NICE Minutes 2014-9-17

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17 September 2014 Teleconference

Attendees: Alan, Paul, Carol, Lee, Randy

Agenda Items: 1. Identify pharmacologic classes as case examples for database searches 2. Review table for documenting database search

Action Items (Follow-Up): 1. Alan will distribute the paper by Bai and Abernethy, 2013 regarding systems pharmacology to predict drug toxicity. Alan will develop a table for documenting database searches - done 2. Alan to check when abstracts are due for the annual FDA-PhUSE Computational Sciences Symposium, to be held in Silver Spring, MD in March 2015

Noteworthy Notes: The following are proposed pharmacologic classes to conduct database searches for evaluating the relationships between clinical and nonclinical safety data. Alan: GLP1-receptor agonists (liraglutide, exenatide) and DPP4 inhibitors (eg, siltagliptin) for type 2 diabetes; Lee: kinase inhibitors for oncology (inhibitors of MEK, BRAF and PD4); Randy: kinase inhibitors for oncology; Paul: PDE5 inhibitors, TNF-alpha inhibitors; Carol: long-acting beta-agonists for asthma and COPD.

Challenges may arise with identifying which kinase(s) is the target for mechanism of action, and when multiple kinases are targeted by a drug. The group discussed some of the challenges and issues which could arise with evaluating the relationships between clinical and nonclinical data, including relating doses in toxicology studies with human doses, differences in terminologies/ontologies and mapping animal toxicology findings to human adverse events. How are human adverse events mapped to animal toxicology findings ? Databases to be considered for evaluating include TGgate (toxicogenomics project in Japan) and DrugBank (from Canada). The team will attempt to put in writing observations/learnings from this exercise.

New Action Items: 1. The group will develop a list of databases with links for the wiki 2. Key references will be listed on the wiki