list of working group members with contact information
  3. How should we merge the wiki’s from the previous individual working groups ? Shall we create a new wiki going forward, with links to the previous ones ?
  4. The following use cases were identified by the Endpoint Predictivity group : a) HERG/CV safety/QT, b) transaminase changes in rats and man, c) new kidney biomarkers and clinical correlates, d) CNS adverse events/findings. The following use cases were identified by the Data Interconnectivity group and related to endpoint predictivity: a) HERG/CV safety pharmacology/QT, b) cardiac safety/cardiac biomarkers. There are some common themes between the groups.
  5. I propose that we select 2-3 different use cases and have individuals work one. Each subgroup can identify goals and objectives for their project. A common goal would be to develope models for correlating electronic nonclinical data with clinical data . What correlations can be made ? Does the nonclinical data agree/disagree with clinical outcomes ?
  6. A common theme for the working group is the use of electronic data/software/models for evaluating nonclinical data for correlations with clinical data. Proposed models are acceptable.

General discussion

  1. New combined working group name is NICE: Nonclincal Data Interconnectivity for Clinical Endpoint Predictivity
  2. Discussed accessing electronic nonclinical and clinical data for analyzing several use cases
  3. Can sanitized nonclinical data, provided by participating companies (eg, JNJ, Eli Lilly) to Point Cross, be used for analysis related to the various use cases ?
  4. Data available via FDA SBA’s may be used for evaluating use cases and developing data analysis models
  5. Pharmapendium may be a source of data for evaluating use cases
  6. PhUSE may have means for storing data – need follow up

Key Decisions

  1. Group endorsed new name (NICE)
  2. A new Wiki page will be developed for the working group
  3. Teleconferences will alternate between different days (M, W) to provide flexibility for group members

Follow up

  1. Paul Cornwell will create a new Wiki for the combined working group with links to and from the previous Wikis for the Data Interconnectivity and Endpoint Predictivity working groups
  2. The next teleconference will be 16 Oct, 2013 from 9 am to 10:30 am (EST). Paul C will send out meeting invite
  3. Paul C will investigate whether a Lilly Sharepoint site can be used to house electronic data

Last revision by Jmbodart,10/13/2015