FDA / PhUSE CSS Initiative

Purpose The FDA wishes to establish collaborative working groups to address current challenges related to the access and review of data to support product development. These groups will work on possible solutions and practical implementations with the goal of helping the broader community align and share experiences to advance computational science. NOTE: Purpose developed leading up to the meeting, FDA to amend

Working Group Structure Working Group Steering Committee Consists of 8-10 members including one liaison to each working group Working Group 1 FDA Co-Leads Industry Co-Leads Steering Committee Liaison Working Group 2 FDA Co-Leads Industry Co-Leads Steering Committee Liaison Working Group 3 FDA Co-Leads Industry Co-Leads Steering Committee Liaison Working Group 4 FDA Co-Leads Industry Co-Leads Steering Committee Liaison Working Group 5 FDA Co-Leads Industry Co-Leads Steering Committee Liaison Working Group 6 FDA Co-Leads Industry Co-Leads Steering Committee Liaison Volunteers FDA Industry SDOs Academia Volunteers FDA Industry SDOs Academia Volunteers FDA Industry SDOs Academia Volunteers FDA Industry SDOs Academia Volunteers FDA Industry SDOs Academia Volunteers FDA Industry SDOs Academia

Working Group Steering Committee Drive the FDA CSS initiative as a whole Communication mechanism across working groups Ensure outputs meet the needs of the FDA Ensure no duplication of effort across working groups; provides the overall framework Consists of representatives from FDA, PhUSE, CDISC and industry

Working Group Leadership Drives the work of a single working group Responsible for working out what needs to be done by the working group; setting the direction for the group Consists of FDA and Industry co-leads WG5 co-leads – Analysis Script Standards – Mary NilssonEli Lilly – Sally CassellsNext Step – Hanming TuOctagon Research – Kevin KanePhastar – Joy LiFDA - CDER – Mat SoukupFDA - CDER – Mark WalderhaugFDA - CBER

Overall Guidelines (1) FDA/PhUSE CSS Working Group concept is a new frontier to meet the FDA needs. – Not Just a single meeting, but an on-going work effort throughout the year – Processes and tools still need work… Contribute with the Spirit of Collaboration among the participants (FDA, industry, academia, vendors, CROs, etc…) FDA representatives are here to contribute and meet the goals of the group – The views and opinions expressed by the FDA representatives are those of the individual and should not be attributed to the FDA or considered policy statements. Industry and Vendors – Do not use this forum as a marketing opportunity. Therefore, no advertizing or discussion of products All participation is on a volunteer basis from the “day job” – You are not limited to one Working Group, but at this meeting stick to one – Give what you can either during the meetings or assignments – The more participation (constructive) means a better industry-wide solution

Overall Guidelines (2) Incorporate other initiatives working in the same space to leverage their work for a common solution Solutions may take on many different forms – Recommendations, guidelines, templates, data exchange standards, process map, testing, etc… Group will schedule of conference calls after this meeting with face to face meetings as needed Group may break up into subgroups to focus and get more done Tools for the groups – List server to distribute s to the group list – Wiki to centrally store related information and documents

Overall Guidelines (3) All contributions will be considered open for use Consider all WG documents or artifacts as Public Domain – Free of charge without limitation to use, copy, modify, merge, publish, distribute, sublicense, and/or sell – “AS IS”, with out warranty or any kind, expressed or implied – The authors will not be liable for any claim, damages or other liability

CSS Meeting Logistics

Sunday – Registration from 4-6 pm Monday, March 19th – Light breakfast begins at 7:30 am – Meeting at 8:30 am – Working groups meet all afternoon Tuesday, March 20th – Light breakfast begins at 7:30 am – Working groups start at 8:30 and meet all morning – Working groups will provide summary and next steps – Meeting ends at 4 pm

Working Group Logistics Groups will have 3 hours on Monday and 3 hours on Tuesday Projectors and flip charts will be available Groups feel free to rearrange or break into groups if need be Wireless available (cost?) Power strips – working on it… Everyone needs to be flexible