Topic 1:

State-of-the-art Approaches for Quantification of Glycoforms in Clinical Study; Fit-for-Purpose Validation of IA-MSA (Hybrid Assay) to derisk a CMC strategy after major changes in the drug production leading to a potential impact on the PK & Safety; Determination of PK profiles for major Drug Glycoforms for comparison to total PK profiles; Importance of thorough understanding of different Critical Quality Attributes as key to answer potential questions from Regulatory Agencies.
Ms. Sandrine Descloux, Head of Hybrid Bioanalytical platform, Sanofi

Topic 2:

Insights on Top/Middle-down analysis of ADC by IA-HRMS (Hybrid Assay) for assessment of DAR Shift and Glycoform Changes in vivo for critical development decision making; ADC behavior measuring individual DAR species during PK or PD assessments; IA-HRMS as only tool that can provide information regarding on ADC payload modification in vivo without loss of the DAR key property measuring the quality of ADC:  Low DAR impact on efficacy and High DAR impact on safety. 
Dr. Jian Chen, Associate Director Bioanalysis, Bristol Myers Squibb

Topic 3:

Advanced investigation/characterization of Deglycosidation Pattern in Anthracycline Derivative ADC Payload in preclinical/clinical samples by novel IA-HRMS (hybrid assay); Direct comparison of deglycosidation rates to reveal payload instability progresses similarly across species and impact on drug efficacy; Specific purification of ADCs from matrix using biotinylated capture reagents immobilized on streptavidin magnetic beads, reduction with TCEP and HRMS analysis of the intact ADC subunits. Cross
Dr. Linzhi Chen, Bioanalytical Group Leader & Senior Research Fellow, Boehringer Ingelheim
Dr. Wei Wei, SME HRMS & Principal Scientist DMPK, Boehringer Ingelheim

Topic 4:

Importance of Dilution-based Parallelism Experiment for Biomarker MSA to reveal quantitation issues beyond traditional Standard Addition assessment; Reasoning why parallelism is not performed in MS as calibrators are considered equivalent to measured endogenous molecule; Emerging evidence of 11-oxygenated C19 steroids as Biomarkers for Hyperandrogenism and Establishment of a Multiplexed MSA for their quantitation by performing both dilution-based parallelism and standard addition assessment; Advantages of using MSA vs LBA for the clinical utility of adrenal steroidogenesis byproducts.
Dr. Barry Jones, Director Bioanalysis & Biomarker , Crinetics

Topic 5:

Focusing on the latest Nano-flow MS Advancements and differentiation from Standard-flow applications; Highlighting the benefits of using nano-flow and potential drawbacks; Nano-flow MS method development/validation experiences for low abundance Target Engagement (TE) Biomarkers, and challenges encountered, lessons learned highlighting what worked and what did not; Future implementation of nano-flow MS, current best practices of when and how to successfully outsource nano-flow MS projects.
Mr. Alex Behling, Assistant Director, Bioanalytical Lead, Clinical Biomarkers, Ionis

Topic 6:

Strategy to ensure Consistent Biomarker Measurement across animal studies conducted at various locations through drug development; Approaches for method development to design a successful Fit-for-Purpose Biomarker Assay Validation (FFP BAV); Comparative evaluation of multiple platforms to determine optimal methods for biomarker quantification; Consideration and feasibility of using Companion Diagnostic (CDx) assay from veterinary laboratories for biomarker measurement in preclinical studies; Innovative Application of Diels-Alder "click" reaction Derivatization reagent (2-nitrosopyridine) in MS for calcitriol in dog serum.
Dr. Linna Wang, Associate Director Bioanalysis & Biomarker , Crinetics

Topic 7:

Effective MS platform to quantitate Homologs or Isomers Biomarkers difficult to differentiate by LBA; Omics Technologies leveraged to understand disease biology and identify putative biomarkers predicting therapeutic response, monitoring disease progression or identifying safety concerns; Biomarker method characterization based on its intended purpose (fit-for-purpose); MS Targeted Quantitation of protein biomarker via signature peptide approach and small molecule biomarker of disease progression. 
Dr. Michael Hoover, Associate Director Integrated Bioanalysis , AstraZeneca

Topic 8:

How to address the bioanalytical challenges with Bispecific ADC and Dual Payload ADC; Understanding the differences with Traditional ADC and unique differences of new types of conjugation/linkers; How to approach cleavable vs non-cleavable linker? What are the critical considerations to support Next-generation ADC programs? Additional challenges presented by bispecific ADCs and dual payload ADCs are not merely incremental but are paradigm shifting; Complexity for assay transfer and cross-validations of multiple PK assays.
Dr. Ang Liu, Director Bioanalysis, Development PK, J&J Innovative Medicine

Topic 9:

Challenges in Dual-Payload ADC (Next Generation ADC) Regulated Bioanalysis; Development of an advanced/ comprehensive bioanalytical strategy from method development to validation to overcome increased complexity into bioanalytical workflows; Needs for quantification of multiple analytes using limited amount of plasma by combined using IA-MS (hybrid assay), Surrogate Analyte Strategies, and Multiplexed Assays  avoiding the time-consuming/uncertain development of anti-payload antibodies; Efficiency maximization & turnaround time reduction by simultaneous measurement of seven analytes across four assays; Understanding the new challenges with Emerging ADC formats (multi-payload ADCs) such as substantial structural heterogeneity  and requirement for simultaneous measurement of multiple analytes.
Dr. Guifen Xu, Senior Director Preclinical Development, Sutro Biopharma

Topic 10:

Sophisticated development of bioanalytical assay to quantify Free Payloads and Thiol-conjugated Metabolites for and ADC with cleavable linker; Importance to determine the Linker Type (cleavable vs non-cleavable) understand the metabolites profile whether payloads exist free or thiol-conjugated; Measurement of Metabolites as linear/cyclized forms of conjugated cysteine-linker-payload; Explores the Stability of the linear form and its conversion to the cyclized form during serum incubation, sample extraction, and analysis.
Dr. Hermes Licea-Perez, Director, Technology Leader Biomarker & Bioanalytical Platforms, GlaxoSmithKline

Topic 11:

Innovative applications of HRMS using Full Scan Assay to quantify Oligonucleotides Full Length and Main Metabolites; Comparison, advantages/disadvantages of PNA and LNA Probe; Handling the significant interference from LNA at low level; Gaining High Sensitivity for full length and metabolites in Tissue samples; Probe length and sequences optimization; Denature temperature and elution buffer optimization using Automation; Design of a Fit-for-purpose Validation to support circulation and tissue PK.
Dr. Guodong Zhang, Director, Group Head Bioanalytical & DMPK, Alnylam

Topic 12:

Enhanced Considerations/Approaches for Efficient Therapeutic Peptide Bioanalysis and ADME Characterization; Relying on Automated Sample Preparation and Optimized MSA core technology; Methodology strategies supporting Oral Peptide therapeutics by meeting Regulatory Standards; Applications to demonstrate permeation enhancer, stability, permeability profiling, and formulation optimization in multiple models; Continuous improvement focusing on enhanced throughput, broader ADME testing, exploration of specialized platforms, and tailored workflows for different peptide types.
Dr. Estelle Maes, Director Quantitative, Translational & ADME Sciences, AbbVie

Topic 13:

Increasing use of IA-MS and IA-HRMS (Hybrid Assays) for Peptides, Oligonucleotide, Complex Therapeutics; While LBA have long been the foundation of Peptides and Oligos, MSA are increasingly redefining what is possible in terms of selectivity, structural insight, and development efficiency while addressing many of the Limitations associated with traditional LBA; Label-Free use not requiring time-consuming/expensive synthesis of labeled ligands; Latest data showing MS simultaneous quantification & structural information, Multiplexing & High Throughput, and/or Tolerance to Interference; Highlighting the versatility and flexibility of MSA in supporting the bioanalysis of diverse therapeutic classes. 
Mr. Kevork Mekhssian, Senior Director Bioanalytical Sciences, Altasciences

2026 White Paper on Mass Spectrometry Assays

Consensus & Conclusions on Mass Spectrometry Assays for 2026 White Paper