Laura Owen is a Consultant Clinical Scientist at Salford Royal NHS Foundation Trust and honorary senior lecturer at the University of Manchester where she teaches chromatography and mass spectrometry at Master’s level. Laura is also proud to be the chair of the practical training committee of MSACL EU and a past member of the endocrinology committee. While working at Wythenshawe hospital and in collaboration with the Christie hospital she became interested in the limitations of immunoassay measurement especially when using it in the breast cancer population. Laura developed and implemented the UK’s first LC-MS/MS assay for oestradiol in an NHS UKAS accredited laboratory which was made available for patient care and clinical trials.

I'm an Associate Principal Scientist in Bioanalysis with almost 10 years experience in the development, validation and sample analysis of exogenous drugs, endogenous molecules and biomarkers with LC-MS/MS assays. I work primarily with small molecules, with some experience in peptide LC-MS/MS.

Mike Wright is a Director in the Bioanalysis, Immunogenicity & Biomarker group within GSK. His team work on the development of assays for the monitoring of drugs and biomarkers, as drug development tools, in a wide variety of matrices. Prior to working at GSK, Mike worked in clinical diagnostics developing LC-MS/MS services for health trusts in the UK and Australia. Mike teaches on LC-MS/MS applications, considerations and troubleshooting and has contributed to a number of online training programs.

Is your laboratory under pressure to purchase an LC-tandem MS or have the instruments arrived and your team are beginning on their mass spectrometry journey? This short course is designed for attendees implementing quantitative LC-tandem MS for patient testing who have laboratory medicine experience but no mass spectrometry training - clinical bench analysts, supervisors, R&D scientists, and laboratory directors.

After starting out with a basic chemistry refresher, theoretical concepts necessary for a robust implementation of clinical mass spectrometry will be presented, however, the main focus of the course will be on practical recommendations for:

- Starting with MSMS, LC and sample extraction parameters
- Choosing internal standards, solvents, and water, making reagents and calibrators
- How to fine tune sample preparation, LC and MSMS parameters to achieve the desired assay performance
- Pre-validation stress testing and method validation
- Preventative maintenance and troubleshooting
- Maintaining quality once your new LC-MS/MS assay has gone live

Using real-world examples, recommendations will also be given on:
- LC-MS/MS system purchasing
- site preparation and installation (dos and don'ts)
- establishing data analysis & review criteria and an interface to the LIS

The course will be a steady mixture of lectures, tutorials and problem solving sessions with our goal being to present just enough theory so you can report high quality results, while opening a window to the depth and complexity of clinical mass spectrometry such that your appetite is whetted to learn more. Previous exposure to the principles of clinical method validation, either theoretical or practical, is assumed.

AGENDA

Day 1
Chemistry - Back to Basics
Sample Extraction
Essentials of Chromatography
Tutorial 1

Day 2
Mass Spectrometry
Tutorial 2

Day 3
Internal Standards
Reagents and Calibrators
Validation

Day 4
Vendor presentations*
Processing data and checking procedures
Maintenance, SST and Troubleshooting
Procurement and Infrastructure

*TBD