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.

Mr. Huidong Gu is a Principal Scientist in the Clinical Biomarker Immunoassays and Mass Spec Department at Bristol-Myers Squibb Company. For the past 17 years, Huidong has been working in the area of LC-MS/MS bioanalysis of small molecules, biologics and biomarkers with over 30 peer-reviewed publications. Huidong developed a novel approach for calculating and mitigating isotopic interferences in LC-MS/MS quantitative analysis. This approach has a significant impact in the area of microdosing absolute bioavailability studies using LC-MS/MS analysis of both the oral dosed non-labeled drug and the IV microdosed stable labeled drug. His recent work of in-sample calibration curve (ISCC) with multiple isotopologue reaction monitoring (MIRM) technique allows the instant and accurate measurement of biomarkers, biotherapeutics and small-molecule drugs in biological samples without using external calibration curves. This methodology can bring unique values of eliminated external calibration curves, simplified the workflows and improved throughput in the areas where absolute quantitation and overall sample turnaround still remain great challenges.

External calibration curves are commonly used in LC-MS/MS quantitative bioanalysis. In this presentation, a novel methodology of In-Sample Calibration Curves (ISCC) using Multiple Isotopologue Reaction Monitoring (MIRM) of a SIL-analyte for instant LC-MS/MS bioanalysis will be discussed. The theoretical isotopic abundances of a SIL-analyte in its MIRM channels can be accurately calculated based on the isotopic distributions of its daughter ion and neutral loss. The isotopic abundances in these MIRM channels can also be accurately measured with a triple quadrupole mass spectrometer. By spiking a known amount of the SIL-analyte into each sample, an ISCC can be established based on the relationship between the calculated isotopic abundances and the measured LC-MS/MS peak areas in each sample for the quantitative bioanalysis. With this novel MIRM-ISCC-LC-MS/MS methodology, instant, accurate and reliable LC-MS/MS bioanalysis of biomarkers, biotherapeutics and small molecule drugs can be achieved without using external calibration curves. Moreover, this methodology can bring unique values of eliminated external calibration curves, simplified workflows and improved throughput in the areas where absolute quantitation and overall sample turnaround still remain great challenges. The potential applications in quantitative proteomics, clinical laboratories and other areas will also be discussed.

Dr. Daojing Wang is Founder and CEO of Newomics Inc. He launched Newomics in September 2013 and led its technology development and commercialization since its inception. Dr. Wang obtained his B.S. degree from University of Science and Technology of China (USTC), Ph.D. in Chemistry from Princeton University, and completed his postdoctoral training at the University of California, Berkeley.

Newomics’ new Microflow-nanospray Electrospray Ionization (MnESI) Source offers unmatched sensitivity, robustness, and reproducibility for small-volume, high-throughput analysis of antibodies, proteins, nucleic acids and lipids derived from cells and human plasma. Researchers can use the platform for the timely identification of thousands of molecules in a multitude of tiny biological samples, while also taking advantage of the system’s superior nanoflow sensitivity and low detection limits. Ultimately, the MnESI Source enables significantly improved mass spectrometry performance. In this seminar, we will showcase the performance of MnESI platform in bottom-up proteomics, targeted proteomics, and top-down proteomics for clinical applications.

Craig E. Wheelock is an Associate Professor in the Department of Medical Biochemistry and Biophysics at the Karolinska Institute, Sweden, where he serves as director of the Integrative Molecular Phenotyping Laboratory (www.metabolomics.se). He is also a Distinguished Visiting Professor of Metabolomics at Gunma University, Japan. Following post-doctoral work on lipid mediators at the University of California Davis, he conducted additional post-doctoral studies at the KEGG laboratory in Kyoto University, Japan. In 2006, he was awarded a Marie Curie Fellowship to relocate to the Karolinska Institute. Research in his group focuses on molecular sub-phenotyping of respiratory disease, with a particular area of interest in investigating the role of eicosanoids and other lipid mediators. The overall aim is to develop personalized molecular profiles that can be associated with an individual’s lifestyle, environmental exposure and susceptibility to disease onset. He has been a founding Board Member of the Nordic Metabolomics Society since 2017, a Board Member of the International Metabolomics Society from 2016-2020, and serves on the European Respiratory Society (ERS) Advocacy Council as the Director of Scientific Relations with the EU. When not balancing his time between Sweden and Japan, he enjoys teaching his kids to kayak and play nicely with others.

"Mass Spectrometry has demonstrated to be a powerful analytical tool for the study of multiple diseases! This month, we will talk with Prof. Craig Wheelock about the application of MS-based approaches in the understanding of the pathophysiology of inflammatory respiratory diseases. His group is focused on the targeted analysis of lipid mediators (e.g., eicosanoids, sphingolipids) and investigating their role in the etiology of inflammatory disease.

Join our Career Fireside chat to learn from Prof. Craig Wheelock about his projects as well as his stories, lessons and advice on career paths in mass spectrometry. This is an interactive event and there will be an opportunity to chat and network with Craig and other attendees."

Ólöf Gerður is a PhD student at Margret Thorsteinsdottir´s and Sigridur Klara Bodvarsdottir lab in Iceland. She is working on a collaborative project with Zoltan Takat´s lab at Imperial College London where she uses imaging mass spectrometry to identify biomarkers in breast tissue. Ólöf obtained her B.Sc. at University of Iceland in Biochemistry with focus on molecular biology. She achieved her M.Sc. at University of Copenhagen (Denmark) in Human Biology, with focus on cellular and molecular biology. She has 3 years experience working as a research assistant for both University of Iceland and University of Copenhagen as well as she did a short-term internship at the Danish pharmaceutical company, Lundbeck.
Ólöf is a current co-Chair of the MSACL Early Career Network (MSACL ECN).

Ethan Yang is a postdoctoral fellow in Prof. Kristine Glunde's Lab in the Department of Radiology at Johns Hopkins University. His current research focuses on combining imaging mass spectrometry with other biomedical imaging approaches to provide a more holistic approach to reserach and diagnosis. He completed his PhD under Prof. Pierre Chaurand at the University of Montreal working on elaborating new techniques to enhance the sensitivity and selectivity of MALDI-TOF imaging mass spectrometry. He obtained his B.Sc. in Biochemistry at McGill University. He is a founding member of the MSACL Early Career Network (MSACL ECN) and is now the interim Chair of the Asia-Pacific Region.

"The early career network - ECN celebrates its 1st anniversary in May. With a lot of new members and the community growing please come and join us for a celebration. The ECN was established to support and connect early career scientist during Covid-19. We are very pleased with our first year, having hosted over 20 events including Fireside Chats, Workshops and Networking fun. Starting in the US the network has expanded to Europe and most recently Asia.

Everyone is welcome - old, young, early career, late career...retired? This event is open to anyone wanting to be an active member of the network. Come celebrate with us in a good networking session!"

Anthony Newman, who is making the presentation today, is a Senior Publisher with Elsevier, and is based in Amsterdam. Currently responsible for sixteen laboratory medicine and biochemistry journals, he joined Elsevier over 30 years ago and has been Publisher for the last 20+ years. Before then he was the marketing communications manager for the biochemistry journals of Elsevier. By training he is a polymer chemist and was active in industry before leaving London and moving to Amsterdam in 1987 to join Elsevier.

Conducting the research is not enough – you must also publish it - or else, in effect, it never happened!
The art of writing scientific papers is not usually taught, and so has to be learned, without much readily available resources. This workshop remedies that. The various tips and tricks shared in the workshop will be helpful to novice post-doc authors, all the way up to experienced researchers.

Knowing the best way of structuring your paper when writing it and the most appropriate journal to send it to
really helps in getting your paper accepted. Apart from these areas, the workshop will also focus on method description to aid reproducibility, figure design, references, publication ethics, understanding the peer review process including appropriate response to referees comments, and concluding with a Q&A session with help from the JMSACL Editor-in-Chief Alan Rockwood.

Understanding how editors and publishers think and what they expect, and knowing how the peer review process works, is an invaluable insight into the publishing process. This should help you get your papers published more easily so that you are one of the 30% accepted authors, not one of the 70% rejected ones.

Paul J. Jannetto, Ph.D., DABCC, FAACC, M.T.(ASCP), is an Associate Professor in the Department of Laboratory Medicine and Pathology and a Consultant at the Mayo Clinic (Rochester, MN), where he serves as the Co-Director for the Clinical Mass Spectrometry Laboratory, Clinical and Forensic Toxicology Laboratory and the Metals Laboratory. Previously, he was an Associate Professor of Pathology at the Medical College of Wisconsin (Milwaukee, WI) where he functioned as the Director of Clinical Chemistry/Toxicology at Dynacare Laboratories (Milwaukee, WI). He earned his BS in Clinical Laboratory Science from the University of Wisconsin-Milwaukee and worked five years as a Medical Technologist for Medical Science Laboratories before entering graduate school. He then earned a Ph.D. in Pharmacology and Toxicology at the Medical College of Wisconsin. He is board-certified by the American Board of Clinical Chemistry and American Society for Clinical Pathology. His clinical and scientific interests are centered on Clinical & Forensic Toxicology, Therapeutic Drug Monitoring, and Elemental Analysis.

Dr. Jannetto has been actively involved in the American Association for Clinical Chemistry (AACC) where he has participated in the TDM/Toxicology, Mass Spectrometry and Separation Sciences, Molecular Pathology, Management Sciences and Patient Safety, Personalized Medicine, and Critical and POCT divisions. In the past, he has served on numerous positions at the local level in both the Chicago and Midwest sections (e.g. Chair of the Chicago Section, Secretary of the Chicago Section, and Treasurer of the Midwest Section of AACC), and at the national level as a member of the Governance Review Advisory Taskforce, NACB Board of Directors, AACC Board of Directors, and Chair of the House of Delegates. Dr. Jannetto is also a member of the American Academy of Pain Medicine, International Association of Therapeutic Drug Monitoring and Clinical Toxicology, and was the President of the Midwest Association for Toxicology and Therapeutic Drug Monitoring. He has over 50 peer-reviewed publications, 14 book chapters, and over 75 abstracts/presentations at various national meetings.

An overview of the fundamentals that are driving research and development in the field of Toxicology.
This is part of a series of Primers on topics relevant to Clinical Mass Spectrometry.

Learning objectives include:
1. Be able to define what Toxicology is, why it matters, and why you personally should care. What is the clinical relevance?
2. Understand what role mass spectrometry plays in this field. Where does mass spec fit in to the big picture of the field?
3. Define any terminology that is specific to this field.
4. Describe how it works, what are the methods and workflows used when studying this field and/or how is it implemented in clinical labs.
5. Identify any challenges to implementation/adoption, where do the opportunities lie?

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.

Joseph Jones has worked in the clinical forensic toxicology field for over 30 years for large workplace drug testing laboratories and boutique forensic laboratories that specialize in testing alternative specimen types and is currently the Chief Operating Officer and Executive Vice President of United States Drug Testing Laboratories. He has contributed to over 25 peer-reviewed scientific papers in the field of forensic toxicology and facilitated numerous workshops and presentations. Jones has provided drug testing expert testimony on behalf of LabCorp and USDTL in a number of venues including union arbitration, unemployment hearings, family court child custody, child abuse/neglect and capital murder cases. Jones has been certified by the National Registry of Certified Chemists at a Toxicological Chemist.

Andre Sukta joined USDTL in early 2013 as our Laboratory Supervisor, bringing more than a decade of forensic toxicology expertise with him.
Andre received his Bachelor of Science degree in Chemistry (Forensics concentration) in 2002 from Benedictine University, Lisle, IL. In 2009, he received his Masters of Science degree in Forensic Science from University of Illinois at Chicago. He has co-authored several peer-reviewed research articles, including papers in the Journal of Analytical Toxicology and Forensic Science International.
In 2002, Andre began his career in toxicology as a Forensic Scientist with the Illinois Racing Board Laboratory. Since then, he has worked with various toxicology groups, including University of Illinois at Chicago - College of Pharmacy, Indiana University - College of Medicine, and the Indiana State Department of Toxicology.
Andre Sukta is a member of the Society of Forensic Toxicologists (SOFT), where he serves as a director of the organization, and serves on the professional mentoring program committee. He is also a member of the National Safety Councils Alcohol, Drugs and Impairment Division, where he serves as the Cannabis and Health and Safety subcommittee chair. He is also a full member of the American Academy of Forensic Sciences (AAFS), Chicago Chromatography Discussion Group (CCDG), and Midwest Association of Toxicology and Therapeutic Drug Monitoring (MATT).

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.