PhUSE Nonclinical WG – Application of SEND data for analysis

AGEnDA/Minutes

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2015-04-10
/ Telecon/WebWebEx / 10:00 am – 11:00 am (EST)
4:00 pm – 5:00 pm (CET)
Meeting Organized by / Gitte Frausing & Laura Kaufman
MEETING PURPOSE / Discussion of use cases for analysis of SEND data
Attendees / Present / Name / Company
X / Anisa Scott / SAS Institute
X / Audrey Walker / Charles River Laboratories
Dan Potenta / Novartis
X / Gitte Frausing / Data Standards Decisions
X / Jillian Sanford / PointCross Life Sciences
X / Laura Kaufman / PDS Life Sciences
x / Lynda Sands / GlaxoSmithKline
Montserrat Cases / Bayer Pharma
X / Paul Brown / FDA
Rachel Harper / Covance
Richard Buchanan / PDS Life Sciences
x / Rihab Kordane / Charles River Laboratories
X / Robert Dorsam / FDA
X / Thomas Gade Bjerregaard / Novo Nordisk
X / Wenxian Wang / Xybion

Agenda topics

1.Brief introduction of participants

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Everyone did a brief introduction of themselves.

2.Appointment of co-lead(s) and meeting schedule confirmation

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Laura Kaufman has volunteered.

The group agreed that we would stick with every other Friday 10-11 EST (4-5 pm CET).

3.Recap the work from CSS

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We reviewed our project scope from the CSS meeting and the Wiki website content


4.Approach and outline of deliverable

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Gitte presented a slide with some overarching questions that may start us off in the right direction (slide copied below). Specifically question 1 can help us address the first level of data analysis that is necessary to support any subsequent scientific assessments of the study findings.

It was mentioned that the toxicological assessment is an integrated analysis with many dimensions including statistical analysis and it will be our challenge to break this integrated analysis into manageable chunks.

Our goal is ultimately to enable this analysis on SEND datasets, and the first order of business must be to look at how subject level data such as SEND needs to be compiled, and in doing so, identifying critical analysis keys (i.e. SEND variables) to fit the puzzle.

It was also cautioned that this can quickly become an all-encompassing exercise where all SEND variables end up being critical if all possible analytical scenarios must be accounted for.

Another point to consider is whether the first layer of data compiling and associated analytical keys is intended to support analysis within or across studies.

There is a first version started on the Wiki site under Working Documents. Everyone is free to add, edit and wordsmith using track changes and comments.

5.Prioritization of SEND domains

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Postponed until the next meeting.

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