Location: Exhibit Hall - Serra (Conference Ctr > Ground Floor)

	Stephen Pennington, PhD University College Dublin, School of Medicine Steve graduated from Imperial College of Science and Technology (Imperial College London) with a joint honours degree in Chemistry and Biochemistry before completing a PhD in Biochemistry at the University of Cambridge. Subsequently, he was an Elmore Medical Research Fellow in the Department of Biochemistry in Cambridge University. His research team in University College Dublin (UCD; www.ucd.ie) is currently developing multiplexed protein biomarker measurements using multiple reaction monitoring mass spectrometry to support the translation of novel multiplexed blood protein biomarkers to clinical diagnostic tests. Steve is currently co-leading HIPPOCRATES with a rheumatologist colleague. HIPPOCRATES is an Innovative Medicines Initiative public-private partnership; it is a 22.5Million Euro project with 27 partners and seeks to address key unmet met needs in psoriatic disease. Patients and patient representative organisations are involved in all aspects of the project. In 2017 he was the lead organiser of the 16th Human Proteome Organisation (HUPO) World Congress, which was held in Dublin and included a Gala Dinner at which former US Vice-President Joe Biden was guest speaker. Steve is currently Professor of Proteomics and Senior Fellow, UCD Conway Institute and past President of HUPO (www.hupo.org)
	Mike Badeau YYZ Pharmatech Inc.
	Robert DeWitte, PhD
	Rejwi Dahal, PhD Indiana University School of Medicine Rejwi Dahal is a Clinical Assistant Professor in the Department of Pathology and Laboratory Medicine at Indiana University School of Medicine in Indianapolis, IN. Her areas of interest include development of small molecule quantitation assays using mass spectrometry.
	Carolyn Slade, MsHIM, CMM, HMCC CASSS – Sharing Science Solutions With a track record as an accomplished Meeting and Program Manager, I possess a history of expertise in developing creative, effective, and successful event strategies with medical associations as well as in the bio/pharmaceutical industry. Among my many talents is the ability to utilize excellent communication and interpersonal skills to productively cultivate and maintain positive working relationships. My reputation as a goal-oriented champion with strong organization and time management attention to detail skills to successfully coordinate multiple projects simultaneously is demonstrated throughout my career. I am highly recognized for completing assigned activities within established deadlines and adapting quickly to changing priorities.
	Mikaela Sanford CASSS - Sharing Science Solutions
	Timothy Collier, PhD Quest Diagnostics Dr. Timothy Collier is Scientific Director of Research & Development for the Quest Cardiometabolic Center of Excellence at Cleveland HeartLab, where his responsibilities include overseeing the identification and development of assays for cardiovascular biomarkers.
	Stephen Master, MD, PhD, FADLM Children's Hospital of Philadelphia Stephen Master received his undergraduate degree in Molecular Biology from Princeton University, and subsequently obtained his MD and PhD from the University of Pennsylvania School of Medicine. After residency in Clinical Pathology at Penn, he stayed on as a faculty member with a research focus in mass spectrometry-based proteomics as well as extensive course development experience in bioinformatics. After time as an Associate Professor of Pathology and Laboratory Medicine at Weill Cornell Medicine in New York City, where he served as Director of the Central Lab and Chief of Clinical Chemistry Laboratory Services, he took a position at the Children's Hospital of Philadelphia at Chief of Lab Medicine. One of his current interests is in the applications of bioinformatics and machine learning for the development of clinical laboratory assays. He would play with R for fun even if he weren't getting paid, but he would appreciate it if you didn't tell that to his department chair.
	Bruce Wilcox, PhD PrognomiQ
	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.
	Ashley Beasley-Green, PhD NIST Ashley Beasley-Green, PhD, received her BS in Biochemistry from Spelman College and obtained her PhD from the Department of Pharmacology and Molecular Sciences at The Johns Hopkins University School of Medicine. Dr. Green received a National Research Council Postdoctoral Fellowship at the National Institute of Standards and Technology (NIST) and is currently a Staff Scientist in the Biomolecular Measurement Division of the Materials Measurement Laboratory (MML) at NIST. Dr. Green’s research primarily focuses on the standardization of protein measurement science and the development of protein-based NIST Reference Materials and Standard Reference Materials to support basic research and clinical applications.
	Sean Pawlowski, PhD Ionpath Sean Pawlowski obtained his Ph.D. from Duquesne University while working under Dr. Mitch Johnson. His work was focused on the ultratrace detection of small biomolecules by fluorescence detection. Upon leaving Duquesne, Sean worked for Extrel, a quadrupole mass spectrometer company, working his way up from a Technical Support Scientist to the Product Manager and Lead Applications Chemist for their Research Mass Spectrometers Division. Sean collaborated with world wide users of Extrel’s MS systems with direct work on systems at NASA, JPL, Max Planck Institute and more. After leaving Extrel, Sean moved on to CAMO, a small cannabis extraction and purification startup, as the Lab Director and VP of Scientific Advancement. Sean established the purification division, helped author their SOPs, and trained a staff of highly skilled scientists. Before leaving CAMO, Sean developed their testing protocols and validation lab and presented those to legislators in Harrisburg as they developed their regulations and testing protocols. Sean is now working for Ionpath, a spatial biology company, where he works on advancing highly multiplexed ion beam imaging techniques. His knowledge and experience has led him to be one of the senior subject matter experts in time-of-flight secondary-ion-mass-spectrometry (TOF-SIMS) as well as mass spectral imaging (MSi) at Ionpath. Sean now travels the world collaborating with researchers and pathologists to help develop spatial biology solutions for immuno-oncology, drug targeting, and other tissue microenvironment needs. Sean currently resides in Springdale, PA with his wife Nikki, daughter Harper, and cat Opal. He is the President and CEO of Alpha Chi Sigma, the Professional Co-Ed Fraternity in the Chemical Sciences, serving a two-year term from 2022 - 2024. When not traveling for work, he can be found enjoying all that Pittsburgh has to offer.
	Carrie Adler, MSFS Agilent Technologies Carrie is the Technical Marketing Manager for Global Life Sciences Research and Clinical Markets at Agilent Technologies. Prior to this role, she was the Global Application Scientist for Clinical Research since 2016. Carrie has many years of clinical research experience from her 8-year tenure at ARUP Laboratories where she worked in Research & Development, focusing on LC-MS/MS and ICP-MS for the clinical toxicology labs. Carrie received her B.S. in toxicology from Ashland University in Ashland, Ohio in 2006 and completed a M.S. in forensic science, with a focus on forensic toxicology, from Virginia Commonwealth University in Richmond, Virginia in 2008.

Table 1: Translational Research: Insights for Today and Tomorrow
Stephen Pennington

In this roundtable we will discuss where we are as a translational research community, the complexities, tools available to researchers, strategies employed, and considerations for the future.

Table 2: YYZ Pharmatech - Is a tsunami coming? The role for LCMS in Alzheimer's Disease diagnostics
Rob DeWitte and Mike Badeau

With the approval of Aducanumab, Lecanemab and Donanemab, treatment options available for care of patients with Alzheimer's Disease have changed dramatically. This has lead to new hope for patients experiencing cognitive impairment, and a renewed focus on identifying disease progression earlier.

Treatment changes have also begun to influence laboratory operations as new invitro tests based on CSF are serving as surrogates for expensive imaging-based diagnostics. Blood based tests are also on the horizon for the most important markers (i.e. Aβ(1-42)/Aβ(1-40), P‐tau181 and P‐tau217), with the important benefits of sampling patients non-invasively, lowering costs and scaling without new infrastructure.

This all leads to the question: Is a tsunami coming?

Please join YYZ Pharmatech as we host a discussion about the impact of these shifts on the clinical laboratory, including:

• What tests are being offered, and where?
• How are laboratories adapting their technologies and workflows to support these trends?
• What are the operational challenges?
• What technical challenges remain to be solved?
• What potential benefits do LCMS methods provide?

Table 3: Building a Toxicology Testing Area - Tox Lab
Rejwi Dahal

Even though there is a need for definitive testing in clinical settings, there aren’t many guidelines available on what should be taken into consideration as laboratory directors tackle design and establishment of toxicology laboratory. This session will provide valuable information to early career professionals who may be tasked with starting up a toxicology section. Even though some vendors are available to assist with site design, site preparation responsibilities fall upon the site personnel. Thus, it is important to have a basic understanding of what is needed to start the project. This roundtable session will address many personal ‘lessons-learned’ based on experience working with design and construction team in an Academic Hospital Laboratory, including factors associated with space design (electrical needs, ventilation needs) that should be taken into consideration before unboxing the LC-MS/MS crates. Well-designed space will assist in facilitating seamless transition from instrument validation to method validations.

Objective 1: Understand the requirements for LC-MS/MS installation.

Objective 2: Discuss the journey of building a toxicology testing area from scratch.

Table 4: Don’t Slow Your Role: Moving the Needle on DE&I in a Damaged Workplace Culture
Carolyn Slade, Mikela Sanford

Diversity, equity, and inclusion (DE&I) goals cannot succeed as a standalone strategy in organizations where the culture is damaged. Signs of a damaged culture include favoritism, unconscious bias, and a lack of psychological safety. To be impactful, DEI initiatives require a strategic and intentional approach all year long, reaching all employees, and building equity into external programs and internal processes. What happens when two, black women who have suffered the most inequities, decide to move the needle on DE&I? Join this interactive roundtable discussion to hear how both transformed their experiences in toxic workplaces into achievable DE&I goals.

Attendees of this session will:

• Discuss the signs of a toxic workplace and discuss coping mechanisms
• Recognize DE&I does not begin or end with a specific title or place within an organizational chart
• Identify ways you can foster an inclusive and diverse workplace culture, and uphold principles of psychological safety in everyday practice
• Discuss tools and strategies for implementing DE&I principles in small group dynamic

Table 5: 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), software settings (gradients, transitions, cone voltages, and collision energies), and matrix effect 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.

Table 6: Use of Reference Materials for Calibration and Validation in Clinical Mass Spectrometry Applications
Ashley Beasley Green and Johanna Camara

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 and harmonization. Standardization is when clinical results are uniform across routine clinical methods and traceable to the International System of Units (SI) via higher-order RMs and Reference Measurement Procedures (RMPs). However, harmonization is established to make clinical results more equivalent across clinical methods when no higher-order RMs or RMPs exist. To support both systems, RMs are available in various forms, including neat powders, solutions, and clinical matrices and the intended uses include calibration and validation, depending on the material. The choice of which RM to use and how to incorporate it into a measurement system depends on laboratory goals. 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 RMPs. These RMPs typically separate and quantify individual peptides, 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. This roundtable is designed to discuss RM production, availability, and options for incorporating RMs into clinical applications. RM users may also need to propagate the measurement uncertainty of RMs or other calibrator values to clinical results. Therefore, the factors that should be accounted for when estimating measurement uncertainty will also be highlighted in the roundtable discussion.

Table 7: Quality Control Strategies for Large, Multiplexed, Omics Panels
Tim Collier, Steve Master, Brian Wilcox

Objective: Discussion of quality control strategies for large, multiplexed LC-MS Omics Panels

Summary: Recent Technological developments in LC-MS/MS instrumentation and bioinformatics approaches have enabled rapid, reproducible, and robust quantitative strategies for the measurement of hundreds, if not thousands of analytes that have the capacity to revolutionize the contribution of mass spectrometry based omics measurements to precision medicine. However, a major hurdle to the translation of large panels into a regulated clinical laboratory environment is how to properly deploy quality control (QC) standards. In this workshop, an expert panel of laboratory scientists and clinical chemists, with active discussion of the participating audience, will discuss how we might begin to address these challenges.

Topics Covered:

• A review of CAP/CLIA Quality Control Standards as deployed for small scale assays.
• Identification of the barriers current standards may present to the deployment of large omics panels in the CAP/CLIA regulated clinical laboratory environment.
• Expert panel and audience-driven discussion of potential strategies for ensuring proper assay QC, i.e. how panels can be adapted to current regulatory frameworks and/or proposing novel QC strategies that may satisfy CAP/CLIA regulatory frameworks.

Table 8: Roche - The Future and Beyond: A discussion on future assay menu needs for mass spectrometry in the busy clinical laboratory
Alex Chin and Allyson Kozak

For decades, immunoassays were considered by many the gold standard for analyte detection in the clinical lab. However, the need for improved sensitive and accurate complementary clinical laboratory methods grew in response to certain challenges in immunoassay performance. Mass spectrometry is renowned for its high sensitivity and accuracy and is therefore considered the gold standard in several clinical indications and has steadily become more prominent in today’s busy clinical laboratories. However gaps need to be addressed in the demands for a diverse test menu to serve a variety of clinical specialties and emerging disease areas. This roundtable will be an open forum to discuss gaps and pain points in current mass spectrometry assay test menus, what can be done to address current unmet and future needs in the clinical laboratory and to facilitate its adoption for improved patient outcomes.

Objectives:
1. Define what gaps exist in current mass spectrometry testing
2. Describe the pain points in current mass spectrometry testing
3. Identify potential future clinical indications for mass spectrometry testing

Table 9: Ionpath - From Bench to Map: Simplifying the MSi Spatial Proteomics Workflow
Sean Pawlowski

Multiplexed ion beam imaging (MIBI) is a technique that has simplified numerous issues present in MS workflows within spatial imaging. Compared to other MSi techniques, MIBI ™ presents a sample preparation workflow identical to fluorescence microscopy while also eliminating the need for messy spectral deconvolution to identify antibody targets. ToF-SIMS as the backbone of MIBI allows for multiple scans on a single ROI to glean more than surface-level information. Coupled with existing and custom data analytics tools, Ionpath’s spatial proteomics services help biologists answer fundamental questions about cellular and spatial interactions. Join this interactive session to discuss the spatial proteomics workflows used to extract information from this complex data and how MIBI can complement it.

Attendees of this session will:

• Discuss the growing pains of MSi in the spatial biology world
• Examine how MIBI technology can strengthen their spatial biology capabilities
• Look at the current state of spatial workflows
• Discuss the gains where MIBI technology can simplify the difficulties present in other MSi workflows
• Discuss the gaps present in the analysis of data in spatial biology

Table 10: Forever and Always - PFAS Monitoring in Human Matrix
Carrie Adler

Is human testing of per- and polyfluoroalkyl substances (PFAS) the next frontier for detecting and quantifying the “forever chemicals” that are now everywhere? PFAS regulations have been proposed or currently exist for drinking water, food packaging, and consumer products. PFAS cleanup and remediation are now being proposed for the 400+ PFAS compounds on the Environmental Protection Agency (EPA) list, however thousands of compounds exist. This brainstorming roundtable will focus on how biomonitoring would best be achieved.

Key Discussion Points:

• What are the drivers for human PFAS testing?
  • Current and anticipated regulations.
  • Direct to consumer requests.
  • With proposed environmental remediations, will repeat monitoring be required?
• Who is currently performing PFAS biomonitoring? Why?
• What are the challenges for targeted PFAS assays?
• What are the future PFAS research topics?
  • Untargeted discovery approaches.
  • Excretion profile and matrix considerations.