Dr. Garrett has over 20 years of experience in the field of mass spectrometry spanning both instrument and application development. He received his PhD from the University of Florida, under Dr. Richard A. Yost, working on the first imaging mass spectrometry-based ion trap instrument. He has also developed MALDI-based approaches to analyze proteins in bacteria and small molecules in tissue specimens. His current interests include the translation of LC-HRMS, MALDI, DESI and LMJSSP in metabolomics to clinical diagnostics. He is an Associate Professor in the Department of Pathology at the University of Florida, and an Associate Director for the Southeast Center for Integrated Metabolomics (SECIM).

Donald H. Chace, PhD, MSFS, FAACC is the Chief Scientific Officer for Medolac, a public benefit corporation. He is one of the primary developers of newborn metabolic screening using tandem Mass Spectrometry. Developed 25 years ago with the first screening publication in Clinical Chemistry that describes the MS-based newborn screening of PKU, the method is now used to screen millions of infants per year, worldwide. Dr. Chace is an expert in metabolism and clinical chemistry using mass spectrometry as well as microsample analysis, e.g. the dried blood spot. He has published 100 peer reviewed articles and has presented at numerous conferences that focus on areas in Neonatology, Clinical Chemistry, Newborn Screening, Mass Spectrometry and Forensic Science. As CSO, at Medolac, he is currently working on bridging the gap of human based nutrition in the Neonatal Intensive Care Unit so that it will help neonatologist use human breast milk more efficiently. Dr. Chace is a guest researcher in the newborn screening and molecular biology division at the CDC and recently joined mQACC.

This is a 4-day Online (Zoom) course.

Metabolomics describes the analysis of the small molecules present in our body and ingested from the surrounding environment (i.e. drugs, pesticides, etc.). The analysis of these metabolites has recently been utilized to discover new markers of disease and perturbed metabolic pathways. Metabolomic analyses can be performed with either targeted or untargeted measurements. In targeted studies, only a small subset of metabolites is analyzed and this prevalent in clinical analyses for measurements such as those for newborn screening. Untargeted measurements, however, study all possible small molecules in a single injection and heavily rely on the use of high resolution mass spectrometry to precisely measure the m/z values across many samples. Untargeted measurements are almost always coupled to either gas or liquid chromatography or ion mobility as the retention time or mobility provides an important secondary distinguishing characteristic of each specific metabolite. It is expected that both targeted and untargeted metabolomic measurements will have an important place in future clinical studies.

Given the growth of metabolomics over the past several years, the use of high resolution mass spectrometry has rapidly progressed. High resolution approaches to measure small molecules offer several advantages for clinical analyses such as confirmation via accurate mass of the precursor and product ions and an evaluation of the isotopic abundance. This short course will cover the application of high resolution mass spectrometry to both quantitative and semi-quantitative analyses with a focus on metabolomics.

Topics in this short course include: mass accuracy for identification, tandem mass spectrometry, quantitative aspects of high resolution mass spectrometry, identifying and measuring the metabolome, statistical analysis, ion mobility spectrometry, and liquid and gas chromatography coupled to high resolution MS.

Anne K Bendt studied Biology focusing on marine biotechnology (Greifswald University, Germany), followed by a PhD in Biochemistry (Cologne University, Germany) employing proteomics and transcriptomics. Driven by her fascination for infectious diseases, she joined the National University of Singapore (NUS) in 2004 to develop lipidomics tools for tuberculosis studies. She is now a Principal Investigator at the Life Sciences Institute, NUS, focussing on translation of mass spec technologies into clinical applications, and serving as the Associate Director of the Singapore Lipidomics Incubator (SLING) taking care of operations and commercialization.

Research Assistant Prof. Cazenave-Gassiot is an early-career researcher and an expert in mass spectrometry-based lipidomics. He graduated with a PhD in analytical chemistry at the University of Southampton (UK), under the supervision of Dr John Langley, specialising in supercritical fluid chromatography and mass spectrometry. His interest in lipids started while a postdoc in the team of Professor Anthony Postle, still in Southampton. A member of SLING since 2009, his research centres on separation sciences, mass spectrometry, and their applications to life sciences, especially lipid biochemistry. He has developed chromatographic and mass spectrometric methods for the identification and quantification of lipids in diverse biological systems. This has included successful local and international collaborations.

Prof. Michael Chen is a Clinical Assistant Professor at the University of British Columbia. He completed his M.D., C.M. undergraduate medical program from McGill University in 2011. His journey at UBC began with the appointment as Adjunct Assistant Professor in the Division of Medical Sciences in 2017. Since 2019 he has been a Medical Director at Victoria Lipid Clinic. Most recently, he is contributing to the UBC COVID-19 Clinical Research Coordination Initiative as Co-Chair of the biobank. His research interests are Clinical and Translational Proteomics, Biomarker validation and Clinical Biobanking.

This 8-hr course is meant to (1) create awareness for the importance and therefore potential value of lipid testing beyond cholesterol and triglycerides for future clinical applications. We will (2) then outline currently available technologies and their respective opportunities and challenges, and (3) discuss candidate molecules in the context of two case studies. (4) Finally, this short course is designed to be engaging thus will require some active participation via online live-feedback.

1) Looking beyond cholesterol and TAG:
- Gain an understanding of the universe of lipids, how they are intricately linked to biology and their implications in health and diseases
- Potential of blood based lipid testing
- Identify physiologically relevant candidate lipids for adoption by the clinical community, for future studies towards establishing clinical utility

2) Current lipidomics R&D workflows:
- Path of translation from R&D laboratory-style methods towards robust and quantitative assays with appropriate turnaround times
- Pre-analytics (sampling requirements, plasma vs serum, storage, etc.)
- Analytics (i.e. batches, internal standards, lipid extractions, direct infusion vs LC-MS and LC-MS/MS, quality assurance)
- Post-analytics (raw data processing, lipid annotations, quality control, quantification), - Ongoing harmonization efforts

3) Case studies of markers that have advanced to clinical settings:
- Examples of markers that have already been implemented in a clinical setting in larger scale studies, to illustrate the feasibility and technical tractability, the clinical impact of lipid testing and its value on overall healthcare

4) Outreach and Engagement between the analytical scientist specialized in mass spectrometry of lipids, the clinician researcher and laboratory medicine as the end user are key to the development of impactful / useful lipidomics in clinical applications.

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.

Mike Wright is the Scientific Director at the Drug Development Solutions division of LGC, in Fordham, Cambridgeshire, UK. 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 LGC, 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 including the AACC’s Introductory Liquid Chromatography Mass Spectrometry certificate.

Coral is an experienced LC-MS/MS Technical Specialist at the Drug Development Solutions division of LGC, in Fordham, Cambridgeshire, UK. She is responsible for the development and validation of assays for the quantitative measurement of exogenous small molecules, biomarkers and small peptides in various human matrices. Prior to working at LGC, Coral worked with LC-MS/MS applications in food safety at the Irish Marine Institute. Coral provides training on method development best practices and teaches the chemistry basics that are fundamental to developing a robust LC-MS/MS assay.

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
  

• 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.

Professor Jack Henion is Emeritus Professor of Toxicology at Cornell University where he was a member of the College of Veterinary Medicine commencing in 1976. Dr. Henion was co-founder of Advion BioSciences in 1993 where he served as President and CEO until 2006 when be became CSO of Advion, Inc. Dr. Henion carried out a wide range of research in many application areas involving GC/MS and LC/MS/MS techniques. Professor Henion has received three Doctor Honoris Causa (Honorary Doctorate) degrees in recognition of his international reputation in modern analytical techniques. These were awarded from each of the University of Ghent, Uppsala University and Albany University. During his tenure at Cornell Professor Henion conducted research and explored applications in many areas of liquid chromatography/mass spectrometry (LC/MS) employing atmospheric pressure ionization (API) sources. Professor Henion has published over 235 peer reviewed papers in the scientific literature, trained nearly 100 students, post-doctoral scientists, and trainees while receiving 12 patents for inventions developed from his work. He has also received a number of awards which recognize his contributions to analytical chemistry and entrepreneurship. More recently in April 2017 Dr. Henion received the Outstanding Contribution to Anti-Doping Science Award from the Partnership for Clean Competition (PCC) for his development of a novel Book-Type Dried Plasma Spot Card and in the Fall of 2017 Dr. Henion was the winner of the 2018 Bioanalysis Outstanding Contribution Award (BOSCA). In December 2019 Dr. Henion retired from Advion, Inc. and is now a consultant for Henion Enterprises.

The cannabis industry is growing rapidly while providing commercial opportunities as well as new challenges. In the absence of FDA regulations, the anecdotal medicinal benefits of CBD along with possible other ‘entourage’ chemicals in the cannabis plant have fostered a ‘wild, wild west’ model for the commercial development of new products for human as well as companion pet treatments. This has created a need for ensuring the cannabis-derived products are safe and effective for the family pet as well as its human caretakers. This begs for technical analytical capabilities and laboratory integrity for providing reliable, accurate analytical services.

This introductory course will introduce the key analytical techniques currently employed in modern analytical service laboratories for the analysis of cannabis-derived products. These techniques include HPLC/UV, GC/MS, LC/MS, LC/MS/MS and ICP/MS. This course will introduce the new student to the basic principles of these analytical techniques along with the important sample preparation procedures necessary to prepare a cannabis ‘sample’ for analysis by one or more of these analytical techniques. A bachelor’s degree in analytical and organic chemistry is considered a very helpful foundation for the interested student.

1. Learn the differences between cannabis, hemp and marijuana.

2. Learn how important yet challenging sample preparation is for the many different sample matrices and widely different target chemical compounds which must be isolated and quantitatively measured.

3. Learn why just one analytical instrumental technique is inadequate to do provide sensitive, accurate and precise qualitative as well as quantitative measurements of cannabis-derived chemicals.

4. Learn what ‘potency’ means with respect to a cannabis sample.

5. Learn why toxic chemicals are unfortunately important with regard to the cannabis safety and efficacy.

6. Learn how the seemingly important role terpenes and other cannabis botanical components contribute to the apparent ‘entourage’ effects of cannabis.

7. Learn why residual solvents may be a concern in the production of some cannabis-derived products.

8. Learn why mold often is present on cannabis plant surfaces which produces very toxic chemicals called aflatoxins.

9. Learn how cannabis plants are hyperaccumulators of heavy metals from the soil and that it is very important to demonstrate that commercial products have been analyzed for heavy metals and shown to be free of these very toxic metals.

10. Learn why a person using cannabis-derived products can have clinical illness symptoms that are common to other ailments such which physicians should become aware of as they diagnose patients and prescribe treatment.

Grace is an LC-MS/MS Applications Development Specialist at St Paul’s Hospital in Vancouver BC. She is passionate about developing the most user friendly and streamlined LC-MS/MS assays as possible for routine use in the Special Chemistry Mass Spec Lab. She loves troubleshooting, especially when the cause of problem has been discovered and the issue solved!

Deborah French Ph.D., DABCC (CC, TC) is currently Assistant Director of Chemistry and Director of Mass Spectrometry at the University of California San Francisco Clinical Laboratories. Her work currently focuses on the development and validation of LC-MS/MS assays for small molecules, specifically therapeutic drug monitoring, steroid hormones and toxicology. Deborah received her Ph.D. in biochemistry from the University of Strathclyde in Glasgow, Scotland and then completed a postdoctoral fellowship at St. Jude Children’s Research Hospital in Memphis, TN. She subsequently completed a ComACC Clinical Chemistry postdoctoral fellowship under the direction of Dr Alan Wu at the University of California San Francisco and is now board certified in Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry.

Lorin Bachmann joined the VCU Department of Pathology in 2007. She currently serves as Co-Director of Clinical Chemistry, Co-Director of Point-of-Care Testing, Director of the New Kent Emergency Department Laboratory, Technical Advisor for the Operating Room Laboratory, Pathology Outreach and Clinical Trials, and Laboratory Director for multiple VCUHS outreach laboratories. Dr. Bachmann received her PhD in Molecular Medicine from the University of Virginia, followed by a fellowship in clinical chemistry and proteomics research at the University of Virginia. Dr. Bachmann is certified by the American Board of Clinical Chemistry.

Dr. Bachmann is active within the American Association for Clinical Chemistry (AACC), where she serves on the Board of Directors. She also serves as the Chair of the Chemistry and Toxicology Expert Panel for the Clinical Laboratory and Standards Institute (CLSI).

Dr. Bachmann’s research interests include evaluation and validation of new clinical laboratory assays, clinical laboratory analyzer design, development of mass spectrometry-based assays for the clinical laboratory and standardization of laboratory testing. She serves as the Chair of the National Kidney Disease Education Program (NKDEP)/International Federation of Clinical Chemistry Laboratory (IFCC) Joint Lab Working Group, whose goal is to accomplish standardization of urine albumin methods to enable utility of clinical decision thresholds.

Dr. Bachmann has received numerous awards for her contributions to professional societies, education and research. She serves as principal investigator for multiple industry-sponsored studies.

This is a VIRTUAL 4-Day Course with 16 total contact hours. CE to be provided (16 hrs).



Online Format

This is a virtual version of the short course that has been presented at MSACL. This online course includes 2.5-5 hours of live lecture each day for four days. Using Zoom (live online lectures, breakout rooms for interactive sessions) and Google Classroom (forms and job aids for download, on demand short lecture videos) provides additional opportunities for interactive and self-paced learning, both during the four-day course and beyond.

The resources posted in Google Classroom will be available to registrants for at least 3 months. We can’t give you hands-on experience with cutting PEEK tubing or changing check valves in an online course. But the potential with a virtual platform for networking and updates with actionable information to help you with your daily LC-MS/MS clinical practice seems almost limitless.

Course Content Description

Is your laboratory under pressure to purchase an LC-tandem MS or is the ROI you wrote last year haunting you now? 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 - CLS bench analysts, supervisors, R&D scientists, and laboratory directors. Theoretical concepts necessary for a robust implementation of clinical mass spectrometry will be presented – but the emphasis is on practical recommendations for:

1. LC-MS/MS system purchasing
2. site preparation and installation
3. defining preliminary MSMS and LC parameters for your first method
4. selecting and optimizing sample preparation for your first method
5. choosing internal standards, solvents, and water, making reagents and calibrators
6. adjusting sample preparation, LC and MSMS parameters to achieve the desired assay performance
7. establishing data analysis & batch review criteria
8. pre-validation stress testing and method validation
9. preventative maintenance and troubleshooting
10. maintaining quality in production.

Our goal is 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. The IFCC Committee for Distance Learning published a curriculum guideline for post-graduate trainees in laboratory medicine in 2017. This course includes all of the IFCC mass spectrometry curriculum listed in the “Principles of Analysis X-MS” section, except that we focus only on triple quadrupole mass spectrometry; metabolomics, proteomics and inborn errors of metabolism are not discussed. See also this reference by one of the team of short course instructors “Liquid chromatography-mass spectrometry education for clinical laboratory scientists”.

Previous exposure to the principles of clinical method validation, either didactic or practical, is assumed. A post-course online exam will be available, with a certificate of completion for those who take and pass the exam within the examination window of two weeks after the four day short course.