Enabling creative Scientists to focus on Science Biopharm Development Formulation Dissolution Accelerated Stability Martin Owen GlaxoSmithKline Measurement, Information and Innovation: Digital Disruption in the Chemical Sciences Tuesday 20th October 2015, RSC, Burlington House, Piccadilly, London

Data to insight...aha! The big ideas Reduce the burden of data workflows Empower scientists to gain insight from data Communicate decisions & take action Concepts Case studies Automation Dashboards Data Workflows Biopharmaceutical development Formulation dissolution Accelerated stability

 

Nine different dissolution tests required by regulators Formulators Analysts 11 campaigns 26 formulations of nine excipients 59 Batches Nine excipients Spray coating & curing 3 layers 60 parameters One site closure Transfer to external contractor Nine different dissolution tests required by regulators Profiles and F2 Values End-point and 25 in-process sampling points 4 reference samples Similarity and equivalence specifications Three site transfers

Excel & pdf are also the enemies of Data visualisation

The App concept Biopharm Development Formulation Dissolution Accelerated Stability

The Biopharm Data Connector “App” Data Selection Preview Manage preferences Manage Extract Lists Formulation Dissolution Batch to batch comparisons “Stacked” data “Split” data, derive data, join tables, Accelerated Stability

The Formulation dissolution “App” Flexible extensible control panel Risk evaluations Formulation Dissolution Accelerated Stability Model comparison Batch to batch comparisons Work package performance Dissolution profiles

The ASAP “App” How good is our model? Packaging control options Risk evaluations Formulation Dissolution Accelerated Stability Automated data handling Automated model generation Attribute control Batch to batch comparisons

Key take home messages The big ideas Reduce the burden of data workflows Empower scientists to gain insight from data Communicate decisions & take action Concepts Seek-Incubate-Industrialise Automation Dashboards Data Workflow Applications Agile build-measure-learn Customer focus Data providers Data consumers Standardisation Extensible flexibility

Acknowledgements The GSK Informatics team Case Study 1: Biopharm project Team Case Study 2: Formulation project team Case Study 3: Accelerated Stability Incubation team David Burnham (Pega Analytics ) The JMP User Community