Main Workshop DAY 3 - Thursday June 22, 2023: 7am - 6pm - Discussion Topic List

"Mass Spectrometry, Chromatography, and Sample Preparation"

Session 1: New Regulatory Challenges and Concerns in Mass Spec Bioanalysis for KDIE, LNP, and Target Proteomics

  • Topic 1:

    Deuterated Drugs Bioanalysis: Should the Bioanalytical Scientists be Worried? Current Status and Implications for Regulated Bioanalysis, Understanding the Application of the Kinetic Deuterium Isotope Effects (KDIEs) in Drug Development, Considerations for Method Development/Validation, Issues due to Isotopic Envelope Overlap of Parent, IS and Metabolites
    Dr. Jason Boer, Senior Director, Incyte

  • Topic 2:

    Quantitation of NanoParticles (NP) in vivo to meet Regulatory Guidelines: Challenges in Identifying the Best Methodology & Validation Crititeria for NP, Increasing Complex set of Bioanalytical Challenges for Optimized siRNA Delivery, Expected Quantitation of both NP payloads & intact NPs, Additional Validation Experiments to ICH M10 Guidelines
    Mr. Mike Baratta, Sr. Director, Takeda

  • Topic 3:

    Lipid Metabolite Identifications by Mass Spec from LNP mRNA Drug Delivery: in vitro and in vivo Lipid Metabolization Comparison and Potential Regulatory Concerns, Understanding Cationic Lipid Metabolism, Proposed Pathways, Met ID Risk Assessment in Human Trial, Cross Species and Preclinical Plasma/Urine Evaluations
    Ms. Ling Morgan, Director, Moderna

  • Topic 4:

    Advancements in Mass Spectrometry Approaches to Targeted Proteomics in Bioanalysis: Comparison of Different Technologies Used, Pros/Cons & Regulatory Considerations for each Platform, Current Status and Strategies for Large Protein Panel Quantification, Acceptance Criteria to ensure Robustness of the Assays and the Quality of the Data
    Dr. Jianing Zeng, Scientific Director, BMS

Session 2: Clinical Tissue, Tumor and FFPE Biopsy Measurements/Quantification by Mass Spec

  • Topic 5:

    The use of Mass Spec to Quantify Protein Biomarkers in Tumor FFPE Tissue: Quantitative Multiplexed Platform for measuring Proteins and PTMs in Fresh/Frozen/FFPE Biopsies, Sample Preparation Compared and Contrasted, Considerations for Targeted/Untargeted Proteomics, Definition of Bioanalytical Characteristics and Assay Performance
    Dr. Michael Lassman, Director, Merck

  • Topic 6:

    Mass Spec Bioanalysis of Protein Biomarkers and Therapeutics in FFPE Tissue Specimens: Analysis of readily Availability of FFPE Tissues from Disease Diagnosis as Alternative to Fresh Tissues, Advanced Anti-peptide IA-MS Workflow for Sensitive Detection, Quantification of Low Abundant Endogenous Proteins or Phosphorylated Proteins
    Dr. Naiyu Zheng , Scientific Associate Director, Bristol Myers Squibb

  • Topic 7:

    Mass Spec-based Biomarkers and CDx Assays for Oncology Therapeutics: Current Technologies and their Limitations, Possible Solutions by Mass Spectrometry in FFPE-Proteomics and Quantitation in Tumor FFPE Biopsies, Evaluation of on-going Challenges and Proposals to overcome Obstacles
    Dr. Yeoun Jin Kim, Senior Director, AstraZeneca

  • Topic 8:

    Clinical Fresh Tissue Biopsy Measurements for Optimizing Dose and Reverse Translation by Mass Spec: Development of Highly Sensitive & Ultra-Targeted Hybrid Assay (IA-2D-MS) for Core Needle Biopsy analysis, Quantification and Assay Performance Evaluation of Endogenous and Drug-bound KRAS G12C at sub-fmol levels
    Dr. Surinder Kaur, Executive Director, Genentech

Session 3: Hybrid Assays (IA-MS) - New Applications and Enhanced Complementarity with Conventional Technologies

  • Topic 9:

    New Modalities by Hybrid Assays and Intact MS: Use of Mass Spec and Ligand-binding Platforms as Complementary TechniquesMultispecific Abs, Fusion mAbs, Fusion Proteins, What forms of the drug needs to be measured?, Total, Fee or/and Intact? The value of hybrid LC-MS for understanding the in vivo stability of multispecific Abs and informing the PK assay strategy.   
    Dr. John Mehl, Director, GSK

  • Topic 10:

    In vivo Protein Half-life Determination with Metabolic Labeling by Hybrid Assays (IA-HRMS): Understanding the Protein Dynamics of a Drug Target, Advanced Workflow, Tracer Labeling, IA Capture, Trypsin Digestion and LC-HRMS analysis at peptide level, Considerations on Amino Acid Labeling or Heavy Water Labeling
    Dr. Wenying Jian, Director, Janssen

  • Topic 11:

    Innovative Application of Hybrid Assay to Answer Specific Immunogenicity Questions: Strategies for Specific Detection of ADA isotypes IgG1, 2, 3, 4, IgM and IgA1, 2, Overcoming Highly Variable Background/Drug Tolerance by High-Capacity Streptavidin Plates, Robustness by ADA Assay ISR and Consistent Recovery 
    Dr. Jennifer Cunliffe, Director, Novartis

  • Topic 12:

    Use of Hybrid Assays to overcome ADA Interference in PK assays: IA-MS Complementary analytical tool to LBA, IA-MS Advantages vs LBA in using a Single Capture Reagent vs Sandwich of Reagents, Hybrid Assays Superiority with Inherent Interferences Inhibiting Binding at certain Regions of the Protein
    Mr. Joe Palandra, Associate Director, Takeda

Session 4: Advanced Mass Spec and Multiplexed Approaches for Biotherapeutics

  • Topic 13:

    Quantitation of Catabolites by Mass Spec: Current Practices, Thresholds & Parameters for Identification of Biotherapeutics Catabolites, Modes of Quantitation for Intact Mass, Intact Mass Adducts, Clipping, Proteinaceous Impurities and Peptide Modifications, When a Catabolite/Mass Variant should be Reported? 
    Dr. John Kellie, Associate Director, GSK

  • Topic 14:

    Multiplexed Mass Spec Methods for Multiple ADC Analytes Determination from One Sample: Improved Sensitivity to support Lower Dose Studies (< 1 mg/kg)  Low Volume Assays, Antibody & Conjugated-drug Levels from a Single Aliquot, Platform Flexibility through CDR Specific Peptides and High-throughput Linker Screening.
    Dr. Shawna Hengel, Director, Seagen

  • Topic 15:

    ADCs with Prodrug-Payloads: Solving the Bioanalytical Challenges by Mass Spec, Lack of Specific Guidance on Bioanalytical Strategies for Prodrug-Payloads , Design Rationale, Stability Issues, Associated Complexity, Power of Orthogonal Platforms and Selection of the Right Analyte, Assay, and Reagents 
    Ms. Hetal Sarvaiya, Director, Biologics Characterization & Bioanalysis, Abbvie

Session 5: 2023 White Paper in Bioanalysis

  • 2023 White Paper on Mass Spectrometry, Chromatography, and Sample Preparation

    Consensus & Conclusions on Mass Spectrometry, Chromatography, and Sample Preparation for 2023 White Paper

Agenda at a Glance Agenda at a Glance