13 April 2018 Meeting Minutes

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A teleconference was held on 13 April 2018. The topic of discussion were plans to create a new project team in 2018. The overall objectives are to enable a collaboration between the Nonclinical Topics Working Group of FDA PhUSE and the IMI eTRANSAFE consortium (in the European Union) to discuss scientific concepts related to nonclinical data visualization, safety signal detection and analyses (including discussion of potential algorhythms for data analysis). An important element will be to have access to data located within the eTOX and eTRANSAFE nonclinical safety databases. A second important goal for the project team is to form the basis of a collaboration between PhUSE and eTRANSAFE, that could involve shared discussions and communications of topics of mutual interest. As an example, clinical trial safety data analysis utilizes eDISH plots of serum ALT and total bilirubin levels for signal identification of hepatotoxicity (based on Hy’s Law). Could similar approaches be incorporated for nonclinical safety data ? The concept of SEND as an enabler for these approaches will be discussed, along with the use of the various SEND domains for signal alerts. The intent is for the project to remain within a theoretical or scientific level of discussion versus expanding into software development or evaluation.

The new project team will be led by A Brown and P Drew and will solicit membership and involvement from the current project team members. A draft PhUSE project proposal form was prepared and A Brown will revise it, and share with the other team members. The project proposal form will be submitted to the Nonclinical Topics Core Team and PhUSE Stearing Committee for approval. At the same time, M Cases will prepare a memorandum of understanding for submission to the eTRANSAFE Executive Committee for endorsement. P Marc will assist with preparation of the memorandum. The memorandum is intended to formalize the collaboration. P Drew will be visiting Novartis, Basel, Switz in early May and will discuss the proposal with F Pognan who is a leader of eTRANSAFE. The next eTRANSAFE consortium meeting is early June in Barcelona, Spain, followed by a second meeting Sept 6-7. The goal is to kick-off the new project team by August 2018.