Integrating Laboratory Informatics with a Process Intelligence System for Parenteral and Oral Formulations
An IT director with experience in business analysis, application development, data management, and infrastructure management. Focused on providing IT solutions to enable business objectives. Known for excellent business knowledge and leadership skills. Recognized for strong performance and consistent delivery.
Specialties: Laboratory Information Systems, Database and Data Warehouse, SFA and CRM Systems
For drug product formulation understanding the process is paramount. For most formulators retrieving all the data necessary to do any type of analysis is often a laborious endeavour.
The data, which includes process parameters, analytical results and batch genealogy, is often dispersed across different electronic systems, exists in paper records, and resides with multiple individuals. Once data collection is complete the formulator faces another challenge. Since data capture is not standardized the data must be normalized before any analysis can be conducted. In this type of environment where a detailed understanding of process experimentation can have a beneficial impact on drug product development the knowledge must be extracted in a reasonable time frame.
This presentation will discuss the implementation of a process intelligence system along with the benefits, challenges, and lessons learned in parenteral and oral formulation.
We have delivered 12 new medicines to patients in the past 7 years.
Our R&D organization is considered among the most productive in the industry. And the business development strategy of innovative alliances, partnerships and acquisitions further enhances our internal capabilities. Our full array of transactions encompasses many of our key disease areas, along with new areas of focus such as genetically defined diseases and fibrotic diseases.