NICE Minutes 2014-7-29

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Meeting Date: 29 July 2014

Attendees: Alan, Carol, Paul, Lee, Randy

Agenda: a) Identify 1-2 case examples of a pharmacologic class/target in which clinical and nonclinical safety data are likely available in the public domain (via various databases , literature, sources; examples include: FDA SBA’s, DailyMed, Pharmapendium, drug labels). Complete by 3Q 2014 b) Document the process of data searching and analyses. What types of data are available and unavailable ? Can relationships be developed between clinical and nonclinical safety data ? What limitations exist regarding these analyses ? Complete by 4Q 2014

Notes: Each member should select at least 2 different case examples of drug/pharmacologic classes with marketed products approved during the last 10 – 20 years, to increase the likelihood that clinical and/or nonclinical data are available electronically in various databases (examples: statins, COX-2 inhibitors, kinase inhibitors, GLP-1 agonists, DPP4 inhibitors). The data could be searched via brand name, generic name, pharmacologic class, mechanism of action/target, CAS #, SMILES code, structure, etc. The FDA established pharmacologic class should be incorporated in the searches. Does the European Union have an analogous pharmacologic class list ? A discussion was held regarding various databases that should be queried for pharmaceutical safety data, which also include US EPA sites (ToxCast), the National Toxicology Program (NTP) and a Japanese site: TG-GATEs (Toxicogenomics Project-Genomics Assisted Toxicity Evaluation System). While searching various databases, the group should record whether raw/individual and/or summarized data are available. Can on-target versus off-target toxicities be identified with this search ? A central theme for evaluating various drug/toxicology databases is determining whether relationships can be developed between clinical and nonclinical safety data. What types of relationships can be developed ? A major goal of this exercise is to devise a flow-chart for data searches. Can we identify metadata which should be incorporated in SEND datasets ?

Action Items: 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

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

3. GSK has information regarding search strategies. Lee and Randy will determine whether this could be shared with the group