22 July 2016 Meeting Minutes

From PHUSE Wiki
Jump to: navigation, search

A teleconference and webex was held on 22 July 2016. Status of the manuscript for the cross-industry surveys was discussed. Potential journals for submission include Regulatory Toxicology and Pharmacology (higher impact factor), and Therapeutic Innovation and Regulatory Science (journal of past precedence for FDA PhUSE Nonclinical Working Group). Journals will be evaluated for ability and costs of publishing color images. A Brown will inquire with Associate Editor W Hayes of Reg Tox and Pharm to see if journal would be interested in paper. A Brown to make edits on manuscript so that authors can submit draft for internal corporate review, prior to submission to journal. The group discussed the next phase of the project with interest in exploring cross-study data analysis and aggregation of data for visualization. Requests will be made to member organizations to determine if demonstrations/case examples of cross-study analyses can be shared with group. Prior examples include the INDS Tree Map and AstraZeneca's display. This can include multiple studies of the same compound within and/or across species. A Brown will inquire with P Marc of Novartis, P Drew will contact PointCross and AZ, L Kauffman will contact J Review. K Snyder mentioned that the nonclinical scripts group may have similar interests and could develop code for aggregating data. L Kauffman will share ideas/questions to consider with regards to cross-study analyses. B Hayes indicated that FDA is actively evaluating SEND data as pilot activity and to providing feedback to sponsor organizations, and will inquire as to whether feedback can be provided to this working group.