NICE Minutes 2014-6-16

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Meeting Date: 16 June 2014 (by teleconference) Attendees: Alan, Paul, Lee, Randy, Philip

Agenda Items: The following were discussed:

1) Impressions of Instem’s Safety Intelligence Program (SIP) 2) Meeting schedule for our group over the next several months 3) Identification of 1-2 common topics of interest

Specific topics to consider include: • What are accepted terminologies/nomenclatures for pharmacologic class and/or mechanism of action ? How are these developed ? • What in silico tools/databases are available for interconnecting clinical adverse events/toxicities with nonclinical toxicity data using pharmacologic class ? • Can guidance be developed regarding the use of in silico/computational tools for interconnecting pharmacologic class with clinical and nonclinical data ? • What resources are available regarding this topic ?

Noteworthy Notes: Initial feedback regarding the SIP was that it provides useful information as chemical structures can be entered, and pharmacologic targets and lists of drugs within a class. Searches were done based on drug class. Are there pre-defined lists of pharmacologic classes in SIP ? However, the program was not intuitive for use and there was difficulty with filters.

The majority of the teleconference was spent discussing issues associated with searching for clinical and nonclinical safety data which are associated with drug class, pharmacologic class, mechanism of action and/or pharmacologic target. Differences exist between these concepts and it was noted that significant amount of approved drug information are associated with broad categories which are not very descriptive or specific.

FDA needs guidance with regards to setting up SEND datasets and having nonclinical data associated with metadata that accurately describes the mechanism of action/target/pharmacologic class; this could be one objective for NICE.

We should identify 1-2 case examples of a pharmacologic class/target in which clinical and nonclinical safety data are expected to be available in the public domain (via various data bases , literature, sources; examples include: FDA SBA’s, DailyMed, Pharmapendium). We should document the process of data searching and analyses. Are there relationships between clinical and nonclinical safety data ? Can we identify a process/strategy for analyzing data in the future, assuming there are no limitations. What information would we need ? What is currently missing ? Can we create a search strategy which is SEND-centric ?

Lastly, there is interest in seeing whether we could interact with IMI’s eTox initiative in the EU.

Key Decisions: 1. Group teleconferences to be conducted monthly, starting at 0800 am (EST) 2. Group to communicate via email with items posted to the wiki

New Action Items: 1. Contact Instem to request trial access for Safety Intelligence Program for Philip (Alan) 2. Schedule next teleconference for July (Alan) 3. Distribute poster on ToxML (Philip)