1 July 2016 Meeting Minutes

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A teleconference and webex was held on 1 July 2016. The agenda was to review draft development of the manuscript being prepared based on the industry surveys conducted in 2015 and the working group's poster presented in March 2016 at the FDA-PhUSE CSS. Significant progress has been made on the manuscript and P Drew prepared a demo of the manuscript in publication format. The group discussed whether Therapeutic Innovation and Regulatory Science is an appropriate journal for submission. While this journal has previously published papers from the Nonclinical Working Group, the impact factor (0.511) is low. Other journals are to be considered with suggestions provided to P Drew and A Brown. The draft manuscript was reviewed and comments shared to the various section authors. Individuals who write sections/contribute to the text will be included as authors. The goal is for manuscript submission to a suitable journal by September. The next TC/webex will be held on July 22.