Translating Pre-Clinical Research to Clinical Patient Care™

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Golden West Diagnostics


Brian Kelly

SCIEX


Agenda (Preliminary) - View Program

Thursday, March 21

Time

Sessions

Registration Desk Open

Location: Serra Foyer (Conference Ctr > Ground Floor)

Industry Breakfast Workshop : Thermo Fisher Scientific

Location: Steinbeck 1 (Conference Ctr > 2nd Floor)

Spatial Proteomics: Considerations for Clinical and Research Applications

Location: De Anza 1 (Portola Hotel > Ground Floor)

Megan Lim, MD, PhD

Memorial Sloan Kettering Cancer Center

20 minute Presentation followed by a Group Discussion.

Coffee Roundtables & Exhibits

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

Mike Badeau

YYZ Pharmatech Inc.

Robert DeWitte, PhD

Rejwi Dahal, PhD

Indiana University School of Medicine

Carolyn Slade, MsHIM, CMM, HMCC

CASSS – Sharing Science Solutions

Mikaela Sanford

CASSS - Sharing Science Solutions

Timothy Collier, PhD

Quest Diagnostics

Stephen Master, MD, PhD, FADLM

Children's Hospital of Philadelphia

Bruce Wilcox, PhD

PrognomiQ

Johanna Camara, PhD

NIST

Ashley Beasley-Green, PhD

NIST

Sean Pawlowski, PhD

Ionpath

Carrie Adler, MSFS

Agilent Technologies

Table 1: Translational Research: Insights for Today and Tomorrow

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

Table 9: Ionpath
Sean Pawlowski

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.
Poster Session 3 with Poster Tours

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

Sign-up and meet at Tour Rally Point in Booth 8 for Poster Tours.

Scientific Session 3

Location: Steinbeck 1 (Conference Ctr > 2nd Floor)

Scientific Session 3

Location: Steinbeck 2 (Conference Ctr > 2nd Floor)

Scientific Session 3

Location: Steinbeck 3 (Conference Ctr > 2nd Floor)

Scientific Session 3

Location: Colton (Conference Ctr > 2nd Floor)

Scientific Session 3

Location: De Anza 1 (Portola Hotel > Ground Floor)

Exhibitor Feedback Meeting

Location: De Anza 3 (Portola Hotel > Ground Floor)

Exhibitors invited to join MSACL admin to provide feedback on MSACL 2024 and begin planning for MSACL 2025 in Montreal (September 21-26, 2025).

Exhibits & Lunch Buffet

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

Poster Session 4

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

Meet at Tour Rally Point in Booth 8.

Exhibits Close

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

Scientific Session 4

Location: Steinbeck 1 (Conference Ctr > 2nd Floor)

Scientific Session 4

Location: Steinbeck 2 (Conference Ctr > 2nd Floor)

Scientific Session 4

Location: Steinbeck 3 (Conference Ctr > 2nd Floor)

Scientific Session 4

Location: Colton (Conference Ctr > 2nd Floor)

Scientific Session 4

Location: De Anza 1 (Portola Hotel > Ground Floor)

Intermission

Location: Steinbeck Foyer (Conference Ctr > 2nd Floor)

Scientific Session 5

Location: Steinbeck 1 (Conference Ctr > 2nd Floor)

Scientific Session 5

Location: Steinbeck 2 (Conference Ctr > 2nd Floor)

Scientific Session 5

Location: Steinbeck 3 (Conference Ctr > 2nd Floor)

Scientific Session 5

Location: Colton (Conference Ctr > 2nd Floor)

Scientific Session 5

Location: De Anza 1 (Portola Hotel > Ground Floor)

Intermission

Location: Steinbeck Foyer (Conference Ctr > 2nd Floor)

Scientific Session 6

Location: Steinbeck 1 (Conference Ctr > 2nd Floor)

Scientific Session 6

Location: Steinbeck 2 (Conference Ctr > 2nd Floor)

Scientific Session 6

Location: Steinbeck 3 (Conference Ctr > 2nd Floor)

Scientific Session 6

Location: Colton (Conference Ctr > 2nd Floor)

Scientific Session 6

Location: De Anza 1 (Portola Hotel > Ground Floor)

Happy Half-Hour & Trivia Dinner Check-In

Location: San Carlos Foyer (Marriott > Mezzanine > Stairs from Lobby or SkyBridge from Conference Ctr)

Enjoy a relaxing moment during check-in for the Closing Pub-Style Trivia Dinner in the San Carlos foyer.

Dinner & Pub-Style Trivia Night

Location: San Carlos (Marriott > Mezzanine | Stairs from Lobby or SkyBridge from Conference Ctr)

Fee-based Pre-Registration Required for Entry

Includes presentation of Poster Awards and Closing statements by the Steering Committee Chair.

MSACL Hospitality Lounge

Location: Club Room (Portola Hotel > Ground Floor)

Drinks provided.