1. 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

2. 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

4. 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

6. Excel & pdf are also the enemies of Data visualisation

7. The App concept Biopharm Development Formulation Dissolution
Accelerated
Stability

8. 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

9. 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

10. 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

11. 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

12. 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