Increasing Efficiency in Pharmaceutical Analysis by Using Enhanced Automation Techniques to Characterize Preclinical and Clinical Drug Candidates

Description:
Automation has been successfully used in quality control and discovery in the pharmaceutical industry for 30 years, or more. Yet its use in reliably testing chemical and physical properties of lead candidate drugs transitioning from discovery to development is less established. What’s needed in the pre-clinical and early clinical phases is to enhance our automation capability for identifying key property and quality attributes when evaluating development risks. For example, molecular properties like solubility, chemical and physical stability, impurities, and the impact these have on biopharmaceutics are investigated. The advances in drug discovery have led to an array of compounds that range from small molecules to structures like mRNAs and proteins making it even more important to quickly identify key method attributes.
While automation is a broad term that includes robotics for sample preparation, it also encompasses knowledge management concepts of data integration, evaluation, and result reporting. The purpose of this symposium will be to explore how we can gain speed and efficiency to assess development risks by using new automation tools and advanced analytical instrumentation.

Speaker: Stacey Marden - AstraZeneca
Stacey Marden is a senior analytical scientist at AstraZeneca with over 30 years’ experience in the pharmaceutical industry. She has been involved in all phases of pharmaceutical development and is currently working in the pre-clinical space. She greatly enjoys the scientific challenges encompassing new molecular entities and is tenacious to discover their hidden secrets. Stacey is a member of the AstraZeneca global Degradation Network and is actively involved in the International Forced Degradation Community (IFDC), a cross-pharma group whose purpose is to study and recommend best practices for performing forced degradation studies. Since finishing her PhD at the University of Massachusetts, she has held many roles over the years including project lead for compounds transitioning from discovery to development, group leader, and business lead for a departmental LIMS system. Personally, Stacey is an outdoor enthusiast and bird watcher, and enjoys cycling to work as often as possible.