SCIEX Petite Suite : The ZenoTOF 8600 system: When sensitivity reveals the unseen
Location: Outremont 4
830
915
Petite Suite Discussion : Patient Centric Remote Sampling for Clinical Diagnostics – How do we overcome the regulatory hurdles?
Location: Outremont 1
Russell Grant, PhD Labcorp
Dr. Grant earned a first-class honors degree in Industrial Chemistry from Cardiff University and a PhD in Chromatographic and Mass Spectrometric technologies from the University of Swansea, Wales, United Kingdom. He continued his scientific training in various industrial settings, which have included senior scientist at GSK, Principal scientist at Cohesive Technologies, Technical director at Eli Lilly, and Director of Mass Spectrometry at Esoterix Endocrinology. Dr Grant is currently the Vice President of Research and Development and co-discipline director for Mass spectrometry at Labcorp. Dr Grant has pioneered the use of direct injection technologies, chromatographic systems multiplexing, microsampling, utility of automation, and other new analytical platforms in direct patient care. His research goals are focused upon improvements in speed, sensitivity, and quality of liquid chromatography with tandem mass spectrometric (LC-MS/MS) analytical systems and assays. Dr Grant has been awarded 100 patents and received both the MSACL Distinguished contribution award and ASMS AL Yergey “Unsung Hero” Award in 2024 for his contributions to Clinical Diagnostics using Mass Spectrometry.
Relevant Financial Disclosures
(within past 24 months, reported on Apr 23, 2026)
Committee/Board/Advisory Board
BCal Diagnostics
Stock/Bonds
Labcorp
Salary
Labcorp
Dajana Vuckovic, PhD Concordia University
Dr. Dajana Vuckovic is Professor and Concordia University Research Chair in Clinical Metabolomics and Biomarkers and the Director of Centre for the Biological Applications of Mass Spectrometry at Concordia University. Her research program focuses on the development of novel mass spectrometry and microextraction methods to accurately measure challenging low-abundance and unstable metabolites and improve metabolite coverage and data quality in clinical metabolomics and lipidomics. Dr. Vuckovic is the recipient of the 2023 Fred Beamish Award from the Canadian Society for Chemistry and the 2024 Metabolomics Society medal. She serves on the editorial boards of Bioanalysis and Analytical and Bioanalytical Chemistry and currently co-leads the Best Practices Working Group of Metabolomics Quality Assurance and Quality Control Consortium. She has co-organized numerous scientific symposia at leading national and international conferences and has co-chaired Metabolomics 2023 conference held in Niagara Falls, Canada.
Relevant Financial Disclosures
(within past 24 months, reported on Mar 12, 2026)
No relevant financial relationship(s) to disclose.
Shelley Hossenlopp, MS Poca International LLC
Executive with 37 years of global and domestic laboratory and medical device commercialization: sales, distribution, marketing, business development, funding, product management, clinical trials, regulatory, manufacturing and Intellectual Property strategy planning. Inventor with two patents as co-inventor with US Army pertain to laboratory consumable for biosecurity for samples. Advanced experience working with the Department of Defense (DoD) and other US and foreign government, Ministries of Health (MOH) and non-government agencies (NGO's) and Fortune 100, 500 firms.
Board level experience with commercial start-ups, universities and nonprofit 501(c)3 organizations.
Executive management level experience working with all business climates: start-ups, mid-level, Fortune 100 & 500 Corporations, and non-profit 501(c)3's to include fund-raising and M & A activities
Areas of Expertise in: sales, marketing, distribution, commercialization strategy, business development, acquisition, funding, intellectual property analysis, clinical affairs, research and product development and manufacturing: Conduct market analysis, develop sales forecasts, budgets, marketing, & distribution strategies, and commercialization plans. SG&A, P&L responsibilities, Manage clinical affairs and trials. IRB, IRC, and FDA PMA, De Novo, 510(k) experience, QSR and cGMP knowledge.
Relevant Financial Disclosures
(within past 24 months, reported on Feb 27, 2025)
No relevant financial relationship(s) to disclose.
Numerous technologies are now commercially available that facilitate the collection of human blood samples in locations away from the clinical setting. This approach is termed patient centric sampling, or microsampling and can involve the collection of samples from a finger stick, or from elsewhere on the body. The samples can be dried or liquid and are often a smaller volume than those obtained by traditional phlebotomy.
The use of these approaches potentially enables samples to be collected from currently underserved communities (pediatric, elderly, remote areas, etc). Furthermore, the approach may enable more regular sampling of individuals to be performed and facilitates choice for the patient about how and where samples will be collected. These technologies also have the potential to overcome the discomfort, pain and fear that is encountered by many when collecting samples by traditional phlebotomy.
However, there are challenges around the regulatory status of the sampling devices and assays developed for clinical diagnostic purposes using these technologies. Participants of this workshop will take part in a facilitated discussion on what the regulatory challenges are to the adoption of these technologies. Different regulatory frameworks and quality systems will be discussed relative to EU (Medical Device Regulation + In Vitro Diagnostic Regulation), USA (FDA class 1 & 2 test “systems”) and Canada (Medical Device Directorate, ICH M10). Exemplars will be discussed relative to current products and workflows that have achieved regulatory approval in these jurisdictions. Participant discussion will then focus on how these barriers may be overcome and what future activities might be required to enable this.
830
915
Petite Suite Discussion : Integration of Mass Spectrometry Imaging with Standard Pathology Lab Workflows
Location: Outremont 5
Peggi Angel, PhD MUSC Proteomics Center
Peggi Angel is tenured Professor at Medical University of South Carolina Department of Pharmacology & Immunology and Co-Director of Mass Spectrometry Imaging. Dr. Angel’s work focuses on the contribution of spatial chemical biology to the external, endogenous environmental in disparities of disease risk, progression, and therapeutic resistance. She has developed multiple mass spectrometry imaging approaches to spatial biology all of which are designed for use on clinically archived human specimens of tissues, cells and fluids, and are developed working with clinicians. Notably, she is the inventor of a spatial method targeting the collagen proteome in formalin-fixed, paraffin-embedded tissues that integrates collagen proteomic maps with spatial transcriptomics and microscopy studies. Dr. Angel has over 14 years cumulative experience in 5 biotech startups including Glycopath, Inc., a company that leveraged glycosylation patterns as a prognostic or diagnostic tool; she currently serves on the board of N-Zyme Scientifics, a company that produces enzymes for targeted mass spectrometry imaging. Dr. Angel is committed to creating a collaborative mass spectrometry imaging community and serves as Past President for the Americas Region of the International Mass Spectrometry Imaging Society, as a Trustee for the International Mass Spectrometry Imaging Society, and as Secretary on the USHUPO Board of Directors. Dr. Angel is devoted to coaching and mentoring, particularly for females and minorities, serving on multiple committees to advise and mentor young scientists in entrepreneurship within multidisciplinary teams
Relevant Financial Disclosures
(within past 24 months, reported on Jul 20, 2025)
No relevant financial relationship(s) to disclose.
Kristina Schwamborn, MD, PhD Technical University of Munich
Relevant Financial Disclosures
(within past 24 months, reported on Apr 01, 2025)
Much work has been done in the last 5 years to integrate tissue sections coming from the pathology lab with MS imaging. We will discuss workflows starting with the pathology laboratory that combine hematoxylin & eosin pathology stains or immunohistochemistry workflows with mass spectrometry imaging. We will discuss the advantages and disadvantages of using the multiplexed power of mass spectrometry imaging for a deeper understanding of patient pathology. Prospects for using mass spectrometry imaging in combination with diagnostic stains from the pathology lab to improve patient care will be discussed.
830
915
Coffee Roundtables & Exhibits
Location: St Laurent (Exhibits)
Prof. Dr. med. Michael Vogeser University Hospital, LMU Munich
Dr. Michael Vogeser, MD, is specialist in Laboratory Medicine and senior physician at the Hospital of the University of the Ludwig-Maximilians-University Munich, Germany (LMU; Institute of Laboratory Medicine). As an Associate Professor he is teaching Clinical Chemistry and Laboratory Medicine. The main scope of his scientific work is the application of mass spectrometric technologies in routine clinical laboratory testing as translational diagnostics. Besides method development in therapeutic drug monitoring and endocrinology a further particular field of his work is quality and risk management in mass spectrometry and in clinical testing in general. Michael has published >240 articles in peer reviewed medical journals. Michael heads the Commission for In Vitro Diagnostics in the German Association of Scientific Medical Societies (AWMF).)
Relevant Financial Disclosures
(within past 24 months, reported on Mar 30, 2026)
Not yet reported.
Stacy Beal, MD LetsGetChecked and University of Florida
Stacy G. Beal, MD is the Laboratory Director for LetsGetChecked, a high volume laboratory in Monrovia, CA and is an Associate Professor in the Department of Pathology, Immunology, and Laboratory Medicine at the University of Florida. She is board certified in Clinical Pathology, Medical Microbiology, and Clinical Informatics by the American Board of Pathology. Her interests include diagnostic testing, laboratory stewardship, and regulatory aspects of laboratory testing. She is an expert in laboratory quality and home collection of laboratory specimen. She served on the College of American Pathologists Quality Practices Committee and has extensive teaching experience. Dr. Beal currently resides in Gainesville, Florida. While not working, she is likely to be found dancing to Disney songs with her two daughters, on a tandem bike ride with her husband, or listening to a podcast about cooking while going for a long walk.
Relevant Financial Disclosures
(within past 24 months, reported on Feb 28, 2025)
No relevant financial relationship(s) to disclose.
Nguyen Nguyen, PhD, DABCC Baylor Scott & White Health, Baylor College of Medicine
Nguyen Nguyen, PhD, DABCC, is a board-certified clinical chemist and laboratory director at Baylor Scott & White Medical Center in Temple, Texas. He also serves as an assistant professor of pathology at Baylor College of Medicine. His work centers on toxicology, mass spectrometry, and promoting culturally competent approaches to drug testing. He’s passionate about making lab results more clinically meaningful for diverse patient populations.
Outside of work, he enjoys spending time with family, playing music, staying active with sports, and diving into a good book.
Relevant Financial Disclosures
(within past 24 months, reported on Jun 12, 2025)
No relevant financial relationship(s) to disclose.
Traci Mizuno, PhD Trajan Scientific and Medical
Relevant Financial Disclosures
(within past 24 months, reported on Jul 17, 2025)
No relevant financial relationship(s) to disclose.
David Colantonio, PhD, DABCC, FCACB The Ottawa Hospital - EORLA
Dr. David Colantonio is a clinical biochemist at The Ottawa Hospital-EORLA and is an Associate Professor in the Department of Pathology and Laboratory Medicine at the University of Ottawa. David completed his PhD under the supervision of Dr. Jennifer Van Eyk followed by a fellowship in Clinical Chemistry at Johns Hopkins University. David oversees the therapeutic drug monitoring and toxicology lab, as well as the porphyria specialty testing lab. David has expertise in developing mass spectrometry assays used in the clinical laboratory. In addition to overseeing the mass spectrometry lab, he is also involved with teaching residents, as well as is actively involved in research.
Relevant Financial Disclosures
(within past 24 months, reported on Aug 05, 2025)
Other Potential Conflicts
I have no financial relationships to disclose. I will be presenting / discussing a product from Chromsystems that I have modified for use, which is in a manner not currently recommended by the vendor, but I am not being renumerated or given any financial benefits for this presentation.
The IVDR has been in a gradual introduction process in the European Union since 2017. In particular, requirements with regard to in vitro diagnostic devices that are manufactured in healthcare facilities and used exclusively there are the subject of continued discussion. It would be desirable for the upcoming IVDR evaluation process to result in changes to the law that would provide the laboratories concerned with clarity and relief in this area. It is very important that the community of affected diagnostic laboratories is heard and taken into account in the EU processes. This should be seen as a shared task.
Table 02: Starting an In-House Clinical Laboratory Scientist//Medical Technologist Training Program
Stacey Beal
The purpose of this roundtable is to explore the feasibility and benefits of starting a Clinical Laboratory Scientist (CLS)/Medical Technologist (MT) training program at your laboratory. With an increasing demand for skilled professionals in clinical laboratory science, establishing an in-house training program can help address staffing shortages, ensure a steady pipeline of qualified personnel, and elevate the quality of services provided to patients. This discussion will focus on the steps needed to create the program, including aligning with accreditation standards and developing a curriculum that meets clinical and laboratory needs. We will also cover the necessary resources such as faculty, clinical mentors, and equipment, along with a timeline for program implementation. Additionally, we will address the potential challenges, such as securing funding, recruiting qualified students and instructors, and ensuring that the program meets the required certification and licensure standards. The discussion will provide insights on how a CLS/MT training program can benefit your laboratory, enhance the professional development of staff, and ultimately improve patient outcomes by providing a highly trained, dedicated workforce.
Table 03: Thebaine Testing to Improve Clinical Interpretation of Drug Testing Results
Nguyen Nguyen
Thebaine, a naturally occurring alkaloid in opium poppy, serves as a precursor in the synthesis of medically relevant opioids such as oxycodone and naloxone. Despite its limited direct pharmacological effects, thebaine is a critical biomarker for distinguishing poppy seed ingestion from illicit opioid use. Understanding the nuances of thebaine testing is essential for clinicians, toxicologists, and forensic professionals, particularly when interpreting complex cases involving drug testing.
This roundtable will cover the biochemical properties of thebaine, the analytical methodologies employed (with a focus on LC-MS/MS for high-precision quantification), and the clinical implication of its detection. Emphasis will also be placed on standardizing sample preparation, utilizing deuterated internal standards, and implementing quality control to ensure reliable results.
Time permitting, we may discuss case studies to illustrate the differentiation between dietary exposure and opioid abuse, highlighting challenges in interpreting results within diverse patient populations. Participants will gain practical insights into integrating thebaine testing into their workflows and leveraging this knowledge to improve diagnostic accuracy, enhance patient care, and support legal decision-making.
Microsampling technologies are reshaping how and where biological specimens are collected. These low-volume, minimally invasive solutions enable more accessible and patient-centric sampling, while also supporting more frequent monitoring in clinical and research settings.
Yet, as adoption grows, labs are confronting practical challenges - not only in sample collection, but also in how to efficiently accession, prepare, and integrate microsamples into LC/MS-based workflows. Manual processes can limit throughput, accuracy, and reproducibility, especially in regulated environments.
This roundtable invites participants to take part in a structured discussion exploring:
- Sample collection challenges in clinical and translational research settings
- Barriers to integrating microsampling with existing laboratory infrastructure
- Needs and opportunities for automation in sample accessioning and preparation
- Desired improvements in device usability, workflow fit, and regulatory support
This session is part of an ongoing initiative to gather actionable end-user insights that will shape the next generation of microsampling technologies - from device to data, seamlessly integrated. Researchers, clinical scientists, and lab professionals working with biofluids, dried blood spots, or microsamples are encouraged to attend and contribute to the conversation.
Table 07: Chromsystems : Assessment of Free Tacrolimus Levels During Pregnancy
David A. Colantonio, PhD, DABCC, FCACB
Pregnancy following solid organ transplantation has been quite successful. However, tacrolimus pharmacokinetic changes during pregnancy make interpretation of whole blood concentrations challenging due to the significant physiological changes that occur throughout pregnancy. As a result, measurement of unbound tacrolimus concentrations is clinically important as free tacrolimus levels correlate more closely with therapeutic efficacy and toxicity than whole blood levels for pregnant women, though such measurements can be technically challenging.
Early Career and first time attendees are encouraged to meet at the MSACL registration desk at 9:25am to join a POSTER TOUR with a guiding mentor. Poster Tour Overview
1030
1130
Plenary Lecture : AI Deployment in the Clinical Laboratory: Practical Considerations and Lessons Learned
Location: Montreal 4-8
David McClintock, MD Mayo Clinic
David McClintock is the Chair of the Division of Computational Pathology and Informatics within the Department of Laboratory Medicine and Pathology at Mayo Clinic (Rochester, MN). He is an AP/CP and Clinical Informatics boarded pathologist, with primary clinical interests including pathology informatics, clinical AI lifecycle/AI model deployment, digital pathology, and clinical laboratory workflow optimization/analytics. His research interests include the use of AI and machine learning tools for improved diagnostics, workflow optimization, and improved patient outcomes, in addition to the application of robotic process automation and computer vision tools within healthcare. Dr. McClintock is involved in multiple pathology organizations, including previously serving as the President of the Association for Pathology Informatics (API, 2018) and currently serves as the API Program Committee Chair.
Relevant Financial Disclosures
(within past 24 months, reported on Oct 11, 2025)
No relevant financial relationship(s) to disclose.
1130
1330
Lunch & Exhibits
Location: St Laurent (Exhibits)
Buffet Lunch hosted by MSACL. Soup, salads, sandwiches, fruit, cheese and dessert.
Discussion Group : Career Exploration in Clinical Mass Spectrometry
Location: Salon Bonaventure, Hotel Level
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.
Relevant Financial Disclosures
(within past 24 months, reported on Jan 14, 2026)
No relevant financial relationship(s) to disclose.
Claire Knezevic, PhD Lurie Childrens Hospital
Dr. Claire Knezevic is a clinical chemist in the Department of Pathology and Laboratory Medicine at Lurie Children's Hospital with a focus on chemistry, point-of-care testing, quality improvement, drug monitoring, and personalized medicine. She is an Associate Professor in Northwestern's Feinberg School of Medicine in the Department of Pathology. Her interests include all things small molecule, from toxicology to therapeutic drug monitoring and their impacts on clinical care.
Relevant Financial Disclosures
(within past 24 months, reported on Mar 06, 2026)
No relevant financial relationship(s) to disclose.
Elie Fux Roche
Relevant Financial Disclosures
(within past 24 months, reported on Jul 10, 2025)
Not yet reported.
Joseph Medeiros Waters
Relevant Financial Disclosures
(within past 24 months, reported on Jul 10, 2025)
Not yet reported.
Peggi Angel, PhD MUSC Proteomics Center
Peggi Angel is tenured Professor at Medical University of South Carolina Department of Pharmacology & Immunology and Co-Director of Mass Spectrometry Imaging. Dr. Angel’s work focuses on the contribution of spatial chemical biology to the external, endogenous environmental in disparities of disease risk, progression, and therapeutic resistance. She has developed multiple mass spectrometry imaging approaches to spatial biology all of which are designed for use on clinically archived human specimens of tissues, cells and fluids, and are developed working with clinicians. Notably, she is the inventor of a spatial method targeting the collagen proteome in formalin-fixed, paraffin-embedded tissues that integrates collagen proteomic maps with spatial transcriptomics and microscopy studies. Dr. Angel has over 14 years cumulative experience in 5 biotech startups including Glycopath, Inc., a company that leveraged glycosylation patterns as a prognostic or diagnostic tool; she currently serves on the board of N-Zyme Scientifics, a company that produces enzymes for targeted mass spectrometry imaging. Dr. Angel is committed to creating a collaborative mass spectrometry imaging community and serves as Past President for the Americas Region of the International Mass Spectrometry Imaging Society, as a Trustee for the International Mass Spectrometry Imaging Society, and as Secretary on the USHUPO Board of Directors. Dr. Angel is devoted to coaching and mentoring, particularly for females and minorities, serving on multiple committees to advise and mentor young scientists in entrepreneurship within multidisciplinary teams
Relevant Financial Disclosures
(within past 24 months, reported on Jul 20, 2025)
No relevant financial relationship(s) to disclose.
Matthew Crawford Labcorp
Matthew Crawford is a Scientist II working in research and development at Labcorp in Burlington, North Carolina. He received his B.S. in Biochemistry from California State University, Northridge and is currently working towards his Ph.D. in Analytical Chemistry from University of Texas at Arlington under the instruction of Professor Kevin Schug. At Labcorp, his focus is high-throughput method development and validation for small molecule biomarkers using LC-MS/MS and GC-MS. He’s been on the MSACL steering committee for 2024 and 2025 conferences where he’s head of the small molecule scientific committee.
Relevant Financial Disclosures
(within past 24 months, reported on Apr 23, 2026)
Honorarium/Expenses
MSACL
Stock/Bonds
Labcorp
Salary
Labcorp
Discover clinical mass spectrometry career paths. This networking event is geared to early career attendees, but open to all.
Get insights through informative, brief presentations on various job profiles within clinical mass spectrometry. Experts and seasoned professionals will guide you through diverse roles, making it easier to envision your own journey in this exciting industry.
In addition to short panelist presentations, the event promises a delightful networking experience. Unwind and engage with fellow attendees, experts, and potential employers to expand your professional connections. Enjoy selections of refreshments; creating a relaxed environment for further discussion and relationship-building. This networking event is the perfect opportunity to continue conversations, ask questions, and make lasting connections.
Employers
This is your chance to connect with talent. We invite you to advertise your job postings at the event and interact with potential candidates who are passionate about clinical mass spectrometry. Share your opportunities and meet prospective candidates who are eager to contribute to your organization's success.
MSACL is offering the opportunity for you to be recognized by the event chair at no charge (RSVP required) to facilitate your discussion of career opportunities with interested parties in attendance.
If you are interested in representing your organization/company/lab at this event, please register your interest here.
This event is formatted as a social mixer to facilitate active networking throughout the event.
For representatives and hiring managers:
-> There will be no booths.
-> Please bring business cards or QR codes describing positions to share with attendees or place on the job board.
-> You may also advertise employment opportunities on a job board. Each open position is limited to an 8.5 x 11 inch poster.
Don’t miss this unique opportunity to blend career exploration, networking, and relaxation.
Discussion Group : Mass Spectrometry Imaging in the Clinic : When Can This Be a Reality?
Location: Montreal 1-2
Pierre Chaurand, PhD Université de Montréal
Professor Chaurand and his group are developing methodologies for analyzing the molecular content of thin tissue sections by mass spectrometry in a region-specific manner. A systematic analysis makes it possible to reconstruct molecular images (proteins, peptides, lipids, metabolites, etc.) that can be directly correlated to the histologies present within the sections and the health of biopsies.
Relevant Financial Disclosures
(within past 24 months, reported on Mar 26, 2025)
No relevant financial relationship(s) to disclose.
Emina Torlakovic, MD, PhD College of Medicine, University of Saskatchewan
Dr. Emina Emilia Torlakovic obtained her M.D. at the University of Zagreb Medical School and her Ph.D. at the University of Oslo Medical School. She is board certified by The American Board of Pathology in Anatomic and Clinical Pathology with subspecialty boards in Hematopathology. She is a professor at the Department of Pathology and Laboratory Medicine, College of Medicine, University of Saskatchewan, with previous appointment at the University of Toronto. She is a Division Head of Hematopathology, Saskatchewan Health Authority. She was a founding member of the NordiQC, has co-founded CIQC, and most recently founded Canadian Biomarker Quality Assurance (CBQA) as well as CBQAReadout.ca (inter)national academic quality assurance programs, which she is currently directing. Dr. Torlakovic is the Chair of the National Standards Committee for High Complexity Testing of the Canadian Association of Pathologists. She is the Past President of the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and a Board Member of the International Quality Network for Pathology (IQN Path). She is also currently leading several projects related to national and global standardization of biomarker testing in oncology.
Relevant Financial Disclosures
(within past 24 months, reported on Aug 03, 2025)
No relevant financial relationship(s) to disclose.
Katerina Djambazova, PhD Vanderbilt University
Relevant Financial Disclosures
(within past 24 months, reported on Apr 02, 2025)
No relevant financial relationship(s) to disclose.
Angela Kruse, PhD Ohio State University
Angela Kruse is a Research Assistant Professor in the department of Cell and Developmental Biology and the Mass Spectrometry Research Center at Vanderbilt University. Her research integrates imaging mass spectrometry, proteomics, spatial transcriptomics, biochemistry, and microscopy to understand how diabetes affects the molecular environment in the pancreas, kidney, and eye. She received her Ph.D. in Plant Pathology with a focus in Biochemistry from Cornell University prior to conducting her postdoctoral studies under the guidance of Drs. Richard Caprioli and Jeff Spraggins at Vanderbilt University. She plans to spend her career applying and integrating cutting edge technologies to address important challenges in human health and the environment.
Relevant Financial Disclosures
(within past 24 months, reported on Mar 13, 2026)
No relevant financial relationship(s) to disclose.
Mass spectrometry imaging (MSI) is a powerful tool with implications in the clinic including diagnostics and patient stratification. This discussion focuses on how immunohistochemistry (IHC) diagnostics have been developed for use in the clinic and how these workflows could be translated to developing MSI diagnostics. A key goal is to have a discussion within the broad range of attendees on moving MSI workflows to a standardization level that can be implemented for diagnostics.
Agenda:
1. Historical overview of MALDI MSI and potential use for diagnostics (10 minutes maximum)
Pierre Chaurand, PhD
2. IHC validation for a predictive biomarker and a diagnostic biomarker: Procedure and Pitfalls (12 minutes maximum)
Dr. Emina Emilia Torlakovic MD, PhD, FCAP
3. Multimodal Mass Spectrometry Imaging: Implementation and Benchmarking (12 minutes maximum)
Katerina Djambazova, PhD & Angela Kruse, PhD
4. Audience and Speaker Discussion Objectives (30 minutes) :
- Identify parallels between early development of quality assurances for IHC and current practices in MSI
- Summarize regulations and guidelines in IHC diagnostics and implementation in MSI
- Define analytical and clinical validation parameters (or procedures) needed for MSI practice
Discussion Group : LDTs in Flux: Will Evolving Regulations Enhance or Complicate Laboratory Practices?
Location: Outremont 1
Alejandro Molinelli, PhD St. Jude Children's Research Hospital
Alejandro Molinelli, PhD is Director of the Clinical Pharmacokinetics Laboratory in the Department of Pharmacy and Pharmaceutical Sciences at St. Jude Children's Research Hospital. His duties include clinical consultancy, technical and regulatory oversight of the laboratory, and method development and validation. Dr. Molinelli also serves as a Clinical Chemist Consultant with the Department of Pathology at St. Jude. Prior to joining St. Jude Dr. Molinelli completed a Clinical Chemistry Fellowship at the University of Washington in Seattle; obtained his PhD in toxicology at the University of North Carolina at Chapel Hill; and bachelor’s and master’s degrees in biology and biochemistry at the University of Puerto Rico. Dr. Molinelli’s professional interests include therapeutic drug monitoring, clinical toxicology, and quality improvement.
Relevant Financial Disclosures
(within past 24 months, reported on Feb 03, 2025)
No relevant financial relationship(s) to disclose.
Dr. Budelier is the Section Chief and Medical Director of Clinical Chemistry and Toxicology at TriCore Reference Laboratories and Clinical Assistant Professor of Pathology at the University of New Mexico. She is also the CLIA laboratory director of TriCore's core laboratory. Her research interests are broadly focused on developing clinically useful, mass spectrometry-based assays to improve diagnosis and treatment of human disease. Her expertise are in Toxicology/TDM, assay development and validation, and protein quantification.
Relevant Financial Disclosures
(within past 24 months, reported on Feb 27, 2026)
Washington Univ - Patents (Methods for Detecting Neurofilament Light Chain in Plasma and Cerebrospinal Fluid; Multiplexed Assay for Amyloidosis Disorders); Tech licensed by WashU to C2N Dx
Lab Developed Test (LDT) regulation is a complex and evolving area of clinical laboratory practice. This interactive workshop, led by members of the MSACL Compliance and Accreditation Committee, will offer an in-depth exploration of the current regulatory landscape and provide insights into potential future developments. Participants will gain a historical perspective on LDT oversight and how regulatory frameworks have evolved over time. The session will feature interactive breakout discussions, allowing attendees to share experiences and challenges in navigating LDT regulations. A key focus will be on quality management systems (QMS), including a review of current U.S. requirements under CLIA and CAP, alongside a comparison with international guidelines such as CLSI EPLDT Ed1-QG, C62, and the new ISO5649. The session will explore how laboratories might align their practices with these standards and highlight the role of a robust QMS in supporting quality and compliance, including considerations of ISO15189. Attendees will also examine the concept of clinical validity and how it applies to different areas of laboratory practice. The workshop will conclude with a forward-looking discussion on the adequacy of the current regulatory framework and potential future changes, encouraging participants to reflect on their existing practices and how they may need to evolve.
Syllabus
Historical overview of LDT Regulations.
Overview of existing requirements and guidelines for LDT Regulations
Explore the role of a Quality Management System in complying with LDT regulations.
Discuss the adequacy of the current regulatory framework and the potential future outlook for LDTs in clinical laboratories
Provide attendees with resources to assist with regulatory compliance and proactive quality improvement for LDTs
Objectives
Review the historical and current state of LDT regulations.
Assess the sufficiency of the current regulatory framework for LDTs
Develop Practical Compliance Strategies and Quality Management Practices for LDTs
1815
2100
Dinner
Location: Your Choice
Your choice! This non-MSACL sponsored meal break is your chance to explore the culinary delights within the city of Montreal. MSACL recommendations.
2100
2330
MSACL Hospitality Lounge
Location: Salon Ville-Marie, Hotel Level
All conference registrants are welcome to join this nightly gathering for continued conversations with drinks and snacks hosted by MSACL. Enjoy a live jazz duo from 9-10pm.
