Location: Steinbeck Foyer

	Margret Thorsteinsdottir, PhD Faculty of Pharmaceutical Sciences, University of Iceland Professor in Pharmaceutical Analytical Chemistry at the Faculty of Pharmaceutical Sciences, University of Iceland and R&D Director of ArcticMass LTd, Reykjavik, Iceland. Dr. Thorsteinsdóttir received her PhD from Uppsala University, Sweden in 1998. From 2000 to 2009 she was the managing director of Bioanalytical Laboratories at deCODE Genetics, Reykjavik, Iceland. She has extensive experience in development of analytical methods for metabolite profiling and quantification of clinical biomarkers in various biofluids utilizing chemometrics with the goal of improved clinical management of patients towards personalized patient care. Her current research interest includes studies of lipid metabolism in cancer cells and profiling plasma derived biomarkers for early detection of BRCA-related breast cancer. She is responsible for implementation of clinical mass spectrometry for support of diagnostics and therapeutic drug monitoring in collaboration with ArcticMass and the Landspitali University Hospital, Reykjavik, Iceland with major focus on quantitative targeted proteomics for clinical diagnosis. She is a principal investigator of the Icelandic Research Rannis projects, profiling metabolites for breast cancer diagnosis and search for novel biomarkers for early breast cancer diagnosis by metabolomics. Dr. Thorsteinsdóttir is a principal investigator for the Marine Biotechnology ERA-net project CYNOBESITY and the Horizon 2020 project MossTech, with the main task to isolate, identify and structurally characterize bioactive compounds from cyanobacteria, Icelandic mosses and liverworts. She is one of the founders of Females in Mass Spectrometry (FeMS), she is a vice-leader of the working group clinical significance and applications of (epi)lipidomics in the pan-European network, EpiLipidNET and vice-chair of the Nordic Metabolomics Society.
	Finnur Eiriksson, PhD ArticMass
	Hsuan-Chieh (Joyce) Liao, PhD, NRCC, DABCC University of Washington Dr. Joyce Liao has more than ten years of clinical and management experience in laboratory medicine. She was a medical laboratory scientist in the newborn screening lab and obtained her Ph.D. degree in Clinical Medicine. She completed postdoctoral fellowship training in Clinical Chemistry at the University of Washington and Seattle Children’s Hospital. She is a board-certified Clinical Chemist and now served as an Associate Director at Harborview Medical Center, focusing on toxicology and mass spectrometry testing. She continues to focus on the translation of the analytical power of mass spectrometry to real clinical applications. Her interests include toxicology, mass spectrometry, and laboratory utilization.
	Liang Li, PhD Metabolomics Innovation Centre of Canada & University of Alberta Dr. Li obtained his B.Sc. degree in Chemistry from Zhejiang (Hangzhou) University, China, in 1983, and his Ph.D. degree in Chemistry from the University of Michigan, Ann Arbor, USA, in 1989, under the direction of Professor David M. Lubman. After graduation, he joined the Department of Chemistry at the University of Alberta, Edmonton, Alberta in July 1989. He was an Assistant Professor from 1989 to 1994 and an Associate Professor from 1994 to 1999. He has been a Full Professor since July 1999. He has also been an Adjunct Professor of Biochemistry Department, Faculty of Medicine, since January 2008. He holds a Visiting Professorship at Zhejiang University supported by K. P. Chao’s Hi-Tech Foundation for Scholars and Scientists since 2006. He is a co-PI of The Metabolomics Innovation Centre (TMIC) mainly supported by Genome Canada. He was a co-PI of the Human Metabolome Database (HMDB) Project; his laboratory generated the HMDB MS/MS spectral library of the endogenous human metabolites that has been widely used by the metabolomics community for unknown metabolite identification based on spectral matches. Dr. Li was a visiting scientist at Hewlett Packard Research Lab (now Agilent), Palo Alto, CA (on sabbatical leave) from July 1998 to June 1999. He served as Director, Alberta Cancer Board Proteomics Resource Lab from February 2000 to December 2005. He served as Chair, Analytical Chemistry Division of Chemistry Department from July 2007 to June 2019. He serves as a Co-Director of TMIC since July 2019. He is a founder of Nova Medical Testing, Inc., a university spin-off company focusing on developing mass spectrometry based analytical solutions for medical and health diagnostic applications, including targeted diagnostic-panel analysis and global biomarker analysis. Dr. Li is an elected fellow of the Royal Society of Canada (Academy of Science) (2019) (watch this video on Youtube). He is a Canada Research Chair in Analytical Chemistry (Tier 1, 2005-2012; renewed for 2012-2019). He has won several awards including McBryde Medal (2001) from the Canadian Society for Chemistry, Faculty of Science Outstanding Research Award (2002), McCalla Professorship (2002-2003), and Killam Annual Professorship (2004-2005) from the University of Alberta. He received the Young Explorers Prize from the Canadian Institute for Advanced Research (CIAR), which was given to Canada’s top twenty researchers aged forty or under in science and engineering (2002) as chosen by a panel of international judges. He was the recipient of the Rutherford Memorial Medal in Chemistry from the Royal Society of Canada (2003). He received The F.P. Lossing Award from the Canadian Society for Mass Spectrometry in 2006, The Maxxam Award from the Canadian Society for Chemistry in 2009 and Gerhard Herzberg Award from the Canadian Society for Analytical Sciences and Spectroscopy in 2010. He was one of the seven researchers selected as Brightest Minds 2016 by Canadian Institutes of Health Research. He is a fellow of the Chemical Institute of Canada since 2001. Dr. Li has published more than 300 research papers mainly in the area of analytical mass spectrometry. He has given many invited talks including Hong Kong Polytechic University Distinguished Lecture in 2011, Distinguished Lectureship on Cerebrating the 50th Anniversary of Hong Kong Baptist University Faculty of Science in 2011, and Thermo Fisher Scientific Distinguished Scientist Lecture at the University of Montreal in 2013. Dr. Li is currently an editor of Analytica Chimica Acta, an international journal on analytical chemistry with an Impact Factor of 6.558 in 2020 (2005-present). He is a member of the editorial advisory boards for Current Analytical Chemistry (2004-present), Journal of Advanced Research (Elsevier) (2014-), Biophysics Reports (Springer) (2015-), and Chemical Data Collections (Elsevier) (2015-). Dr. Li was a member of the editorial advisory boards for Journal of the American Society for Mass Spectrometry (2001-2006), Canadian Journal of Chemistry (2004-2006), Clinical Proteomics (2011-2016), and Analytical Chemistry Insights (2006-2018). He was a member of Analytical Chemistry’s A-Page Advisory Panel (2006-2008).
	Adam McShane, PhD Cleveland Clinic
	Brian Kelly, PhD, DABCC, FAACC BNK Clinical Laboratory Consulting, LLC Brian N. Kelly, PhD, DABCC, FAACC, As a clinical toxicology specialist with ARUP, I perform a review of test results to confirm if the patient is compliant with their prescriptions and not using illicit or non-prescribed medications. In my independent consulting business, I am pursuing opportunities to assist small clinical laboratories in the implementation of liquid-chromatography mass-spectrometry based analysis of biological specimens as well as other methods, such as immunoassays, that will increase the quality of care and reduce result turn-around-time. Combining my education, board-certification, expertise in analytical methods alongside regulatory knowledge, I am uniquely positioned to improve patient care via laboratory medicine. Previously, I was the Partnership for Clean Competition Research Fellow at the Sports Medicine Research and Testing Laboratory in Salt Lake City, Utah. There, I developed mass-spectrometry based detection methods for various substances that are prohibited by the World Anti-Doping Agency. I have been fortunate to have been awarded the Paul E. Strandjord Young Investigator Award by the Academy of Clinical Laboratory Physicians and Scientists two times; I have been invited to present my research results both domestically and internationally; and I have published numerous articles in peer-reviewed journals. In total, I have over 12 years of post-PhD research and teaching experience ranging from X-ray crystallography to molecular biology to interfering substances in point-of-care glucose meters as well as in toxicology and general laboratory medicine. I graduated with a double major in Biochemistry and Molecular, Cellular, and Developmental Biology from the University of Colorado and completed my PhD in Biochemistry from the University of Utah.

1. Is There a Better Way to Plan and Perform Experiments? Introduction to Experimental Design
Margrét Thorsteinsdóttir & Finnur Eiriksson

Experimental design (DOE) is a technique that allows to be more efficient in planning, conducting and interpreting results of experiments. In Analytical Chemistry, DOE can be used during method development and optimization, troubleshooting performance and method evaluation. The DOE technique is also very helpful for identifying critical parameters, which have the most significant effect on performance of the methods, products, processes, or systems. The participants will learn why DOE is better than performing experiments by changing one variable at a time, learn about cause-and-effect relationships and interactions between factors. The participants will be introduced to several types of DOE, will learn some of the principles and guidelines for planning experiments.

2. Do Identical Instruments Produce Comparable Patient Results? A Stumbling Block of Harmonizing LC-MS/MS Assays in Clinical Laboratories
Joyce Liao

Clinical mass spectrometry laboratories usually validate individual assays on more than one instrument for continuous operation. Instrument comparison is a requirement of the College of American Pathologists and should be monitored at least twice a year to ensure comparability of results. Although the same style of liquid chromatography-tandem mass spectrometry system is preferred to minimize the variations between instruments, labs will inevitably encounter bias between two or more identical LC-MS/MS systems. Even in the absence of bias, the same instrument model with two different serial numbers may require different instrument settings to obtain similar sensitivity and specificity. In this roundtable session, we will review several comparison data sets from the same extractions injected and analyzed on two LC-MS/MS systems of the same make and model. We will discuss the potential factors, including mass spectrometer hardware (probe type and cleanness) and software settings (gradients, transitions, cone voltages, and collision energies) that could bias patient results and how to establish quality assurance policies to ensure adequate data review and accurate resulting. Examples of challenges we have faced and approaches we have found useful will be presented as a starting point for discussion.

3. Challenges and Possible Solutions on Direct Metabolome Profiling for Clinical Applications
Liang Li

Metabolomics is mainly used for disease biomarker discovery with an objective of translating newly discovered metabolite biomarkers into clinical applications. On the other hand, direct metabolome profiling of human biofluids may be used for monitoring health status of individuals on a population scale. However, there are a number of challenges in realizing this goal. This roundtable discussion will focus on exchanging views on several key areas of technical development that are needed to bring large-scale metabolome profiling to clinical settings. These include sample type, sample handling, analytical platforms, data processing, clinical metabolome informatics, cost and scale, etc.

4. Thyroid Function Testing Interference and How Mass Spectrometry Can Help: Interactive Case Studies
Adam McShane

Thyroid disease affects approximately 20 million Americans, and can lead to a multitude of symptoms. These are often grouped into 2 categories: hyperthyroidism (e.g., anxiety, weight loss, and sleep loss) and hypothyroidism (e.g. fatigue, weight gain, and forgetfulness). Clinicians rely heavily on biochemical assessment of the thyroid for accurate diagnosis to ensure prompt treatment. Routine thyroid function tests utilize immunoassays for their availability, speed, and automation. However, this testing suffers from a variety of interferences which can delay diagnosis or worse lead to miss diagnosis. Liquid chromatography-mass spectrometry (LC-MS) is a much more specific platform than immunoassays that can be utilized in the investigation of potential inferences. This session will utilize real-life, interactive cases to exemplify common thyroid function testing interferences, investigatory considerations, and how LC-MS can be utilized.

5. A Day in The Life of a Remote Laboratory Director
Brian Kelly

Have you ever considered directing a small clinical laboratory, while continuing, or in addition to, your regular work? Do you want to start on your own, or as part of a larger laboratory staffing group? If so, come chat with me, Brian Kelly. I’m a board-certified clinical chemist and have been working as a remote laboratory director for 10 years. Learn about the differences between directing off-site from on-site directorship as well as some basic requirements for running your own small business. This session will be geared toward a question-and-answer format in hopes that other well-trained scientists will improve the quality of laboratory medicine in smaller settings by considering being a remote laboratory director.

Location: Steinbeck 1

	Hsuan-Chieh (Joyce) Liao, PhD, NRCC, DABCC University of Washington Dr. Joyce Liao has more than ten years of clinical and management experience in laboratory medicine. She was a medical laboratory scientist in the newborn screening lab and obtained her Ph.D. degree in Clinical Medicine. She completed postdoctoral fellowship training in Clinical Chemistry at the University of Washington and Seattle Children’s Hospital. She is a board-certified Clinical Chemist and now served as an Associate Director at Harborview Medical Center, focusing on toxicology and mass spectrometry testing. She continues to focus on the translation of the analytical power of mass spectrometry to real clinical applications. Her interests include toxicology, mass spectrometry, and laboratory utilization.
	Joshua Hayden, PhD, DABCC, FACB Norton Healthcare Joshua is currently the Chief of Chemistry at NortonHealthcare. He earned his PhD in chemistry from Carnegie Mellon University. He conducted postdoctoral research at Massachusetts Institute of Technology before completing a two-year clinical chemistry fellowship at University of Washington and 4 years as Assistant Professor at Weill Medical College. Joshua has special expertise developing and overseeing mass spectrometry assays in the clinical laboratory.
	Heather Stieglitz, PhD, DABCC The Ohio State University Wexner Medical Center Dr. Stieglitz is currently an Assistant Professor at The Ohio State University Wexner Medical center and Co-Director of Clinical Chemistry and Toxicology. She received her PhD from Emory University and completed a postdoctoral fellowship in Clinical Chemistry at the University of North Carolina before joining Ohio State. She is board certified in Clinical Chemistry by the American Board of Clinical Chemistry. Her interests are in mass spectrometry-based clinical toxicology testing in adults and newborns.

Confirmatory urine drug testing by liquid chromatography tandem mass spectrometry (LC-MS/MS) remains a corner stone of clinical mass spectrometry testing. This testing offers significant financial and patient care advantages and thus represents an excellent opportunity for new labs looking to establish or expand their LC-MS/MS testing. A clinical laboratory aiming to setup such testing will be faced with what can seem like an overwhelming number of options and decisions, especially if the laboratory is new or has limited experience with LC-MS/MS testing. This interest group discussion aims to help labs navigate these complex decisions by highlighting some approaches used by three clinical chemists who oversee toxicology testing at three medical centers. Topics that will be discussed include 1. choosing what drug classes and analytes (parent drug, metabolites, etc) to include, 2. whether to detect conjugated or unconjugated drugs, and 3. determining appropriate measuring and reportable intervals. This interactive session will begin with an introduction of the topic using case examples of how each speaker approached the issue followed by an open discussion with the audience on the advantages and limitations of different approaches.

Location: Steinbeck 2

Esthelle Hoedt, Ph.D PrognomIQ Esthelle Hoedt is a Senior Scientist at PrognomIQ. Her research focuses on the development, validation and deployment of clinical mass spectrometry assays for relative and accurate protein quantification in complex matrices. She received her PhD at Lille University of Sciences and Technology in France. As a Postdoctoral Fellow, she continued her research and training in the Mass Spectrometry Core Facility for Neuroscience at NYU, before working as a Senior Scientist at Caprion in Montreal, Canada. Prior to her current position, she focused on translating discovery proteomics assays to the clinic at Cedars Sinai Hospital in Los Angeles

Angela Mc Ardle, PhD, MSc, BSc Evosep Biosystems Angie is a Senior Scientist at Evosep Biosystems where her focus is proteomics and clinical applications. She has a strong background in mass spectrometry-based proteomics and has gained experience in multi-omic biomarker studies integrating both discovery and targeted approaches. Angie is originally from Ireland and received her PhD at University College Dublin. She continued her research career at Cedars Sinai, Los Angeles before joining Evosep Biosystems based in Denmark.

This workshop will focus on describing strategies for the translation of proteomic markers from a basic science environment to the clinical laboratory. Specifically, presenters will focus on cases studies describing strategies used to translate assays into use prior to the release of CLSI C64. We also aim to propose strategies and considerations clinical scientists should make for the translation of proteomic targets to clinical assays utilizing the most up to date guidance from CLSI C64.

• Attendees should have some previous experience in proteomic research and/or assay development or have previously attended the Proteomics Short Course or Proteomics Practical Training session.
• Participants will discuss specific case studies and the process of translating a proteomic assay from a basic research environment to the clinical lab.
• Attendees will be familiarized with strategies involved in the development and implementation of high quality clinical proteomic assays, drawing from the new CSLI C64 guide and other sources.

Location: Steinbeck 3

Location: Colton

Johanna Camara, PhD NIST Johanna began her employment at NIST as an NRC Postdoctoral Associate. Her activities have encompassed a wide variety of areas, including: MALDI-ToF mass spectrometry of bacteria, molecular cloning of stable-isotope labeled proteins for mass spectral internal standards, and the quantification of small organic molecules in pharmaceuticals, foods, and biological SRMs with liquid chromatography-mass spectrometry. She has participated in the Summer Undergraduate Research Fellowship program at NIST as an application reviewer and research mentor. Johanna is also the Clinical SRM Program Coordinator, the Quality Manager for the Organic Chemical Metrology Group, and the Deputy Quality Manager for the Chemical Sciences Division.

Reference materials (RMs), including certified reference materials (CRMs), are provided by the National Institute of Standards and Technology (NIST) and other RM producers to support global clinical measurement standardization. These materials are available in various forms, including neat powders, solutions, and clinical matrices. The intended RM uses include calibration and validation, depending on the material. Calibration with RMs may provide traceability to higher-order references when incorporated into specific measurement schemes. The choice of which RM to use and how to incorporate it into a measurement system depends on laboratory goals. This roundtable is designed to discuss RM production, availability, and options for incorporating RMs into clinical laboratory measurement applications. Many RMs are ideally suited for mass spectrometry-based measurement procedures. Many matrix matched RMs (blood serum, plasma, urine) are value assigned based on mass spectrometry-based Reference Measurement Procedures (RMPs). These RMPs typically separate and quantify individual metabolites, epimers, or other chemical variations of clinically relevant measurands that are not necessarily separated and detected by other laboratory techniques, such as immunoassays or microbiological assays. RM users may also need to propagate the measurement uncertainty of RM or other calibrator values to measurement results. NIST provides a publicly available online application ABACUS (Apps for Bayesian Analysis of Chemical quantities Using Shiny) intended as a tool for users to use all data from their experiments to calculate results with rigorous estimates of measurement uncertainty.

Location: Stevenson 1

Judy Stone, MT (ASCP), PhD, DABCC UCSF Judy Stone, MT (ASCP), PhD, DABCC has worked with LC-MS in diagnostic laboratories since 1999. Her clinical practice involved small molecule method development, instrument to instrument and instrument to LIS interfacing, LC-MS automation, monitoring quality of LC-MS methods in production and staff training for clinical LC-MSMS. She served as faculty chair for the 2009 AACC online certificate program “Using Mass Spectrometry in the Clinical Laboratory”, as a scientific committee member for the MSACL Practical Training track, and is editor-in-chief for the AACC Clinical Laboratory News quarterly feature series on Clinical LC-MS. She enjoys documenting and presenting esoteric as well as absurdly common LC-MS problems in creative ways in order to help trainees learn troubleshooting (and avoid repeating her mistakes).

Currently, there exist no formal training programs or licensure prerequisites for medical laboratory quantitative LC-MS/MS method development scientists or technologists. Although rudimentary LC-MS/MS theory may be part of Medical Laboratory Scientist (MLS) or Medical Laboratory Technologist (MLT) programs, quantitative LC-MS/MS method development is highly complex and typically not included. Lab Directors who are authorized to approve LDT methods are not necessarily trained in the details of technical quantitative LC-MS/MS validation.

We see a need for training and certification. This round table aims to get input and discuss a way forward and discussion topics will include:

(1) Training options

• Traveling Trainer
• Laboratory Participant Training Sites

• how can we move forward?
• What certification body is best?

This session is geared towards lab directors, lab scientists, and lab technologists. The goal is to get input from the community about what is needed and how the needs can be addressed.