Main Workshop DAY 3 - Thursday May 09, 2024: 7am - 5:45pm - Discussion Topic List

"Mass Spectrometry, Chromatography, and Sample Preparation"

Session 1: New Regulatory Challenges and Concerns in Mass Spec Bioanalysis for Novel Modalities, PCS and NHP Studies

  • Topic 1:

    Mass Spec Sophisticated Bioanalytical Support for Novel Modalities: Cancer therapeutics essential bioanalytical support, Conditionally Active T Cell Engagers, scientifically strategies and novel bioanalytical assays to support PK, interreference of Targets/ADA on bioanalytical method development and solutions, gaps in generation of critical reagents and fit for purpose (FFP) vs Full Compliance with ICH M10 BMV
    Dr. Mark Qian, Global Head of Bioanalytical Sciences and Immunogenicity , Takeda Pharmaceuticals

  • Topic 2:

    Innovative Approaches for Confirming Equivalent PK and Biomarkers concentrations between Patient-Centric Micro-Sampling (PCS) vs Venipuncture for Small and Large Molecules: Best options for whole/dried blood collection device formats 510(K) or CE marked status, confirming analyte integrity during the sample collection, processing/storage, non-specific binding, hemolysis and extended stabilities
    Mr. Mike Baratta, Senior Director & Head of Mass Spectrometry Clinical Bioanalysis, Takeda

  • Topic 3:

    Critical Role of Integrative Bioanalytical Strategy in Supporting the Quantitative Assessment of NHP Biodistribution Studies: Increasing demand for NHP biodistribution for neuroscience, infectious disease and aging research, enhanced strategies for FFP Validation vs Full Validation as per ICH M10, issues with limited experimental NHP supply, prioritization of assay requirement & tissue collection for biodistribution studies
    Dr. Hiroshi Sugimoto, Director, Nonclinical Biomarker , Takeda

Session 2: TE/PD Biomarkers and Free & Drug Bound Soluble Targets Measurements/Quantification by Mass Spec

  • Topic 4:

    State-of-the-Art Applications of Mass Spec Proteomics in Various Therapeutic Areas as Powerful Technology to enable Quantitative Measurement of Proteins from a Single Assay: Advanced use of spatial/cell-type resolution Mass Spec proteomics for a better understanding of disease MoA and for identifying druggable targets & biomarkers, advanced analytics and multi-omics data integration
    Dr. Yu Tian, Director, Quantitative Proteomics and Omics Technology, AbbVie

  • Topic 5:

    Advantages of Mass Spec to Quantitatively Assess Target Engagement (TE) and Pharmacodynamic (PD) Effect of Drugs: Clinical Biomarker Development for Oncology clinical trials, key role of laser microdissection and Targeted Proteomics to tackle challenges of implementing MS proteomics assays in clinical setting, lessons learned & challenges remain for MS-based TE/PD as primary/secondary endpoints
    Dr. Yeoun Jin Kim, Senior Director, Translational Proteomics , Astra Zeneca

  • Topic 6:

    Evolution of Mass Spec Targeted Protein Bioanalysis platform to measure Proximal & Distal PD Biomarkers with Selective & Sensitive (S&S) Approaches in-vivo: Targeted protein quantitation for Protein Degrader Molecules in which TE/PD/Tox are monitored by assessing drug target across tissue types, considerations on best approaches for no-enrichment/direct vs plate-based SPE vs off-line LC vs immunocapture
    Dr. Eugene Ciccimaro, Scientific Associate Director, Bioanalysis, Bristol Myers Squibb

  • Topic 7:

    Strategies to Measure Free & Drug Bound Soluble Target by Hybrid Assay (IA-MS): Method development, FFT BAV, and method transfer challenges to support a novel Peptide Inhibitor of PCSK9 as cholesterol lowering agent for dose selection and to understand PK/PD, evaluation of data from clinical studies from Phase I to Phase III along with the impact of the Target Engagement (TE) assays
    Dr. Michael Lassman, Director, Translational Biomarkers, Merck

Session 3: Advancements in Oligonucleotides by Mass Spec: Quantification, Metabolite Profiling and Use of Microsampling

  • Topic 8:

    Recent Advancements in Mass Spec Methods for Oligonucleotide Therapeutics with focus on Locked Nucleic Acid (LNA) Probe Design & Improved Sensitivity: Method Development for Oligos Novel Chemical Modifications, Comparison of data generated by 4 platforms: SPE MS vs Hybridization MS vs Hybridization ELISA vs Stem-loop RT qPCR, Bioanalytical strategy based on stage of program, needs of Sensitivity & Specificity (S&S) and throughput
    Dr. Wenying Jian, Director, Bioanalytical Discovery and Development Sciences, Johnson & Johnson Innovative Medicine

  • Topic 9:

    Latest Developments of a Novel Hybridization Mass Spec Methodology for ASO and siRNA Bioanalysis: Strategies, challenges and solutions for developing hybridization MS methods, comparison of DNA, PNA, and LNA probes and optimization of key parameters, comparison of Capillary Microsampling and conventional sampling for the quantification of ASO in Regulated Bioanalysis
    Dr. Long Yuan, Director & Head of Bioanalytical Group, Biogen

  • Topic 10:

    Overcoming Challenges Associated with Metabolite Profiling of Oligonucleotides using HRMS: Workflow and methods utilized for characterization of ASO and siRNA metabolites, understanding the nuclease-mediated and non-nucleolytic metabolic pathways for oligonucleotide, considerations for assessing oligonucleotide metabolites impact on Target Engagement (TE) and Off-Target
    Dr. Susovan Mohapatra, Director, DMPK, Stoke

Session 4: Hybrid Assays (IA-MS) - New Applications for Multispecifics, Engineered Antibodies and Complement Proteins

  • Topic 11:

    What is the best Bioanalytical Strategy & Assay Design for PK Characterization of ADC in Preclinical/Clinical Studies? Current understanding of Pros/Cons for assay platform selection, LBA vs Hybrid Assay (IA-MS), How to switch from one method to another? Is Cross-Validation always needed? considerations on comparability/cross-validation studies, addressing DAR sensitivity in LBA and Hybrid Assay platforms in evaluation of PK of ADCs
    Dr. Inna Vainshtein, Executive Director, Bioanalysis, Exelixis

  • Topic 12:

    Importance of Biotransformation for Biotherapeutics: Cutting-edge combinations of sample preparation, chromatographic separation and mass spec to comprehensively characterize biotransformation, understanding of inter-subject variance, mechanism of the formation/elimination, impact on protein backbone structure and/or chemical modifications which may impact 3-dimentional structure and efficacy/safety
    Dr. Anton Rosenbaum, Senior Group Director, Integrated Bioanalysis, AstraZeneca

  • Topic 13:

    Innovative Bioanalytical Strategies for Characterization and in-vivo PK Assessment Multispecifics & Engineered Antibodies using Mass Spec-based Methods: Overcoming the issues of novel modalities diverse structural variations combined with complex MoA, need for appropriate guidance in characterizing Stability and PTMs in relevant biological matrices, selection of best platform, assay format, analyte to measure these biotherapeutics
    Ms. Hetal Sarvaiya, Director, Biologics Characterization & Bioanalysis, AbbVie

  • Topic 14:

    Solving the Issues in the Complement Proteins Quantification by Novel Mass Spec Methods: Understanding the complexity & role of Complement System in protective immune processes, limitations of current LBA unable to distinguish between proteins with high sequence homology, Multiplexing MS to simultaneously measure 17 circulating complement proteins, special use endoproteinase Glu-C to produce distinct proteotypic peptides
    Dr. Rachel Green, Director, Bioanalysis & Biomarkers , Complement

Session 5: 2024 White Paper in Bioanalysis

  • 2024 White Paper on Mass Spectrometry, Chromatography, and Sample Preparation

    Consensus & Conclusions on Mass Spectrometry, Chromatography, and Sample Preparation for 2024 White Paper





Agenda at a Glance Agenda at a Glance