1 April 2016 Meeting Minutes

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A teleconference/webex was held on 1 April 2016 in which P Drew and A Brown gave an update of the 2016 FDA PhUSE Computational Sciences Symposium held March 13-15 in Silver Spring, MD. The working group's poster was very well received with a lot of interest from FDA Pharm-Tox Reviewers. The conference was very well attended with a significant number attending the nonclinical working group sessions. Our project was endorsed to continue in 2016 with two primary objectives: 1) prepare a white paper for submission for publication based on the survey results presented in the poster, and 2) investigate/explore cross-domain visualizations (eg, organ weight, clinical pathology with histopathology) and cross-study visualizations (eg, aggregate historical control data, data from multiple studies of the same compound in the same species). The working group should reach out and interact with other FDA PhUSE working groups such as the Nonclinical Scripts Assessment Project (headed by B Houser) and the clinical data visualization groups. A recent publication from the Historical Controls working group came out in press in the journal Therapeutic Innovation and Regulatory Science regarding an industry survey on the use of historical control data in toxicology studies (see references below). This paper provides an example and model for preparing a white paper/manuscript for the survey results on graphical displays of histopathology data. The working group will target 4-6 months for manuscript preparation. S Troth is a member of a science and regulatory policy working group of the Society of Toxicologic Pathology which is involved with discussing graphical display of histopath data. This group has similar goals/interests as ours and can provide ideas for discussion and development. The information and deliverables generated by our working group have provided a resource for the STP group.


- Community Opinions on the Collection and Use of Historical Control Data in Nonclinical Toxicity Studies - paper
- Community Opinions on the Collection and Use of Historical Control Data in Nonclinical Toxicity Studies - poster at CSS 2016