NICE Minutes 2013-09-30
When: 11:00AM , 30Sept2013
Facilitator: Paul Cornwell / Alan Brown
Scribe: Alan Brown
Attendance: Paul Brown, Paul Cornwell, Alan Brown, Jyotsna Kasturi, Joelle Ibanes, Paul Bradley, Jon Kimball
- New name for combined working group.
- Develop a list of working group members with contact information
- 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 ?
- 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.
- 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 ?
- 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.
- New combined working group name is NICE: Nonclincal Data Interconnectivity for Clinical Endpoint Predictivity
- Discussed accessing electronic nonclinical and clinical data for analyzing several use cases
- 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 ?
- Data available via FDA SBA’s may be used for evaluating use cases and developing data analysis models
- Pharmapendium may be a source of data for evaluating use cases
- PhUSE may have means for storing data – need follow up
- Group endorsed new name (NICE)
- A new Wiki page will be developed for the working group
- Teleconferences will alternate between different days (M, W) to provide flexibility for group members
- 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
- The next teleconference will be 16 Oct, 2013 from 9 am to 10:30 am (EST). Paul C will send out meeting invite
- Paul C will investigate whether a Lilly Sharepoint site can be used to house electronic data
Last revision by Jmbodart,10/13/2015