Martin Owen, Quality by Design Leader, GlaxoSmithKline
Emily Matthews, Post-Graduate Research Student, University of Southampton
David Woods, Professor of Statistics, University of Southampton
Verity Fisher, Principal Statistician, GlaxoSmithKline
The University of Southampton and GlaxoSmithKline are collaborating to generate enhanced statistical design, modelling and visualisation capability. An academic/industrial multidisciplinary partnership enables all aspects of the modern scientific cycle to be addressed: discovery of new problems from fundamental science, development of innovative statistical methodology, implementation and application of the solutions, and the translation and communication of the results. Working together, the team can ensure the quality and appropriateness of the statistical theory underpinning the applications while ensuring meaningful scientific interpretation through interactive models in a dashboard format. We add value to the scientific process by generating process understanding using optimal resource, requiring (a) the use of maximally efficient quantitative and statistical methods, and (b) better understanding and quantification of uncertainty and risk to product quality. The final piece is the technology transfer, including the use of JMP to empower data creators and data users to improve the way project teams communicate risk and evaluate options. The process, methodology and results from the collaboration will be demonstrated through a case study using statistics and visualisation techniques to support the development of a formulated product in the pharmaceutical industry.