NICE Minutes 2014-4-29

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When: 29 April 2014
Place: Teleconference
Facilitator: Philip Judson (Lhasa Ltd.)
Scribe: Alan Brown
Attendance: A Brown, Kathleen Briggs (Lhasa Ltd), P Brown, J Kasturi

  1. General discussion regarding the possibility of FDA PhUSE-NICE collaborating with the eTOX Consortium

General discussion

The eTOX Consortium is supported by the European Innovative Medicines Initiative (IMI)which is involved with the development and use of toxicology databases and in silico toxicity predictions. Both P Judson and K Briggs are involved with eTOX (Lhasa Ltd is a member). P Judson provided a rough draft of a proposed interaction between eTOX and FDA PhUSE-NICE. The eTOX database is primarily nonclinical data, but has some human adverse event data. Analysis is based primarily on chemical structure, with some datasets associated with pharmacologic class/mechanism of action. The NICE group should put together a proposal for collaboration and present to eTOX, especially individuals who are members of same pharma organizations. The benefits to eTOX are increased visability with PhUSE and FDA-PhUSE Nonclinical Working Group. The NICE group is interested in exploring the use of the eTOX database for predicting potential human adverse events/toxicity with preclinical data, and for developing guidances for searching/data integration. Utilizing the database exploring the use of drug class, mechanism of action for identifying patterns and/or interconnecting nonclinical with clinical data is of interest. Case examples from group's recent publication could be examined with eTOX database.

Follow up

A. Brown: Revise proposal for interaction between FDA PhUSE and eTox, share with NICE members
P Judson and K Briggs: Discuss collaboration with other eTOX members

Last revision by APBrown,04/30/2014