Topic 1:

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.

Topic 2:

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.

Topic 3:

How has MS been used in support of nonclinical biodistribution study for Gene Therapy Development? What are the challenges with MS Quantitation of Transgene expressed proteins in vivo for GT? How to use MS to differentiate transgene expressed proteins from endogenous proteins? Comparison between MSA and LBA for detection of intracellular proteins; How to address Discrepancies between expressed protein levels from MSA or LBA and gene expression RNA levels from RT-qPCR? How important and how often do you establish correlation in transgene protein expression level between tissue and plasma? 

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.

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.

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.

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. 

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.

Topic 9:

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.

Topic 10:

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. 

Topic 11:

Latest developments in overcoming ADA Interferences in PK LBA by using ADA Tolerant PK IA-MSA (Hybrid Assay); For LBA, ADA should be viewed as matrix component with strong potential to interfere with PK assay; Impossibility to generate a true reference material to assess ADA interference in the PK assay since Positive Controls (PC) from immunized animals can not mimic ADA from patients; Evaluation of LBA vs IA-MSA Clinical Data Comparison showing the ADA tolerability of MSA and divergence in results.

Topic 12:

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.

Topic 13:

MS Power of Simplicity in Strategic Discovery Bioanalysis balancing quality, speed, cost; Using MSA vs LBA when LBA Kits Fail demonstrating effectiveness of MS platform for Protein Biomarker; Optimized Protein Precipitation for siRNA and Oligonucleotide Bioanalysis as streamlined approach to enable high throughput quantification in plasma through refined protein precipitation techniques, which was not effective previously; Enhancing Tissue Assay Sensitivity with Strategic Acid Dissociation post-immunoprecipitation to improve sensitivity in tissue analysis.

Topic 14:

The Power of Simplicity: How are MSA advantages vs LBA shaping the Future of Bioanalysis? Increasing use of IA-MS and IA-HRMS (Hybrid Assays) for Novel Modalities, Next-generations Therapeutics, Complex Biomarkers; Enhanced applications showing MSA superior selectivity/specificity, faster/simpler Method Development, and 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.

2026 White Paper on Mass Spectrometry Assays

Consensus & Conclusions on Mass Spectrometry Assays for 2026 White Paper