Specialized Workshop T1 - Tuesday June 20, 2023: 7am to 5:50pm - Discussion Topic List

"Mass Spectrometry Assays - Latest Developments, Challenges, and Solutions"

NEW Case Studies on Mass Spec Innovative Approaches and Next-Generation Technology Advancements; Challenges with Automated Tissues/Non-Liquid Matrices/Cell Lysate; Method Development Strategies for Novel Modalities, Oligonucleotides, ADC Therapeutics, and Complex Large Protein Biomarkers; Small Molecule Covalent Inhibitors & Chiral Molecules; Advanced HRMS, IA-MS, Ion Mobility, Online Capturing Applications; Recent Discovery Bioanalysis Solution and How to Transfer them to Regulated Bioanalysis

Session 1: Advancements in Small Molecule Bioanalysis - Next-generation Technologies, Emerging Applications/Therapeutic Agents

  • Topic 1:

    Next-generation Technologies to Overcome Bioanalysis Challenges for Small Molecule: Optimized, Streamlined, Automated High-throughput Bioanalytical Workflows, Harmonized Method Development Approaches, Lesson Learned in Non-regulated Bioanalysis for Preclinical Drug Discovery
    Dr. Estelle Maes, Director, AbbVie

  • Topic 2:

    Small Molecule Covalent Inhibitors: Bioanalytical Challenges & Advanced Strategies to Mitigate Atypical Instability in Plasma/Whole Blood, Unknown Degradation Mechanism, Identification of Stabilizers and Special Handling Procedures, in vivo Interfering Metabolites
    Dr. Luca Ferrari, Strategy Area Leader Small Molecule Bioanalysis, F. Hoffmann-La Roche

  • Topic 3:

    Chiral Small Molecules Bioanalysis: Emerging Applications of Quantitative SFC and Comparison with Traditional approaches, Limitations and Operational Complexity of RPLC and NPLC vs SFC, Challenges in Electrospray Ionization, Advantages of New Generation SFC Methods in Robustness, Reliability, Higher Resolution, Shorter Run Time and Higher Throughput
    Dr. Y-J Xue, Scientific Dir, BMS

Session 2: Oligonucleotides Novel Approaches for Method Development/Validation - High-throughput & Automated Approaches

  • Topic 4:

    Automation in Oligonucleotides Quantification: Specific Method Optimization for PK and Biological Function Evolutions, Mass Spec High-throughput, Overcoming High Polarity, 3D-folding Structure, Strategies for best MRM Transition, Choice of Internal Standard, LLE Sample Preparation
    Dr. Honglue (Holly) Shen, Director, Merck

  • Topic 5:

    ASO and siRNA Quantification and Tissue Distribution by Mass Spec: Novel Methodologies and Applications: Novel data on Hybridization LC-MS/MS Methodology. Microflow LC Approaches to boost Sensitivity, Advantages and Comparison vs Traditional Methodologies for Oligonucleotide Bioanalysis 
    Dr. Long Yuan, Associate Scientific Director, Biogen

  • Topic 6:

    Advanced HRMS Applications in Met ID and Profiling for ASOs in line with the Small Molecule Industry Standards: Challenge with new Chemistry, new Metabolites, new Extraction/Ion-pairing Reagents/ Mass Spec Instrumentation, Adapting Bioanalysis to these new Oligos
    Mr. Noah Post, Assistant Director, Ionis Pharmaceuticals

Session 3: Antibody-drug Conjugates (ADC) Novel Approaches for Method Development/Validation - Simultaneous Determinations

  • Topic 7:

    Tumor, Tissue and Cell Lysate Bioanalysis for ADC: Recent Developments in Bioanalysis & Biotransformation of ADCs, Evolving need of Bioanalysis for the further Understanding of ADC Pharmacology by ADC, Total Ab, Total Warhead, Unconjugated Warhead Characterization
    Dr. Yue Huang, Associate Director, Astra Zeneca

  • Topic 8:

    Use of HRMS for Hybrid Assay Approach for Quantifying ADCs at the Intact Protein Level in Biological Samples: Novel Applications of Intact Mass Analysis, Troubleshooting in Sample Preparation, Immunoaffinity (IA) Purification and LC Method Development/Data Analysis  
    Dr. Luca Barbero, Associate Director, EMD Serono

  • Topic 9:

    Novel Strategies for Mass Spec Simultaneous Determination of Free & Conjugated ADC Payloads in support of Preclinical and Clinical Studies: Strategies for Harvesting Total ADC and Releasing Conjugated Payloads, Considerations for Limited Sample Volume/Single Aliquot, Requirements for High Specificity/Selectivity
    Ms. Yunlin Fu, Senior Principal Scientist, Novartis

Session 4: Biomarkers Novel Approaches for Method Development/Validation - Innovation in Automated Tissue Preparation & Online Capturing Techniques

  • Topic 10:

    Quantification of Protein Biomarkers in an Unconventional Matrix by Mass Spec using a Surrogate Analyte Approach: Challenges in Sputum Bioanalytical Method Development and Qualification for Extremely Large & Heavily Modified Proteins in support of PD
    Dr. Kevin Contrepois, Director, AstraZeneca

  • Topic 11:

    Automated Tissue Preparation Strategies for Biomarkers: Recent Developments and Ongoing Work for Increasing Speed, Accuracy, and Transferability of High Quality Tissue Bioanalysis/Target Measurements, Overcoming Issues with Automated Homogenizers and Liquid Handlers
    Mr. Jay Johnson, Principal Scientist, Pfizer

  • Topic 12:

    Ion Mobility Spectrometry (IMS) in Biomarker Development: Novel Strategies to Improve Separation and Identification in Lipid Biomarkers in Clinical Studies, Advantages/Limitations of IMS in BAV and Clinical Sample Analyses, Operation and Assay controls for IMS Performance
    Dr. Lin Tao, Associate Director, Sanofi

  • Topic 13:

    Peptide Biomarkers/Hormones Quantitation by Mass Spec: Hybrid Assays vs Reagent-free HRMS, Issues with Clinical LBA, Robustness Improvements to Multi-D nano-LC Applications, Interplay between Assay Platform/Complexity, and Laboratory Quality System (GLP/GCLP vs CLIA)  
    Dr. Barry Jones, Associate Director, Biomarker Bioanalysis, Crinetics Pharmaceuticals

  • Topic 14:

    Advanced Online Capturing Techniques for Biomarkers/Hormones Measurement: Method Development Strategies for Time Saving, High throughput and Increased sensitivity for Human Urine Bioanalysis, Comparison with traditional Offline SPE, Evaluation of Various Approaches for Eicosanoids Quantification
    Ms. Monika Kansal, Scientist 3, Genentech

Session 5: 2023 White Paper in Bioanalysis

  • 2023 White Paper on Mass Spectrometry Assays - Latest Developments, Challenges, and Solutions

    Consensus & Conclusions on Mass Spectrometry Assays - Latest Developments, Challenges, and Solutions for 2023 White Paper

Agenda at a Glance Agenda at a Glance