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

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

Topic 9:

New Modalities by Hybrid Assays and Intact MS: Use of Mass Spec and Ligand-binding Platforms as Complementary Techniques, Multispecific 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 Isotopologue Analysis 
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

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

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

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