Topic 1:

Advance of AI/ML and general access to chatGPT and their current use for Biomarker Assays/Data; How to enable biomarker data sets to be Digestible by AI and Automation Tools; Opening new doors for automation of traditionally manual processes: QC Trending, Bioanalytical/Study Reports; Review the status of these tools and potential implementation within the Bioanalytical realm; Current short comings and areas where more growth is expected to happen in the near to medium term future. 

Topic 2:

Present AI/ML impact on Data Processing, Automated Sample Preparation, and by Enabling Autonomous Instruments; Bioanalysis use of AI/ML to predict Chiral Column Chromatography outcomes, streamlining the traditionally trial-and-error process; Robotic Liquid Handling platforms fully programmed/integrated using ChatGPT API for enhanced automation; Steps enabling Agentic AI in Labs by enhancing interoperability among AI Models, integrating sensors for real-time monitoring, standardizing processes for better data management, and adopting unified AI approaches to support scalability and adaptability in lab environments.

Topic 3:

Latest AI/ML Applications for expediting tedious processes for Small Molecule Bioanalysis; Leveraging significant knowledge in small molecule for development of AI to Predict Sample Preparation & Chromatographic Conditions; Integration of existing methodology & compound physicochemical properties with ML; AI/ML Creation of starting sample extraction procedure and chromatographic conditions; Highlighting close Alignment of Final Assay Conditions with the predictions leading to efficiency gains in method development time. 

Topic 4:

How much is AI/ML really helping Discovery/Regulated Bioanalysis? Despite of all the hype around AI/ML, Real Scientific Impact comes only when AI/ML is fully integrated into workflows, with strong leadership and focus on real problems; Only 5% AI/ML project survive; AI/ML is not a standalone solution but an accelerator to enhance decision-making, automate routine tasks, and produce data-driven insights; Leveraging Graph Neural Networks, internal LLMs, wide datasets for preclinical optimization, Bioanalysis, ADME/Tox predictions, multi-omics integration, and high-throughput, automated reporting. 

Topic 5:

Understanding the MS for T Cell Engagers & Multispecific Abs to meet project needs; Limitations of typical LBA and formats for complex biotherapeutics; MS strategies for T Cell Engagers considering dose level, expected PK, and possible biotransformation; Involving Intact Mass Determination of T Cell Engagers and Multispecific Abs in vivo; Use of Quantitative Digestion MSA of T cell engagers and multispecific Abs to monitor biotransformation dynamics.

Topic 6:

Evaluation of strategies & assay designs for Next-generation ADC Regulated Studies; Focus on challenging issues in simultaneous development of Free Payload, Total Antibody, and Total ADC PK and ADA assay with limited sample volumes; Innovative 2-in-1 IA-MS (Hybrid Assay) workflow with Sequential Protease Digestion to enable simultaneous measurement of surrogate peptides and conjugated payload; Issue in Validation and Sample Analysis: TAb contamination, matrix effect, DAR Variability, interfering peaks, and regulatory scrutiny.

Topic 7:

Current Bioanalytical Challenges with Novel Genetic Medicine Modalities; Major hurdles in accurate measurement in biological samples due to complex architectures, structural heterogeneity, and instability; which complicate; Integrated Bioanalytical Strategy for Antibody-LNP and Antibody-siRNA Conjugates; Application of recent innovations in HRMS, Multiplexed Detection, improved Sample Preparation for quantitation and deep characterization; Crucial importance of in vitro stability assessment for revealing degradation pathways, confirming molecular integrity, and guiding conjugation and formulation development decisions.

Topic 8:

Novel Antibody-Oligonucleotide Conjugates & Novel Bioanalytical Strategies; Why is there the need to develop antibody-oligonucleotide conjugates? Different design, advantages/challenges versus traditional Oligos; MSA & LBA Strategies for different components of antibody-oligonucleotide conjugates, antibody-oligonucleotide conjugate, total and free antibody, and free oligonucleotide; Focus on Antibody-siRNA Conjugate using IA-MS (hybrid assay) for quantification and for Antibody-ASO Conjugate using LBA for quantification. 

Topic 9:

An AI/ML & Data-Driven Approach for Advancing MAPPs MSA for Immunogenicity Risk Assessment for the determination of the natural presentation of T cell epitopes; Challenges with current constraint of MAPPs workflow due to lack of throughput for high-volume screening; Novel strategies centered on major throughput improvement driven by streamlining technological integration: EvoSep and MultiMACs; Largest Immunopeptidomics datasets for training advanced AI/ML Models; Broadening MAPPs applications to Complex Modalities to enhance predictability. 

Topic 10:

Achieving required Sensitivity & Specificity for detecting Low-abundance Alzheimer's Disease Biomarkers in Plasma/CSF; Variability from sample collection, handling to storage conditions, impact on biomarker stability and reproducibility; Influence of Assay platforms, reagents, calibration standards, data readouts, limiting cross-study or clinical comparability; Matrix Effects, Interferences from Endogenous substances on  assay detection and quantitation; Ongoing issues in establishing robust biomarker assays and proving that biomarkers are translatable to meaningful patient. 

Topic 11:

Evolution of Multiple Methods for quantifying human Total & Subclasses Immunoglobulin G (IgG) Levels in clinical trials; Comparison of IgG assays relying on different methods and reference material;IA-MS (Hybrid Assay) as new technology of choice for precise, sensitive, and economical quantification of IgG in human samples; Use of interchangeable reference materials for human IgG measurement using IA-MS; Opportunities and issues with use of nephelometry, turbidimetry, and MS methodologies for measurement of human IgG.

Topic 12:

Method Development/Validation for IA-MS (Hybrid Assay) for quantification of a Recombinant Fusion Protein; Focus on Assay Robustness Assessment, Analytical Run QC Performance, Incurred Sample Reanalysis (ISR) across several large clinical trials; Criteria for selection of Stable Isotope Labelled IS;  Discussion of SIL-IS Variability and the impact on surrogate analyte quantification; Evaluation of Range of Acceptance Criteria for SIL-IS performance.

Topic 13:

Evolution of IA-MSA (Hybrid Assay) from exploratory tools to robust platforms for Regulated Bioanalysis to improve timelines with Technology Advancements; Operational challenges and best practices in adapting IA-MSA for Regulatory Compliance: Full Validation, SOPs, documentation, audit readiness; IA-MSA used in non-clinical drug development: Why MS was chosen over LBA and key lessons learned; Navigating evolving Regulatory Expectations for IA-MSA and current lack of Guidance; Importance of early alignment between Discovery and Regulatory teams.

Topic 14:

Updated considerations after more than a decade of Industry Experience on Application of IA-MS (Hybrid Assay) for the quantification of mAb & ADC in Clinical Study; Pros/Cons of using IA-MS quantification of signature peptide for supporting a clinical study; Unresolved challenges with developing and running IA-MSA in a clinical program: selection of capture antibody, internal standard, curve fitting model, assay selectivity; Does it add value to monitor 2 different signature peptides in Regulated Bioanalysis? 

2026 White Paper on Mass Spectrometry, Chromatography, and Sample Preparation

Consensus & Conclusions on Mass Spectrometry, Chromatography, and Sample Preparation for 2026 White Paper